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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) Peripheral Arterial Disease (3) Polymyalgia Rheumatica (3) Precursor Cell Lymphoblastic Leukemia-Lymphoma (3) Pregnancy Complications, Infectious (3) Premature Birth (3) Psychological Trauma (3) Pulmonary Edema (3) Rheumatic Fever (3) ST Elevation Myocardial Infarction (3) Schizophrenia (3) Seizures (3) Sleep Apnea, Obstructive (3) Sleep Wake Disorders (3) Systemic Inflammatory Response Syndrome (3) Taste Disorders (3) Tobacco Use Disorder (3) Triple Negative Breast Neoplasms (3) Ventricular Dysfunction (3) Ventricular Dysfunction, Left (3) Acute Disease (2) Ageusia (2) Agoraphobia (2) Alopecia (2) Alpha 1-Antitrypsin Deficiency (2) Amyotrophic Lateral Sclerosis (2) Anemia, Sickle Cell (2) Angina Pectoris (2) Angioedema (2) Angioedemas, Hereditary (2) Anxiety, Separation (2) Arteritis (2) Asymptomatic Infections (2) Atherosclerosis (2) Atrial Fibrillation (2) Bacterial Infections (2) Behcet Syndrome (2) Bipolar Disorder (2) Caliciviridae Infections (2) Clinical Deterioration (2) 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)

D007239: Infecti

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (723)


Name (Synonyms) Correlation
drug1520 Hydroxychloroquine Wiki 0.24
drug2505 Placebo Wiki 0.21
drug1296 Favipiravir Wiki 0.19
Name (Synonyms) Correlation
drug2557 Placebo oral tablet Wiki 0.11
drug2637 Presatovir Wiki 0.10
drug1521 Hydroxychloroquine (HCQ) Wiki 0.09
drug229 Anakinra Wiki 0.09
drug1684 Interferon Beta-1B Wiki 0.09
drug1383 Gam-COVID-Vac Wiki 0.09
drug1196 Enoxaparin Wiki 0.08
drug832 Colchicine Tablets Wiki 0.07
drug304 Ascorbic Acid Wiki 0.07
drug1874 Losartan Wiki 0.07
drug2002 Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.07
drug1294 Famotidine 20 MG Wiki 0.07
drug3749 Zinc Wiki 0.07
drug1524 Hydroxychloroquine + azithromycin Wiki 0.07
drug1304 Favipiravir Placebo Wiki 0.07
drug2980 SARS-Cov2 testing Wiki 0.07
drug2414 PUL-042 Inhalation Solution Wiki 0.07
drug1331 Flow cytometric analysis Wiki 0.07
drug2443 Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances Wiki 0.07
drug1253 Exposure Wiki 0.07
drug2554 Placebo on a 0- and 28-day schedule Wiki 0.07
drug1886 Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.07
drug1433 HB-adMSCs Wiki 0.07
drug422 BNT162b2 Wiki 0.07
drug3475 Thymalfasin Wiki 0.07
drug1148 Ebselen Wiki 0.07
drug3676 Vitamin D Wiki 0.07
drug1480 High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.07
drug895 Convalescent Plasma Wiki 0.07
drug1853 Lopinavir / Ritonavir Wiki 0.07
drug2161 Nasopharyngeal swab Wiki 0.07
drug2215 No intervention Wiki 0.07
drug1745 Ivermectin Wiki 0.06
drug2741 Questionnaire Wiki 0.06
drug798 Clazakizumab Wiki 0.06
drug498 Biospecimen Collection Wiki 0.06
drug4099 self-administered questionnaire Wiki 0.06
drug1538 Hydroxychloroquine Sulfate Wiki 0.06
drug2221 No intervention, observational study Wiki 0.06
drug2892 Ribavirin Wiki 0.06
drug1126 EIDD-2801 Wiki 0.06
drug3297 Supportive Care Wiki 0.06
drug421 BNT162b1 Wiki 0.06
drug2146 Nafamostat Mesilate Wiki 0.06
drug3621 VPM1002 Wiki 0.06
drug4123 standard therapy Wiki 0.06
drug3674 Vitamin C Wiki 0.06
drug2046 Midazolam injection Wiki 0.05
drug3331 T3 solution for injection Wiki 0.05
drug1781 Ketamine Injectable Product Wiki 0.05
drug1523 Hydroxychloroquine + Azithromycin Wiki 0.05
drug1669 Inhaled beclomethasone Wiki 0.05
drug983 Daclatasvir 60 mg Wiki 0.05
drug3049 Sarilumab Prefilled Syringe Wiki 0.05
drug3428 Testing procedure for Binding antibodies Wiki 0.05
drug2705 Pulmonary function test Wiki 0.05
drug1338 Fluzone High Dose Wiki 0.05
drug1297 Favipiravir (3200 mg + 1200 mg) Wiki 0.05
drug3727 Women receiving extra remembering by healthcare Wiki 0.05
drug1260 Expression of receptors and activating proteases Wiki 0.05
drug1812 Lambda 180 mcg S.C Wiki 0.05
drug3179 Specimen Collection Wiki 0.05
drug336 Atovaquone/Azithromycin Wiki 0.05
drug3426 Testing for SARS-CoV-2 Wiki 0.05
drug1765 JNJ-53718678 125 mg Wiki 0.05
drug2566 Placebo- 1.00 mg/kg Wiki 0.05
drug3471 Thrombin Generation Assay (TGA) Wiki 0.05
drug4003 non-interventional Wiki 0.05
drug4103 serology test Wiki 0.05
drug1785 Knowledge, Attitude, Practice, Awareness, Preference Wiki 0.05
drug799 Clazakizumab 12.5 mg Wiki 0.05
drug328 Atazanavir Wiki 0.05
drug3262 Standard-titer Convalescent COVID-19 plasma (CCP2) Wiki 0.05
drug4101 serological test Wiki 0.05
drug3805 biological samples collection Wiki 0.05
drug1508 Human Coach first, then Virtual Assistant Wiki 0.05
drug3842 congenital malformation Wiki 0.05
drug2471 Personal Protective Testing Booth Wiki 0.05
drug3757 Zithromax Oral Product Wiki 0.05
drug1832 Liberase Enzyme (Roche) Wiki 0.05
drug2921 Rosuvastatin (Inhibitor arm) Wiki 0.05
drug1903 Lower-dose prophylactic anticoagulation Wiki 0.05
drug3276 Stool collection or fecal swab Wiki 0.05
drug2526 Placebo Group Wiki 0.05
drug3862 diagnostic tests for COVID-19 infection Wiki 0.05
drug578 C3+ Holter Monitor Wiki 0.05
drug3991 nebulization Wiki 0.05
drug3909 hydroxychloroquine placebo Wiki 0.05
drug3259 Standard treatment for COVID-19 Wiki 0.05
drug1807 Laboratory tests Wiki 0.05
drug2881 Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening Wiki 0.05
drug827 Cognitive testing Wiki 0.05
drug3164 Sofosbuvir + Daclatasvir 120 mg Wiki 0.05
drug2638 Presatovir placebo Wiki 0.05
drug3504 Tradipitant Wiki 0.05
drug3789 artus Influenza A/B RT-PCR Test Wiki 0.05
drug2574 Plant Polyphenol Wiki 0.05
drug4025 oxyhydrogen Wiki 0.05
drug1908 Lung Function Test Wiki 0.05
drug2922 Rosuvastatin (Placebo arm) Wiki 0.05
drug1415 Group B: Placebo oropharyngeal spray + Active principle immunostimulant Wiki 0.05
drug1416 Group C:Active principle oropharyngeal spray + Placebo taken PO Wiki 0.05
drug1668 Inhaled Supplemental Oxygen Wiki 0.05
drug2845 Rehabilitation Wiki 0.05
drug1463 Hemanext One Wiki 0.05
drug1444 HOME-CoV rule implementation Wiki 0.05
drug4158 unfractionated heparin Wiki 0.05
drug3036 Saliva specimen Wiki 0.05
drug1262 Extra blood sample Wiki 0.05
drug1185 Emtricitabine/tenofovir disoproxil Wiki 0.05
drug1747 Ivermectin + Doxycycline Wiki 0.05
drug3536 Treatment with Dexmedetomidine Wiki 0.05
drug2041 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.05
drug1896 Low nitrite/NDMA meals Wiki 0.05
drug1270 F-652 Wiki 0.05
drug407 BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki 0.05
drug3243 Standard screening strategy Wiki 0.05
drug3109 Serum testing Wiki 0.05
drug1825 Leukapheresis Wiki 0.05
drug1305 Favipiravir and Hydroxychloroquine Wiki 0.05
drug2001 Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki 0.05
drug1220 Estradiol patch Wiki 0.05
drug797 Clarithromycin Wiki 0.05
drug1569 Hydroxychloroquine/Chloroquine Wiki 0.05
drug1221 Estrogen Therapy Wiki 0.05
drug3840 complication Wiki 0.05
drug546 Breath Test & Cheek Swab Wiki 0.05
drug1051 Dietary Intervention Wiki 0.05
drug4030 peripheral blood draw Wiki 0.05
drug310 Assembled mask Wiki 0.05
drug4112 spirometry Wiki 0.05
drug1247 Experimental Group Wiki 0.05
drug2748 Questionnaire with precaution information Wiki 0.05
drug3514 Tranexamic acid tablets Wiki 0.05
drug1865 Lopinavir/ Ritonavir Wiki 0.05
drug2645 Previfenon® Wiki 0.05
drug97 ARBOX Wiki 0.05
drug3032 Saliva Wiki 0.05
drug4159 urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic Wiki 0.05
drug3681 Vitamins Wiki 0.05
drug3981 muscle ultrasound Wiki 0.05
drug3533 Treatment as usual vitamin D Wiki 0.05
drug1551 Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki 0.05
drug4042 plasma from convalescent patients with COVID-19 Wiki 0.05
drug4002 non-contact magnetically-controlled capsule endoscopy Wiki 0.05
drug1489 High-intensity training Wiki 0.05
drug3275 Stool collection Wiki 0.05
drug2976 SARS-CoV2 Autoantibody detection Wiki 0.05
drug3837 collection of swabs Wiki 0.05
drug1587 ID NOW vs. Accula Wiki 0.05
drug1423 Group1 Wiki 0.05
drug898 Convalescent Plasma 1 Unit Wiki 0.05
drug4075 rapid serological test Wiki 0.05
drug2824 Recombinant Interferon Alfa-2b Wiki 0.05
drug3750 Zinc (Placebo) Wiki 0.05
drug1272 FAVICOVIR 200 mg Film Tablet Wiki 0.05
drug1103 Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) Wiki 0.05
drug1174 Elisa-test for IgM and IgG to SARS-CoV-2 Wiki 0.05
drug1215 Escin Wiki 0.05
drug1852 Lopinavir Wiki 0.05
drug1578 Hyperimmune plasma Wiki 0.05
drug1165 Electric pad for human external pain therapy Wiki 0.05
drug2331 Online instruction Wiki 0.05
drug1216 Esflurbiprofen hydrogel patch 165 mg (EFHP) Wiki 0.05
drug522 Blood sample for serology to measure past infection with SARS-CoV-2 Wiki 0.05
drug4082 remdesivir Wiki 0.05
drug3946 lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Wiki 0.05
drug1314 Fidaxomicin Wiki 0.05
drug2901 Rintatolimod Wiki 0.05
drug3381 Technology-assisted Index Wiki 0.05
drug1386 Ganovo+ritonavir+/-Interferon nebulization Wiki 0.05
drug4063 qRT-PCR and serology Wiki 0.05
drug1337 Fluvoxamine Wiki 0.05
drug2564 Placebo- 0.10 mg/kg Wiki 0.05
drug931 CovX Wiki 0.05
drug1300 Favipiravir (3600 mg + 1600 mg) Wiki 0.05
drug701 CYNK-001 Wiki 0.05
drug3950 lung ultrasound (LUS) Wiki 0.05
drug1437 HCQ+AZT Wiki 0.05
drug964 DAS181 COVID-19 Wiki 0.05
drug3631 Vancomycin with Taper/Pulse Wiki 0.05
drug3305 Surgical facial mask Wiki 0.05
drug4081 regular care Wiki 0.05
drug1095 Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment Wiki 0.05
drug4105 serum chemistry analysis Wiki 0.05
drug2808 Rapid detection test Wiki 0.05
drug3906 hydroxychloroquine Wiki 0.05
drug3987 nasal pharyngeal (NP) swab samples Wiki 0.05
drug299 ArtemiC Wiki 0.05
drug2571 Placebo: Hydroxychloroquine Wiki 0.05
drug1059 Diffusing capacity of carbon monoxide Wiki 0.05
drug4173 washed microbiota transplantation Wiki 0.05
drug3723 Whole exome sequencing Wiki 0.05
drug3172 Sofusbuvir + Daclastavir 60 mg Wiki 0.05
drug1333 Flucelvax Wiki 0.05
drug1679 Inspiratory training device Wiki 0.05
drug420 BNT162a1 Wiki 0.05
drug643 COVID-19 Pneumonia Wiki 0.05
drug3836 collection of biological samples Wiki 0.05
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Correlated MeSH Terms (136)


Name (Synonyms) Correlation
D003141 Communicable Diseases NIH 0.66
D045169 Severe Acute Respiratory Syndrome NIH 0.31
D018352 Coronavirus Infections NIH 0.27
Name (Synonyms) Correlation
D014777 Virus Diseases NIH 0.19
D012141 Respiratory Tract Infections NIH 0.18
D003333 Coronaviridae Infections NIH 0.11
D018357 Respiratory Syncytial Virus Infections NIH 0.11
D012327 RNA Virus Infections NIH 0.10
D003428 Cross Infection NIH 0.09
D030341 Nidovirales Infections NIH 0.07
D021821 Communicable Diseases, Emerging NIH 0.07
D058345 Asymptomatic Infections NIH 0.07
D009410 Nerve Degeneration NIH 0.07
D004066 Digestive System Diseases NIH 0.06
D004408 Dysgeusia NIH 0.06
D018184 Paramyxoviridae Infections NIH 0.06
D005767 Gastrointestinal Diseases NIH 0.06
D014808 Vitamin D Deficiency NIH 0.05
D007251 Influenza, Human NIH 0.05
D000071074 Neonatal Sepsis NIH 0.05
D000070627 Chronic Traumatic Encephalopathy NIH 0.05
D001997 Bronchopulmonary Dysplasia NIH 0.05
D055732 Pulmonary Aspergillosis NIH 0.05
D008595 Menorrhagia NIH 0.05
D006929 Hyperaldosteronism NIH 0.05
D001228 Aspergillosis NIH 0.05
D001229 Aspergillosis, Allergic Bronchopulmonary NIH 0.05
D054559 Hyperphosphatemia NIH 0.05
D028361 Mitochondrial Diseases NIH 0.05
D004314 Down Syndrome NIH 0.05
D015163 Superinfection NIH 0.05
D011645 Puerperal Infection NIH 0.05
D011649 Pulmonary Alveolar Proteinosis NIH 0.05
D063806 Myalgia NIH 0.05
D066087 Perinatal Death NIH 0.05
D005879 Tourette Syndrome NIH 0.05
D003384 Coxsackievirus Infections NIH 0.05
D004660 Encephalitis NIH 0.05
D000309 Adrenal Insufficiency NIH 0.05
D007008 Hypokalemia NIH 0.05
D006560 Herpes Labialis NIH 0.05
D055501 Macrophage Activation Syndrome NIH 0.05
D063130 Maternal Death NIH 0.05
D011014 Pneumonia NIH 0.05
D006331 Heart Diseases NIH 0.05
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.04
D012140 Respiratory Tract Diseases NIH 0.04
D008173 Lung Diseases, Obstructive NIH 0.04
D011024 Pneumonia, Viral NIH 0.04
D007676 Kidney Failure, Chronic NIH 0.04
D003327 Coronary Disease NIH 0.04
D009369 Neoplasms, NIH 0.04
D000690 Amyotrophic Lateral Sclerosis NIH 0.04
D000075902 Clinical Deterioration NIH 0.04
D014552 Urinary Tract Infections NIH 0.04
D009181 Mycoses NIH 0.04
D009101 Multiple Myeloma NIH 0.04
D000755 Anemia, Sickle Cell NIH 0.04
D000013 Congenital Abnormalities NIH 0.04
D011565 Psoriasis NIH 0.04
D009220 Myositis NIH 0.04
D016472 Motor Neuron Disease NIH 0.04
D001424 Bacterial Infections NIH 0.04
D000073296 Noncommunicable Diseases NIH 0.04
D054990 Idiopathic Pulmonary Fibrosis NIH 0.04
D017250 Caliciviridae Infections NIH 0.04
D014115 Toxemia NIH 0.04
D001714 Bipolar Disorder NIH 0.04
D054219 Neoplasms, Plasma Cell NIH 0.04
D013577 Syndrome NIH 0.03
D004417 Dyspnea NIH 0.03
D016638 Critical Illness NIH 0.03
D011251 Pregnancy Complications, Infectious NIH 0.03
D009080 Mucocutaneous Lymph Node Syndrome NIH 0.03
D012640 Seizures NIH 0.03
D058070 Asymptomatic Diseases NIH 0.03
D003139 Common Cold NIH 0.03
D000163 Acquired Immunodeficiency Syndrome NIH 0.03
D000257 Adenoviridae Infections NIH 0.03
D015535 Arthritis, Psoriatic NIH 0.03
D020141 Hemostatic Disorders NIH 0.03
D001778 Blood Coagulation Disorders NIH 0.03
D012127 Respiratory Distress Syndrome, Newborn NIH 0.03
D055371 Acute Lung Injury NIH 0.03
D012120 Respiration Disorders NIH 0.03
D005356 Fibromyalgia NIH 0.02
D003643 Death, NIH 0.02
D001927 Brain Diseases NIH 0.02
D004211 Disseminated Intravascular Coagulation NIH 0.02
D009164 Mycobacterium Infections NIH 0.02
D001289 Attention Deficit Disorder with Hyperactivity NIH 0.02
D009362 Neoplasm Metastasis NIH 0.02
D006470 Hemorrhage NIH 0.02
D000857 Olfaction Disorders NIH 0.02
D018450 Disease Progression NIH 0.02
D012128 Respiratory Distress Syndrome, Adult NIH 0.02
D004198 Disease Susceptibility NIH 0.02
D003550 Cystic Fibrosis NIH 0.02
D008171 Lung Diseases, NIH 0.02
D007153 Immunologic Deficiency Syndromes NIH 0.02
D007154 Immune System Diseases NIH 0.02
D018805 Sepsis NIH 0.02
D000066553 Problem Behavior NIH 0.02
D019337 Hematologic Neoplasms NIH 0.02
D050177 Overweight NIH 0.02
D011665 Pulmonary Valve Insufficiency NIH 0.02
D010300 Parkinsonian NIH 0.02
D015212 Inflammatory Bowel Diseases NIH 0.02
D003324 Coronary Artery Disease NIH 0.02
D002318 Cardiovascular Diseases NIH 0.02
D004630 Emergencies NIH 0.02
D000070642 Brain Injuries, Traumatic NIH 0.02
D011248 Pregnancy Complications NIH 0.02
D009205 Myocarditis NIH 0.02
D004194 Disease NIH 0.02
D008175 Lung Neoplasms NIH 0.02
D003424 Crohn Disease NIH 0.02
D001930 Brain Injuries, NIH 0.02
D059350 Chronic Pain NIH 0.02
D001172 Arthritis, Rheumatoid NIH 0.02
D007674 Kidney Diseases NIH 0.02
D053120 Respiratory Aspiration NIH 0.01
D017563 Lung Diseases, Interstitial NIH 0.01
D011658 Pulmonary Fibrosis NIH 0.01
D005355 Fibrosis NIH 0.01
D012598 Scoliosi NIH 0.01
D009103 Multiple Sclerosis NIH 0.01
D015658 HIV Infections NIH 0.01
D001168 Arthritis NIH 0.01
D020521 Stroke NIH 0.01
D006973 Hypertension NIH 0.01
D000860 Hypoxia NIH 0.01
D055370 Lung Injury NIH 0.01
D040921 Stress Disorders, Traumatic NIH 0.01
D014947 Wounds and Injuries NIH 0.01
D013313 Stress Disorders, Post-Traumatic NIH 0.01

Correlated HPO Terms (52)


Name (Synonyms) Correlation
HP:0011947 Respiratory tract infection HPO 0.16
HP:0002180 Neurodegeneration HPO 0.07
HP:0002905 Hyperphosphatemia HPO 0.05
Name (Synonyms) Correlation
HP:0003811 Neonatal death HPO 0.05
HP:0006802 Abnormal anterior horn cell morphology HPO 0.05
HP:0002900 Hypokalemia HPO 0.05
HP:0000846 Adrenal insufficiency HPO 0.05
HP:0000132 Menorrhagia HPO 0.05
HP:0003326 Myalgia HPO 0.05
HP:0002383 Encephalitis HPO 0.05
HP:0100614 Myositis HPO 0.05
HP:0007354 Amyotrophic lateral sclerosis HPO 0.05
HP:0006517 Intraalveolar phospholipid accumulation HPO 0.05
HP:0040187 Neonatal sepsis HPO 0.05
HP:0000859 Hyperaldosteronism HPO 0.05
HP:0006510 Chronic pulmonary obstruction HPO 0.05
HP:0006536 Pulmonary obstruction HPO 0.05
HP:0002090 Pneumonia HPO 0.05
HP:0011024 Abnormality of the gastrointestinal tract HPO 0.04
HP:0002664 Neoplasm HPO 0.04
HP:0100512 Low levels of vitamin D HPO 0.04
HP:0003765 Psoriasiform dermatitis HPO 0.04
HP:0100754 Mania HPO 0.04
HP:0002098 Respiratory distress HPO 0.04
HP:0006775 Multiple myeloma HPO 0.04
HP:0001250 Seizure HPO 0.03
HP:0000458 Anosmia HPO 0.03
HP:0001928 Abnormality of coagulation HPO 0.03
HP:0005521 Disseminated intravascular coagulation HPO 0.02
HP:0007018 Attention deficit hyperactivity disorder HPO 0.02
HP:0001298 Encephalopathy HPO 0.02
HP:0002088 Abnormal lung morphology HPO 0.02
HP:0002721 Immunodeficiency HPO 0.02
HP:0100806 Sepsis HPO 0.02
HP:0001677 Coronary artery atherosclerosis HPO 0.02
HP:0002037 Inflammation of the large intestine HPO 0.02
HP:0000708 Behavioral abnormality HPO 0.02
HP:0010444 Pulmonary insufficiency HPO 0.02
HP:0100526 Neoplasm of the lung HPO 0.02
HP:0001626 Abnormality of the cardiovascular system HPO 0.02
HP:0001370 Rheumatoid arthritis HPO 0.02
HP:0012819 Myocarditis HPO 0.02
HP:0002206 Pulmonary fibrosis HPO 0.02
HP:0012532 Chronic pain HPO 0.02
HP:0000077 Abnormality of the kidney HPO 0.02
HP:0100280 Crohn's disease HPO 0.02
HP:0006515 Interstitial pneumonitis HPO 0.01
HP:0001369 Arthritis HPO 0.01
HP:0001909 Leukemia HPO 0.01
HP:0001297 Stroke HPO 0.01
HP:0000822 Hypertension HPO 0.01
HP:0012418 Hypoxemia HPO 0.01

Clinical Trials

Navigate: Correlations   HPO

There are 404 clinical trials


1 Olfactory and Gustatory Disturbances as a Clinical Presentation of Coronavirus Disease 2019 (COVID-19) Infection in Malaysia - A Nationwide Multicentre Case-Control Study

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

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

Primary Outcomes

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

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

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

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

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

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

Secondary Outcomes

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

Measure: Clinical manifestations of study participants

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

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

Measure: Other pre-existing health conditions

Time: Baseline

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

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

Time: Baseline

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

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

Time: Baseline

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

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

Time: Baseline

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

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

Time: Baseline
2 Effectiveness of a Novel Respirator With Chitosan Nanoparticles to Reduce the Incidence of SARS-CoV-2 Infection in Healthcare Professionals: Randomized Controlled Trial (VESTA Trial)

The use of nanomaterials in facial respirators could decrease the permeability of particles and promote a biocidal effect compared to conventional respirators (N95) and, therefore, enhance the filtering power, aiming to mitigate harmful effects of bacteria and viruses. Chitosan is a natural cationic polymer derived from chitin, with important characteristics such as being biodegradable, biocompatible, non-toxic, and presenting antimicrobial activity. This polymer shows virucidal activity in several types of viruses, including other coronavirus serotypes, given the attractive factor of its cationic charge for negative charges. The effectiveness of a novel individual protection semi facial respirator (called VESTA) will be investigated, compared to a conventional N95 respirator. The respirators will be tested in healthcare professionals working in hospital environments and the effectiveness will be attributed to the lower incidence rate of infection by the SARS-CoV-2. The effectiveness of respirators will also be attributed to the ability to filter these viruses after use by healthcare professionals exposed to potentially contaminated environments. The study will be carried out in two stages: i) Pilot Randomized Clinical Trial with reduced sample and ii) Controlled Randomized Clinical Trial (RCT). This RCT will be conducted with healthcare professionals who have contact with environments/patients infected by SARS-CoV-2 in hospital sectors with greater vulnerability to infection (urgency, emergency and intensive care units). The pilot trial will be conducted initially with a group of fifty participants (n = 25 in each group) for initial investigation of the potential for efficacy with the use of the respirators (VESTA and conventional N95) in two sectors (emergency and ICU) of a Hospital. The RCT will consist of two parallel groups: (1) Experimental Group (GExp) that will use the novel respirator (VESTA) and (2) Control Group (CG) that will use the standard respirator (N95). Participants will be recruited from participating centers and will be accompanied by eight consecutive shifts (each shift lasting 6 to 12 hours, followed by approximately 36 hours of rest). Participants will be accompanied during 21 days, and will be assessed at baseline (T0), at the end of the 10th day (T1) and at the end of the 21st day (T2). The respirators will be assessed after the end of the 1st hospital shift for morphological characterization (virus quantity and inactivation).

NCT04490200
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Worker-Patient Transmission, Healthcare
Interventions
  1. Device: VESTA respirator
  2. Device: Conventional N95 respirator
MeSH:Infecti Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of professionals infected, confirmed by reverse-transcription polymerase chain reaction (RT-PCR)

Measure: Incidence of laboratory-confirmed COVID-19

Time: 21 days

Description: Electron microscopy technique will be used, to identify if there is viruses present (through its direct visualization and morphological recognition) and they are inactive. This assessment will occur after the end of the first hospital shift.

Measure: Ability of the filtering element to inactivate the SARS-Cov-2

Time: 24 hours

Secondary Outcomes

Description: 11-point Likert scale ranging from -5 ("extremely unsatisfied"), 0 ("neutral"), to 5 ("completely satisfied")

Measure: Usability and comfort of the respirator

Time: Assessments at T1 (day 10) and T2 (day 21)

Description: quantified based on the activities and procedures performed by the participants. Adherence will be measured by a self-report recorded in a diary, estimating the percentage of use referring to the total workhours.

Measure: Adherence to the use of the Respirator

Time: Assessments at the end of the first and second weeks of intervention

Description: Measured by the Job Stress Scale Questionnaire (17 questions composed by 4-point Likert scales)

Measure: Stress

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by the Maslach Burnout Inventory

Measure: Burnout

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by the Six-dimensional short form quality of life questionnaire (SF-6D), with scores ranging from 0 to 1 (in which 0 is equal to the worst health state and 1 is equal to the best health state).

Measure: Self-reported quality of life

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by the Nordic Musculoskeletal Questionnaire, which assess the self-report of musculoskeletal symptoms in the last 12 months and last 7 days. Identification of areas of the body causing musculoskeletal problems in a body map (possible sites being neck, shoulders, upper back, elbows, low back, wrist/hands, hips/thighs, knees and ankles/feet).

Measure: Musculoskeletal discomfort

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by a VAS-scale ranging from 0 to 10, being 0 the worst work ability and 10 the best work ability, considering the present time.

Measure: Work ability

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)
3 Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases

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

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

Primary Outcomes

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

Measure: Symptoms and signs

Time: 1 year
4 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.
5 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
6 SEA022 Oseltamivir Treatment in Children Under One Year of Age With Moderate or Severe Influenza Lower Respiratory Tract Infection - a Clinical and Pharmacokinetic Study.

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

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

Primary Outcomes

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

Measure: Viral clearance

Time: 5-10 days

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

Measure: Pharmacokinetics of Oseltamivir

Time: Day 0 and Day 9

Secondary Outcomes

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

Measure: Viral end points

Time: 5-10 days

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

Measure: Clinical Efficacy Endpoints

Time: 5-10 days

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

Measure: Safety Endpoints

Time: 5-10 days
7 A Prospective Study to Detect Novel Pathogens and Characterize Emerging Infections

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

NCT01979705
Conditions
  1. Prospective Studies
MeSH:Infection

Primary Outcomes

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

Measure: Detecting of Novel Pathogens

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

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

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

Primary Outcomes

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

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

Time: Baseline to Day 5

Secondary Outcomes

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

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

Time: Baseline to Day 5

Measure: Number of Hospitalization-Free Days Following Presatovir Administration

Time: Up to Day 28

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

Measure: Rate of Unplanned Medical Encounters

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

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

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

Primary Outcomes

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

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

Time: Baseline; Day 9

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

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

Time: Up to Day 28

Secondary Outcomes

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

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

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

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

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

Primary Outcomes

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

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

Time: Baseline to Day 9

Secondary Outcomes

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

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28
11 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
12 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
13 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
14 Assessment of Pharyngeal Carriage of Microorganisms Responsible for Transmissible Acute Respiratory Infections in HAJJ Pilgrims.

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

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

Primary Outcomes

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

Time: up to 3 years
15 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.
16 An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections

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

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

Primary Outcomes

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

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

Time: 26 Days

Secondary Outcomes

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

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

Time: Day 5,12,19 and 26

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

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

Time: Day 19 and 26

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

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

Time: Day 19 and 26

Other Outcomes

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

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

Time: Day 26

Description: Measured by death from all causes

Measure: Efficacy in reduction of mortality

Time: Day 26

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

Measure: Antiviral effect

Time: Day 26

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

Measure: Efficacy on clinical improvement

Time: Day 26

Description: Measured by change in the Modified Jackson Cold Score

Measure: Efficacy on the respiratory symptoms

Time: Day 26
17 Genome-wide CRISPR Screen for Host Factors Associated With Norovirus Infections in Stem Cell-derived Human Intestinal Enteroid Model

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

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

Primary Outcomes

Description: Viability of enteroids as determined by microscopy

Measure: Establishment of human intestinal stem cell-derived enteroids

Time: An average of three months
18 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
19 A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

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

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

Primary Outcomes

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

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

Time: by Day 28

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

Time: Day 14

Secondary Outcomes

Measure: All-cause mortality rate (main study)

Time: at Day 28

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

Time: by Day 21

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

Time: Days 10, 14, 21, 28

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

Time: by Day 28

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

Time: by Days 14, 21, 28 and 35

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

Time: through Day 35

Measure: Total number of inpatient days (main study)

Time: up to Day 35

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

Time: at Day 28

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

Time: at Day 35

Measure: All-cause mortality rate (main study)

Time: at Day 35

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

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

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

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

Measure: Time to RTRA

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

Measure: Time to Clinical stability

Time: Day 14, Day 21, Day 28

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

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

Measure: Time to Clinical deterioration

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

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

Time: Day 14, Day 21, Day 28

Measure: Time to Death (all causes)

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

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

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

Primary Outcomes

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

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

Time: within 6 weeks (42 days)

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

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

Time: 4 weeks (28 days) post-delivery

Secondary Outcomes

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

Measure: Incidence of chorioamnionitis

Time: prior to delivery

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

Measure: Incidence of endometritis

Time: within 42 days post-delivery

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

Measure: Incidence of other infections

Time: within 42 days post-delivery

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

Measure: Incidence of use of subsequent maternal antibiotic therapy

Time: after randomization to 42 days post-delivery

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

Measure: Maternal initial hospital length of stay

Time: within 42 days post-delivery

Description: Maternal readmissions within 42 days of delivery

Measure: Incidence of maternal readmissions

Time: within 42 days post-delivery

Description: Maternal admission to special care units

Measure: Incidence of maternal admission to special care units

Time: within 42 days post-delivery

Description: Maternal unscheduled visit for care

Measure: Incidence of maternal unscheduled visit for care

Time: within 42 days post-delivery

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

Measure: Incidence of maternal GI symptoms

Time: within 42 days post-delivery

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

Measure: Incidence of maternal death due to sepsis

Time: within 42 days post-delivery

Description: Incidence of other neonatal infections.

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

Time: within 42 days post-delivery

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

Measure: Neonatal initial hospital length of stay

Time: within 28 days of delivery

Description: Neonatal readmissions within 42 days of delivery

Measure: Incidence of neonatal readmissions

Time: within 42 days of delivery

Description: Neonatal admission to special care units

Measure: Incidence of neonatal admission to special care units

Time: within 28 days of delivery

Description: Neonatal unscheduled visit for care

Measure: Incidence of neonatal unscheduled visit for care

Time: within 42 days post-delivery

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

Measure: Incidence of neonatal death due to sepsis

Time: within 28 days of delivery

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

Measure: Incidence of pyloric stenosis within 42 days of delivery

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

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

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

Primary Outcomes

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

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

Time: 1.5 years
22 Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

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

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

Primary Outcomes

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

Measure: Prevention of COVID-19

Time: Five years

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

Measure: Treatment of COVID-19

Time: Five years

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

Measure: Treatment of Symptoms

Time: Five years

Secondary Outcomes

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

Measure: Cannabis Impact on Quality of Life

Time: Five years

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

Measure: Cannabis Route and Dosing

Time: Five years

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

Measure: Monitoring Adverse Events

Time: Five years
23 PREDICT 2: Personalized Responses to Dietary Composition Trial 2

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

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

Primary Outcomes

Description: Species count in fecal sample

Measure: Gut microbiome species richness

Time: 1 Day

Description: Measurement of blood lipids

Measure: Lipids

Time: 3 days

Description: Measurement of blood glucose

Measure: Glucose

Time: 11 days

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

Measure: Sleep

Time: 10 days

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

Measure: Physical activity

Time: 10 days

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

Measure: Hunger and appetite assessment

Time: 10 days

Secondary Outcomes

Description: C-peptide

Measure: Glucose metabolism

Time: 3 days

Description: Weighed food log

Measure: Dietary assessment

Time: 10 days

Description: Weight (kg)

Measure: Anthropometry

Time: 1 day

Description: Height (cm)

Measure: Anthropometry

Time: 1 day

Description: Hip and waist circumference (cm)

Measure: Anthropometry

Time: 1 day

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

Measure: Metabolomics by NMR analysis

Time: 1 day

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

Measure: Dietary assessment

Time: 1 month

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

Measure: Covid-19 symptom assessment

Time: 6 months
24 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
25 Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial

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

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

Primary Outcomes

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

Measure: Lower Murray lung injury score

Time: 7 days after randomization

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

Measure: Lower Murray lung injury score

Time: 14 days after randomization

Secondary Outcomes

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

Measure: The difference of PaO2/FiO2 between two groups

Time: 7 days after randomization

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

Measure: Lower Sequential Organ Failure Assessment (SOFA) score

Time: 7 days after randomization

Description: Percentage of patients requiring Mechanical ventilation support

Measure: Mechanical ventilation support

Time: 7 days after randomization

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

Measure: The difference of PaO2/FiO2 between two groups

Time: 14 days after randomization

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

Measure: Lower Sequential Organ Failure Assessment (SOFA) score

Time: 14 days after randomization

Description: Percentage of patients requiring Mechanical ventilation support

Measure: Mechanical ventilation support

Time: 14 days after randomization

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

Measure: Clearance of noval coronavirus

Time: 14 days after randomization

Description: All-cause mortality

Measure: All-cause mortality

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

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

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

Primary Outcomes

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

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

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

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

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

Primary Outcomes

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

Measure: The rate of virus inhibition

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

Secondary Outcomes

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

Measure: The disease prorogation-temperature

Time: Day 0 till day 21

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

Measure: The disease prorogation-respiratory function 1

Time: Day 0 till day 21

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

Measure: The disease prorogation-respiratory function 2

Time: Day 0 till day 21

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

Measure: The disease prorogation-respiratory function 3

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

Other Outcomes

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

Measure: Patients health condition-routine test

Time: Day 0 till day 21

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

Measure: Patients health condition-liver function

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

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

Measure: Patients health condition-kidney function

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

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

Measure: Patients health condition-other blood routine test

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

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

Measure: Patients health condition-blood routine test

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

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

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

Primary Outcomes

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

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

Time: 5 months

Secondary Outcomes

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

Measure: distribution map of evaluated people

Time: 5 month

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

Measure: Effect of medical guidance by designated feedback questionnaire

Time: 5 month

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

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

Time: 5 month
29 Clinical Characterisation Protocol for Severe Emerging Infections

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

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

Primary Outcomes

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

Measure: Clinical features

Time: 6 months

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

Measure: Response to treatment

Time: 6 months

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

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

Time: 6 months

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

Measure: Immune host responses to infection and therapy

Time: 6 months

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

Measure: Host genetic variants

Time: Day 1
30 A Multicenter Observational Study About the Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children

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

NCT04270383
Conditions
  1. 2019-nCoV
MeSH:Infection

Primary Outcomes

Description: Percentage

Measure: The cure rate of 2019-nCoV.

Time: 6 months

Description: Percentage

Measure: The improvement rate of 2019-nCoV.

Time: 6 months

Measure: The incidence of long-term adverse outcomes.

Time: 6 months

Secondary Outcomes

Description: Days

Measure: Duration of fever

Time: 2 weeks

Description: Days

Measure: Duration of respiratory symptoms

Time: 2 weeks

Description: Days

Measure: Duration of hospitalization

Time: 2 weeks

Measure: Number of participant(s) need intensive care

Time: 2 weeks

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

Time: 2 weeks

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

Time: 2 weeks

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

Time: 10 months
31 An Open-label Randomized Controlled Trial on Lopinavir/ Ritonavir, Ribavirin and Interferon Beta 1b Combination Versus Lopinavir/ Ritonavir Alone, as Treatment for 2019 Novel Coronavirus Infection

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

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

Primary Outcomes

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

Measure: Time to negative NPS

Time: Up to 1 month

Secondary Outcomes

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

Measure: Time to negative saliva

Time: Up to 1 month

Description: Time to NEWS of 0

Measure: Time to clinical improvement

Time: Up to 1 month

Description: Length of hospitalisation

Measure: Hospitalisation

Time: Up to 1 month

Description: 30-day mortality

Measure: Mortality

Time: Up to 1 month

Description: Cytokine/ chemokine changes

Measure: Immune reaction

Time: up to 1 month

Description: Adverse events during treatment

Measure: Adverse events

Time: up to 1 month

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

Measure: Time to negative all clinical specimens

Time: up to 1 month
32 Phase I/II Multicenter Trial of Lentiviral Minigene Vaccine (LV-SMENP) of Covid-19 Coronavirus

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

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

Primary Outcomes

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

Measure: Clinical improvement based on the 7-point scale

Time: 28 days after randomization

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

Measure: Lower Murray lung injury score

Time: 7 days after randomization

Secondary Outcomes

Description: Number of deaths during study follow-up

Measure: 28-day mortality

Time: Measured from Day 0 through Day 28

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

Measure: Duration of mechanical ventilation

Time: Measured from Day 0 through Day 28

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

Measure: Duration of hospitalization

Time: Measured from Day 0 through Day 28

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

Measure: Proportion of patients with negative RT-PCR results

Time: 7 and 14 days after randomization

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

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

Time: 7,14 and 28 days after randomization

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

Measure: Proportion of patients with normalized inflammation factors

Time: 7 and 14 days after randomization

Description: Frequency of vaccine/CTL Events

Measure: Frequency of vaccine/CTL Events

Time: Measured from Day 0 through Day 28

Description: Frequency of Serious vaccine/CTL Events

Measure: Frequency of Serious vaccine/CTL Events

Time: Measured from Day 0 through Day 28
33 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

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

NCT04278404
Conditions
  1. Coronavirus Infection (COVID-19)
  2. Pulmonary Arterial Hypertension
  3. Urinary Tract Infections in Children
  4. Hypertension
  5. Pain
  6. Hyperphosphatemia
  7. Primary Hyperaldosteronism
  8. Edema
  9. Hypokalemia
  10. Heart Failure
  11. Hemophilia
  12. Menorrhagia
  13. In
  14. Insomnia
  15. Pneumonia
  16. Skin Infection
  17. Arrythmia
  18. Asthma in Children
  19. Bronchopulmonary Dysplasia
  20. Adrenal Insufficiency
  21. Fibrinolysis; Hemorrhage
  22. Attention Deficit Hyperactivity Disorder
  23. Multisystem Inflammatory Syndrome in Children (MIS-C)
  24. Kawasaki Disease
  25. Coagulation Disorder
  26. Down Syndrome
Interventions
  1. Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
MeSH:Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Bronchopulmonary Dysplasia Down Syndrome Menorrhagia Hypertension Hemostatic Disorders Mucocutaneous Lymph Node Syndrome Blood Coagulation Disorders Hyperphosphatemia Hypokalemia Adrenal Insufficiency Hyperaldosteronism Disease Syndrome Hemorrhage Attention Deficit Disorder with Hyperactivity
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Adrenal insufficiency Attention deficit hyperactivity disorder Hyperaldosteronism Hyperphosphatemia Hypertension Hypokalemia Menorrhagia Primary hyperaldosteronism

Primary Outcomes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
34 A Multicenter Observational Study of the Perinatal-neonatal Population With or With Risk of COVID-19 in China

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

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

Primary Outcomes

Measure: The death of newborns with COVID-19

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

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

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

Time: within 7days after the admission

Secondary Outcomes

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

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

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

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

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

Time: at birth

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

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

Time: at birth

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

Measure: The disease severity of neonates with COVID-19

Time: through study completion, estimated an average of 2 weeks
35 Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection

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

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

Primary Outcomes

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

Measure: Screening accuracy

Time: 1 month

Secondary Outcomes

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

Measure: Cost-effectiveness analysis

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

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

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

Primary Outcomes

Description: Fever to normal time (day)

Measure: Fever to normal time (day)

Time: 30 days

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

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

Time: 30 days

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

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

Time: 30 days
37 Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID19 Infection: a Randomized Clinical Trial

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

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

Primary Outcomes

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

Measure: Reduction in the incidence of intubation and mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Mortality from all causes

Measure: Mortality

Time: 28 days

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

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

Time: 7 days

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

Measure: Time to clinical recovery

Time: 28 days
38 An Open Clinical Trial to Evaluate Ganovo(Danoprevir ) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

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

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

Primary Outcomes

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

Measure: Rate of composite adverse outcomes

Time: 14 days

Secondary Outcomes

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

Measure: Time to recovery

Time: 14 days

Description: Rate of no fever

Measure: Rate of no fever

Time: 14 days

Description: Rate of no cough

Measure: Rate of no cough

Time: 14 days

Description: Rate of no dyspnea

Measure: Rate of no dyspnea

Time: 14 days

Description: Rate of no requiring supplemental oxygen

Measure: Rate of no requiring supplemental oxygen

Time: 14 days

Description: Rate of undetectable New coronavirus pathogen nucleic acid

Measure: Rate of undetectable New coronavirus pathogen nucleic acid

Time: 14 days

Description: Rate of mechanical ventilation

Measure: Rate of mechanical ventilation

Time: 14 days

Description: Rate of ICU admission

Measure: Rate of ICU admission

Time: 14 days

Description: Rate of serious adverse event

Measure: Rate of serious adverse event

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

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

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

Primary Outcomes

Description: Percent of subjects who have returned to room air

Measure: Percent of subjects who have returned to room air

Time: 7 days

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

Measure: Percent change of subjects return to baseline oxygen requirement

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

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

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

Primary Outcomes

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

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

Time: 3 months

Secondary Outcomes

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

Measure: Identification of risk factors for seroconversion

Time: 3 months

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

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

Time: 3 months

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

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

Time: 3 months
41 Acute Respiratory Failure and Continuous Positive Airway Pressure Therapy in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: a Real Life Evaluation

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

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

Primary Outcomes

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

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

Time: 1-6 months

Secondary Outcomes

Description: How many patients died during the hospitalization

Measure: in-hospital mortality

Time: 1 month

Description: How many patients died 30 days after the discharge

Measure: 30 days mortality

Time: 1 month

Description: How many patients died 6 months after the discharge

Measure: 6 months mortality

Time: 6 months

Description: How many patients were intubated during the hospitalization

Measure: Intubation rate

Time: 7 days

Description: How many days/hours from admittance to intubation

Measure: Time to Intubation

Time: 7 days

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

Measure: Time to ventilation

Time: 7 days

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

Measure: Non invasive to Invasive time

Time: 7 days

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

Measure: Recovery rate

Time: 1 month

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

Measure: Recurrence rate

Time: 1 month

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

Measure: Risk factor for COVID19

Time: retrospective

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

Measure: Blood tests and outcome

Time: 1 month

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

Measure: Antiviral therapy

Time: 1 month

Description: Assessment of bacterial, fungal or other coinfections rate

Measure: Coinfections

Time: 1 month

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

Measure: Radiological findings

Time: 1 month

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

Measure: Ultrasound findings

Time: 1 month

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

Measure: Myocardial injury

Time: 1 month

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

Measure: Medical management

Time: 1 month
42 Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

Study Objective: 1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus. 2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.

NCT04308668
Conditions
  1. Corona Virus Infection
  2. Acute Respiratory Distress Syndrome
  3. SARS-CoV Infection
  4. Coronavirus
  5. Coronavirus Infections
Interventions
  1. Drug: Hydroxychloroquine
  2. Other: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Number of participants at 14 days post enrollment with active COVID19 disease.

Measure: Incidence of COVID19 Disease among those who are asymptomatic at baseline

Time: 14 days

Description: Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Measure: Overall change in disease severity over 14 days among those who are symptomatic at baseline

Time: 14 days

Secondary Outcomes

Description: Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.

Measure: Incidence of Hospitalization

Time: 14 days

Description: Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.

Measure: Incidence of Death

Time: 90 days

Description: Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.

Measure: Incidence of Confirmed SARS-CoV-2 Detection

Time: 14 days

Description: Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID19 infection.

Measure: Incidence of Symptoms Compatible with COVID19 (possible disease)

Time: 90 days

Description: Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.

Measure: Incidence of All-Cause Study Medicine Discontinuation or Withdrawal

Time: 14 days

Description: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Measure: Overall symptom severity at 5 and 14 days

Time: 5 and 14 days

Description: Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.

Measure: Ordinal Scale of COVID19 Disease Severity at 14 days among those who are symptomatic at trial entry

Time: 14 days
43 Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization

This is a multi-center, double-blinded study of COVID-19 infected patients randomized 1:1 to daily losartan or placebo for 10 days or treatment failure (hospital admission).

NCT04311177
Conditions
  1. Corona Virus Infection
  2. Acute Respiratory Distress Syndrome
  3. SARS-CoV Infection
Interventions
  1. Drug: Losartan
  2. Other: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Outcome reported as the number of participants per arm admitted to inpatient hospital care due to COVID-19-related disease within 15 days of randomization. Currently, there is a pre-planned pooled analysis with a national trial network under development.

Measure: Hospital Admission

Time: 15 days

Secondary Outcomes

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

Measure: Change in PROMIS Dyspnea Functional Limitations

Time: baseline, 10 days

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

Measure: Change in PROMIS Dyspnea Severity

Time: baseline, 10 days

Description: Participants will report their maximum daily oral temperature to the study team. Outcome is reported as the mean maximum daily body temperature (in degrees Celsius) over 10 days.

Measure: Daily Maximum Temperature

Time: 10 days

Description: Outcome is reported as the mean number of emergency department and clinic presentations combined per participant in each arm.

Measure: Emergency Department/Clinic Presentations

Time: 28 days

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

Measure: Disease Severity Rating Day 7

Time: 7 days

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

Measure: Disease Severity Rating Day 15

Time: 15 days

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

Measure: Disease Severity Rating Day 28

Time: 28 days

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

Measure: Viral Load by Oropharyngeal Swab Day 9

Time: 9 days

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

Measure: Viral Load by Oropharyngeal Swab Day 15

Time: 15 days

Description: Outcome reported as the mean number of days participants in each arm did not require ventilator use.

Measure: Ventilator-Free Days

Time: 28 days

Description: Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen use.

Measure: Therapeutic Oxygen-Free Days

Time: 28 days

Description: Outcome reported as the percent of participants in each arm who require hospital admission by day 15 following randomization.

Measure: Need for Hospital Admission at 15 Days

Time: 15 days

Description: Outcome reported as the percent of participants in each arm who require oxygen therapy by day 15 following randomization.

Measure: Need for Oxygen Therapy at 15 Days

Time: 15 days
44 Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization

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

NCT04312009
Conditions
  1. Corona Virus Infection
  2. Acute Respiratory Distress Syndrome
  3. SARS-CoV Infection
Interventions
  1. Drug: Losartan
  2. Other: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available. A correction is applied for endotracheal intubation and/or positive end-expiratory pressure. Patients discharged prior to day 7 will have a home pulse oximeter send home for measurement of the day 7 value, and will be adjusted for home O2 use, if applicable. Patients who died will be applied a penalty with a P/F ratio of 0.

Measure: Difference in Estimated (PEEP adjusted) P/F Ratio at 7 days

Time: 7 days

Secondary Outcomes

Description: Outcome reported as the mean number of daily hypotensive episodes (MAP < 65 mmHg) prompting intervention (indicated by a fluid bolus >=500 mL) per participant in each arm.

Measure: Daily Hypotensive Episodes

Time: 10 days

Description: Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.

Measure: Hypotension Requiring Vasopressors

Time: 10 days

Description: Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines: Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR Urine output less than 0.5 mL/kg/h for 6 hours.

Measure: Acute Kidney Injury

Time: 10 days

Description: The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.

Measure: Sequential Organ Failure Assessment (SOFA) Total Score

Time: 10 days

Description: Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless.

Measure: Oxygen Saturation / Fractional Inhaled Oxygen (F/S)

Time: 10 days

Description: Outcome reported as the number of participants who have expired at 28 days post enrollment.

Measure: 28-Day Mortality

Time: 28 days

Description: Outcome reported as the number of participants who have expired at 90 days post enrollment.

Measure: 90-Day Mortality

Time: 90 days

Description: Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).

Measure: ICU Admission

Time: 10 days

Description: Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.

Measure: Number of Ventilator-Free Days

Time: 10 days

Description: Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.

Measure: Number of Therapeutic Oxygen-Free Days

Time: 10 days

Description: Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.

Measure: Number of Vasopressor-Free Days

Time: 10 days

Description: Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.

Measure: Length of ICU Stay

Time: 10 days

Description: Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.

Measure: Length of Hospital Stay

Time: 10 days

Description: Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.

Measure: Incidence of Respiratory Failure

Time: 10 days

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

Measure: Change in PROMIS Dyspnea Functional Limitations

Time: 10 days

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

Measure: Change in PROMIS Dyspnea Severity

Time: 10 days

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

Measure: Disease Severity Rating

Time: 10 days

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

Measure: Viral Load by Nasopharyngeal Swab Day 9

Time: 9 days

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

Measure: Viral Load by Nasopharyngeal Swab Day 15

Time: 15 days

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

Measure: Viral Load by Blood Day 9

Time: 9 days

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

Measure: Viral Load by Blood Day 15

Time: 15 days
45 Nitric Oxide Gas Inhalation for Prevention of COVID-19 in Healthcare Providers

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

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

Primary Outcomes

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

Measure: COVID-19 diagnosis

Time: 14 days

Secondary Outcomes

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

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

Time: 14 days

Other Outcomes

Description: Mean/ Median in the two groups

Measure: Total number of quarantine days

Time: 14 days

Description: Percentage in the two groups

Measure: Proportion of healthcare providers requiring quarantine

Time: 14 days
46 A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

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

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

Primary Outcomes

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

Measure: Severity of COVID-19

Time: 28 days

Secondary Outcomes

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

Measure: SARS-CoV-2 infection

Time: 28 days

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

Measure: Severity of COVID-19 over 14 days

Time: 14 days

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

Measure: Severity of COVID-19 symptoms

Time: 28 days

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

Measure: ICU admission

Time: 28 days

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

Measure: Mechanical Ventilation

Time: 28 days

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

Measure: Mortality

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

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

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

Primary Outcomes

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

Measure: Severity of COVID-19

Time: 28 days

Secondary Outcomes

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

Measure: Incidence of SARS-CoV-2 infection

Time: 28 days

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

Measure: Incidence of SARS-CoV-2 infection

Time: 14 days

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

Measure: Severity of COVID-19

Time: 14 days

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

Measure: ICU admission

Time: 28 days

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

Measure: Mechanical ventilation

Time: 28 days

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

Measure: Mortality

Time: 28 days
48 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
49 Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in a Cohort of Negative Patients for Coronavirus Infection for the Early Detection of Positive Antibodies for COVID-19

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

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

Primary Outcomes

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

Measure: Number of patients with constant negative results

Time: 30 days

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

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

Time: 30 days

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

Measure: Overall Number of patients positive for COVID-19

Time: six months

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

Measure: Overall Number of patients negative for COVID-19

Time: six months

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

Measure: Number of patients with contrasting results

Time: 30 days

Secondary Outcomes

Description: Number of Invalid results

Measure: Reliability of the test

Time: 30 days

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

Measure: Positive HCW

Time: 60 days

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

Measure: Number of Chronic Patients

Time: 60 days
50 Effect of Counseling Between Pregnant Women During Corona Infection

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

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

Primary Outcomes

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

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

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

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

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

Primary Outcomes

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

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

Time: Hospital stay (2-3 weeks)
52 Pandemic Response Network: Duke Community Health Watch

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

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

Primary Outcomes

Measure: Number of participants who experience inpatient admission

Time: 2 months

Secondary Outcomes

Measure: Number of participants admitted to the intensive care unit

Time: 2 months

Measure: Number of participants requiring mechanical ventilation

Time: 2 months

Measure: Number of deceased participants

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

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

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

Primary Outcomes

Description: Maneuvarability of the remote control MCE system

Measure: Technical success

Time: During the procedure

Secondary Outcomes

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

Measure: Clinical success

Time: During the procedure

Description: Adverse events during and after the procedure

Measure: Adverse events

Time: During and within 2 weeks after the procedure
54 The Impact of Camostat Mesilate on COVID-19 Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial

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

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

Primary Outcomes

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

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

Time: 30 days

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

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

Time: 30 days

Secondary Outcomes

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

Time: 30 days

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

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

Time: 30 days

Description: Mortality

Measure: Cohort 1: Day 30 mortality

Time: 30 days

Description: NEWS2

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

Time: 30 days

Description: ICU

Measure: Cohort 1: Admission to ICU

Time: 30 days

Description: invasive mechanical ventilation or ECMO

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

Time: 30 days

Description: Nasal or high-flow oxygen

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

Time: 30 days

Description: Subjective clinical improvement

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

Time: 30 days

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

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

Time: 30 days

Description: Hospital admission

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

Time: 30 days
55 Evaluation of the Safety and Clinical Efficacy of Hydroxychloroquine Associated With Azithromycin in Patients With Pneumonia Caused by Infection by the SARS-CoV2 Virus - Coalition COVID-19 Brasil II - SEVERE - Patients

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

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

Primary Outcomes

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

Measure: Evaluation of the clinical status

Time: 15 days after randomization

Secondary Outcomes

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

Measure: All-cause mortality

Time: 29 days after randomization

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

Measure: Evaluation of the clinical status

Time: 7 and 29 days after randomization

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

Measure: Number of days free from mechanical ventilation

Time: 29 days after randomization

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

Measure: Duration of mechanical ventilation

Time: 29 days after randomization

Description: Length of hospital stay on survivors

Measure: Duration of hospitalization

Time: 29 days after randomization

Description: Presence of other secondary infections

Measure: Other secondary infections

Time: 29 days after randomization

Description: Time from treatment start to death

Measure: Time from treatment start to death

Time: 29 days after randomization

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

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

Time: 3, 6, 9 and 12 months

Description: Leucocyte transcriptome

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

Time: Baseline

Other Outcomes

Description: Occurrence of QT interval prolongation

Measure: QT interval prolongation

Time: 29 days after randomization

Description: Occurrence of gastrointestinal intolerance

Measure: Gastrointestinal intolerance

Time: 29 days after randomization

Description: Occurrence of laboratory hematimetric parameters, creatinine and bilirubin

Measure: Laboratory abnormalities

Time: 29 days after randomization

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

Measure: Adverse events

Time: 29 days after randomization
56 An Open-label, Randomized Controlled Trial of Hydroxychloroquine and Azithromycin for COVID-19 Infection on Hospitalized, Noncritical Patients

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

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

Primary Outcomes

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

Measure: Evaluation of the clinical status

Time: 15 days after randomization

Secondary Outcomes

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

Measure: Ordinal scale in 7 days

Time: 7 days after randomization

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

Measure: Need of intubation and mechanical ventilation

Time: 7 days after randomization

Description: Use of mechanical ventilation during hospital stay

Measure: Use of mechanical ventilation during hospital stay

Time: 15 days after randomization

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

Measure: Use of non-invasive ventilation

Time: 7 days after randomization

Description: Hospital Length of Stay

Measure: Hospital Length of Stay

Time: 28 days after randomization

Description: All-cause mortality rates during hospital stay

Measure: All-cause mortality

Time: 28 days after randomization

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

Measure: Thromboembolic complications

Time: 15 days after randomization

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

Measure: Acute renal disfunction

Time: 15 days after randomization

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

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

Time: 15 days

Other Outcomes

Description: Corrected QT interval

Measure: Safety outcome on corrected QT interval

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

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

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

Primary Outcomes

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

Measure: mortality in siltuximab treated patients

Time: 30 days

Secondary Outcomes

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

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

Time: 30 days

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

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

Time: 30 days

Description: Safety of siltuximab treatment

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

Time: 30 days

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

Measure: the effect on inflammatory parameters

Time: 30 days

Description: Correlation of outcomes with IL-6 levels

Measure: Correlation of outcomes with IL-6 levels

Time: 30 days
58 Efficacy and Safety of Escin as add-on Treatment in Covid-19 Infected Patients

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

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

Primary Outcomes

Description: All cause mortality

Measure: Mortality rate

Time: up to 30 days

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

Measure: Clinical status evaluated in agreement with guidelines

Time: up to 30 days

Secondary Outcomes

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

Measure: The differences in oxygen intake methods

Time: up to 30 days

Description: days

Measure: Time of hospitalization (days)

Time: up to 30 days

Description: days

Measure: Time of hospitalization in intensive care units

Time: up to 30 days

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

Measure: Pulmonary function

Time: up to 3 months after discharge
59 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
60 Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection

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

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

Primary Outcomes

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

Measure: Biomarkers expression

Time: up to 30 days

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

Measure: Liver Biomarkers expression

Time: up to 30 days

Secondary Outcomes

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

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

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

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

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

Primary Outcomes

Description: Number patients developing severe infection or death

Measure: Number patients developing severe infection or death

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

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

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

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

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

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

Primary Outcomes

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

Measure: Treatment success

Time: Up to Day 15

Secondary Outcomes

Description: Measured in days

Measure: Time to mechanical ventilation

Time: Date of randomization to date of mechanical ventilation

Description: Measured in total score

Measure: Change from baseline in Modified Early Warning system score

Time: Baseline, Day 15

Description: Measured in percent (%)

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

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

Description: Measured in percent (%)

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

Time: Baseline, Day 15

Description: Measured in local units

Measure: Change of pH in hemogasanalysis from baseline

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

Description: Measured in local units

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

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

Description: Measured in local units

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

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

Description: Measured in local units

Measure: Change of potassium in hemogasanalysis from baseline

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

Description: Measured in local units

Measure: Change of sodium in hemogasanalysis from baseline

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

Description: Measured in local units

Measure: Change of chloride in hemogasanalysis from baseline

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

Description: Measured in local units

Measure: Change of lactic acid in hemogasanalysis from baseline

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

Description: Measured in local units

Measure: Change of hemoglobin in hemogasanalysis from baseline

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

Description: Measured in l/min

Measure: Change from baseline in oxygen supplementation

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

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

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

Time: Screening, Day 15

Description: Measured in local units

Measure: Change from baseline in Ferritin

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

Description: Measured in local units

Measure: Change from baseline in lactate dehydrogenase (LDH)

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

Description: Measured in local units

Measure: Change from baseline in D-dimers

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

Description: Measured in local units

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

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

Description: Measured in local units

Measure: Change from baseline in Red Blood Counts

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

Description: Measured in local units

Measure: Change from baseline in Hemoglobin

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

Description: Measured in local units

Measure: Change from baseline in Platelet count

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

Description: Measured in local units

Measure: Change from baseline in Fibrinogen

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

Description: Measured in local units

Measure: Change from baseline in Complement factors C3/C4

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

Description: Measured in local units

Measure: Change from baseline in Prothrombin time

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

Description: Measured in local units

Measure: Change from baseline in Cardiac troponin

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

Description: Measured in local units

Measure: Change from baseline in aspartate aminotransferase (AST)

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

Description: Measured in local units

Measure: Change from baseline in alanine aminotransferase (ALT)

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

Description: Measured in local units

Measure: Change from baseline in total bilirubin levels

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

Description: Measured in local units

Measure: Change from baseline in C-Reactive Protein

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

Description: Measured in local units

Measure: Change from baseline in Creatinine

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

Description: Confirmation of death

Measure: Overall survival

Time: Weeks 6 and 10

Description: Measured in days

Measure: Time to hospital discharge

Time: Weeks 6 and 10
64 Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy

This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.

NCT04324866
Conditions
  1. Coronavirus Infection
Interventions
  1. Diagnostic Test: Nasopharyngeal swab
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Psoriasis
HPO:Palmoplantar pustulosis Psoriasiform dermatitis

Primary Outcomes

Measure: Point prevalence of COVID-19 infection

Time: Baseline up to 6 months

Secondary Outcomes

Measure: Incidence of COVID-19 infection

Time: Baseline up to 6 months

Measure: Percentage of subjects presenting fever or respiratory symptoms

Time: Baseline up to 6 months

Measure: Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments

Time: Baseline up to 6 months

Measure: Evaluate the relationship between COVID-19 infection and comorbid medical conditions

Time: Baseline up to 6 months
65 Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.

NCT04326036
Conditions
  1. Pulmonary Alveolar Proteinosis
  2. COPD
  3. Idiopathic Pulmonary Fibrosis
  4. Viral Pneumonia
  5. Coronavirus Infection
  6. Interstitial Lung Disease
Interventions
  1. Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)
  2. Device: Centricyte 1000
  3. Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution
  4. Drug: Liberase Enzyme (Roche)
  5. Drug: Sterile Normal Saline for Intravenous Use
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Lung Diseases Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases, Interstitial Pulmonary Alveolar Proteinosis
HPO:Abnormal lung morphology Interstitial pneumonitis Interstitial pulmonary abnormality Intraalveolar phospholipid accumulation Pulmonary fibrosis

Primary Outcomes

Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 1 month

Secondary Outcomes

Description: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics

Measure: Pulmonary Function Analysis

Time: baseline, 3 Month, 6 months

Description: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency

Measure: Digital Oximetry

Time: 3 months, 6 months
66 Effectiveness and Safety of Respiratory Training Devices in the Prevention and Severity of COVID-19: A Randomized Controlled Clinical Trial

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

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

Primary Outcomes

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

Measure: COVID-19 disease diagnosis

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

Secondary Outcomes

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

Measure: COVID-19 disease symptoms severity

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

Description: Polytomous categorical variable measured by adverse effects responses

Measure: Adverse effects

Time: Change from Baseline adverse effects at 8 weeks
67 Audio Data Collection for Identification and Classification of Coughing

An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.

NCT04326309
Conditions
  1. COVID-19
  2. Coronavirus Infections
  3. Hay Fever
  4. Asthma
  5. Chronic Obstructive Pulmonary Disease
  6. Influenza
  7. Common Cold
  8. Respiratory Tract Infections
  9. Healthy
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Common Cold Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive
HPO:Chronic pulmonary obstruction Pulmonary obstruction Respiratory tract infection

Primary Outcomes

Description: Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.

Measure: Dataset size

Time: 14 days

Secondary Outcomes

Description: Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity

Measure: Cough sound identification

Time: 14 days

Description: Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%

Measure: Improvement of the existing model

Time: 14 days

Description: Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.

Measure: Evaluate the usability of the application

Time: 14 days
68 Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol

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

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

Primary Outcomes

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

Measure: COVID-19 App-based platform

Time: 6 months

Secondary Outcomes

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

Measure: COVID-19 infection

Time: 6 months
69 ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection

This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection. On evaluation for enrollment, participant will need to meet all inclusion and exclusion criteria. If participant consents, they will be randomized 1:1 to treatment with either tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily following randomization. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.

NCT04326426
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Tradipitant
  2. Drug: Placebo
MeSH:Infection Co Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Time to improvement on a 7-point ordinal scale as compared to baseline

Time: 14 days or discharge

Secondary Outcomes

Measure: Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)

Time: 14 days or discharge

Measure: Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples

Time: 14 days or discharge

Measure: In-hospital mortality

Time: 14 days or discharge

Measure: Mean change in NEWS2 score from baseline

Time: 14 days or discharge

Measure: Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus

Time: 14 days or discharge

Measure: Reduction from baseline of NRS for cough

Time: 14 days or discharge

Measure: Reduction from baseline of NRS for nausea

Time: 14 days or discharge

Measure: Time to normalization of fever for at least 48 hours

Time: 14 days or discharge

Measure: Time to improvement in oxygenation for at least 48 hours

Time: 14 days or discharge
70 The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection

This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.

NCT04326452
Conditions
  1. Coronavirus Infection
Interventions
  1. Device: bidirectional oxygenation mouthpiece
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve

Measure: Pulse oximetry level

Time: Change from Baseline pulse oximetry level at 15 minutes post treatment

Secondary Outcomes

Measure: Respiratory rate

Time: Change from Baseline clinical measurements at 15 minutes post treatment

Measure: Heart rate

Time: Change from Baseline clinical measurements at 15 minutes post treatment

Measure: Blood pressure

Time: Change from Baseline clinical measurements at 15 minutes post treatment

Description: Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.

Measure: Systemic carbon dioxide

Time: Change from Baseline clinical measurements at 15 minutes post treatment
71 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
72 Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in Tropical Regions

This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in tropical regions such as French Guiana, Guadeloupe and New-Caledonia.

NCT04328129
Conditions
  1. Coronavirus Infections
  2. Severe Acute Respiratory Syndrome
  3. SARS-CoV Infection
Interventions
  1. Procedure: Human biological samples
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The extent of the virus transmission within households will be assessed by evaluating the rate of intra-household secondary transmission of the virus

Measure: Evaluation of the extent of the virus transmission within households

Time: 2 years

Secondary Outcomes

Description: The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household

Measure: Characterization of the secondary cases

Time: 2 years

Description: The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.

Measure: Characterization of the secondary cases

Time: 2 years

Description: The extent of the virus transmission within contact persons will be assessed by evaluating the rate of extended-contact secondary transmission of the virus

Measure: In New-Caledonia, evaluation of the extent of the virus transmission within contact persons

Time: 2 years
73 Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers : A Randomized Double-blind Placebo-controlled Clinical Trial

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

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

Primary Outcomes

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

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

Time: Up to 2.5 months

Secondary Outcomes

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

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

Time: Up to 2.5 months

Description: Number of treatment discontinuations in each arm

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

Time: Up to 2 months

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

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

Time: Up to 2 months

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

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

Time: Up to 2.5 months

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

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

Time: Up to 2.5 months

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

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

Time: Up to 2.5 months

Description: Safety. Electrocardiogram (ECG)

Measure: corrected QT interval (ms)

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

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

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

Primary Outcomes

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

Measure: Viral clearance time

Time: Up to 56 days post randomization

Secondary Outcomes

Description: The time since randomization to discharge between study groups

Measure: Lengh of hospital stay

Time: Up to 56 days post randomization

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

Measure: Ventilator free days

Time: first 28 days

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

Measure: Oxygene free days

Time: first 28 days

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

Measure: Time to death

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

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

Measure: Adverse events

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

Description: Time since randomization to the first defervescence day

Measure: fever clearance time

Time: Up to 56 days post randomization

Description: WHO Ordinal outcome scale for COVID-19

Measure: Ordinal outcome scale

Time: Up to 56 days post randomization

Description: Development of ARDS defined by the Kigali criteria

Measure: Development of ARDS

Time: Up to 56 days post randomization
75 Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study

This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).

NCT04328961
Conditions
  1. COVID-19
  2. Corona Virus Infection
  3. SARS (Severe Acute Respiratory Syndrome)
  4. SARS-CoV-2
Interventions
  1. Drug: Hydroxychloroquine Sulfate
  2. Drug: Ascorbic Acid
MeSH:Infection Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome

Primary Outcomes

Description: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected daily for 14 days

Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection

Time: Day 1 through Day 14 after enrolment

Description: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit

Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection

Time: Day 28 after enrolment

Secondary Outcomes

Description: Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults

Measure: Rate of participant-reported adverse events

Time: 28 days from start of Hydroxychloroquine therapy

Description: PCR-confirmed COVID-19 diagnosis

Measure: Incidence rates of COVID-19 through study completion

Time: 28 days from enrolment
76 ACE Inhibitors or ARBs Discontinuation for Clinical Outcome Risk Reduction in Patients Hospitalized for the Endemic Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection: the Randomized ACORES-2 Study

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

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

Primary Outcomes

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

Time: from day 0 to day 28 or hospital discharge

Secondary Outcomes

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

Time: at day 28

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

Time: at days 7, 14 and 28

Measure: Number of days alive free of oxygen.

Time: from day 0 to day 28 or hospital discharge

Measure: Number of days alive outside hospital until day28

Time: at day28

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

Time: at day28

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

Time: at day28

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

Time: at day28

Measure: Rate of all-cause mortality at day 28

Time: at day 28

Measure: Rate of cardiovascular death at day 28

Time: at day 28

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

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

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

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

Primary Outcomes

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

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

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

Description: percentage of cases of COVID 19

Measure: Prevalence of COVID-19 cases in both arms

Time: 27 weeks after the beginning of the study

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

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

Time: 27 weeks after the beginning of the study

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

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

Time: 27 weeks after the beginning of the study

Secondary Outcomes

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

Measure: Adverse events

Time: 12 weeks after the start of treatment

Description: Proportion of participants that drop out of study

Measure: Adverse events

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

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

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

Primary Outcomes

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

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

Time: within 30 days

Secondary Outcomes

Measure: Mortality rate at D30

Time: At day30

Measure: Time (in days) from randomization to death

Time: up to 30 days after randomization

Measure: Number of days alive outside ICU within 30 days

Time: At day30

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

Time: At day30

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

Time: At day30

Measure: Maximal oxygen rate within 30 days

Time: At day30

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

Time: at Day 7

Measure: Number of days alive outside hospital within 30 days

Time: at Day 30

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

Time: at Day 30

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

Time: at Day 7

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

Time: up to 30 days after randomization
79 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
80 Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease

ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

NCT04332991
Conditions
  1. Coronavirus
  2. Acute Respiratory Infection
  3. SARS-CoV Infection
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome
HPO:Respiratory tract infection

Primary Outcomes

Description: We will determine the COVID Ordinal Scale for all patients on study day 15 COVID Ordinal Scale defined as: Death Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation) Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)

Measure: COVID Ordinal Outcomes Scale on Day 15

Time: assessed on study day 15

Secondary Outcomes

Description: Vital status of the patient on day 15 will be determined using any of the following methods: medical record review, phone calls to patient or proxy

Measure: all-location, all-cause mortality assessed on day 15

Time: assessed on study day 15

Description: Vital status of the patient at day 28 will be determined using any of the following methods: medical record review, phone calls to patient or proxy

Measure: all-location, all-cause mortality assessed on day 29

Time: assessed on study day 29

Description: We will determine the COVID Ordinal Scale for all patients on study day 3

Measure: COVID Ordinal Outcomes Scale on Study Day 3

Time: assessed on study day 3

Description: We will determine the COVID Ordinal Scale on study day 8

Measure: COVID Ordinal Outcomes Scale on Study Day 8

Time: assessed on study day 8

Description: We will determine the COVID Ordinal Scale on study day 29

Measure: COVID Ordinal Outcomes Scale on Study Day 29

Time: assessed on study day 29

Description: We will determine the number of patients who are either dead or on ECMO ( extracorporeal membrane oxygenation) between enrollment and day 28

Measure: Number of patients dead or with receipt of ECMO between enrollment and Day 28

Time: Enrollment to Day 28

Description: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of oxygen therapy. Patients who die prior to day 28 are assigned zero oxygen free days.

Measure: Oxygen-free days through Day 28

Time: 28 days after randomization

Description: Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.

Measure: Ventilator-free days through Day 28

Time: 28 days after randomization

Description: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of vasopressor therapy. Patients who die prior to day 28 are assigned zero vasopressor free days.

Measure: Vasopressor-free days through Day 28

Time: 28 days after randomization

Description: The number of days spent out of the ICU to day 28.

Measure: ICU-free days to Day 28

Time: 28 days after randomization

Description: Defined as 28 days minus the number of days from randomization to discharge home.If a patient has not been discharged home prior to day 28 or dies prior to day 28, hospital free days will be zero.

Measure: Hospital-free days to Day 28

Time: 28 days after randomization

Other Outcomes

Description: We will determine the number of patients that experience seizure between randomization and day 28

Measure: Number of patients with seizures to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience ventricular arrhythmia between randomization and day 28

Measure: Number of patients with atrial or ventricular arrhythmia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience cardiac arrest between randomization and day 28

Measure: Number of patients with cardiac arrest to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal between randomization and day 28

Measure: Number of patients with elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience acute pancreatitis between randomization and day 28

Measure: Number of patients with acute pancreatitis arrest to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience acute kidney injury between randomization and day 28

Measure: Number of patients with acute kidney injury to day28

Time: 28 days after randomization

Description: We will determine the number of patients that experience renal replacement therapy between randomization and day 28

Measure: Number of patients with receipt of renal replacement therapy to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience symptomatic hypoglycemia between randomization and day 28

Measure: Number of patients with symptomatic hypoglycemia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience neutropenia, lymphopenia, anemia, or thrombocytopenia between randomization and day 28

Measure: Number of patients with neutropenia, lymphopenia, anemia, or thrombocytopenia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience severe dermatologic reaction between randomization and day 28

Measure: Number of patients with severe dermatologic reaction to day 28

Time: 28 days after randomization

Description: Time to recovery, defined as time to reaching level 5, 6, or 7 on the COVID Outcomes Scale, which is the time to the earlier of final liberation from supplemental oxygen or hospital discharge

Measure: Time to recovery, defined as time to reaching level 5, 6, or 7 on the COVID Outcomes Scale, which is the time to the earlier of final liberation from supplemental oxygen or hospital discharge

Time: 28 days after randomization
81 A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures

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

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

Primary Outcomes

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

Measure: Rate of COVID-19 positive conversion

Time: 7 weeks

Secondary Outcomes

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

Measure: Time-to-first clinical event

Time: 7 weeks

Other Outcomes

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

Measure: Time-to-first clinical worsening event

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

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

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

Primary Outcomes

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

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

Time: 90 days

Secondary Outcomes

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

Measure: Fraction of healthcare workers with COVID-19

Time: 90 days

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

Measure: Number of patients infected in the hospital

Time: 90 days

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

Measure: Development of SARS-CoV2 specific antibody repertoire

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

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

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

Primary Outcomes

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

Measure: 28-day survival rate

Time: 28 days from randomization

Secondary Outcomes

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

Measure: Time to clinical improvement

Time: 28 days from randomization

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

Measure: Clinical status

Time: Day 7, Day 14, Day 28

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

Measure: Mean change in clinical status from baseline to days

Time: Day 7, Day 14, Day 28

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

Measure: Overall survival

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

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

Measure: Length of stay in Intensive Care Unit

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

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

Measure: Duration of mechanical ventilation or high flow oxygen devices

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

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

Measure: Duration of hospitalization

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

Measure: Rate of throat swab negativation

Time: Day 7, Day 14, Day 28

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

Time: Day 7, Day 14, Day 28

Measure: Rate of secondary infection by other documented pathogens

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

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

Measure: Biological parameters

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

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

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

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

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

Measure: Cost-Effectiveness Analyses (CEA)

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

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

Measure: Biological parameters

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

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

Measure: Biological parameters

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

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

Measure: Biological parameters

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

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

Measure: Biological parameters

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

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

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)
84 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection

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

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

Primary Outcomes

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

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

Time: 12 weeks

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

Measure: Reduction or Progression of Symptomatic Days

Time: 12 weeks

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

Measure: Assess the safety of Quintuple Therapy

Time: 12 weeks

Description: Pulse from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via pulse

Time: 12 weeks

Description: Oxygen saturation from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via oxygen saturation

Time: 12 weeks

Description: EKG response from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via EKG

Time: 12 weeks

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

Measure: Assess Tolerability of Quintuple Therapy

Time: 12 weeks
85 Prevention of SARS-CoV-2 (COVID-19) Through Pre-Exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Hydroxychloroquine in Healthcare Personnel: Randomized Clinical Trial Controlled With Placebo

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

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

Primary Outcomes

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

Time: 12 weeks

Secondary Outcomes

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

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

Time: 12 weeks

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

Time: 12 weeks
86 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

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

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

Primary Outcomes

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

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

Time: 24 weeks

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

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

Time: 24 weeks
87 Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

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

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

Primary Outcomes

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

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

Time: Day 14

Secondary Outcomes

Measure: Rates of death during the index hospitalization

Time: Index hospitalization, up to 46 days

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

Time: Baseline

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

Time: Index hospitalization, up to 46 days

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

Measure: WHO ordinal scale measured at 28 days after enrollment

Time: Day 28

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

Time: Index hospitalization, up to 46 days

Measure: Rates of all-cause study medication discontinuation

Time: Index hospitalization, up to 46 days

Measure: Rates of severe adverse events

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

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

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

Primary Outcomes

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

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

Time: 1 month

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

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

Time: 1 month

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

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

Time: 1 month

Secondary Outcomes

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

Measure: Positive oropharyngeal/nasal swab (PCR);

Time: 1 month

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

Measure: Positive oropharyngeal/nasal swab (PCR);

Time: 1 month

Other Outcomes

Description: Returned swabs

Measure: Difference between the two study groups

Time: 1 month

Description: Psychological aspects of face mask wearing in the community

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

Time: 1 month

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

Measure: Costs associated with wearing vs not wearing face masks

Time: 1 month

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

Measure: Differences in the participants preferences

Time: 1 month

Description: Symptoms of COVID-19

Measure: Difference between the two study groups

Time: 1 month

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

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

Time: 1 month

Description: Willingness to wear face masks in the future

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

Time: 1 month

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

Measure: Healthcare diagnosed COVID-19 between study groups

Time: 1 month

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

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

Time: 1 month

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

Measure: Infection in the household between the two study groups

Time: 1 month

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

Measure: Sick leave among participants beteeen the two study groups

Time: 1 month

Description: Predictors of primary outcome or its components

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

Time: 1 month
89 Multi-Center, Randomized, Controlled, Phase II Clinical Efficacy Study Evaluating Nitric Oxide Releasing Solution Treatment for the Prevention and Treatment of COVID-19 in Healthcare Workers and Individuals at Risk of Infection

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

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

Primary Outcomes

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

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

Time: 14 days

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

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

Time: 21 days

Secondary Outcomes

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

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

Time: 21 days

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

Measure: Prevention Study: Measure the tolerability of NORS treatments

Time: 21 days

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

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

Time: 21 days

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

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

Time: 21 days

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

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

Time: 21 days

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

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

Time: 21 days
90 Nitric Oxide Inhalation Therapy for COVID-19 Infections in the Emergency Department

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

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

Primary Outcomes

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

Measure: Rates of return visits to the ED

Time: 28 days

Secondary Outcomes

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

Measure: Inpatient hospitalizations required

Time: 28 days

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

Measure: Rates of intubation

Time: 28 days

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

Measure: Rates of mortality

Time: 28 days
91 HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With Confirmed or Probable SARS-CoV-2 Infection. A Before and After Implementation of a Consensus Help-decision Making Rule Study

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

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

Primary Outcomes

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

Measure: the composite rate of adverse outcomes

Time: day 7

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

Measure: The rate of hospitalization

Time: 24 hours
92 Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection

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

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

Primary Outcomes

Description: COVID-19 serology testing

Measure: Virology Cure Rate

Time: 10 days

Secondary Outcomes

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

Measure: Incidence of GI adverse events

Time: 47 days

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

Measure: Cardiac Toxicity

Time: 10 days

Other Outcomes

Description: Measure blood counts

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

Time: 10 days

Description: Measure changes in plasma cytokines throughout course of infection

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

Time: 10 days
93 Efficiency in Management of Organ Dysfunction Associated With Infection by the Novel SARS-CoV-2 Virus (COVID-19) Through a Personalized Immunotherapy Approach: the ESCAPE Clinical Trial

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

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

Primary Outcomes

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

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

Time: Visit study day 8

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

Measure: Improvement of lung involvement measurements

Time: Visit study day 8

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

Measure: Increase of pO2/FiO2 ratio

Time: Visit Study Day 8

Secondary Outcomes

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

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

Time: Screening, Day 8

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

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

Time: Screening, Day 8

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

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

Time: Screening, Day 8

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

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

Time: Day 28

Description: Mortality on day 28

Measure: Rate of Mortality

Time: Day 28

Description: Mortality on day 90

Measure: Rate of Mortality

Time: Day 90

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

Measure: Cytokine stimulation

Time: Screening, Day 4

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

Measure: Gene expression

Time: Screening, Day 4

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

Measure: Serum/plasma proteins

Time: Screening, Day 4

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

Measure: Classification of the immune function

Time: Screening
94 French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study

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

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

Primary Outcomes

Description: Mortality at day 28

Measure: Mortality at day 28

Time: day 28

Secondary Outcomes

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

Measure: severe complications

Time: up to day 28

Description: Delay in imaging in hours

Measure: Imaging

Time: day 1

Description: delay in microbiological diagnosis in hours

Measure: Delay in Microbiological diagnosis

Time: day 1

Description: Antiviral therapy Yes / no

Measure: Antiviral therapy

Time: up to day 28

Description: Antibiotic therapy Yes / No

Measure: Antibiotic therapy

Time: day 28

Description: Covid-19 treatments Yes / No

Measure: Covid-19 treatments

Time: up to day 28

Description: number

Measure: Patients receiving renal replacement therapy

Time: up to day 28

Description: number

Measure: Patients receiving mechanical ventilation

Time: up to day 28

Description: Patient alive at day 28 : yes / No

Measure: Vital status

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

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

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

Primary Outcomes

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

Measure: Mechanical ventilation

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

Secondary Outcomes

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

Measure: ICU transfer

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

Description: Number of days requiring oxygen therapy

Measure: Oxygen therapy

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
96 CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection, Nested In The CORIMUNO-19

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

NCT04341584
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Anakinra
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.

Measure: Survival without needs of ventilator utilization at day 14

Time: 14 days

Description: Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5.

Measure: WHO progression scale ≤ 5

Time: 4 days

Description: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.

Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) or withdrawal of NIV or high flow (for > 48h), at day 14

Time: 14 days

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

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

Time: 4 days

Secondary Outcomes

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

Measure: WHO progression scale

Time: 7 and 14 days

Description: Overall survival.

Measure: Survival

Time: 14, 28 and 90 days

Measure: 28-day ventilator free-days

Time: 28 days

Description: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours.

Measure: Respiratory acidosis

Time: 4 days

Description: Evolution of PaO2/FiO2 ratio.

Measure: PaO2/FiO2 ratio

Time: day 1 to day 14

Description: Time to oxygen supply independency.

Measure: Time to oxygen supply independency

Time: 14 days

Description: Duration of hospitalization.

Measure: Duration of hospitalization

Time: 90 days

Description: Time to negative viral excretion.

Measure: Time to negative viral excretion

Time: 90 days

Description: Time to ICU discharge.

Measure: Time to ICU discharge

Time: 90 days

Description: Time to hospital discharge.

Measure: Time to hospital discharge

Time: 90 days
97 WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection

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

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

Primary Outcomes

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

Measure: Hours to recovery

Time: 42 days

Secondary Outcomes

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

Measure: Time fever resolution

Time: 42 days
98 Hydroxychloroquine for Outpatients With Confirmed COVID-19

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

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

Primary Outcomes

Measure: Duration of viral shedding

Time: Days 1-14

Secondary Outcomes

Measure: Duration of COVID-19-attributable symptoms

Time: Everyday through 6 months

Measure: Hospitalization

Time: within 14 days of enrollment

Measure: Duration of viral shedding

Time: Days 1-14 and Day 28

Measure: Adult household contact viral acquisition

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

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

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

Primary Outcomes

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

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

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

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

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

Primary Outcomes

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

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

Time: 7 days after randomization

Secondary Outcomes

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

Measure: Mortality rate

Time: after randomization, up to 28 days

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

Measure: Number of participants in need of intensive care support

Time: during and after intervention, up to 28 days

Description: Viral load change in blood and oropharyngeal swab samples

Measure: Viral concentration

Time: After randomization, up to 7 days

Description: Incidence of serious adverse events during and after treatment

Measure: Cumulative incidence of serious adverse events

Time: During and after intervention, up to 28 days

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

Measure: Cumulative incidence of grade 3 and 4 adverse events

Time: During and after intervention, up to 28 days

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

Measure: Proportion of patients with discontinued treatment

Time: after randomization, up to 28 days

Description: proportion of patients with increased levels of troponin I

Measure: Incidence of cardiac lesions

Time: after randomization, up to 120 days

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

Measure: Incidence of cardiac disfunctions

Time: after randomization, up to 120 days

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

Measure: Change in respiratory capacity

Time: Day 120 after randomization
101 A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection

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

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

Primary Outcomes

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

Measure: Time to clinical worsening

Time: RCT (approximately 15 days)

Secondary Outcomes

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

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

Time: RCT (approximately 15 days)

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

Measure: clinical deterioration measured by number of days

Time: RCT (approximately 15 days)

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

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

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

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

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

Primary Outcomes

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

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

Time: One month from the start of treatment

Secondary Outcomes

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

Measure: Time to clinical recovery (TTCR)

Time: One month from the start of treatment

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

Measure: Symptom Severity Score

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

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

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

Primary Outcomes

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

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

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

Measure: the value of FEV1 by lung function test

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

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

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

Secondary Outcomes

Measure: the predicted value of FEV1 by lung function test

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

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

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

Description: laboratory result

Measure: Lymphocyte value

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

Description: laboratory result

Measure: Neutrophil value

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

Description: laboratory result

Measure: DDI value

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

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

Measure: the proportion of applying ACEIs/ARBs medication

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

Description: clinical symptoms

Measure: number of clinical symptoms after hospital discharge

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

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

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

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

Time: one month, three month, six month and one year after discharge
104 Coronavirus Disease 2019- Using Ascorbic Acid and Zinc Supplementation (COVIDAtoZ) Research Study A Randomized, Open Label Single Center Study

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

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

Primary Outcomes

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

Measure: Symptom Reduction

Time: 28 days

Secondary Outcomes

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

Measure: Symptom Resolution: Fever

Time: 28 days

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

Measure: Symptom Resolution: Cough

Time: 28 days

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

Measure: Symptom Resolution: Shortness of Breath

Time: 28 days

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

Measure: Symptom Resolution: Fatigue

Time: 28 days

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

Measure: Symptom Resolution: Muscle/body aches

Time: 28 days

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

Measure: Symptom Resolution: Headache

Time: 28 days

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

Measure: Symptom Resolution: New loss of taste

Time: 28 days

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

Measure: Symptom Resolution: New loss of smell

Time: 28 days

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

Measure: Symptom Resolution: Congestion/ runny nose

Time: 28 days

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

Measure: Symptom Resolution: Nausea

Time: 28 days

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

Measure: Symptom Resolution: Vomiting

Time: 28 days

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

Measure: Symptom Resolution: Diarrhea

Time: 28 days

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

Measure: Day 5 Symptoms

Time: 5 days

Description: Differences in hospitalization events between the study arms

Measure: Hospitalizations

Time: 28 days

Description: Differences in severity of symptoms between study arms

Measure: Severity of Symptoms

Time: 28 days

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

Measure: Adjunctive Medications

Time: 28 days

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

Measure: Supplementation Side Effects

Time: 28 days
105 Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial

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

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

Primary Outcomes

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

Measure: Time to clinical improvement

Time: day 14

Secondary Outcomes

Measure: Overall survival

Time: day 28

Measure: Overall survival

Time: day 90

Measure: Cumulative incidence of ICU admission

Time: day 28

Measure: Length of hospital stay

Time: day 90

Measure: Positive nasal PCR

Time: day 7

Measure: Incidence of adverse events

Time: day 28

Description: according to CTC AE-4.03

Measure: Incidence of grade 3-4 adverse events

Time: day 28

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

Measure: World Health Organisation (WHO) progression scale

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

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

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

Primary Outcomes

Description: Compare rates of intubation between treatment and control groups

Measure: Decrease incidence of intubation by 30% or greater

Time: one month

Secondary Outcomes

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

Measure: Decrease renal injury

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

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

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

Primary Outcomes

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

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

Time: 7 Days

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

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

Time: 30 Days

Secondary Outcomes

Description: The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date.

Measure: Duration of hospitalization

Time: 60 Days

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

Measure: Duration of mechanical ventilation

Time: 60 Days

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

Measure: Time to symptoms resolution

Time: 60 Days

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

Measure: Overall survival

Time: 60 Days

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

Time: 60 Days

Measure: Impact of donor titers level on efficacy

Time: 60 Days

Measure: Impact of donor titers level on safety

Time: 60 Days

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

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

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

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

Primary Outcomes

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

Measure: Critical condition or death

Time: 28 days

Description: Kinetics of circulating IL-6

Measure: IL-6

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

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

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

Primary Outcomes

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

Time: 60 days

Secondary Outcomes

Measure: Cumulative incidence of intubation

Time: 14 days

Measure: Time to extubation

Time: 14 days

Measure: Length of ICU stay

Time: 14 days

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

Time: 14 days

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

Measure: Patient Survival

Time: 28 days

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

Measure: Patient Survival

Time: 60 days
110 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
111 Randomized Multicenter Study Evaluating the Efficacy of Azithromycin and Hydroxychloroquine in the Prevention of SARS-CoV-2 Infection in the Hospital Population Exposed to Virus

The Investigators propose to set up a preventive trial of infection in hospital workers at risk of coronavirus infection by comparing the rate of SARS-Cov-2 infection in a population of negative SARS-Cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a Placebo

NCT04344379
Conditions
  1. SARS-CoV-2 Infection
Interventions
  1. Drug: hydroxychloroquine
  2. Drug: azithromycin
  3. Drug: hydroxychloroquine placebo
MeSH:Infection

Primary Outcomes

Description: The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up.

Measure: To assess the impact of hydroxychloroquine and azithromycin on the prevention of SARS-CoV-2 contamination in hospital workers exposed to 40 days of treatment.

Time: 3 months

Secondary Outcomes

Description: Clinical signs suggesting SARS-2 CoV infection confirmed by positive endonasal PCR

Measure: Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR

Time: 40 days

Description: number of seroconversion by serology between Day 0 and Day 40.

Measure: Reducing seroconversion for SARS-CoV-2 without any clinical sign

Time: 3 months

Description: number of cardiological severe adverse events assessed (ECG abnormalities : widening QT, ventricular arythmia, and cardiac arrests), other serious adverse events including hospitalizations, and deaths

Measure: Evaluation of drug tolerance in the study

Time: 40 days

Description: Number of work stoppages over the period

Measure: Evaluation on work stopping of hospital workers

Time: 40 days

Description: Plasmatic concentrations of treatments

Measure: Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine

Time: 40 days

Description: number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments

Measure: Incidence of cardiologic events

Time: 40 days
112 Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection

This is a phase 2b prospective, randomized, single-blind, controlled trial of a single subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2 infection in non-hospitalized participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All participants will be followed for up to 12 weeks.

NCT04344600
Conditions
  1. Sars-CoV2
Interventions
  1. Drug: Peginterferon lambda alfa-1a subcutaneous injection
  2. Other: Saline
MeSH:Infection

Primary Outcomes

Description: No evidence of SARS-CoV-2 infection at or before study day 28

Measure: Proportion of participants with no evidence of SARS-CoV-2 infection

Time: Up to 28 days

Description: Resolution of SARS-CoV-2 infection in the upper respiratory tract

Measure: Time (days) to no detection of SARS-CoV-2 in two upper respiratory samples

Time: Up to 14 days
113 An Open Clinical Trial to Evaluate Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

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

NCT04345276
Conditions
  1. COVID-19
Interventions
  1. Drug: Danoprevir+Ritonavir
MeSH:Infection

Primary Outcomes

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

Measure: Rate of composite adverse outcomes

Time: Within 10 days after administration

Secondary Outcomes

Description: Clinical recovery was defined as sustained (48 hours) alleviation of illness based on symptom scores (fever, cough, diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 30 breaths per min without supplemental oxygen).

Measure: Time to recovery

Time: Within 10 days after administration

Measure: Rate of no fever

Time: Within 10 days after administration

Measure: Rate of no cough

Time: Within 10 days after administration

Measure: Rate of no dyspnea

Time: Within 10 days after administration

Measure: Rate of no requiring supplemental oxygen

Time: Within 10 days after administration

Measure: Rate of undetectable New coronavirus pathogen nucleic acid

Time: Within 10 days after administration

Measure: Rate of mechanical ventilation

Time: Within 10 days after administration

Measure: Rate of ICU admission

Time: Within 10 days after administration

Measure: Rate of serious adverse event

Time: Within 10 days after administration
114 Correlative Study on Cancer Patients and Healthcare Professionals Exposed to SARS-CoV-2 Infection

Translational, prospective / retrospective, non-profit, non-pharmacological study, with cohort characteristics. The study consists of two parts: the first to study epidemiological aspects of the spread of the disease and the second one to identify infection-related genetic factors.

NCT04345315
Conditions
  1. COVID-19
  2. SARS-CoV-2
Interventions
  1. Other: serological test
  2. Other: Rapid molecular test
  3. Genetic: Next generation Sequencing (NGS) analysis
  4. Other: serum chemistry analysis
MeSH:Infection

Primary Outcomes

Description: Investigate the epidemiology of the infection in an asymptomatic population including both healthy individuals at high risk of infection and oncological patients by assessing the seroprevalence of IgG and IgM antibodies against the SARS-CoV-2

Measure: epidemiology

Time: 12 months

Secondary Outcomes

Description: IgG and IgM antibodies evaluation over time

Measure: Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation

Time: 12 months

Description: Make a comparison between different serological investigation methods and rapid molecular methods becoming available

Measure: methods comparison

Time: 24 months

Description: To evaluate correlation between biochemical and coagulative factors with SARS-CoV-2 positivity

Measure: correlation between biochemical and coagulative factors with SARS-CoV-2 positivity.

Time: 24 months

Description: Building a phylogenetic map of an epidemic Italian macro-region

Measure: phylogenetic map

Time: 24 months

Description: Evaluate the spectrum of possible interactions between the virus and host cells, considering their genetic variability / instability in patients diagnosed with COVID-19

Measure: interactions between the virus and host cells

Time: 24 months
115 Testing for COVID-19 Infection in Asymptomatic Persons

Intensive action has been taken around the globe to fight the corona virus SARS-COV-2 (COVID-19) pandemia. Clinical symptoms of the infection appear to be variable, from basically asymptomatic infections and mild, flu-like symptoms up to severe respiratory insufficiency, requiring mechanical ventilation at the intensive care unit, and death. Broad testing for COVID-19 infection has been proven difficult in clinical practice and hampered by limited resources. Urgently needed epidemiological data on the rate of silent, asymptomatic infections in the population and the percentage of individuals that have already developed immunity are still missing. Within this study we therefore plan to (i) determine the proportion of asymptomatic COVID-19 virus carriers in (a) German Cancer Research Center (DKFZ) employees, who work and are present at the center during the time of extended minimum operation and (b) in all DKFZ employees before onboarding when extended minimum operation has been terminated. We plan to (ii) develop a high-throughput assay for COVID-19 testing as well as (iii) a serum-based COVID-19 antibody assay. Finally, we will (iv) analyze for a possible correlation between oral microbiome and COVID-19 infection status.

NCT04345510
Conditions
  1. COVID-19 Infection
MeSH:Infection Communicable Diseases

Primary Outcomes

Measure: COVID-19 infection

Time: 6 weeks
116 An Open Randomized Study of the Effectiveness of the Drug Dalargin for the Prevention and Treatment of Symptoms of Pulmonary Complications in Patients With Coronavirus Infection (SARS-COVID-19)

The purpose of the study is to evaluate an effectiveness of the drug Dalargin for the prevention and treatment of severe pulmonary complications symptoms associated with severe and critical coronavirus infection cases (SARS COVID19, expanded as Severe acute respiratory syndrome Cоrona Virus Disease 2019 ). Test drug that will be administered to patients are: - Dalargin, solution for inhalation administration, - Dalargin, solution for intravenous and intramuscular administration.

NCT04346693
Conditions
  1. Acute Respiratory Tract Infection
  2. Acute Respiratory Insufficiency
  3. Pneumonia
  4. Septic Shock
  5. Hypoxemia
Interventions
  1. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation.
  2. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection
  3. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation
  4. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation
MeSH:Infection Respiratory Tract Infections Pneumonia Respiratory Insufficiency Pulmonary Valve Insufficiency Hypoxia
HPO:Hypoxemia Pneumonia Pulmonary insufficiency Respiratory tract infection

Primary Outcomes

Description: Estimated by Polymerase chain reaction (PCR)

Measure: The change of viral load in patients with SARS-COVID-19.

Time: Upon patient inclusion in the study, after 96 hours and on the 10day;

Description: Assessed through the entire patient participation in the study

Measure: The frequency of development of Acute Respiratory Distress Syndrome (ADRS)

Time: up to 10 days

Description: The number of days a patient is hospitalized

Measure: Duration of hospitalization

Time: up to 10 days

Description: Early mortality from all causes will be estimated

Measure: The frequency of early mortality

Time: up to 30 days

Description: Late mortality from all causes will be estimated

Measure: The frequency of late mortality

Time: up to 90 days

Description: Clinical status at the time of completion of participation in the study will be estimated based upon the following criteria: Death; Hospitalization is extended, on invasive mechanical ventilation of the lungs with extracorporeal membrane oxygenation; Hospitalization extended, on non-invasive ventilation; Hospitalization is extended, needs additional oxygen; Hospitalization is extended, additional oxygen is not required; Discharged.

Measure: Clinical status at the time of completion of participation in the study

Time: an average of 10 days
117 CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort

The overall objective of the study is to determine the therapeutic effect and tolerance of Eculizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Eculizumab is a terminal complement inhibitor that has been investigated for more than 10 years in numerous complement-mediated diseases. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Eculizumab administration to patients enrolled in the CORIMUNO-19 cohort. Eculizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Eculizumab will receive standard of care. Outcomes of Eculizumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

NCT04346797
Conditions
  1. SARS-CoV-2
  2. COVID19
Interventions
  1. Drug: Eculizumab
MeSH:Infection

Primary Outcomes

Description: Survival without needs of intubation, events considered are intubation or death

Measure: Survival without needs of intubation at day 14

Time: 14 days

Description: Change in organ failure at day 3, defined by the relative variation in Sequential Organ Failure Assessment score

Measure: Change in organ failure at day 3

Time: 3 days

Secondary Outcomes

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

Measure: Intubation free survival at day 14

Time: Day 14

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

Measure: WHO progression scale at days 4, 7 and 14

Time: 4, 7 and 14 days

Description: Overall survival

Measure: Survival at 14, 28 and 90 days

Time: 14, 28 and 90 days

Description: Time between inclusion and hospital discharge

Measure: Time to discharge

Time: 90 days

Description: Time between inclusion and oxygen supply independency

Measure: Time to oxygen supply independency

Time: 90 days

Description: Time between inclusion and negative viral excretion

Measure: Time to negative viral excretion

Time: 90 days

Description: Incidence of secondary infections (acquired pneumonia)

Measure: Incidence of secondary infections

Time: 90 days

Description: Vasopressor-free survival

Measure: Vasopressor-free survival

Time: 90 days

Description: Ventilator-free survival

Measure: Ventilator-free survival

Time: 90 days

Description: Number of ventilator-free days alive up to day 28

Measure: 28-day ventilator-free days

Time: 28 days

Description: Incidence of dialysis (renal replacement therapy)

Measure: Incidence of dialysis

Time: 90 days

Description: PaO2/FiO2 ratio

Measure: PaO2/FiO2 ratio

Time: days 4, 7, 14

Description: Number of patients with arterial blood pH of <7.25, with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours

Measure: Rate of respiratory acidosis at day 4

Time: 4 days

Description: Time to ICU discharge

Measure: Time to ICU discharge

Time: 90 days
118 IMPACT RAPPORT: IMPact of Antimalarials on Covid Infections: a Case Control sTudy of RAPPORT

This study aims to evaluate the experience of Alberta patients with inflammatory arthritis who participate in the the RAPPORT-ONTRAAC registry during the COVID-19 pandemic, specifically comparing the experience of those taking anti-malarial medications compared to those who do not. This registry includes approximately 2500 northern Alberta patients with inflammatory arthritis who receive highly complex therapies which may be associated with side effects. This program of data collection and research has been evaluating the effectiveness and safety as well as associated health care costs of rheumatoid and psoriatic arthritis patients since 2004. The principle investigators are based at the University of Alberta while the co-investigators are academic rheumatologists at the University of Alberta. The registry has approximately 900 patients taking anti-malarials combined with their complex therapies and ~ 1500 not on anti-malarials in combination with their complex therapies. We aim to perform a case control study evaluating the impact of anti-malarial drugs (eg. hydroxychloroquine and chloroquine) on the development of COVID-19 compared to those patients who are not on anti-malarial drugs over the next 6-12 months. In addition to frequent e-mail surveys screening for the clinical symptoms of COVID-19 and understanding their concomitant arthritis medication use, we will compare the healthcare outcomes of both groups of arthritis patients with and without COVID-19 for the duration of the pandemic. This information will provide critical information beyond an anecdotal level on whether or not anti-malarials truly provide a protective benefit against COVID-19 or reduce the severity of infection. A blood sample from all participants (Covid-19 positive and negative) will be drawn approximately six months into the study for measurement of antibodies to Covid-19 and possible blood types and HLA alleles. Additionally, this study will be linked to another study "Persistence of SARS-Cov2 in immunocompromised patients" which will specifically evaluate COVID-19 serology and nasopharyngeal swab findings in the subset of patients who develop COVID-19.

NCT04347798
Conditions
  1. Covid-19 Infection
  2. Rheumatoid Arthritis
  3. Psoriatic Arthritis
  4. Hydroxychloroquine
Interventions
  1. Other: Hydroxychloroquine/Chloroquine
MeSH:Infection Communicable Diseases Arthritis Arthritis, Rheumatoid Arthritis, Psoriatic
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis

Primary Outcomes

Description: Number of patients developing signs and symptoms of Covid-19 or other infections

Measure: Impact of anti-malarials on the development and severity of Covid-19 in the anti-malarial group compared to the non-anti-malarial group

Time: 12 months

Secondary Outcomes

Description: Number of patients developing Covid-19 infection

Measure: Incidence of Covid-19 infection in the anti-malarial group compared to the non-anti-malarial group

Time: 12 months

Description: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action

Measure: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action

Time: 12 months

Other Outcomes

Description: Quantitative measurement of Covid-19 serology to understand possible differences in degree of immune response adjusted for anti-malarial and/or biologic exposure

Measure: Quantification of Covid-19 antibodies in anti-malarial vs non-anti-malarial groups of inflammatory arthritis patients

Time: 6 months
119 Screening and Risk Assessment of Healthcare Workers and Infection Control in University and COVID-19 Quarantine Hospitals Using Real-time Geospatial Mapping for Emergency Healthcare Resource Mobilization and Management

A prospective investigation and screening of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals using an online survey and laboratory testing using rapid serological tests and PCR. To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently. For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. For confirmation of infection and determination of the secondary infection rate, paired serological samples at baseline and after exposure will be collected. For measuring the validity of the available rapid serological tests, a respiratory sample will be taken for viral detection by RT-PCR. A real-time interactive map using geographical information system programming will be developed to flag hotspots for HCWs' risk and infection control needs that originated from the online survey risk categorization in governmental university and COVID-19 quarantine hospitals. Policy and decision makers will use the map to manage emergency healthcare resource mobilization based on HCWs' risk and infection control needs.

NCT04348214
Conditions
  1. Coronavirus Disease (COVID-19)
MeSH:Infection Coronavirus Infections

Primary Outcomes

Description: To determine the risk categorization of HCWs for exposure to a COVID-19 patient using an online survey in governmental university and COVID-19 quarantine hospitals

Measure: Risk categorization of healthcare workers

Time: 9 months

Description: To estimate the COVID-19 infection rate among HCWs in governmental university and quarantine hospitals.

Measure: COVID-19 infection rate among health care workers

Time: 9 months

Description: To determine the risk factors for COVID-19 among health care workers in governmental university and quarantine hospitals.

Measure: Risk factors for COVID-19 among health care workers

Time: 9 months

Description: To evaluate adherence of HCWs to infection prevention and control measures using an online survey in governmental university and COVID-19 quarantine hospitals.

Measure: Adherence of health care workers to infection prevention

Time: 9 months

Description: To determine the validity (sensitivity and specificity) of the available rapid serological test for detecting COVID-19 virus infection among HCWs in governmental university and COVID-19 quarantine hospitals.

Measure: Validity of the available rapid serological test for detecting COVID-19 virus infection

Time: 9 months

Secondary Outcomes

Description: To characterize the risk factors, clinical spectrum, duration and severity of COVID-19 infections among HCWs in governmental university and quarantine hospitals.

Measure: Clinical spectrum of COVID-19

Time: 9 months

Description: To evaluate the effectiveness of infection prevention and control measures programs at health facility level using an online survey tool in governmental university and COVID-19 quarantine hospitals

Measure: Effectiveness of infection prevention in the health care facility

Time: 9 months

Description: To determine the emergency infection prevention and control needs among HCWs using an online survey tool in governmental university and COVID-19 quarantine hospitals

Measure: Emergency infection prevention and control needs

Time: 9 months

Description: To determine the isolation rate among HCWs and the need for emergency HCW replacement in governmental university and COVID-19 quarantine hospitals.

Measure: Isolation rate and emergency health care worker replacement needs

Time: 9 months

Description: To determine the serologic response for HCWs with symptomatic and possibly asymptomatic COVID-19 virus infection in governmental university and COVID-19 quarantine hospitals.

Measure: Rate of seroconversion

Time: 9 months
120 Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support)

This study is a phase II, parallel, prospective, randomized, double-blind, placebo controlled trial. The present study will aim to address the efficacy and safety of acute administration of triiodothyronine on ICU patients diagnosed with pulmonary infection due to COVID-19 and require mechanical respiratory support or ECMO.

NCT04348513
Conditions
  1. Pulmonary Infection
  2. Covid-19
Interventions
  1. Drug: T3 solution for injection
  2. Drug: Placebo
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: The primary objective of the study is to determine whether the administration of intravenous triiodothyronine in ICU patients diagnosed with pulmonary infection due to COVID-19 facilitates weaning from cardiorespiratory support compared to placebo. Successful weaning is defined as no requirement for ventilatory support after extubation (mechanical support) or support from ECMO for 48 hours. The primary objective will be measured as percentage of patients successfully weaned after 30 days of follow-up.

Measure: Assessment of weaning from cardiorespiratory support

Time: 30 days

Secondary Outcomes

Description: Hemodynamic status will be assessed by continuous blood pressure measurements (systolic BP in mmHg)

Measure: Assessment of hemodynamic status

Time: 30 days

Description: Hemodynamic status will be assessed by continuous blood pressure measurements (diastolic BP in mmHg)

Measure: Assessment of hemodynamic status

Time: 30 days

Description: Hemodynamic status will be assessed by continuous blood pressure measurements (mean BP in mmHg)

Measure: Assessment of hemodynamic status

Time: 30 days

Description: Hemodynamic status will be assessed by the number of participants with use of inotropic and vasoactive drugs

Measure: Assessment of hemodynamic status

Time: 30 days

Description: Pulmonary function will be assessed by arterial measurement of blood gases (arterial partial pressure of oxygen in mmHg)

Measure: Assessment of pulmonary function

Time: 30 days

Description: Pulmonary function will be assessed by arterial measurement of blood gases (arterial partial pressure of carbon dioxide in mmHg)

Measure: Assessment of pulmonary function

Time: 30 days

Description: Pulmonary function will be assessed by arterial measurement of lactate levels (in mmol/L)

Measure: Assessment of pulmonary function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in aspartate aminotransferase (AST in IU/L) will be measured.

Measure: Assessment of hepatic function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in alanine aminotransferase (ALT in IU/L) will be measured.

Measure: Assessment of hepatic function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in gamma-glutamyl transpeptidase (γ-GT in IU/L) will be measured.

Measure: Assessment of hepatic function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in bilirubin in mg/dL will be measured.

Measure: Assessment of hepatic function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in fibrinogen in mg/dL will be measured.

Measure: Assessment of hepatic function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in d-dimers in ng/ml will be measured.

Measure: Assessment of hepatic function

Time: 30 days

Description: Urine volume during 24 hours (in ml) will be recorded.

Measure: Assessment of renal function

Time: 30 days

Description: Changes in urea (in mg/dL) will be recorded.

Measure: Assessment of renal function

Time: 30 days

Description: Changes in uric acid (in mg/dL) will be recorded.

Measure: Assessment of renal function

Time: 30 days

Description: Changes in creatinine (in mg/dL) will be recorded.

Measure: Assessment of renal function

Time: 30 days

Description: Echocardiographic assessment of cardiac left ventricular ejection fraction (LVEF, %)

Measure: Assessment of cardiac function

Time: 30 days

Description: Measurements of cardiac troponin I (in μg/L) will be used to assess myocardial injury

Measure: Assessment of cardiac injury

Time: 30 days

Description: COVID-19 infection will be assessed by inflammatory indices in blood (white blood cells in number per μL)

Measure: Assessment of the course of COVID-19 infection

Time: 30 days

Description: COVID-19 infection will be assessed by inflammatory indices in blood (CRP in mg/L)

Measure: Assessment of the course of COVID-19 infection

Time: 30 days

Description: COVID-19 infection will be assessed by inflammatory indices in blood (erythrocyte sedimentation rate in mm/hr)

Measure: Assessment of the course of COVID-19 infection

Time: 30 days

Description: COVID-19 infection will be assessed by temperature monitoring (in degrees Celsius)

Measure: Assessment of the course of COVID-19 infection

Time: 30 days

Description: COVID-19 infection will be assessed by time needed (in days) for the patient to become negative in COVID-19

Measure: Assessment of the course of COVID-19 infection

Time: 30 days

Description: Number of participants with major (death, cardiac Arrest, electromechanical dissociation, pulmonary embolism, new myocardial infarction, stroke, pulmonary edema, cardiogenic shock and hypotension, septic shock, pulmonary embolism, serious bleeding) events be recorded during the follow up period

Measure: Assessment of clinical outcome and safety

Time: 30 days

Description: Number of participants with minor (myocarditis, Venous Thromboembolism, left Ventricular mural thrombus, renal failure, hepatic failure, stress ulcers, minor bleeding, paroxysmal supraventricular tachycardia and atrial fibrillation, rhythm disturbances) events will be recorded during the follow up period

Measure: Assessment of clinical outcome and safety

Time: 30 days
121 Assessment of COVID-19 IgM/IgG Self-testing Using Virtual Point-of-care

The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic tests, like Coris Bioconcept Ag Respi-strip COVID-19 test, and LAMP-based molecular tests) in order to judge their clinical accuracy compared to Centers for Disease Control (CDC)-recommended molecular genetic testing and clinical diagnosis. Second, it is our goal to determine if self-testing assisted by COVIDscanDX mobile device camera acquisition software platform and telemedicine clinical/technical support (virtual point-of-care) improves the ease of use and immediate interpretation of the tests, thus making self-testing comparable in accuracy and safety to testing in a clinical setting. The overall purpose of the study is to dramatically increase the capacity of COVID-19 testing by establishing the safety, ease-of-use and validity of self-testing assisted by mobile device imaging and telemedicine remote support.

NCT04348864
Conditions
  1. Communicable Disease
  2. COVID-19
  3. Sars-CoV2
  4. Infectious Disease
  5. Coronavirus
  6. Virus
Interventions
  1. Diagnostic Test: COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support
  2. Other: Telemedicine
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Accuracy refers to the amount of agreement between the results of the antibody-based rapid test and the results of a PCR-based reference test

Measure: Clinical accuracy of the antibody and antigen rapid tests compared to LAMP/PCR-based test result

Time: 1 year

Description: Accuracy refers to the amount of agreement between the results of the rapid tests and a clinical diagnosis of COVID-19

Measure: Clinical accuracy of the antibody and antigen rapid tests based on Clinical diagnosis

Time: 1 year

Description: Clinical accuracy of the subject's visual interpretation of the test result vs image analysis from clinician

Measure: Self-test interpretation of result vs expert clinical image interpretation of result

Time: 1 year

Secondary Outcomes

Description: Subjects will complete a survey to rate the testing procedure for ease of use and convenience. The survey will ask subjects to rate the ease of use on a scale from 1 (easiest procedure to complete and understand) to 10 (most complicated and confusing procedure)

Measure: Ease of self-testing procedure

Time: 1 year
122 A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection

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

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

Primary Outcomes

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

Time: Baseline to Day 14

Secondary Outcomes

Measure: Time to Clinical Improvement (TTCI)

Time: Up to Day 28

Measure: Overall Death Rate

Time: Day 14, Day 28

Measure: Rate of Mechanical Ventilation

Time: Up to Day 28

Measure: Time to Mechanical Ventilation

Time: Up to Day 28

Measure: Overall Survival

Time: Up to Day 28

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

Time: Baseline, Day 28

Measure: Time to Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Rate of Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Length of Stay in Hospital

Time: Up to Day 28

Measure: Percentage of Participants Discharged from Hospital

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Duration of Oxygen Supplementation

Time: Up to Day 28

Measure: Duration of Mechanical Ventilation

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Change in Oxygenation Index

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Change from Baseline in Ferritin Levels

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Changes from Baseline in Blood Plasma Cytokines Levels

Time: Up to Day 28

Measure: Number of Participants with Adverse Events (AE)

Time: From start of study drug administration up to Day 28
123 Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection

The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations. Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics. The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.

NCT04350086
Conditions
  1. COVID-19 Infection
  2. Sars-cov-2
  3. Respiratory Failure
  4. Palliative Situation
Interventions
  1. Drug: Treatment with Dexmedetomidine
MeSH:Infection Communicable Diseases Respiratory Insufficiency

Primary Outcomes

Description: Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule.

Measure: Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine.

Time: Day 30

Secondary Outcomes

Description: Overall survival time in days from inclusion.

Measure: Overall survival of patients on Dexmedetomidine

Time: Day 30

Description: The daily effectiveness of Dexmedetomidine on pain assessed by the NCS-R scale (Nociception Coma Scale) : the score is between 0 and 9.

Measure: Daily analgesic effect of Dexmedetomidine

Time: Day 30

Description: Number of the various sedative molecules used in the subjects of the study in addition to Dexmedetomidine.

Measure: Other sedative pharmacological agents

Time: Day 30

Description: Daily dosage measurement in ug / kg / h of Dexmedetomidine necessary to obtain light to moderate sedation

Measure: Average dosage required for Dexmedetomidine to achieve mild to moderate sedation

Time: Day 30
124 Emotional Burden of Healthcare Professionals and the Epidemic Related to Covid Infection 19 -

COVID-19 ( known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)) has a highly polymorphic clinical presentation, ranging from pauci-symptomatic infection to severe, potentially complicated forms with acute respiratory distress syndrome or multisystemic organs failure. The picture may be initially severe, or it may progress in two stages, with worsening 7 to 10 days after the first symptoms with an overall case-fatality rate of 3 to 4%. Its management is essentially symptomatic, as no antiviral treatment has so far demonstrated a clinical benefit in this condition. In such a context, healthcare professionals assigned to COVID units will be faced with a heavy workload and emotional burden that could lead to psychological suffering or even burnout and its consequences. We would therefore like to describe, using validated tools, the emotional evolution of the care workers at the Limoges University Hospital and the Esquirol University Hospital faced with this new pandemic infection. An initial and end-of-study evaluation of the caregivers will be carried out concerning their anxiety and depressive state, their personal capacity for resilience and their degree of empathy

NCT04350099
Conditions
  1. Emotionnal Distress; COVID-19
Interventions
  1. Other: quetionnary
MeSH:Infection

Primary Outcomes

Description: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Measure: anxiety

Time: 7 days,

Description: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Measure: anxiety

Time: 15 days,

Description: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Measure: anxiety

Time: 1 month

Description: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Measure: anxiety

Time: 3 month
125 Austrian COVID-19 Registry (AGMT_COVID-19)

The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2. Data will be collected from all sites in Austria willing to participate. Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF.

NCT04351529
Conditions
  1. Infectiou
  2. Infectious Disease
  3. COVID-19
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF. Treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations, and response assessments shall be exclusively based on the risk/benefit estimation of the treating physician.

Measure: Documentation of natural course and the therapeutic landscape of patients with COVID-19.

Time: 2 years
126 SARS-CoV-2 Infection in Patients With Hematological Malignancies: the Italian Hematology Alliance

This is a retrospective/prospective, cohort, non-interventional observational study. This means that all patients with documented COVID and HM diagnosed between February 2020 and study initiation will compose the retrospective part, while those diagnosed after study approval will enter prospective part. The total duration of the study will be 12 months. The study population will must be older than 18 years of age with HM and SARS-CoV-2 infection. All patients with documented SARS-CoV-2 infection (COVID) and history or active hematological malignancies, who refer to any Hematological Unit will be included.

NCT04352556
Conditions
  1. SARS-CoV-2 Infection
  2. Hematological Malignancies
MeSH:Infection Neoplasms Hematologic Neoplasms
HPO:Hematological neoplasm Leukemia Neoplasm

Primary Outcomes

Description: The percentage of HM patients with COVID-19 who died.

Measure: To evaluate mortality.

Time: At 2 months from study initiation

Description: We will assess the correlation between some biochemical parameters at diagnosis of COVID (i.e. hemoglobin, platelets, lymphocytes, clotting tests, CRP), each on the basis of its specific unit of measure, and mortality.

Measure: To evaluate potential predictive biochemical parameters of mortality.

Time: At 2 months from study initiation

Description: We will assess the correlation between HM-related parameters at diagnosis of COVID [i.e. disease type (leukemia, lymphomas, myeloma), disease status (remission / stable / progression), therapy status (on / off therapy)] and mortality.

Measure: To evaluate potential predictive HM-related parameters of mortality.

Time: At 2 months from study initiation

Description: We will assess the correlation between COVID severity [mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical (respiratory failure, septic shock, and/or multiple organ disfunction or failure)] and mortality

Measure: To evaluate COVID severity as predictive parameter of mortality.

Time: At 2 months from study initiation

Secondary Outcomes

Description: Description of the different types of hematological malignancies (WHO criteria) in patients with SARS-CoV-2 infection. All aggregated data will be stratified on the basis of COVID severity: mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical disease (respiratory failure, septic shock, and/or multiple organ disfunction or failure)

Measure: Epidemiology of patients with HM infected by SARS-CoV-2with any spectrum of illness severity

Time: At 6 months from study initiation

Description: Characterization of clinical and biochemical profile of patients with SARS-CoV-2 positivity.

Measure: Definition of complete clinical picture of COVID-19 in HM

Time: At 2 months from study initiation

Description: Assessment of HM status post SARS-CoV-2 infection stratified as no implication, loss of response, progression of the hematological disease.

Measure: Evolution of HM

Time: At 2 months from study initiation

Description: Percentage of HM patients being admitted to ICU requiring mechanical ventilation, or death stratified per disease type, status, per off-therapy/on-therapy, per type of therapy (chemo, immunotherapy, cell therapy, stem cell transplant).

Measure: To evaluate admission to ICU requiring mechanical ventilation or death per characteristics

Time: At 2 months from study initiation

Measure: Viral dynamics in infected HM patients

Time: At 12 months from study initiation
127 Multicenter Randomized Controlled Trial of the Efficacy of Melatonin in the Prophylaxis of SARS-coronavirus-2 Infection Among High Risk Contacts.

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

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

Primary Outcomes

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

Measure: SARS-CoV 2 infection rate

Time: up to 12 weeks
128 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
129 Prediction of Acute Heart or Kidney Injury With Cardiovascular-renal Biomarkers in Patients Hospitalised for Severe or Critical Covid-19 Infection

The Nancy Cov-H-AKI: study is a prospective, non-randomized, monocenter study performed in patients hospitalised for either the severe or the critical form of Covid-19. The main objective of the Nancy Cov-H-AKI study is to evaluate the association of variations (from inclusion to 72H post-inclusion) of 5 blood-based cardio-vascular-renal biomarkers selected a priori, cardiac (NT-proBNP), coagulation (D-dimers), related to the renin angiotensin aldosterone system (ACE2) and renal (Penkid, and NGAL) with the appearance of acute kidney injury KDIGO grade 1 or higher OR cardiac injury in patients hospitalised for either the severe or the critical form of Covid-19

NCT04354610
Conditions
  1. COVID 19
Interventions
  1. Procedure: Biological samples specific to research
  2. Procedure: Clinical examination
  3. Procedure: Telephone follow-up
MeSH:Infection

Primary Outcomes

Description: Composite endpoint : Worsening of renal function by at least KDIGO grade 1 criteria from inclusion visit OR troponin greater than 99th percentile during hospitalization for Covid-19 infection (with Outcome 2).

Measure: Worsening of renal function by at least KDIGO grade 1 during hospitalization for Covid-19 infection

Time: From inclusion to hospital discharge, an average of 21 days

Description: Composite endpoint : Worsening of renal function by at least KDIGO grade 1 criteria from inclusion visit OR troponin greater than 99th percentile during hospitalization for Covid-19 infection (with Outcome 1)

Measure: Troponin greater than 99th percentile during hospitalization for Covid-19 infection

Time: From inclusion to hospital discharge, an average of 21 days

Secondary Outcomes

Description: Composite endpoint : AKI KDIGO grade 1 or higher or Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) ((with Outcome 3 )

Measure: AKI KDIGO grade 1 or higher in hospitalisation (approach with AND without a priori)

Time: From inclusion to hospital discharge, an average of 21 days

Description: Composite endpoint : AKI KDIGO grade 1 or higher or Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) (with Outcome 3)

Measure: Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori)

Time: From inclusion to hospital discharge, an average of 21 days

Description: AKI KDIGO grade 1 in hospitalisation

Measure: AKI KDIGO grade 1 or higher

Time: From inclusion to hospital discharge, an average of 21 days

Description: Association with troponin elevation >99th percentile during hospitalisation

Measure: Association with troponin elevation >99th

Time: From inclusion to hospital discharge, an average of 21 days

Description: Association with elevation of serum creatinine >30% during hospitalisation

Measure: Association with elevation of serum creatinine >30%

Time: From inclusion to hospital discharge, an average of 21 days

Description: With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from hospital

Measure: With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2)

Time: 3 months after discharge from hospital

Description: Composite outcome : the occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) and death from any cause during hospitalisation and three months after discharge from hospital

Measure: The occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) during hospitalisation and three months after discharge from hospital

Time: From inclusion to three months after discharge from hospital

Description: Composite outcome : the occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) and death from any cause during hospitalisation and three months after discharge from hospital

Measure: The occurrence of death from any cause during hospitalisation and three months after discharge from hospital

Time: From inclusion to three months after discharge from hospital
130 Antikörperseroprävalenz Und Hintergrundinfektionsrate Von SARS-CoV-2 in Einem österreichischen Schlüsselkollektiv an Arbeitnehmer*Innen

Context: On March 11, the World Health Organization (WHO) announced the current corona virus disease 2019 (COVID-19) outbreak as a pandemic. The first laboratory-confirmed case of COVID-19 in Austria was announced on February 27, 2020. Since then, the incidence of infection follows a gradual increase. Measurements taken by the Austrian government include travel restrictions, closing of national borders, social distancing, a mandatory use of facemasks in public, and closing of stores and restaurants. The underlying aim of those imposed restrictions is to contain the viral transmission and to slow spreading of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Objectives: The aims of this study are to determine i) how many employees in Austrian trauma hospitals and rehabilitation facilities have virus specific IgG and IgM antibodies against SARS-CoV-2, ii) how many are active virus carriers (symptomatic and asymptomatic), iii) how many employees are in their incubation period during the study period, and iv) to calculate the SARS-CoV-2 prevalence together with a specific occupation associated infection risk within the different specifications of health care workers. Study Design: Open uncontrolled observational cross-sectional study. Setting/Participants: A total of 4000 employees in 11 Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) will be invited to participate in the study. Study Interventions and Measures: An antibody test for SARS-CoV-2 specific IgG and IgM antibodies, and a RT-PCR test based on oropharyngeal swab samples, as well as laboratory-based antibody tests using ELISA, will be implemented to ensure protection and preservation of health in hospital staff and are not part of the study. The tests will be conducted twice, with approximately two weeks in between testing. The results of the tests will be used for statistical analysis in this study together with a questionnaire including questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities.

NCT04354779
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. SARS-CoV 2
  3. Coronavirus Infection
  4. Covid19
Interventions
  1. Diagnostic Test: a specifically designed self-administered questionnaire
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To determine how many employees in Austrian trauma hospitals and rehabilitation facilities have already virus specific IgG and IgM antibodies against SARS-CoV-2.

Measure: Antibody status in HCW

Time: 4 months

Description: To determine how many are actively infected with or without showing symptoms.

Measure: Active virus carriers in HCW

Time: 4 months

Description: To determine how many employees are in their incubation period during study time.

Measure: Incubation time

Time: 4 months

Secondary Outcomes

Description: To evaluate the "background incidence rate" of COVID-19 to calculate the SARS-CoV-2 prevalence in a defined cohort of the Austrian population.

Measure: Background incidence rate

Time: 4 months

Description: To calculate a specific occupation associated infection risk within the different specifications of health care workers amongst AUVA employees.

Measure: Occupation associated infection risk

Time: 4 months
131 Asymptomatic SARS- CoV2 Infection Among Healthcare Workers in Three University Hospitals: A Cross Sectional Study.

To assess the seroprevalence of SARS-CoV-2 IgG in Health care workers in three University Hospitals

NCT04354792
Conditions
  1. Immunologic Activity Alteration
Interventions
  1. Diagnostic Test: Serum SARs COV 2 IGg screening in health care workers
MeSH:Infection

Primary Outcomes

Description: health care workers who have positive IGg in seum

Measure: Number of IGg seropositive health care workers

Time: single measurement from each person collected over 2 months

Secondary Outcomes

Description: to know positive IGg persons and IGg negative persons to understand risk factors

Measure: Differentiation between low risk and high risk HCWs

Time: 2 months through out duration of study
132 An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection

This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.

NCT04354831
Conditions
  1. COVID-19
Interventions
  1. Biological: anti-SARS-CoV-2 convalescent plasma
MeSH:Infection

Primary Outcomes

Description: Overall mortality within 60 days

Measure: Overall Mortality within 60 days

Time: sixty days from infusion of plasma

Secondary Outcomes

Description: length of admission for COVID

Measure: Length of ICU stay during current admission for COVID

Time: Length of admission for COVID through study follow-up period, an average of 60 days
133 Prevalence and Impact of SARS-COV-2 Infection in Pregnant Women, Fetuses and Newborns

A novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission. Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery . This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures. Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth. It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.

NCT04355234
Conditions
  1. Pregnancy
Interventions
  1. Diagnostic Test: identify SARS-CoV-2 infection by serology
  2. Biological: collection of biological samples
MeSH:Infection

Primary Outcomes

Description: Number of women who are positive for SARS-CoV-2

Measure: Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman

Time: at delivery

Secondary Outcomes

Description: Correlation between exposure to the virus (confirmed by serology) and its impact on pregnancy and its outcome : Pregnancy outcome, maternal or neonatal complications

Measure: Consequences of SARS-CoV-2 infection in pregnant women and their newborns : Pregnancy outcome, maternal or neonatal complications

Time: 2 months after delivery

Description: Presence of virus (objectified by PCR) in the different biological compartments tested :In the mother: vaginal, anal, amniotic fluid and in the newborn: nasopharyngeal swabs, gastric aspiration, anal swab.

Measure: Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy

Time: at delivery

Description: Presence of virus (objectified by PCR) in the different biological compartments tested :In the mother: milk and stool samples and in the newborn: nasopharyngeal swabs, urine and stool.

Measure: Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy

Time: 5 days after delivery

Description: Evaluation of gestational age at SARSCoV-2 infection by performing serology on monthly collected serum samples (samples collected for routine management of pregnancy).

Measure: Assessment of susceptibility to infection during the 3 trimesters of pregnancy

Time: 5 days after delivery

Description: Study of the methods of confinement by investigation

Measure: Evaluation of the confinement on the risk of exposure to the virus during pregnancy .

Time: 5 days after delivery

Description: A biobank will be carried out, including the collection of several biological samples at the time of maternal SARS-CoV-2 infection, at delivery and in the postpartum period in the parturient and her newborn

Measure: collection of biological samples for new investigations in women who are positive for SARS-CoV-2 during pregnancy.

Time: 5 days after delivery

Description: Risk factors in uninfected women

Measure: Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.

Time: at delivery

Description: Risk factors in infected and symptomatic women.

Measure: Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.

Time: at delivery

Description: risk factors in newborns

Measure: Assessment of the rate of SARS-CoV-2 infection in newborns and the risk factors for the disease.

Time: at delivery
134 Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil

This is an observational study, meaning that no interventions is tested, to determine incidence of SARS-CoV-2 infection and COVID-19 in different clinical sites in Brazil in several age groups. The study aims to assess baseline number of infected participants and perform a follow-up along two years to determine the new cases occurring among participants during the period. All participants will collect blood samples to get more details on the immune response.

NCT04355338
Conditions
  1. COVID-19
MeSH:Infection

Primary Outcomes

Description: Number of cases with serological/virological diagnosis for SARS-Co-2 infection

Measure: Incidence of SARS-CoV-2 infection

Time: 24 months

Description: Number of cases of symptomatic SARS-CoV-2 infection

Measure: Incidence of COVID-19

Time: 24 months

Secondary Outcomes

Description: Number of cases of hospitalization due to symptomatic SARS-Co-2 infection

Measure: Incidence of hospitalization due to COVID-19

Time: 24 years

Description: Level of neutralizing antibodies in participants with SARS-Co-2 infection

Measure: Level of neutralizing antibodies

Time: 24 months

Description: Positive serology for SARS-Co-2 infection at baseline

Measure: Previous SARS-CoV-2 infection

Time: 6 months

Other Outcomes

Description: Number of a new SARS-CoV-2 infection in an individual with a proven previous infection

Measure: Incidence of SARS-CoV-2 reinfection

Time: 24 months

Description: Number of COVID-19 cases requiring mechanical ventilation

Measure: Incidence of COVID-19 cases requiring mechanical ventilation

Time: 24 months

Description: Number of deaths due to COVID-19

Measure: Incidence of deaths due to COVID-19

Time: 24 months

Description: Number and description of sequels attributed to COVID-19

Measure: Incidence of sequels after COVID-19

Time: 24 months
135 Study of Immune Response During SARS-CoV-2 Infection

Study of the cellular immune response during the SARS-CoV-2 infection and identify cytokinic profiles in caregivers exposed to the virus with asymptomatic forms of COVID19, patients with an asymptomatic form followed in ambulatory care and patients hospitalized in the infectious disease department or in resuscitation at the CHU de Nice COVID-19 according to their clinical symptomatology and the kinetics of clinical aggravation using functional tests evaluating the Th1 type immune response. The project is divided into a clinical component comprising the study of the immune response in different populations and a cellular component focusing on the in vitro study of different immunomodulating treatments on their ability to induce an anti-viral Th1

NCT04355351
Conditions
  1. New Coronavirus Disease (COVID-19), Infection With SARS-CoV-2
Interventions
  1. Other: blood sampling
  2. Other: additional blood tubes
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Peripheral T lymphocytes will be stimulated with an anti-CD3 for 16-24h. The Level of IFN-gamma (pg/mL) will be defined using an automated ELISA test (Protein Simple) on the stimulated and non-stimulated plasma.

Measure: Level of IFN-gamma after a non-specific stimulation of T lymphocytes

Time: 6 months
136 Seroprevalence and Antibody Profiling Against SARS-CoV2 in Children and Their Parents

The purpose of this study is to provide weekly data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.

NCT04355533
Conditions
  1. COVID-19 Infection
Interventions
  1. Biological: serology test
  2. Diagnostic Test: NG Biotech
  3. Biological: nasopharyngeal swab
  4. Biological: rectal swab
  5. Biological: saliva sample
MeSH:Infection

Primary Outcomes

Description: serology

Measure: Seroconversion against SARS-CoV2 in children

Time: at inclusion

Secondary Outcomes

Description: Serology, measure of Ab in children

Measure: Protective immunity

Time: at inclusion

Description: Serology in children

Measure: Measure of Ab antiN and Ab anti-S1/2

Time: at inclusion

Description: Serology in children

Measure: Neutralization activity

Time: at inclusion

Description: in children, qualitative and quantitative measure , in nasopharynx, saliva and stool

Measure: Positive qPCR in children

Time: at inclusion

Description: in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum

Measure: correlation between different Ab and qPCR and neutralization activity

Time: at inclusion

Description: Serology, measure of Ab in PCR positive children

Measure: Protective immunity

Time: Day 7

Description: Serology, measure of Ab in PCR positive children

Measure: Protective immunity

Time: Day 15

Description: Serology, measure of Ab in PCR positive children

Measure: Protective immunity

Time: Day 30

Description: Serology, measure of Ab in PCR positive children

Measure: Protective immunity

Time: At 6 months

Description: Serology, measure of Ab in PCR positive children

Measure: Protective immunity

Time: At 12 months

Description: Sars-Cov2 PCR in PCR positive children

Measure: duration of viral carriage in stool, saliva and or nasopharynx

Time: until 30 days post onset

Description: Serology in PCR positive children

Measure: correlation between antibody profile and viral clearance

Time: until 30 days post onset

Description: Immune cells in positive PCR children

Measure: Ab profile and memory of immunity

Time: At Day 7

Description: Immune cells in positive PCR children

Measure: Ab profile and memory of immunity

Time: At Day 15

Description: Immune cells in positive PCR children

Measure: Ab profile and memory of immunity

Time: At Day 30

Description: Immune cells in positive PCR children

Measure: Ab profile and memory of immunity

Time: At 6 months

Description: Immune cells in positive PCR children

Measure: Ab profile and memory of immunity

Time: At 12 months

Description: Serology and qPCR in positive PCR children

Measure: Transmission to other family members

Time: Until 30 days

Description: Clinical examination and questioning in positive PCR children

Measure: Presence of COVID-19 Symptom

Time: Until 12 months of follow-up

Description: Ancillary study: Serology in parents

Measure: seroconversion against SARS-CoV2 in parents

Time: at inclusion

Description: Ancillary study: Serology in parents

Measure: Measure of Ab antiN and Ab anti-S1 and neutralization activity

Time: at inclusion

Description: Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva

Measure: Positive qPCR in parents

Time: at inclusion

Description: Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum

Measure: correlation between different Ab and qPCR

Time: at inclusion

Description: Ancillary study: Serology in PCR positive parents

Measure: correlation between antibody profile and viral clearance

Time: until 30 days post onset

Description: Ancillary study: Immune cells in positive PCR parents

Measure: Ab profile and memory of immunity

Time: at Day 7

Description: Ancillary study: Immune cells in positive PCR parents

Measure: Ab profile and memory of immunity

Time: at Day 15

Description: Ancillary study: Immune cells in positive PCR parents

Measure: Ab profile and memory of immunity

Time: at Day 30

Description: Ancillary study: Immune cells in positive PCR parents

Measure: Ab profile and memory of immunity

Time: at 6 months

Description: Ancillary study: Immune cells in positive PCR parents

Measure: Ab profile and memory of immunity

Time: at 12 months

Description: Serology and qPCR in positive PCR parents

Measure: Transmission to other family members

Time: Until 30 days
137 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
138 Long-term Use of Drugs That Could Prevent the Risk of Serious COVID-19 Infections or Make it Worse: Cases of Synthetic Antimalarial Drugs and Anti-hypertensive Drugs

The COVID-19 emerging disease due to a novel coronavirus (SARS-CoV-2), started in Wuhan, China, last December, 2019. In the past three months, the virus has spread rapidly worldwide to reach the pandemic threshold. Research has since been carried out and is intensifying in order to describe the clinical characteristics of infected patients, to identify the prognostic factors of acute respiratory distress syndrome [ARDS] and the death; and to assess the effectiveness of new antivirals and therapeutic strategies to treat COVID-19. Treatments currently being investigated include: - Potentially effective treatments: (hydroxy)chloroquine, Remdesivir, Lopinavir, Ritonavir +/- IFN-ß-1a (currently evaluated in the European discovery trial), methylprednisolone in patients with ARDS; - Potentially harmful treatments: antihypertensives such as converting enzyme inhibitors and angiotensin receptor antagonists. We made the hypothesis that (1) patients receiving ARBs or ACEi's have a higher risk to present a serious COVID-19 infection disease and (2) patients receiving synthetic AMD (e.g. HCQ and CQ) have a lower risk to present a serious covid19 infection disease. Using data from the French insurance health database (SNDS) and hospital discharge database (PMSI), our objectives are - Main objective: To assess the risk of moderate to serious COVID-19 infections in patients using synthetic anti-malarial drugs (AMD) or anti-hypertensive drugs (Angiotensin receptor-blocking/Angiotensin-converting-enzyme inhibitors). - Secondary objective : To examine the risk of moderate to serious COVID-19 infections according of age, sex, co-morbidities, level of exposure of AMD, geographical locations and underlying comorbidities. This in order to: - To prevent moderate to serious COVID-19 infections in at-risk population (diabetes, elderly, respiratory failure population) using synthetic AMD. - To prevent moderate to serious COVID-19 infections in at-risk population stopping angiotensin receptor-blocking and angiotensin-converting-enzyme inhibitors.

NCT04356417
Conditions
  1. AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection
Interventions
  1. Other: - Synthetic anti-malarial drugs
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Participants as those with the emergency ICD-10 (international classification of diseases, 10th revision) code of U07.1 which was assigned to the disease diagnosis of COVID-19.

Measure: Identification of serious COVID-19 infections

Time: From 2020/01/01 to 2020/06/30

Secondary Outcomes

Measure: Pneumonia infections

Time: From 2020/01/01 to 2020/06/30

Measure: ICU stay

Time: From 2020/01/01 to 2020/06/30

Measure: Oro-tracheal intubation

Time: From 2020/01/01 to 2020/06/30

Measure: Death

Time: From 2020/01/01 to 2020/06/30
139 Outpatient Treatment of Elderly People With Symptomatic SARS-CoV-2 Infection (COVID-19): a Multi-arm, Multi-stage (MAMS) Randomized Trial to Assess the Efficacy and Safety of Several Experimental Treatments to Decrease the Risk of Hospitalization or Death (COVERAGE Trial)

This trial will estimate the efficacy and tolerance of several experimental treatments to prevent hospitalization or death in outpatients aged 60 years or above with Symptomatic SARS-CoV-2 Infection (COVID-19).

NCT04356495
Conditions
  1. Corona Virus Infection
  2. Sars-CoV2
Interventions
  1. Dietary Supplement: Vitamins
  2. Drug: Imatinib
  3. Drug: Telmisartan
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Proportion of participants with an occurrence of hospitalization

Time: From inclusion (day0) to day 14

Description: Proportion of participants with an occurrence of death

Measure: Death

Time: From inclusion (day0) to day 14

Secondary Outcomes

Measure: Proportion of hospitalizations, overall and by cause, in each group

Time: From inclusion (day0) to day 28

Description: Proportion of deaths, overall and by cause, in each group

Measure: Death and causes of death

Time: From inclusion (day0) to day 28

Measure: Proportion of intensive care hospitalizations, overall and by cause, in each group

Time: From inclusion (day0) to day 28

Measure: Proportion of participants with negative nasopharyngeal SARS-CoV-2 RT-PCR

Time: day 7 and day 14

Measure: Proportion of participants with a loss of autonomy evaluated by the ADL and IADL scale

Time: day 14 and day 28

Description: Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR

Measure: Haematological markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Evolution of Biochemical markers in each group : ferritin, serum creatinine, urea, sodium, potassium, chlorine, calcium, magnesium, albumin, bicarbonates / tCO2, LDH, CPK, ASAT, ALAT, uricemia

Measure: Biochemical markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Evolution of Inflammatory markers in each group : PCT, CRP

Measure: Inflammatory markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Evolution of immunological markers in each group : B ans T Cells phenotypic profiles

Measure: Immunological markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Number and proportion of grade 1,2,3,4 adverse events in each group

Measure: Adverse events

Time: from inclusion (day 0) to day 14

Description: Number and proportion of grade 1,2,3,4 adverse events in each group

Measure: Adverse reactions

Time: from inclusion (day 0) to day 14

Description: Plasma concentration of the study drugs at D7

Measure: Plasma concentration

Time: day 7

Description: Acceptability of the treatment by participant will be assessed with an interview

Measure: Acceptability of the treatment

Time: from inclusion (day 0) to day 10
140 A Phase II Single-Center, Randomized, Open-Label, Safety and Efficacy Study of Etoposide in Patients With COVID-19 Infection

This is a randomized, open-label phase II study designed to evaluate the safety and efficacy of etoposide in patients with the 2019 novel coronavirus (COVID-19) infection. Randomization will be performed with a 3:1 allocation ratio. Treatment will be comprised of etoposide administered intravenously at a dose of 150 mg/m2 on Days 1 and 4 in patients with COVID-19 infection meeting eligibility criteria. Subsequent doses of etoposide will be allowed if the investigator and treating physician believe the patient had clinical benefit from etoposide therapy but subsequently has evidence of recurrent clinical deterioration. Subjects randomized to control will receive standard of care treatment. No placebo will be used.

NCT04356690
Conditions
  1. COVID-19
Interventions
  1. Drug: Etoposide
MeSH:Infection

Primary Outcomes

Description: An 8 point ordinal scale will be used to assess pulmonary status consisting of the following values: 8= Death; 7= Ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT), or need for vasopressors (dopamine ≥5 μg/kg/min OR epinephrine ≥0.1 μg/kg/min OR norepinephrine ≥0.1 μg/kg/min); 6= Intubation and mechanical ventilation; 5= Non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4= Oxygen by mask or nasal prongs; 3= Hospitalization without oxygen supplementation; 2= Discharged from hospital either to home with supplemental oxygen OR to inpatient rehabilitation/skilled nursing facility (+/- supplemental oxygen); 1= Discharged to home without supplemental oxygen

Measure: Change in pulmonary status

Time: baseline, through study completion, an average of 45 days

Secondary Outcomes

Measure: Change in ferritin levels

Time: baseline, through study completion, an average of 45 days

Measure: Change in C-reactive protein levels

Time: baseline, through study completion, an average of 45 days

Measure: Change in d-dimer levels

Time: baseline, through study completion, an average of 45 days

Measure: Change in white blood cell count

Time: baseline, through study completion, an average of 45 days

Description: number of events

Measure: Incidence of serious adverse events

Time: baseline, through study completion, an average of 45 days

Measure: Overall survival

Time: Days 15, 30 and 60

Description: When calculating days of hospitalization, re-hospitalization or death occurring in the first 28 days should result in zero ascribed to time out of the hospital prior to readmission.

Measure: Length of hospitalization

Time: From date of enrollment until the date of extubation, assessed study completion, an average of 45 days

Measure: Duration of ventilation

Time: From date of enrollment until the date of extubation, assessed study completion, an average of 45 days

Description: Reintubations or death within 28 days will result in zero ascribed time off ventilator prior to reintubation

Measure: Ventilator free days

Time: baseline, through study completion, an average of 45 days

Measure: Improvement in arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2)

Time: baseline, through study completion, an average of 45 days
141 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
142 Randomized Open Pilot Study to Evaluate the Efficacy of Subcutaneous Sarilumab in Patients With Moderate-severe COVID-19 Infection

The global health emergency created by the rapid spread of the SARS-CoV-2 coronavirus has pushed healthcare services to face unprecedent challenges to properly manage COVID-19 severe and critical manifestations affecting a wide population in a short period of time. Clinicians are committed to do their best with a great uncertainty in this evolving crisis. Off label use of plenty of drugs has arisen the need for clinical trials to demonstrate their true role in the therapy. Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are available yet. Sarilumab is a human monoclonal antibody that binds membrane-bound and soluble IL-6 receptors to inhibit IL-6 signalling, licensed in a subcutaneous route administration.

NCT04357808
Conditions
  1. Covid-19
Interventions
  1. Drug: Sarilumab
  2. Other: Standar of care
MeSH:Infection

Primary Outcomes

Description: Score ranges 1-7 Death; Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized

Measure: Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation

Time: 7 days from enrolment

Description: Days from the date of enrolment to the date of discharge

Measure: Duration of hospitalisation (days)

Time: 30 days from enrolment

Description: Number of deaths

Measure: Death

Time: 30 days from enrolment

Secondary Outcomes

Description: Time to become afebrile for a minimum period of 48 hours, without antipyretics

Measure: Time to become afebrile (days)

Time: 30 days from enrolment

Description: Days from enrolment to non-invasive mechanical ventilation

Measure: Time to non-invasive mechanical ventilation (days)

Time: 30 days from enrolment

Description: Days from enrolment to invasive mechanical ventilation

Measure: Time to invasive mechanical ventilation (days)

Time: 30 days from enrolment

Description: Days from enrolment to supplementary oxygen therapy withdrawal

Measure: Time to independence from supplementary oxygen therapy (days)

Time: 30 days from enrolment

Description: Scale ranges 1-7: Death Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles. Hospitalized with oxygen supplement Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID) Hospitalized, without oxygen supplement and without the need for continued medical care Not hospitalized

Measure: Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation

Time: 14 days from enrolment

Other Outcomes

Description: Number of adverse events and number of patients with adverse events

Measure: Incidence of serious and non-serious adverse events.

Time: 30 days after enrolment

Description: Number of adverse reactions that requires discontinuation of any drug in the study

Measure: Discontinuation due to adverse reactions

Time: 30 days after enrolment
143 Classification of COVID-19 Infection in Posteroanterior Chest X-rays With Common Deep Learning Architectures

The objective of this study is to assess three configurations of two convolutional deep neural network architectures for the classification of COVID-19 PCX images.

NCT04358536
Conditions
  1. COVID-19
Interventions
  1. Device: CovX
MeSH:Infection

Primary Outcomes

Description: Identification of COVID-19 infection from chest X-ray analysis

Measure: Identification of COVID-19

Time: Through study completion, an average of 2 months
144 A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

NCT04359680
Conditions
  1. COVID-19
  2. Viral Respiratory Illnesses
Interventions
  1. Drug: Nitazoxanide
  2. Drug: Placebo
  3. Dietary Supplement: Vitamin Super B-Complex
MeSH:Infection

Primary Outcomes

Measure: The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period.

Time: Up to 6 weeks

Measure: The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period.

Time: Up to 6 weeks
145 Impact of SARS-CoV-2 Infection on the Incidence of Ventilator-acquired Infections

Observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients and two control groups: one with influenza pneumonia and the other with no viral pneumonia.

NCT04359693
Conditions
  1. SARS-CoV 2
MeSH:Infection

Primary Outcomes

Description: the incidence of ventilator associated pneumonia and ventilator associated tracheobronchitis

Measure: Cumulative incidence of ventilator-associated lower respiratory tract infection

Time: from day 3 of mechanical ventilation to extubation or day 28 post-intubation.

Secondary Outcomes

Description: incidence of ventilator-associated tracheobronchitis

Measure: Cumulative incidence of ventilator-associated tracheobronchitis

Time: from day 3 of mechanical ventilation to extubation or day 28 post intubation

Description: incidence of ventilator-associated pneumonia

Measure: Cumulative incidence of ventilator-associated pneumonia

Time: from Day 3 of mechanical ventilation to extubation or day 28 post intubation.

Description: incidence of ICU-acquired bacteremia

Measure: the cumulative incidence of ICU acquired bacteremia diagnosed

Time: from ICU admission to extubation or Day 28.

Description: death in the ICU

Measure: ICU mortality

Time: at day 28

Description: death

Measure: Mortality

Time: at day 28

Description: number of days Under mechanical ventilation

Measure: the duration of mechanical ventilation

Time: from the start of mechanical ventilation to extubation or day 28 post intubation

Description: number of days in the ICU

Measure: Length of stay in Intensive Care Unit

Time: from admission to ICU until extubation or Day 28
146 A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection

This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.

NCT04359836
Conditions
  1. Gut Microbiome
  2. Gastrointestinal Microbiome
  3. COVID
  4. COVID-19
  5. Corona Virus Infection
  6. Coronavirus
  7. Coronaviridae Infections
  8. Coronavirus 19
  9. Coronavirus-19
  10. COVID 19
Interventions
  1. Other: There is no intervention in this study
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections

Primary Outcomes

Description: Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.

Measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

Time: One year

Secondary Outcomes

Description: To validate the methods used to sequence samples

Measure: Validation of Sequencing Methods

Time: One year
147 Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial

Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .

NCT04360980
Conditions
  1. COVID-19
Interventions
  1. Drug: Colchicine Tablets
MeSH:Infection

Primary Outcomes

Description: increasing inflammatory status

Measure: CRPxN/R ratio change

Time: 2 weeks

Description: including change in fever or O2 Saturation

Measure: Clinical deterioration by the WHO definition

Time: 2 weeks

Description: change in RT-PCR

Measure: PCR Viral Load

Time: 2 weeks

Description: change in CT involvement

Measure: CT severity involvement index

Time: 2weeks

Secondary Outcomes

Description: change in LDH

Measure: LDH change

Time: 2 weeks
148 A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity

In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.

NCT04361253
Conditions
  1. COVID
  2. Infectious Disease
Interventions
  1. Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP)
  2. Biological: Standard Plasma (FFP)
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: The primary outcome will be the MOS numerical score (score 0-9) where a score of 0 attributes to 'no clinical evidence of infection' and a score of 9 attributes to 'death'. The eligibility requirements for this trial select individuals at level 3 or higher on the modified scale, but the day 14 outcome can be any one of 10 levels.

Measure: Modified WHO Ordinal Scale (MOS) score

Time: Day 14
149 Neurodegeneration Markers and Neurological Course in Severe Covid-19 Infection - MARNEVO-Covid

Emergence of Covid-19 virus is associated with high frequency of extremely severe clinical pictures, with minor signs of CNS impairment (e.g. anosmia, headache). Since neurotropism is a common feature of coronavirus infection in animals, the investigators examine if indirect signs of CNS lesion are observed in association with severe Covid-19 infection.

NCT04361344
Conditions
  1. COVID-19 Infection
  2. Encephalitis
Interventions
  1. Biological: blood samples
MeSH:Infection Communicable Diseases Encephalitis Nerve Degeneration
HPO:Encephalitis Neurodegeneration

Primary Outcomes

Description: Change of neurofilament light chain (NFL) (pg/ml) level between first day of hospitalisation and one week; and change of GFAP (pg/ml) level between first day of hospitalisation and one week.

Measure: Change of neurodegeneration markers level

Time: Level of neurofilament light chain (NFL) is dosed at inclusion (day 0) and week 1. Level of GFAP is dosed at inclusion (day 0) and week 1 (day 7).
150 Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial

This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

NCT04361552
Conditions
  1. Cerebrovascular Accident
  2. Chronic Obstructive Pulmonary Disease
  3. Chronic Renal Failure
  4. Coronary Artery Disease
  5. Diabetes Mellitus
  6. Malignant Neoplasm
  7. SARS Coronavirus 2 Infection
Interventions
  1. Other: Best Practice
  2. Biological: Tocilizumab
MeSH:Infection Neoplasms Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Stroke Kidney Failure, Chronic Coronary Artery Disease
HPO:Chronic pulmonary obstruction Coronary artery atherosclerosis Neoplasm Pulmonary obstruction Stroke

Primary Outcomes

Description: The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.

Measure: 7-day length of invasive mechanical ventilation (MV)

Time: Up to 7 days

Description: Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: 30-day mortality rate

Time: Up to 30-day after randomization

Secondary Outcomes

Description: The rate of ICU transfer for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: Rate of intensive care (ICU) transfer

Time: Up to 2 years

Description: The rate of invasive mechanical ventilation for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: Rate of invasive mechanical ventilation

Time: Up to 2 years

Description: The rate of tracheostomy for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: Rate of tracheostomy

Time: Up to 2 years

Description: Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test

Measure: Length of ICU stay

Time: Up to 2 years

Measure: Length of hospital stay

Time: Up 2 years
151 Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection: Search for Acquired Thrombophilia and Interferon-alpha Signature

Spectrum of skin lesions may arise during Covid-19 virus infection. It includes non-specific urticaria, aphtoids lesions, but also acrosyndromes, in particular suggestive of chilblains. Pathological findings showed thrombocytic lymphocytic vasculitis. Chilblains are sometimes associated with Raynaud's phenomenon or acrocyanosis. Dermatological features may present pathophysiological similarities with the inflammatory and respiratory vascular disturbances, which makes all the gravity of this disease, or even with other organs. Indeed, genetic conditions such as familial lupus chilblains, linked to a mutation of TREX1 gene, and SAVI (Sting associated vasculopathy with onset on infancy) have similar clinical presentations. In particular, SAVI associates both acral skin and lung damage, and auto-antibodies. They have recently been identified as type I interferonopathies. Hallmark is interferon signature, i.e. hyperexpression of type I interferon in the blood. The investigators hypothesize Covid-19 may lead to similar skin involvement as in type I interferonopathies. The interferon pathway is involved in anti-viral defense. Covid-19 could cause excessive activation of this pathway. In addition, hyperactivation of the type I interferon pathway leads to modulation of the adaptive immune response. Production of autoantibodies, in particular antiphospholipid antibodies, have thrombogenic properties. Searching for acquired hemostasis disorders and high level of interferon secondary Covid-19 virus infection, could explain this new and misunderstood skin disorder. Then, targeted therapies, both treating and preventing, could be considered.

NCT04361786
Conditions
  1. COVID 19
MeSH:Infection

Primary Outcomes

Description: Searching for presence or absence of abnormal acquired thrombophilic condition as antibodies, hemostasis disturbances. Presence or absence of thrombophilic markers in the blood

Measure: Biological acquired thrombophilia

Time: 1 day

Secondary Outcomes

Description: Dosing transcriptomic interferon signature in a blood sample. Presence or absence of interferon in the blood

Measure: Overexpression of interferon type I

Time: 1 day
152 Impact of Multi-Denominational Prayer on Morbidity and Mortality of Patients Admitted to the Intensive Care Unite With Corona Virus Infection

This is a multicenter; double blind randomized controlled study investigating the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 + patients in the intensive care unit. All patients enrolled will be randomized to use of prayer vs. no prayer in a 1:1 ratio. Each patient randomized to the prayer arm will receive a "universal" prayer offered by 5 religious denominations (Christianity, Hinduism, Islam, Judaism and Buddhism) in addition to standard of care. Whereas the patients randomized to the control arm will receive standard of care outlined by their medical teams. During ICU stay, patients will have serial assessment of multi-organ function and APACHE-II/SOFA scores serial evaluation performed on a daily basis until discharge. Data assessed include those listed below.

NCT04361838
Conditions
  1. Coronavirus Infection
Interventions
  1. Behavioral: prayer
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This study will measure the difference in mortality of COVID-19 patients who are admitted to ICU - given prayer vs no prayer as an adjunct to standard therapy.

Measure: Impact of multi-denominational prayer on clinical outcomes of critically ill COVID-19 patients in the Intensive Care Unit on mortality.

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Secondary Outcomes

Description: APACHE II uses 0-71 scale, the higher the score the higher the risk for mortality.

Measure: Difference in patient outcomes - Acute Physiology and Chronic Health Enquiry. APACHE II score.

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days.

Description: The higher the SOFA score the increased likelihood of organ failure.

Measure: Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Description: A prolonged length of time in ICU increases mortality.

Measure: Difference in patient outcomes - Length of stay in ICU.

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Description: A prolonged length of time with ventilator support increases mortality.

Measure: Difference in patient outcomes - Length of ventilator support

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Description: A prolonged length of time with vasopressor support increases recovery time.

Measure: Difference in patient outcomes - length of vasopressor support

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
153 National Cohort Study to Assess the Influence of COVID-19 Infection in Thromboembolic Venous Disease:

There is an urgent need to understand the outcomes of COVID-19 infected patients regarding the thromboembolic venous disease. Capturing real-world data and sharing Spanish national experience will inform the management of this complex group of patients, improving their clinical care. Interventions are needed to reduce both the incidence and severity of COVID-19. Although it shares characteristics with other similar viruses that also arose in outbreaks, the physiological mechanisms of the virus and its responses on the host are not yet fully known. There are indications that the clinical picture of this disease is in a procoagulant state, with possible increase in episodes of thromboembolic disease. This study aims to analyze the influence of COVID-19 on the incidence of deep vein thrombosis (DVT) in lower and upper limbs, and the variation in the clinical presentation of COVID-19, as well as to provide new evidence applicable to the clinical management of these patients and the establishment of prognostic factors that help early take therapeutic decisions. To this end, an observational, multicenter, national cohorts study will be carried out, sponsored by the Spanish Society of Angiology and Vascular Surgery (SEACV) and the Spanish Chapter of Phlebology and Linfology through its Vascular Research Network (RIV), which will collect demographic variables, comorability, concomitant treatment, analytical status and complementary and ultrasound diagnostic tests, parameters of clinical evolution, therapeutic and complications and mortality to 30 days. All national centers you wish to participate through a secure server that will be accessed through the SEACV and CEFyL website. The global community has recognised that rapid dissemination and completion of studies in COVID-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, IRBs) to work as quickly as possible to approve this project. This investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.

NCT04361981
Conditions
  1. COVID-19
Interventions
  1. Other: Deep Venous Disease Diagnostic
MeSH:Infection

Primary Outcomes

Description: Incidence of Deep Venous Disease events in patients with COVID-19 infection

Measure: Deep Venous Disease Incidence

Time: 30 days

Secondary Outcomes

Description: 30-days mortality in COVID-19 infection patients with a Deep Venous Disease event

Measure: 30-days mortality

Time: 30 days

Description: Rate of ICU admission in COVID-19 infection patients with a Deep Venous Disease event

Measure: ICU admission

Time: 30 days

Description: Type of anticoagulant treatment in COVID-19 infection patients with a Deep Venous Disease event

Measure: Anticoagulant treatment

Time: 30days
154 Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection in Medellín, Colombia, 2020

Until the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view. Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question may be that there are differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe. This finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses. Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations, and currently there are no vaccines or proven preventive interventions available to protect them. For this reason, this research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death. In the future, and if these results are as expected, they may be the basis for undertaking a population vaccination campaign that improves clinical outcomes in the general population.

NCT04362124
Conditions
  1. COVID-19
Interventions
  1. Biological: vaccine BCG
  2. Other: Placebo
MeSH:Infection

Primary Outcomes

Description: Incidence of COVID-19 cases confirmed or probable in the study population

Measure: Primary outcome

Time: From date of randomization to 360 day of the study

Secondary Outcomes

Description: Incidence of severe or critical infection in COVID-19 cases

Measure: Secondary outcome

Time: From date to diagnosis to 1 month after

Description: Lethality of the infection in both groups

Measure: Secondary outcome

Time: From date to diagnosis to 1 month after

Description: Assess the safety (frequency, seriousness, and severity of adverse events) of BCG vaccination

Measure: Secondary outcome

Time: From date of randomization to 7 day of the study

Description: Prevalence of SARS-Cov-2 infection

Measure: Secondary outcome

Time: At baseline evaluation
155 Incidence of SARS-Cov2 Infection Among HCW in Lille University Hospital

The aim of the study is to determine the incidence o of SARS-cov2 infection among health care workers highly exposed to covid 19 during 10 weeks et to analyze the determinants of their occupational and environmental exposure. Every 14 days, we performed SARS-Cov2 RT- PCR, serological testing and clinical questionnaire among a cohort of 100 HCW with a high degree of exposure to covid19 infection. Information about occupational exposure as the workplace, the activity of care, the characteristics of patient infected are captured, as well as environmental or personal exposure. The results will support the design of a new care organization and will define new ways of protection for patients (covid or not covid 19) and prevention for HCW.

NCT04362267
Conditions
  1. Sars-CoV2
Interventions
  1. Other: self-administered questionnaire
  2. Diagnostic Test: SARS-Cov2 testing
MeSH:Infection

Primary Outcomes

Measure: the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing

Time: at 14 weeks

Secondary Outcomes

Measure: the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing

Time: once every 14 days for an average of 14 weeks

Measure: Occupational exposures associated with the SARS-Cov2 infection

Time: once every 14 days for an average of 14 weeks

Measure: Environmental exposures associated with the SARS-Cov2 infection

Time: once every 14 days for an average of 14 weeks
156 Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection

Background: People who get infected with COVID-19 have an unpredictable risk to worsen and die. This makes it hard to decide who can quarantine at home and who should be treated at a hospital. Researchers think the risk may be related to how a person s B and T cells respond to the virus. B and T cells are the major components of a person s immune response. B and T cells responding to the virus with a favorable pattern may lead to recovery, and this favorable pattern may be helpful to establish. If people in a vaccine trial get this same favorable pattern when responding to a vaccine, this may be a useful early signal that the vaccine will be successful. Objective: To examine how immune cells respond to COVID-19 infection. Eligibility: Adults ages 18 and older who have a confirmed or suspected COVID-19 infection or had COVID-19 in the past. Also, healthy donors with no suspected COVID-19 infection Design: Participants will be screened with medical record review. Participants will be tested with a research assay to determine who was infected with COVID-19 and who was not. This test will be used to understand research results, not to advise patients. Participants with active infection must be isolated, usually in a hospital. Other participants may give blood samples at NIH or at their local doctor s office or lab. Participants may give blood samples up to three times a week for a total of ten times, and may also give blood samples after starting a vaccine trial. Participants will be contacted by phone or email every 2 months for up to 2 years.

NCT04362865
Conditions
  1. COVID-19
MeSH:Infection

Primary Outcomes

Description: characterize immune response in patients with active or prior COVID-19 infection

Measure: Characterize immune response

Time: Ongoing

Secondary Outcomes

Description: determine if the B- or T-cell arm of the immune response is more active in responding to COVID-19 infection

Measure: B- and T-cell arm immune response

Time: Ongoing

Description: determine if there is a correlation between the pattern of immune response to COVID-19 and outcome in patients with acute or resolved infection

Measure: Immune response and outcome

Time: Ongoing
157 Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina

This is a multi-center prospective study that aims to investigate the clinical and immunologic impact of SARS-CoV-2 infection in pregnant women and neonates. The goal is to recruit 200 SARS-CoV-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. Clinical data will be collected from women and neonates. Upper airways samples will be obtained from both for bio-markers investigation. Finally, maternal and umbilical cord serum and human milk will be obtained for antibody assessment.

NCT04362956
Conditions
  1. Covid19
  2. Pregnancy Related
  3. Neonatal Infection
MeSH:Infection

Primary Outcomes

Description: Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate

Measure: Vertical transmission

Time: 96 hours from birth

Description: Presence of IgG in umbilical cord

Measure: Neonatal protection due to maternal antibodies

Time: 24 weeks of gestation to birth

Secondary Outcomes

Description: Respiratory distress, hypothermia, poor feeding and others

Measure: Increase risk of neonatal morbidity

Time: up to 30 days of life

Measure: Increase risk of obstetric complications

Time: Up to 14 days of hospitalization
158 ACCESS (American COVID-19 Collaborative, Enabling Seamless Science) Master Digital Surveillance and Associated Clinical Trials Protocol for COVID-19

ACCESS enables individuals to contribute to critical research, via an iOS and Android smartphone mobile application. ACCESS combines patient reported outcomes, data from wearable devices and real-world data (such as claims, EHRs, etc), with an opt-in to participate in current and future studies for diagnostics, treatments and vaccines. The data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale and participants a way to be personally matched and prescreened for future research.

NCT04363268
Conditions
  1. Coronavirus
  2. COVID
  3. COVID-19
  4. COVID19
  5. Corona Virus Infection
  6. Coronavirus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To use multifaceted participant data consisting of participant reported outcomes, environmental surface and presence or absence of COVID-19 based on testing results, prescription medications (including off-label use), claims, lab, and medical record data to develop population-based models of disease risk, short and long-term outcomes, and efficacy of interventions and prevention measures.

Measure: Development of population-based models of disease risk

Time: Up to 10 years

Description: To leverage geolocation and lab results to provide population-level real-time data regarding disease burden at the community, state and national levels.

Measure: Relation between disease burden and geolocation

Time: Up to 10 years

Description: To specifically identify medications and regimens that address disease symptoms

Measure: Effect of medications on symptoms of COVID19

Time: Up to 10 years

Description: To specifically identify medications and regimens that treat and reduce disease severity.

Measure: Effect of medications on disease severity of COVID19

Time: Up to 10 years

Secondary Outcomes

Description: To identify regional variations in disease incidence and outcomes.

Measure: Rate of COVID19 infection and disease outcomes

Time: Up to 10 years

Description: To understand long-term outcomes such as risk of pulmonary and cardiovascular disease complications.

Measure: Effect of COVID19 on health outcomes

Time: Up to 10 years

Description: To conduct long-term follow up of individuals who tested positive for COVID-19 compared to demographically matched individuals that did not.

Measure: Long-term follow up and recontact

Time: Up to 10 years
159 A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

In this study Investigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms that will receive clazakizumab at a dose of 25 mg or placebo.

NCT04363502
Conditions
  1. Covid19
Interventions
  1. Drug: Clazakizumab
  2. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Serum CRP (measured in mg/dl) will be evaluated at baseline and on days 1 and 2 following clazakizumab or placebo administration to assess response

Measure: Change in C-reactive protein (CRP) level

Time: Up to 3 days
160 Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection

National multicentre epidemiological study to describe retrospectively and prospectively the clinical outcomes of patients with a suspected coronavirus infection (either confirmed or not) while receiving a medical treatment for the underlying cancer

NCT04363632
Conditions
  1. Sars-CoV2
  2. Cancer
MeSH:Infection

Primary Outcomes

Description: Mortality rate, defined as the proportion of patients who are dead 28 days after the date of the diagnostic procedure for the 2 cohorts of patients (positive and negative).

Measure: Mortality of cancer patients under active anticancer treatment

Time: 28 days after the date of the diagnostic procedure

Secondary Outcomes

Description: Overall survival will be defined as the time from the date of the first diagnostic procedure (either diagnostic test or chest imaging) to the date of death due to any cause.

Measure: Overall survival

Time: 6 months (i.e. at the the time of last patient last visit)

Description: The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)

Measure: Hospitalizations

Time: 28 days after the date of the diagnostic procedure

Description: Cause of death, related or not to the COVID-19

Measure: Death

Time: 6 months (i.e. at the the time of last patient last visit)

Description: Associated complications described by their type

Measure: Complications

Time: 28 days after the date of the diagnostic procedure

Description: proportion of hospitalizations

Measure: Hospitalizations

Time: 28 days after the date of the diagnostic procedure

Description: To describe accurately patients' characteristics in terms of demographics

Measure: Patients' characteristics

Time: At the date of the diagnostic procedure

Description: To describe accurately patients' characteristics in type of tumor

Measure: Patients' characteristics

Time: At the date of the diagnostic procedure

Description: To describe accurately patients' characteristics in type of anticancer treatment,

Measure: Patients' characteristics

Time: At the date of the diagnostic procedure

Description: To describe accurately patients' characteristics in terms of comorbidities

Measure: Patients' characteristics

Time: At the date of the diagnostic procedure
161 Multi-centre EuRopean Study of MAjor Infectious Disease Syndromes (MERMAIDS) - Acute Respiratory Infections (MERMAIDS ARI) 2.0

Background Rapid European COVID-19 Emergency Research response (RECoVER), is a project involving 10 international partners that has been selected for funding by the European Union under the Horizon 2020 research framework responding to call topic SC1-PHE-CORONAVIRUS-2020: Advancing knowledge for the clinical and public health response to the SARS-CoV-2 epidemic. MERMAIDS 2.0 is the hospital care study within RECOVER. Rationale Detailed patient-oriented studies are needed to determine the spectrum of SARS-CoV-2 disease and the combined influences of age, comorbidities and pathogen co-infections on the development of severe disease, together with virological and immunological profiles. This research is key to understanding the pathophysiology and epidemiology of this new disease, as well as to identifying potential targets for therapeutic or preventive interventions. Objective To establish the prevalence, disease spectrum and severity, clinical features, risk factors, spread and outcomes of novel 2019 coronavirus infection (SARS-CoV-2) in Hospital Care. Study design Prospective observational cohort study in selected European countries. Study population Children and adults with 1) acute respiratory illness (ARI) presenting to hospital care during the SARS-CoV-2 epidemic (including both COVID-19 and non-COVID-19 patients) and 2) patients with confirmed COVID-19 infection, but with atypical presentation (non-ARI) or with nosocomial acquisition. Sites can optionally participate in the following tiers: Tier 0 (Clinical data collection only) - Clinical data will be collected but no biological samples will be obtained for research purposes. Summary of the illness episode and outcome, including a selection of risk factors and comorbidities and medications. Tier 1 (Clinical data and biological sampling) - Clinical samples and data will be collected on enrolment day and then at scheduled time points. Tier 2 (Clinical data an extended biological sampling). Optional add-on study In a subset of sites and patients, COVID-19 positive patients will be followed post-discharge for 6 months to study clinical recovery and long-term sequelae Main study parameters/endpoints: Prevalence of COVID-19 among patients with acute respiratory illness. COVID-19 disease spectrum and host and pathogen risk factors for severity. Long-term sequelae of COVID-19 requiring hospital care. Proportion hospital-acquired COVID-19 infections and characteristics of nosocomial transmission. Study Duration Scheduled 2 years and based on COVID-19 dynamics. Nature and extent of the burden associated with participation, benefit and group relatedness This study is observational in nature. There will be no direct benefit to research participants. The study may include biological sampling in addition to sampling required for medical management. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.

NCT04364711
Conditions
  1. COVID-19
  2. SARS-CoV 2
MeSH:Communicable Diseases Infection

Primary Outcomes

Measure: Pneumonia Severity indexes

Time: 2 years

Measure: Need for supplemental oxygen; non-invasive or invasive mechanical ventilation; extra-corporeal life support

Time: 2 years

Measure: Hospital - and ICU/HCU length of stay

Time: 2 years

Measure: In-hospital mortality

Time: 2 years

Measure: Activities of daily life, quality of life, variations in home living status and employment status

Time: 2 years

Measure: Proportion of SARS-CoV2 positive patients

Time: 2 years
162 Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection (COVID-19). A Randomized Trial

Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection.

NCT04364893
Conditions
  1. Corona Virus Infection
  2. COVID-19
Interventions
  1. Other: Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary outcome of the study will be days alive and outside the hospital (DAOH) at 30 days. This endpoint will be calculated for each included patient and the calculation will be from the date of randomization to the 30-day post-randomization. The DAOH endpoint represents the follow-up time (30 days) subtracted from the hospitalization days and/or the days between death and the end of follow-up.

Measure: Median days alive and out of the hospital

Time: 30 days

Secondary Outcomes

Description: Cardiovascular outcomes such as progression of COVID-19, mortality (general and cardiovascular), acute myocardial infarction, stroke / TIA, new heart failure or worsening of pre-existing HF, myocarditis, pericarditis, arrhythmias requiring treatment, phenomena thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure. All events will be reported according to CTCAE 4.0

Measure: Number of participants with adverse cardiovascular outcomes and new worsening heart failure

Time: 30 days

Description: Evaluate levels of biomarkers [troponin, type B natriuretic peptide (BNP), N-terminal natriuretic peptide type B (NT-ProBNP), D-dimer, total lymphocytes , CD4, CD8, macrophages, cytokines, in addition to biomarkers detected by proteomics and metabolomics].

Measure: Cardiovascular biomarkers related to COVID-19

Time: up to 30 days
163 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
164 Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections.

This study is a retrospective cohort trial to assess the efficacy of remdesivir in hospitalized adult patients diagnosed with COVID-19. The study is a multicenter trial which will be carried out on different sites in France. This trial is retrospective and will analyze the data collected during treatment.

NCT04365725
Conditions
  1. COVID-19
Interventions
  1. Drug: Remdesivir
MeSH:Infection

Primary Outcomes

Description: Study the prognostic factors of the clinical course of patients on Day 15 under treatment with remdesivir. Clinical progress will be categorized using a 7-point ordinal scale.

Measure: Clinical course on Day 15.

Time: 15 days

Secondary Outcomes

Description: Explore the prognostic factors of the clinical course of patients on Day 3

Measure: Clinical course on Day 3.

Time: 3 days

Description: Explore the prognostic factors of the clinical course of patients on Day 8

Measure: Clinical course on Day 8

Time: 8 days

Description: Explore the prognostic factors of the clinical course of patients on Day11

Measure: Clinical course on Day 11.

Time: 11 days

Description: Explore the prognostic factors of the clinical course of patients on D29.

Measure: Clinical course on Day 29.

Time: 29 days

Description: Duration of treatment with remdesivir

Measure: Duration of treatment

Time: 29 days

Description: PaO2 / FiO2 and artificial ventilation; platelets; bilirubin; average blood pressure and use of vasoactive drugs; Glasgow score; creatinine.

Measure: Sepsis-related Organ Failure Assessment score

Time: Day 3, 8, 11, 15 and 29

Description: Duration without mechanical ventilation within 29 days of initiation of treatment with remdesivir

Measure: Duration without mechanical ventilation

Time: 29 days

Description: Mortality at 29 days after initiation of treatment with remdesivir.

Measure: Mortality

Time: 29 days

Description: Evaluate the safety of the treatment with cumulative incidence of grade 3 and 4 adverse events (AEs).

Measure: cumulative incidence of grade 3 and 4 adverse events (AEs).

Time: 29 days
165 Pulmonary Rehabilitation in Post-Acute Period of COVID-19 Infection: Prospective Randomized Controlled Trial

The aim of this study is to investigate the efficacy of pulmonary rehabilitation(PR) applied in the isolation processes of post-acute patients with mild and moderate symptoms who had positive COVID-19 test on dyspnea,muscle pain,chest expansion,lower limb muscle strength and dynamic balance,fatigue,anxiety and depression.

NCT04365738
Conditions
  1. COVID-19
Interventions
  1. Other: Rehabilitation
MeSH:Infection

Primary Outcomes

Description: The Borg scale is a scale scored between 0-10, indicating the severity of dyspnea. 0 indicates no shortness of breath, 10 indicates severe shortness of breath

Measure: Dyspnea

Time: Baseline, up to 4 weeks

Secondary Outcomes

Description: Chest expansion was evaluated by measuring the difference between the maximum inspiration and maximum expiration from the level of xsphoid processus of the patients.

Measure: Chest expansion

Time: Baseline, up to 4 weeks

Description: Fatigue severity scale is a questionnaire consisting of 9 questions showing the degree of fatigue of patients. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome

Measure: Fatigue severity

Time: Baseline, up to 4 weeks

Description: Patients were instructed and asked to give a score between 0-10 with 0 equating to no pain, 10 indicating severe pain

Measure: Visual Analog Scale for pain

Time: Baseline, up to 4 weeks

Description: The HAD scale is a short self administered questionnaire used to screen for anxiety and depression. The questionnaire consists of 14 items, seven each measuring anxiety and seven to measure depression. According to research literature, the cut-off point for elevated anxiety and depression as measured by the HAD scale is eight

Measure: Hospital anxiety and depression scale

Time: Baseline, up to 4 weeks
166 Evaluation of the Repercussions of the Coronavirus (Covid 19) Infection on Nutritional Health Status and Nutritional Care : an Observational French Cohort Study One Month After Their Discharge From Hospital

Describe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus.

NCT04365816
Conditions
  1. COVI
  2. COVID-19
Interventions
  1. Other: Interview
MeSH:Infection

Primary Outcomes

Description: Self assessment on the SEFI (Self-Evaluation of Food Intake) scale at one month after hospital discharge: 0 corresponds to the worsen score (no ingesta) and 10 corresponds to the best (same ingesta than before the disease)

Measure: Evaluation of food intake at 1 month after discharge from hospital for COVID

Time: one month after hospital discharge

Secondary Outcomes

Description: Self-reported weight in kilograms, or in the absence of self-reported variations before the disease, during hospitalisation, at hospital discharge, one month after hospital discharge

Measure: Weight variation during the infection

Time: one month after hospital discharge

Description: Effect of these factors (anorexia, dysgeusia, Ear Nose and Throat pain, swallowing disorders, intestinal transit disorders...) on SEFI and weight

Measure: Clinical signs limiting food intake

Time: one month after hospital discharge

Description: Effect of these factors (supply difficulties, disease-related food disgust, limiting food habits or prior diet, hydration difficulties, need for help) on SEFI and weight

Measure: Factors limiting food intake

Time: one month after hospital discharge

Description: Effect of nutritional strategy and interventions that were implemented (nutritional advice, adapted meals, oral nutritional supplementation, enteral and parenteral nutrition during hospitalisation and one month after hospital discharge) on SEFI and weight

Measure: Implemented nutritional strategy

Time: one month after hospital discharge

Description: Effect of pre-existing chronic disorders (pulmonary, chronic inflammatory bowel disease, cardio-vascular disease, diabetes, obesity, cognitive disorders, immunodepression, cancer, inflammatory joint disorder) on SEFI and weight

Measure: Pre-existing chronic disorders

Time: one month after hospital discharge

Description: Quantifying unscheduled consultations or hospitalisations in the month following discharge from hospital

Measure: Covid-19 repercussions

Time: one month after hospital discharge
167 Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers

This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus. We will also assess the psychological impact of the pandemic in patients but also in caregivers

NCT04366154
Conditions
  1. COVID-19
  2. Cancer
Interventions
  1. Other: Questionnaire
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Proportion of patients with modification of the treatments administered

Measure: To assess the impact of the COVID-19 pandemic on the modifications of treatments administered in hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Description: Proportion of patients with change in the rate of treatment administration

Measure: To assess the impact of the COVID-19 pandemic on the change in the rate of treatment administration in hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Description: Proportion of patients with change in the number of cures administered

Measure: To assess the impact of the COVID-19 pandemic on the number of cures administeredin hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Description: Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)

Measure: To assess the impact of the COVID-19 pandemic on change of modality of administration in hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Secondary Outcomes

Description: Score of questionnaires of Perceived Stress Scale [0-40 points]

Measure: Evaluate the perceived stress on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of Impact of Event Scale-Revised [0-88 points]

Measure: Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of sleep disorders (ISI scale, 0-28 points)

Measure: Evaluate the sleep disorders on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of quality of life (FACT-G scale)

Measure: Evaluate the quality of life on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of cognitive complaints (Fact-Cog scales; 0-148 points)

Measure: Evaluate the cognitive complaints on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of Perceived Stress Scale [0-40 points]

Measure: Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months

Description: Score of questionnaires of Impact of Event Scale-Revised [0-88 points]

Measure: Evaluate the post-traumatic stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months

Description: Score of questionnaires of burnout ((Maslach Burn Out Inventory scale, 0-132 points)

Measure: Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months

Description: Score of questionnaires of feeling of personal effectiveness (0-30 points)

Measure: Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months
168 Phase I / II Multicentre, Randomized and Controlled Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection

Phase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19 infection.

NCT04366245
Conditions
  1. SARS-CoV 2
Interventions
  1. Biological: Hyperimmune plasma
  2. Drug: Standard of care for SARS-CoV-2 infection
MeSH:Infection

Primary Outcomes

Description: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).

Measure: Safety: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).

Time: 30 days after enrollment

Measure: Efficacy: Death from any cause

Time: Day +21 after randomization

Measure: Efficacy: Need for mechanical ventilation

Time: Day +21 after randomization

Description: IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL.

Measure: Efficacy: Any of the following analytical data after 72h of randomization.

Time: Day +21 after randomization

Measure: Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level

Time: Day +21 after randomization

Secondary Outcomes

Measure: Efficacy. Mortality on days 14 and 28.

Time: Days 14 and 28.

Measure: Efficacy: Proportion of patients who required mechanical ventilation

Time: Until day 28

Description: IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL until the cure test.

Measure: Efficacy: Proportion of patients who develop analytical alterations.

Time: Day +21 after randomization.

Measure: Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.

Time: Day +21 after randomization

Measure: Efficacy: PCR negative for SARS-CoV-2

Time: On days 7 and 21

Description: Proportion of patients requiring treatment with Tocilizumab Sarilumab, Anakimra or other IL-6 or IL-1 antagonists, or corticosteroids at doses of methylprednisolone greater than 2 mg / Kg / day (or equivalent) and / or any investigational medication.

Measure: Efficacy: Proportion of patients requiring treatment.

Time: Until day 21.

Measure: Efficacy: Duration of hospitalization (days)

Time: Until day 21.

Measure: Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample

Time: At baseline and on day 21

Measure: Virology and immunological variables: Total antibody quantification

Time: At baseline and on days 3, 7 and 21

Measure: Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.

Time: Before infusion
169 Prospective Registry for Multimodal Assessment of Neuromuscular Pathology Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

Prospective registry for multimodal assessment of neuromuscular pathology associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, enrolling consecutive patients with corona virus disease 2019 (Covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at Tübingen University Hospital.

NCT04367350
Conditions
  1. COVID
  2. Sars-CoV2
  3. Corona Virus Infection
  4. Myositis
  5. Myocarditis
Interventions
  1. Diagnostic Test: laboratory biomarkers
  2. Diagnostic Test: muscle ultrasound
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Myositis Myocarditis
HPO:Inflammatory myopathy Myocarditis Myositis

Primary Outcomes

Description: Elevation of creatine kinase during hyperacute phase of corona virus disease 2019 (Covid-19)

Measure: Rate of elevated creatine kinase in hyperacute phase

Time: 1 week

Secondary Outcomes

Description: Elevation of creatine kinase during hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)

Measure: Rate of elevated creatine kinase

Time: 24 months

Description: Two-peak elevation of creatine kinase during acute phase of corona virus disease 2019 (Covid-19)

Measure: Rate of two-peak elevation of creatine kinase during acute phase

Time: 30 days

Description: Presence of myositis-specific antibodies on admission, at two weeks, and at end of follow-up

Measure: Rate of myositis-specific antibodies

Time: 24 months

Description: Presence of antimyocardial antibodies on admission, at two weeks, and at end of follow-up

Measure: Rate of antimyocardial antibodies

Time: 24 months

Description: Level of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19) assessed by the area under the curve (AUC)

Measure: Area under the curve (AUC) of elevated creatine kinase

Time: 24 months

Description: Maximal value of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)

Measure: Peak-levels of elevated creatine kinase

Time: 24 months

Description: Maximal value of troponin in the acute phase of corona virus disease 2019 (Covid-19)

Measure: Peak-levels of troponin

Time: 30 days

Description: Maximal value of urine myoglobin in the acute of corona virus disease 2019 (Covid-19)

Measure: Peak-levels of urine myoglobin

Time: 30 days

Description: Muscle hyperechogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score) during the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)

Measure: Rate of muscle hyperechogenicity

Time: 24 months

Description: Peak-muscle hyperechogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score) during the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)

Measure: Peak-muscle hyperechogenicity

Time: 24 months
170 COST (COvid STudio) ACTION: Study for the Evaluation of Specific Antibodies Anti Covid-19 Linked to Covid-19 Infection, Symptoms and Genetic Expression of ACE2 Polymorphisms in Patients

The aims of this study is to define the genetic bases of COVID-19 related disease heterogeneity in frail population, to carry out a retrospective study on individuals w/wo symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis and on the presence of genetic profiling and to explore the therapeutic potential of the modulation of ACE2 expression.

NCT04367402
Conditions
  1. COVID-19
Interventions
  1. Other: BioMedomics COVID-19 IgM-IgG Rapid Test
MeSH:Infection

Primary Outcomes

Description: BioMedomics Rapid IgM-IgG Combined Antibody Test for COVID-19 is immunochromatography based. The test card contains colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. When 10 microL of test sample is added to the sample well of the test cassette, the sample will move forward along the test card via capillary action. If the sample contains IgM antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The antibody/antigen complex will be captured by the anti-human IgM antibody immobilized on the membrane, forming a red M line and indicating a positive result for the IgM antibody. If the sample contains IgG antibodies, the same thing happens, forming a red G line and indicating a positive result for the IgG antibody. If neither antibody is present, a negative result is displayed.

Measure: Retrospective study on individuals with or without symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis.

Time: 6 months

Secondary Outcomes

Description: By an in silico analysis, we found 2 missense variants in ACE2 gene annotated at residues 82 (rs766996587) and 355 (rs961360700) involved in PPIs with MAF<0.01. Variants in other residues of the ACE2 may affect protein structure and/or activity/localization, influence the binding of the spike protein and thus the virus ability to enter the respiratory tract.In light of its relevance in cell entry, pharmacological approaches aimed at modulating ACE2 expression, through the modulation of SIRT1 activity in the lung or by selective oligo antisense treatment, should help in counteracting COVID-19 infection. Annotated SNPs evaluation of the TMPRSS2 gene showed 4 exonic common polymorphisms (MAF>1%); of these, rs12329760 is a missense variant in the SRCR domain mediating PPI and ligand binding. Common SNPs are at the 3'UTR, possibly involved in regulating mRNA stability and several rare variants mapped in exons encoding the peptidase domain, potentially affecting protein activity.

Measure: ACE2 expression in patients with COVID-19 infection

Time: 6 months
171 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
172 Mapping Organ Health Following COVID-19 Disease Due to SARS-CoV-2 Infection

A prospective, longitudinal, observational cohort study looking at patients following COVID-19 disease using multi-parametric magnetic resonance imaging (MRI) to assess the degree and prevalence of organ injury.

NCT04369807
Conditions
  1. COVID-19
Interventions
  1. Diagnostic Test: Outpatient MRI
MeSH:Infection

Primary Outcomes

Description: In patients recovering from COVID-19 disease: Characterise using summary statistics the prevalence and severity of organ volume change and damage to heart, kidneys and liver

Measure: Characterise prevalence and severity of organ volume change and damage (heart, kidneys and liver)

Time: 12 Months

Secondary Outcomes

Description: In patients recovering from COVID-19 disease: To characterise using summary statistics the prevalence and severity of organ volume change and damage in lung, pancreas and spleen

Measure: Characterise prevalence and severity of organ volume change and damage (lung, pancreas and spleen)

Time: 12 Months

Description: In patients recovering from COVID-19 disease: Characterise liver damage as assessed by liver volume in liters, iron corrected T1 (cT1) in milliseconds, liver fat content as %, liver T2star in milliseconds (a correlate of liver iron content)

Measure: Change from Baseline in liver-specific biomarkers: volume, iron corrected T1(cT1), fat content and T2star

Time: 6 Months

Description: In patients recovering from COVID-19 disease: Characterise heart and spleen damage as assessed by liver volume in liters as well as kidney, liver and pancreas damage as assessed by volume in liters, iron corrected T1 (cT1) in milliseconds, fat infiltration as %, T2star in milliseconds (a correlate of liver iron content).

Measure: Change from Baseline in organ-specific biomarkers characterising organ volume change in the heart and spleen along with organ volume and damage in the kidney, liver and pancreas assessed by volume, iron corrected T1 (cT1) and fat infiltration

Time: 12 Months

Description: In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by Dyspnea-12. Each question is assigned a value between: none, mild, moderate and severe and is used to assess breathing characteristics.

Measure: Change in patient reported outcome measured by the Dyspnea-12 questionnaire

Time: 12 Months

Description: In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by the St. George's Respiratory questionnaire. Each section comprises of questions in various formats allowing to assess which aspects of the illness cause the participant the most problems in daily life.

Measure: Change in patient reported outcome measured by the St. George's Respiratory questionnaire (SGRQ)

Time: 12 Months

Description: In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by the EQ-5D-5L questionnaire. Two main sections provide the opportunity to capture statements best describing a participant's daily health and a scale form 0 to 100 capturing self-reported health stats. (100 being the best health imaginable and vice versa)

Measure: Change in patient reported outcome measured by the EQ-5D-5L questionnaire

Time: 12 Months

Description: In patients recovering from COVID-19 disease: Difference from Baseline in degree of change in liver MR-derived biomarkers with and without known genetic variants associated with liver disease (e.g., PNPLA3) using a paired t-test (or non-parametric alternative)

Measure: Degree of change in liver MR-derived biomarkers

Time: 12 Months
173 Observational Study of COVID-19 Treatment Efficacy

To compare various treatments provided to positive COVID-19 patients at locations across the OSF Ministry. Provide the opportunity to compare the effectiveness of various treatments and treatment timelines provided to specific cohorts of patients that have the potential to impact future treatment plans for COVID-19 patients and/or future research hypotheses.

NCT04369989
Conditions
  1. Coronavirus
  2. Coronavirus Infection
  3. Corona Virus Infection
  4. COVID
  5. Sars-CoV2
  6. Coronavirus as the Cause of Diseases Classified Elsewhere
  7. SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
  8. COVID-19
  9. Coronavirus Disease
  10. Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
Interventions
  1. Other: No intervention
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Mortality during the COVID-19 treatment hospital encounter

Time: up to 6 weeks

Measure: ICU admission during the COVID-19 treatment hospital encounter

Time: up to 6 weeks

Measure: Ventilator use during the COVID-19 treatment hospital encounter

Time: up to 6 weeks
174 Efficacy and Safety of Hydroxychloroquine in Primary Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers at Risk of Exposure: Randomised Control Trial

Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. There are in vitro studies available which show inhibition of corona virus by hydroxychloroquine, a widely-used agent against malaria and certain autoimmune conditions and of low-cost and limited toxicity. However, evidence regarding its effects in patients is limited. We plan to conduct a randomized controlled trial to evaluate the safety and potential prophylactic efficacy of hydroxychloroquine in preventing secondary SARS-CoV-2 infection among healthcare workers at high-risk of exposure while managing such patients.

NCT04370015
Conditions
  1. SARS-CoV-2
  2. Healthcare Workers
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo oral tablet
MeSH:Infection

Primary Outcomes

Description: Negative RT-PCR for SARS-CoV-2 both at baseline and at end of 12 weeks in experimental arm

Measure: Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period

Time: From date of randomization until study completion 12 weeks after treatment initiation

Description: To assess the presence or absence of side effects from HCQ treatment.

Measure: Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

Secondary Outcomes

Description: Symptomatic infection by SARS-CoV-2 defined as cough, dyspnea, fever, myalgia, arthralgia or rhinorrhea.

Measure: Confirmed SARS-CoV-2 infection based on symptoms and confirmed by RT-PCR

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

Description: Disease severity including i) asymptomatic. ii) Mild symptoms but ambulatory. iii) Moderate symptoms requiring hospitalisation. iv) severe symptoms requiring ICU care and oxygen. v) Severe symptoms requiring assisted mechanical ventilation. vi) Death.

Measure: Clinical disease severity in confirmed SARS-CoV-2 participants

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

Description: Symptomatic non-COVID viral infection (any other acute respiratory illness with fever but without evidence of epidemiological risk factors such as close contact with SARS-CoV-2 positive patient or travel to or residence in high-risk area).

Measure: Incidence of any acute respiratory infection

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
175 Screening for SARS-CoV-2-Infections and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers

The main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 in asymptomatic healthcare workers (HCWs) in an early phase of community spread as well as 2) to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve the assessment of the immune response and its protective effect as well as the assessment of infectivity of affected HCWs and 4) to evaluate the value and significance of antibody formation and serological antibody tests and 5) to be able to evaluate possible future preventive and / or therapeutic approaches against SARS-CoV-2

NCT04370119
Conditions
  1. SARS-Cov-2
Interventions
  1. Diagnostic Test: Nasal swab
  2. Diagnostic Test: Serum testing
MeSH:Infection

Primary Outcomes

Description: Anti-SARS-COV2 S protein IgG ELISA

Measure: Number of people with detectable antibodies to SARS-COV2

Time: 1 year

Secondary Outcomes

Description: SARS-COV2 PCR

Measure: Number of people with detectable SARS-COV2 nucleic acid

Time: 1 year

Other Outcomes

Description: Anti-SARS-COV2 S protein IgG ELISA

Measure: Number of people with detectable antibodies to SARS-COV2

Time: 2 years

Description: Anti-SARS-COV2 S protein IgG ELISA

Measure: Number of people with detectable antibodies to SARS-COV2

Time: 3 years

Description: Anti-SARS-COV2 S protein IgG ELISA

Measure: Number of people with detectable antibodies to SARS-COV2

Time: 4 years

Description: Anti-SARS-COV2 S protein IgG ELISA

Measure: Number of people with detectable antibodies to SARS-COV2

Time: 5 years

Description: SARS-COV2 PCR

Measure: Number of people with detectable SARS-COV2 nucleic acid

Time: 2 years

Description: SARS-COV2 PCR

Measure: Number of people with detectable SARS-COV2 nucleic acid

Time: 3 years

Description: SARS-COV2 PCR

Measure: Number of people with detectable SARS-COV2 nucleic acid

Time: 4 years

Description: SARS-COV2 PCR

Measure: Number of people with detectable SARS-COV2 nucleic acid

Time: 5 years
176 VITACOV: Vitamin D-related Polymorphisms and Vitamin D Levels as Risk Biomarkers of COVID-19 Infection Severity

Vitamin D deficiency has been linked to hypertension, autoimmune, infectious and cardiovascular diseases which are risk factors for COVID-19. Moreover, COVID-19 patients have a very high prevalence of hypovitaminosis D (Turin data). Taken together, we aim to investigate whether genetic variants in vitamin D-related genes contribute to a poor COVID-19 outcome, particularly in hypertension and CV patients, proposing thus a personalized therapeutics based on vitamin D supplementation in order to reduce the severity and deaths.

NCT04370808
Conditions
  1. COVID-19
Interventions
  1. Other: Exposure
MeSH:Infection

Primary Outcomes

Measure: Differences in vitamin D blood levels between COVID-19 patients with different degrees of disease severity.

Time: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).

Measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients with different degrees of disease severity.

Time: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).

Secondary Outcomes

Measure: Differences in vitamin D blood levels between COVID-19 patients in relation to mortality.

Time: Through study completion, an average of 3 months.

Measure: Differences in vitamin D blood levels between COVID-19 patients in relation to length of stay in hospitals.

Time: Through study completion, an average of 3 months.

Measure: Differences in vitamin D blood levels between COVID-19 patients in relation to duration of mechanical ventilation.

Time: Through study completion, an average of 3 months.

Measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to mortality.

Time: Through study completion, an average of 3 months.

Measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to length of stay in hospitals.

Time: Through study completion, an average of 1 year.

Measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to duration of mechanical ventilation.

Time: Through study completion, an average of 3 months.
177 Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children

Patient are being asked to provide respiratory and blood samples for a clinical research study because the patients have a virus called the novel coronavirus, or SARS-CoV-2, that causes the disease known as Covid-19. Investigators do not know a lot about this virus, including all the ways it travels from person to person. Investigators also do not know if a person will get sick or not from the virus after being in close contact with someone who has the virus. Because of this, investigators are performing research on the virus found in respiratory secretions to get more information on how investigators can best detect and treat this new virus in the future. Primary Objective - To determine the clinical characteristics and outcomes of Covid-19 in children. - To characterize the clinical risk factors of Covid-19 in children.. Secondary Objectives - To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children. - To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective

NCT04371315
Conditions
  1. Corona Virus Infection
  2. Pediatric Cancer
  3. Adult Children
  4. Cancer
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical characteristics, including demographics, underlying diagnosis, and signs/symptoms, and outcomes, such as hospitalization, oxygen requirements, and mortality, will be summarized with counts and percentages.

Measure: Characteristics and outcomes of acute respiratory infections due to COVID-19 in children.

Time: Baseline-Day 60

Description: Pearson or Spearman's correlation of clinical risk factors such as age, underlying diagnosis, immunosuppression with outcomes as detailed in primary objective 1 will be evaluated.

Measure: Clinical risk factors of acute respiratory infection due to COVID-19 in children.

Time: Baseline-day 60

Secondary Outcomes

Description: Immunological (Absolute lymphocyte/monocyte counts (mm3) and Immunoglobin level (mg/dL) response measures, will be summarized with mean, standard deviation, median and range.

Measure: Immunologic response to acute respiratory infection due to COVID-19 in children.

Time: Baseline-day 60

Description: The duration of viral shedding, defined as the time between the first positive test date and the first negative test date, will be summarized for all participants with mean, standard deviation, median and range.

Measure: Duration of viral shedding and evolution in children longitudinally.

Time: Baseline-Day 60
178 Prevalence of SARS-Cov2 Infection Among HCW in Lille University Hospital

The objective of this study is to determine the prevalence of SARS-Cov2 infection among health care workers exposed of Lille University Hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants.

NCT04371692
Conditions
  1. Sars-CoV2
Interventions
  1. Other: self-administered questionnaire
  2. Diagnostic Test: SARS-Cov2 testing
MeSH:Infection

Primary Outcomes

Measure: the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection

Time: at 2 months

Secondary Outcomes

Measure: the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection

Time: once week during 2 months

Measure: Occupational exposures associated with the SARS-Cov2 infection

Time: once week during 2 months

Measure: Environmental exposures associated with the SARS-Cov2 infection

Time: once week during 2 months

Measure: immunologic status of health Care Worker

Time: once week during 2 months

Measure: inflammatory biomarkers status of Health Care Worker

Time: once week during 2 months
179 COVID-19 in People Living With HIV: Evaluation of Risk Factors and Outcomes in Resource-limited Settings. A Pooled Substudy of ADVANCE, D²EFT, DolPHIN2 and NAMSAL

COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.

NCT04371835
Conditions
  1. HIV-infection/Aids
  2. Coronavirus Infection
MeSH:Infection Communicable Diseases HIV Infections Coronavirus Infections Severe Acute Respiratory Syndrome Acquired Immunodeficiency Syndrome

Primary Outcomes

Description: To characterise the clinical features of symptomatic COVID-19 in PLWH (cardio-respiratory and other clinical signs or symptoms), described overall and by HIV and comorbid disease factors including pregnancy status.

Measure: Clinical features of symptomatic COVID-19 in people living with HIV (PLWH)

Time: At baseline

Description: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.

Measure: Clinical outcomes of symptomatic COVID-19 in PLWH

Time: At Day 28

Description: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.

Measure: Clinical outcomes of symptomatic COVID-19 in PLWH

Time: At Month 3

Secondary Outcomes

Description: To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history.

Measure: Seroprevalence of COVID-19 in all parent study participants

Time: Through study completion, an average of one year
180 Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)

This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.

NCT04372004
Conditions
  1. COVID-19
Interventions
  1. Diagnostic Test: diagnostic tests for COVID-19 infection
MeSH:Infection

Primary Outcomes

Description: Detection of viral infection in the two test platforms using 3 specimen (blood, nasal swab and sputum) from the same subject, in detecting COVID-19 infection

Measure: detection of viral infection using serology and viral-RNA detection kits

Time: 1 day

Secondary Outcomes

Description: Temporal trend of the IgM and IgG production in response to the infection by conducting serial serology tests at bi-weekly interval

Measure: Temporal trend of antibodies in blood

Time: 1 month
181 Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection

This is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.

NCT04372017
Conditions
  1. COVID-19
  2. SARS-CoV 2
Interventions
  1. Drug: Hydroxychloroquine
  2. Dietary Supplement: Vitamin D
MeSH:Infection

Primary Outcomes

Description: Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in healthcare workers who have been exposed to a known case of COVID-19.

Measure: Cohort A: Percentage of COVID-19 exposed healthcare workers treated with hydroxychloroquine with a positive COVID-19 test.

Time: At enrollment completion outcome 1 will be analyzed.

Description: Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in high-risk individuals who have been exposed to a known case of COVID-19.

Measure: Cohort B: Percentage of COVID-19 exposed high-risk individuals treated with hydroxychloroquine with a positive COVID-19 test.

Time: At enrollment completion outcome 2 will be analyzed.
182 An Open-label, Prospective, Randomized, Comparative Clinical Trial to Evaluate the Efficacy and Safety of ENKORTEN® as an Immunomodulatory Therapy, Within the Usual Therapeutically Established Protocol, for the Treatment of Patients With Moderate to Severe COVID-19 Infection

An Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment of patients with moderate to severe COVID-19 infection

NCT04374032
Conditions
  1. COVID-19 Infection
Interventions
  1. Drug: metenkefalin + tridecactide
  2. Drug: The standard of care
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: The time of onset of improvement in the patient's clinical condition will be measured following the clinical objective and subjective signs and radiological indicators.

Measure: Time to onset of change in the patient's clinical condition

Time: 21 day

Description: At every examination/evaluation, all AEs, whether noticed by investigators and their associates in the trial, or spontaneously reported by the subjects, or given as answer to direct question, must be evaluated by the investigator and reported on case report forms for AE. AE will be recorded in the e-CRF. Three-degree scale will be used for assessment of AE's severity: mild, moderate, severe.

Measure: Safety and tolerability evaluation - treatment-related adverse events will be assessed by CTCAE

Time: 21 day

Secondary Outcomes

Description: To monitor the period of patient's hospitalization

Measure: Length of in-hospital stay

Time: 21 day

Description: To monitor the survival rate during the hospitalization

Measure: Survival rate

Time: 21 day

Description: To monitor the intubation frequency during the hospitalization

Measure: Intubation rate

Time: 21 day

Description: To monitor the levels of proinflammatory markers during the hospitalization (IL-6)

Measure: Proinflammatory markers levels

Time: 21 day
183 Phase II Study of N-acetylcysteine in Severe or Critically Ill Patients With Refractory COVID-19 Infection

The study researchers think that a medication called N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system that attacks infections. By helping your immune system fight the virus, the researchers think that the infection will get better, which could allow the patient to be moved out of the critical care unit or go off a ventilator, or prevent them from moving into a critical care unit or going on a ventilator. The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat the liver side effects resulting from an overdose of the anti-inflammatory medication Tylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD). This study is the first to test N-acetylcysteine in people with severe COVID-19 infections.

NCT04374461
Conditions
  1. Covid-19
Interventions
  1. Drug: N-acetylcysteine
  2. Other: Peripheral Blood
MeSH:Infection

Primary Outcomes

Measure: Arm A: number of patients who are successfully extubated and/or transferred out of critical care due to clinical improvement

Time: 1 year

Measure: Arm B: number of patients who are discharged from the hospital due to clinical improvement

Time: 1 year
184 Efficacy and Safety of High-Titer Anti-SARS-CoV-2 (COVID19) Convalescent Plasma for Hospitalized Patients With Infection Due to COVID-19 to Decrease Complications: A Phase II Trial

This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.

NCT04374565
Conditions
  1. Corona Virus Infection
  2. SARS-C
  3. SARS-CoV 2
  4. SARS Pneumonia
  5. Pneumonia
Interventions
  1. Drug: High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Will be done by comparing the admission rate to the ICU between patients who received convalescent plasma and a control group who did not enroll in the study, or receive another experimental therapy.

Measure: Transfer to ICU

Time: Days 0 - 60

Description: Will be done by comparing the 28 day mortality rate between enrolled subjects and the control group.

Measure: 28 day mortality

Time: Days 0 - 60

Secondary Outcomes

Description: Will be collected from time of enrollment until completion of the study. The adverse events will be evaluated by CTCAE V5.0 and MedDRA.

Measure: Cumulative incidence of serious adverse events

Time: Days 0 - 60

Description: Will be done by collecting respiratory tract swabs and testing for SARS-CoV-2 positivity.

Measure: Rates and duration of SARS-CoV-2

Time: Days 0, 7, 14, and 21

Description: Serum or plasma will be collected and analyzed for SARS-CoV-2 antibody.

Measure: Serum of plasma antibody titer to SARS-CoV-2

Time: Days 0, 7, 14, and 28

Description: Blood will be collected and analyzed for cellular and humoral response.

Measure: Cellular and humoral immune response

Time: Days 0, 7, 14, 28

Description: All days where a supplemental oxygen is needed will be recorded as a concomitant medication and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the supplemental oxygen free days.

Measure: Supplemental oxygen free days

Time: Days 0-28

Description: All days where a ventilator is needed will be recorded as a concomitant procedure and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ventilator free days.

Measure: Ventilator free days

Time: Days 0 - 28

Description: All days where the participant is admitted to the ICU will be recorded and subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ICU free days.

Measure: ICU free days

Time: Days 0 - 28

Description: The patient will be evaluated throughout their enrollment in the study. The score will be evaluated to see if the score improved or worsened throughout their admission.

Measure: Sequential organ failure assessment score

Time: days 0, 1, 4, 7, 14, 21, 28

Description: Concomitant medications will be recorded throughout the patients participation in the study and vasopressors will be recorded, if they are needed.

Measure: Need for vasopressors

Time: Days 0 - 60

Description: Renal function will be assessed throughout the patients participation in the study. If renal replacement therapy is needed, it will be captured as a concomitant procedure.

Measure: Need for renal replacement therapy

Time: Days 0 - 60

Description: Respiratory function will be assessed throughout the patients participation in the study. If ECMO is needed, it will be captured as a concomitant procedure.

Measure: Need for extracorporeal membrane oxygenation (ECMO)

Time: Days 0 - 60

Description: Will be calculated from the date the patient entered the hospital until they were discharged.

Measure: Hospital length of stay (LOS)

Time: Days 0-60

Description: Will be calculated from the date the patient entered the ICU until they were discharged from the ICU.

Measure: ICU LOS

Time: days 0 - 60

Description: All adverse events will be recorded and evaluated by CTCAE v.5.0. All grade 3 and 4 AEs will be calculated to determine safety of convalescent plasma.

Measure: Grade 3 or 4 Adverse Events (AEs)

Time: days 0 - 60
185 Health-related Quality of Life (HRQOL) and Physical Performance in Individuals After COVID-19 Induced Hospitalisation and the Impact of a Standard Care Follow-up Program: a Longitudinal Observational Cohort Study

This study aims to observe the long-term health-related quality of life (HRQOL) and physical performance in individuals hospitalized due to a COVID-19 infection. Therefore, data is extracted from a study-site standard aftercare program which has been adjusted for this patient population. This comprehensive aftercare program includes education sessions and physical exercise. A second aim is to observe adherence and feasibility to the program and if indicated compare the clinical data and outcomes from patients following the program with patients denying to participate in guided exercise and education sessions. It is expected that patients hospitalized due to COVID-19 infection show a reduction in physical performance and HRQOL directly after discharge. The severity of illness is hypothesized to be associated with a reduction as well in HRQOL and physical performance after one-year post-discharge.

NCT04375709
Conditions
  1. Covid-19 (New Coronavirus) Infection
Interventions
  1. Other: Physical exercise
  2. Behavioral: Education sessions
MeSH:Infection Coronavirus Infections

Primary Outcomes

Description: Self-managed questionnaire on functional status, anxiety, pain and independence in daily living; The EuroQoL includes a five item scale and a visual analog scale from 0-100 in order to quantify perception of current health. The five item scale includes ordinary scores from 0-5. Lower numbers equal less problems and better quality of life. For the visual analog scale a higher number represents a better health status perceived.

Measure: Health-related quality of life; EuroQoL (EQ-5D-5L)

Time: 01.04.2020 - 30.05.2021

Description: 6-minute walk test measures the distance acquired during six minutes walking, it quantifies the physical performance, dyspnoea and endurance.

Measure: 6-minute walk test

Time: 01.04.2020 - 30.05.2021

Secondary Outcomes

Description: Measures the handgrip strength and is associated with sarcopenia, mortality and independence in life (e.g. for older individuals and patients after or with critical illness)

Measure: Jamar dynamometer

Time: 01.04.2020 - 30.05.2021

Description: Self-administered questionnaire on anxiety and depression after hospitalization; bot, anxiety and depression is quantified by an ordinal scale from 0-3, respectively. The lower the number the less signs of depression or anxiety are present.

Measure: Hospital Anxiety and Depression Scale (HADS)

Time: 01.04.2020 - 30.05.2021

Description: Questionnaire on avoidance, intrusion and arousal (or overreaction) in order to identify potential risk for post-traumatic stress. The Scale includes 22 questions ordinally scored from "not at all" to " very frequent" with four scores. The scores are transformed into numbers (0,1,3,5). The values are put in a formula resulting in a single value.A value below zero indicates no risk of post-traumatic stress disorder (PTSD) is present. Values equal or higher than zero indicate the risk of a PTSD

Measure: revised Impact of Event Scale (IES-R)

Time: 01.04.2020 - 30.05.2020

Description: Questionnaire on the nutritional condition of the patient. It includes 16 questions and 2 measures. Points range from 0-30; A score <17 indicates malnutirtion, a score from 17-23.5 indicates a risk of malnutrition and scores between 24-30 indicate normal nutritional behaviour.

Measure: Mini-Nutritional Assessment (MNA)

Time: 01.04.2020 - 30.05.2021

Description: Measures the lung function (bedside screening)

Measure: Spirometry (bed-side)

Time: 01.04.2020 - 30.05.2021

Description: This scale measures the functional state and Independence of patients after COVID-19 infection. The scale includes two items scored from 0-4 and 0-5. A high value indicates more restrictions in function and independence during daily life.

Measure: Post-Covid Functional Scale (PCFS)

Time: 01.04.2020 - 30.05.2021

Description: Quantifies and stratifies the perception of dyspnoea with a score ranging from 0-4. The higher the value the more frequent and more severe is the perception of dyspnoea during daily life activities.

Measure: modified Medical Research Council Dyspnoea Scale (mMRC Dyspnoea)

Time: 01.04.2020 - 30.05.2021
186 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
187 Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)

The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis. In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional. Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response. In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.

NCT04376476
Conditions
  1. Infection, Coronavirus
  2. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Biological: Blood sample
  2. Biological: Low or upper respiratory tract sample
  3. Biological: Stool collection or fecal swab
  4. Genetic: Blood sample for whole genome sequencing
  5. Other: phone call
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Describe the immune response (biological profile in blood samples) of children and adults with COVID-19 infection and correlate it with the initial clinical presentation measurement of the following parameters in blood at time of inclusion: white blood cell count, C-reactive protein, procalcitonin, hepatic and renal functions, ferritin, vitamin C and D, fibrinogen, prothrombin time test and partial thromboplastin time in order to correlate them with the initial clinical presentation.

Measure: Initial biological profile of children and adults with COVID-19 infection

Time: Day 0

Description: measurement of the following parameters in blood at time of inclusion: interferon alpha and gamma, Tumor necrosis factor (TNF) alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte Human Leukocyte Antigen - DR isotype (HLA-DR) expression in order to correlate them with the initial clinical presentation.

Measure: Initial immunological profile of children and adults with COVID-19 infection

Time: Day 0

Secondary Outcomes

Description: Determine whether the initial biological and immunological profiles (see primary outcome measures) are predictive of a secondary worsening (i.e., admission to intensive care unit, and/or increase in NEWS-2 score, and/or increase in oxygen dependence level) of COVID-19 infection

Measure: Clinical worsening

Time: Within 21 days following inclusion

Description: measurement of the following parameters in blood at day 7, and at time of worsening: interferon alpha and gamma, TNF alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte HLA-DR expression in order to correlate them with with the secondary worsening

Measure: Evolution of the immunological profile of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured at day 0 and correlation to the initial clinical presentation

Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19

Time: Day 0

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured at day 0 and correlation to the initial clinical presentation

Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19

Time: Day 0

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured at day 0 and correlation to the initial clinical presentation

Measure: titers in specific Immunoglobulin M (IgM) antibodies of children and adults with COVID-19

Time: Day 0

Description: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured within 21 days following inclusion, and correlation to the secondary worsening

Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening

Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening

Measure: titers in specific Immunoglobulin G (IgM) antibodies of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Genotyping using the whole exome sequencing technic (by Illumina HiSEQ 2500) in order to correlate with the initial clinical presentation.

Measure: Genetic profile of adults with COVID-19 infection

Time: Day 0

Description: Genotyping using the whole exome sequencing technic (Illumina HiSEQ 2500) in order to correlate with with the secondary worsening

Measure: Genetic profile of adults with COVID-19 infection

Time: Within 21 days following inclusion
188 18F-αvβ6-binding-peptide PET/CT in Patients Post SARS CoV2 Infection

This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.

NCT04376593
Conditions
  1. COVID-19
  2. SARS-CoV-2 Infection
Interventions
  1. Drug: 18F-αvβ6-BP
MeSH:Infection

Primary Outcomes

Description: Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

Measure: Administration of 18F-αvβ6-BP

Time: baseline

Description: Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

Measure: Administration of 18F-αvβ6-BP

Time: 3 months

Description: Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

Measure: Administration of 18F-αvβ6-BP

Time: 6 months

Secondary Outcomes

Description: Uptake of 18F-αvβ6-BP in lung damage will be measured by PET

Measure: Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage

Time: baseline

Description: Uptake of 18F-αvβ6-BP in lung damage will be measured by PET

Measure: Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage

Time: 3 months

Description: Uptake of 18F-αvβ6-BP in lung damage will be measured by PET

Measure: Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage

Time: 6 months

Other Outcomes

Description: Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.

Measure: Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.

Time: baseline

Description: Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.

Measure: Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.

Time: 3 months

Description: Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.

Measure: Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.

Time: 6 months
189 Fluoxetine to Reduce Intubation and Death After COVID19 Infection

This project will test the efficacy of fluoxetine to prevent serious consequences of COVID-19 infection, especially death. Becoming sick with COVID-19 virus or any other serious respiratory condition is not fun. However, the dramatic effects of the COVID-19 pandemic on human society stem from its significant mortality, not the number of individuals who become sick. This project aims to prevent serious outcomes such as hospitalization, respiratory failure and death during the time it takes to develop vaccinations and other strategies to prevent COVID-19 infectionPoor outcomes with COVID-19 infection such as hospitalization, respiratory failure, organ failure and death are associated with a dysfunctional exaggerated immune response, called a cytokine storm, that is triggered by Interleukin-6 expression (IL-6) and seems to occur around day 5 to 7 of symptoms. Fluoxetine has extraordinarily strong evidence in its action as a blocker of IL-6 and cytokine storms in both animal models of infection and in human illness such as rheumatoid arthritis and others. This action of fluoxetine is an entirely separate pathway than the serotonergic pathway that allows fluoxetine to act as an antidepressant. This pathway has been demonstrated in cell culture, in animal models, in human illness and by novel bioinformatics analyses of protein transcripts to be relatively unique for fluoxetine and appears to be a novel pathway. This project aims to inhibit the increase in IL-6 expression and thereby prevent the cytokine storm that causes poor outcomes. Patients who have tested positive or are presumptively positive for COVID-19 will be entered into the study and given the option to start the medication fluoxetine, which is demonstrated to prevent IL-6 surges in infectious and inflammatory conditions. Participants will be monitored daily for COVID-19 symptoms and weekly for side effects and tolerance of fluoxetine. A subset of patients will have blood drawn weekly and stored to monitor IL-6 and other cytokine levels at a later date. This project aims to reduce the serious outcomes of COVID-19 infection by preventing or inhibiting the cytokine storm associated with organ failure, respiratory failure and death.

NCT04377308
Conditions
  1. COVID-19
  2. Cytokine Storm
Interventions
  1. Drug: Fluoxetine
MeSH:Infection

Primary Outcomes

Description: whether the subject is hospitalized for COVID-19 symptoms

Measure: Hospitalizations

Time: 2 months

Description: whether the subject is intubated for COVID-19 symptoms

Measure: Intubation

Time: 2 months

Description: whether the subject dies of COVID-19 symptoms

Measure: Death

Time: 2 months

Secondary Outcomes

Measure: Number of days of illness

Time: 2 months

Description: depression

Measure: PHQ-9 score for depressive symptoms,

Time: 2 months

Description: anxiety

Measure: generalized anxiety Disorder-7 scale

Time: 2 months
190 A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)

A multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to Zinc compared to hydroxychloroquine, in the prevention of Military Health Professionals Exposed to SARS CoV2 in Tunisia

NCT04377646
Conditions
  1. Sars-CoV2
  2. COVID19
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Hydroxychloroquine (placebo)
  3. Drug: Zinc
  4. Drug: Zinc (Placebo)
MeSH:Infection

Primary Outcomes

Description: Frequency of confirmed SARS CoV2 infection

Measure: SARS CoV2 infection

Time: At 2 months of follow-up

Secondary Outcomes

Description: Any COVID-19 related symptoms (cough, fever, headache, vomiting, nausea, dyspnea, diarrhea, smell disorder,conjunctivitis, dizziness)

Measure: COVID-19 symptoms description

Time: At 2 months of follow-up

Description: Any adverse event or serious adverse event

Measure: Adverse Events

Time: each month up to 2 months
191 A Phase II Study of IL-6 Receptor Antagonist Tocilizumab to Prevent Respiratory Failure and Death in Patients With Severe COVID-19 Infection

The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.

NCT04377659
Conditions
  1. COVID-19
Interventions
  1. Drug: Tocilizumab
MeSH:Infection Respiratory Insufficiency

Primary Outcomes

Description: The primary endpoint for this cohort is progression of respiratory failure (binary yes/no while hospitalized). Progression of respiratory failure will be defined as a sustained increase in oxygen requirement (FiO2) or need for intubation/mechanical ventilation.

Measure: Progression of respiratory failure or death

Time: 14 days
192 Analysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by (SARS-CoV-2): Predictive Interest in Short-term Evolution

The study of volatile organic compounds (VOCs) detected in exhaled air is an innovative research area for respiratory diseases. This analysis can be done by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOCs without identifying them. The VOCs in exhaled air in patients hospitalized for COVID-19 infection are analysed in this study, using electronic noses.

NCT04379154
Conditions
  1. COVID-19
Interventions
  1. Device: Volatile Organic Compounds analysis
MeSH:Infection

Primary Outcomes

Description: Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between patients who improve and patients who get worse during their hospitalisation for COVID-19 infection

Measure: Profiles of volatile organic compounds (VOCs) in exhaled air between 2 health conditions

Time: 1 day

Secondary Outcomes

Description: Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between the start and the discharge to the hospital in patients infecting and recovering from COVID-19.

Measure: Profiles of volatile organic compounds (VOCs) in exhaled air on 1 health condition

Time: 2 weeks

Description: Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between the hospitalisation period and a post-hospitalisation follow-up consultation in patients infected by COVID-19 and recovered.

Measure: Profiles of volatile organic compounds (VOCs) in exhaled air between 2 periods

Time: 4 months
193 Study of the Attack Rate of COVID-19 Infection in Patients Infected With HIV and/or on Pre-exposure Prophylaxis (PrEP) and Possible Impact of Treatment With an HIV Protease Inhibitor

The SARS-CoV-2 epidemic was declared as a global pandemic by the WHO on March 12, 2020. France is affected with approximately 120,000 biologically confirmed cases, as of April 30, 2020, a figure probably very underestimated. Its distribution in different populations, in particular immunocompromised, has not yet been measured. The in vitro efficacy of lopinavir coupled with ritonavir, an HIV protease inhibitor, on SARS-CoV, responsible for SARS has been discussed and this therapeutic combination is currently being evaluated in patients infected with COVID-19. The possible protective role of treatment with Lopinavir / ritonavir or another HIV protease inhibitor has not been studied. In addition, patients receiving HIV pre-exposure prophylaxis (PrEP) share certain epidemiological and behavioral characteristics with HIV-infected patients. The objective was to carry out an epidemiological study aimed at determining the attack rate of COVID-19 infection in patients infected with HIV and or on PrEP and to analyze this attack rate according to the characteristics of these 2 populations and in particular the existence or not of an antiretroviral treatment comprising Lopinavir / Ritonavir or another inhibitor of the HIV protease. Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data can be easily carried out using a unique identification number in the 2 software programs and will allow an almost exhaustive epidemiological analysis in 2 well identified populations.

NCT04379245
Conditions
  1. HIV
  2. Pre-exposure Prophylaxis
Interventions
  1. Other: Data research, database analysis
MeSH:Infection

Primary Outcomes

Description: Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data using the unique identification number in the 2 databases. This cross-checking of files will allow an almost exhaustive epidemiological analysis in 2 well identified populations.

Measure: Covid attack rate

Time: During hospitalisation for Covid symptoms: one week (max 2 weeks) after symptoms initiation
194 Assessment of the Clinical Effect of Dialyzable Leukocyte Extracts in Individuals With Acute Respiratory Infection (Suspected or Confirmed Cases of COVID-19) (FUTURE-T)

Main goal: To generate information on the efficacy and safety of Dialyzable Leukocyte Extract (DLE) as an aid in the treatment of patients with acute respiratory infection (suspected or confirmed cases of COVID-19). Primary goal: To generate information on the efficacy of DLE as an aid in symptomatic treatment, by reducing the signs and symptoms of acute respiratory infection (suspected/confirmed cases of COVID-19). Secondary goals: 1. To evaluate clinical deterioration and respiratory alarm data. 2. To evaluate the duration of the clinical picture. 3. To explore cytokine changes associated with the therapeutic effect induced by DLE. 4. To obtain data on the safety of DLE as an aid in the symptomatic treatment of acute respiratory infection (suspected/confirmed cases of COVID-19). 5. To generate information to validate the contingency scale to assess the severity of acute respiratory disease (suspected/confirmed cases of COVID-19). Justification The systemic inflammatory response has been recognized as being responsible for COVID-19 complications. Immunomodulation strategies to control it are currently being considered, including the use of systemic steroids to down-regulate the systemic inflammatory response, the use of human immunoglobulin and even chloroquine given its anti-inflammatory and antiviral qualities; however, none of these treatments has been sufficiently studied or has shown any significant change in the clinical course of infected patients. Due to the importance of the COVID-19 pandemic and in the absence of specific treatment, it is important to implement new treatments that allow modulating the immune response, and one strategy may be the addition of DLE to symptomatic and supportive treatment. Hypotheses by goals. 1. The addition of DLE to the symptomatic treatment could decrease the severity of the clinical outcome (signs and symptoms) in individuals with an acute respiratory infection (cases suspected/confirmed by COVID-19). 2. The addition of DLE to the symptomatic treatment could decrease the clinical deterioration due to the acute respiratory infectious process (suspected/confirmed cases of COVID-19). 3. The addition of DLE to the symptomatic treatment could decrease the duration of the clinical outcome (suspected/confirmed cases of COVID-19).

NCT04379479
Conditions
  1. COVID-19
  2. SARS-CoV-2 Infection
Interventions
  1. Drug: Dialyzable Leukocyte Extract
  2. Drug: Placebo oral
MeSH:Infection

Primary Outcomes

Description: Change in the score of the "Contingency scale to assess the severity of acute respiratory disease in cases suspected/confirmed by COVID-19" at the end of treatment concerning the baseline value. The clinical effect will be daily evaluated with the patient's diary in the cell app. Minimum value 0, Maximum value 32 points. Higher scores mean worse outcome.

Measure: Change in the score of the "Contingency scale to assess the severity of acute respiratory disease in cases suspected/confirmed by COVID-19"

Time: 35 days

Secondary Outcomes

Description: Defined as the presence of signs and symptoms related with respiratory alarm symptoms. The respiratory alarm data will be daily evaluated with the patient's diary in the cell app.

Measure: Clinical deterioration

Time: 35 days

Description: Defined as the number of days with any of the symptoms mentioned in contingency table during the visits and follow-up through the patient's diary in the cell app.

Measure: Duration of the clinical status

Time: 35 days

Other Outcomes

Description: Defined as the changes in the total concentration of the serum cytokines IL-6, TNF-α and type I and II Interferons due to DLE treatment.

Measure: Cytokine concentration

Time: 35 days
195 Phase 1/2A Study of Rintatolimod and IFN-Alpha Regimen in Cancer Patients With Mild or Moderate COVID-19 Infection

This prospective phase I/IIa trial studies the side effects of rintatolimod and Intron A (IFNa) alpha-2b in treating cancer patients with mild or moderate COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.

NCT04379518
Conditions
  1. Malignant Neoplasm
  2. SARS Coronavirus 2 Infection
Interventions
  1. Biological: Recombinant Interferon Alfa-2b
  2. Drug: Rintatolimod
MeSH:Infection Communicable Diseases Neoplasms
HPO:Neoplasm

Primary Outcomes

Description: This refers to the frequency of grade 3 or 4 AEs considered to be possibly, probably or definitely related to the treatment regimen. Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE version [v] 5.0).

Measure: Incidence of adverse events (AEs)

Time: Up to 30 days post treatment intiation

Description: will be evaluated based on quantitative polymerase chain reaction PCR

Measure: Kinetics of viral load in nasopharyngeal swabs

Time: Up to 30 days post treatment initiation

Secondary Outcomes

Description: Will be analyzed using quantitative polymerase chain reaction (PCR).

Measure: Kinetics of viral load in the peripheral blood and nasopharyngeal swabs

Time: During the course of treatment up to day 30

Description: The circulatory inflammatory mediators include C-reactive protein (CRP), cytokines, chemokines, interferons.

Measure: Kinetics of changes of the immune subsets and circulating inflammatory mediators in peripheral blood

Time: During the course of treatment up to day 30

Description: The binary endpoint of 30-day mortality will be analyzed using a logistic regression model.

Measure: 30-day mortality

Time: At 30 days post treatment initiation

Description: Rate of hospitalization due to infection

Measure: Hospitalization due to infection

Time: Up to 30 days post treatment initiation

Description: Will be tested in nasopharyngeal swabs and blood cells of patients

Measure: Determine known mediators of antiviral immunity

Time: UP to 30 days post treatment initiation

Other Outcomes

Description: ARDS will be defined by Berlin criteria

Measure: acute respiratory distress syndrome (ARDS)

Time: Up to 30 days post treatment initiation

Description: Need for mechanical ventilation

Measure: respiratory failure requiring mechanical ventilation

Time: up to 30 days post treatment initiation
196 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
197 Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19: A Descriptive, Longitudinal, Pragmatic Cohort Study

The purpose of the study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19.

NCT04380870
Conditions
  1. Coronavirus Infection
Interventions
  1. Dietary Supplement: Chinese Herbal Medicine
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Patient reported change

Measure: Patient reported main complaint

Time: 24 hours

Description: Patient reported change

Measure: Patient reported main complaint

Time: 48 hours

Description: Patient reported change

Measure: Patient reported main complaint

Time: 3 months

Description: Patient reported change

Measure: Patient reported main complaint

Time: 12 months

Secondary Outcomes

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 24 hours

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 48 hours

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 3 months

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 12 months
198 A Randomized Placebo-Controlled Safety and Dose-Finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

In this study, the investigators propose to administer clazakizumab to patients with life-threatening Coronavirus Disease 2019 (COVID-19) infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms and receive clazakizumab at a dose of 25 mg or placebo.

NCT04381052
Conditions
  1. COVID-19
Interventions
  1. Drug: Clazakizumab
  2. Other: Placebo
MeSH:Infection

Primary Outcomes

Measure: Cumulative incidence of serious adverse events associated with clazakizumab or placebo

Time: 60 days

Secondary Outcomes

Measure: Cumulative Incidence of Intubation

Time: 14 days

Measure: Time to Extubation

Time: 14 days

Measure: Length of Intensive Care Unit (ICU) stay

Time: 14 days

Measure: Number of Patients who Present a Decrease in C-reactive protein (CRP)

Time: 14 days

Measure: Number of Patients with Acute Kidney Injury (AKI)

Time: 14 days

Measure: Number of Patients with a Need for Renal Replacement Therapy (RRT)

Time: 14 days

Measure: Duration of Renal Replacement Therapy (RRT)

Time: 60 days

Description: Number of participants alive at day 28.

Measure: Patient Survival

Time: 28 days

Description: Number of participants alive at day 60, end of study.

Measure: Patient Survival

Time: 60 days

Measure: Number of Patients with Hemodialysis

Time: 60 days

Measure: Number of Patients with Continuous Renal Replacement Therapies (CRRT)

Time: 60 days

Measure: Number of Patients with Peritoneal Dialysis

Time: 60 days
199 A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19

Agent Name and Study Duration ArtemiC is a medical spray comprised of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (=Boswellia) (15 mg/ml) and vitamin C (60 mg/ml) in micellar formulation for spray administration. Patients will receive up to 6 mg Artemisinin, 20 mg Curcumin, 15 mg Frankincense and 60 mg vitamin C given daily as an add-on therapy (in addition to standard care) in two divided doses, on Days 1 and 2. Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care. Patient follow-up will last 2 weeks. During this time, patients will be monitored for adverse events. Additional time will be required for follow up (until hospital discharge) in order to check side effects and study drug efficacy. Placebo, composed of the same solvent but without active ingredients, will be given in the placebo group as add-on therapy, 2 times a day, on Days 1 and 2. Overall rationale A preparation of ArtemiC, comprising Artemisinin, Curcumin, Boswellia, and Vitamin C in a nanoparticular formulation, is proposed as a treatment for the disease associated with the novel corona virus SARS-CoV-2. It is readily available in light of its status as a food supplement. This initiative is presented under the urgent circumstances of the fulminant pandemic caused by this lethal disease, which is known as COVID-19 and has spread across the globe causing death and disrupting the normal function of modern society. The grounds for the proposal are rooted in existing knowledge on the components and pharmacological features of this formulation and their relevance to the current understanding of the disease process being addressed. Leading among these considerations are well established immuno-modulatory activities of the active ingredients as established in vitro and in vivo and published over the years. These activities as apparent, for example, in diminishing activity of TNF alpha and IL-6 levels are acknowledged to be relevant to the pathophysiology processes involved in the progressive form of COVID-19. The active agents have in addition prominent anti-oxidant, anti-inflammatory as well as anti-aggregant and anti-microbial activities. Based on these activities and observations in animal models, together with clinical experience of the separate ingredients and in various combinations in other contexts it is proposed to evaluate their effect in the context of COVID-19. Study Purpose This study is designed to evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19. Methodology 50 adult patients who suffer from COVID-19 infection studied in parallel groups treated with active agent or placebo as add on to standard care. Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs.

NCT04382040
Conditions
  1. COVID-19
  2. Corona Virus Infection
  3. SARS-CoV 2
  4. Coronavirus
  5. Coronavirus Infection
Interventions
  1. Drug: ArtemiC
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: patient will be assessed using a scoring table for changes in clinical signs

Measure: Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of Time: 24 hours

Description: Adverse events caused by the study drug will be assessed

Measure: Percentage of participants with definite or probable drug related adverse events

Time: 14 days

Secondary Outcomes

Measure: Time to negative COVID-19 PCR

Time: 14 days

Measure: Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms

Time: 14 days

Measure: COVID-19 related survival

Time: 14 days

Measure: Incidence and duration of mechanical ventilation

Time: 14 days

Measure: Incidence of Intensive Care Init (ICU) stay

Time: 14 days

Measure: Duration of ICU stay

Time: 14 days

Measure: Duration of time on supplemental oxygen

Time: 14 days
200 Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

A weekly questionnaire is sent to patients and parents of patients who are vulnerable for infections. Possible symptoms of COVID19 are asked for and use of healthcare services and testing for COVID19. Weekly reports are being send to the national institutions to update advice given to this group.

NCT04382508
Conditions
  1. Immune Suppression
  2. Immune Deficiency
  3. Infection
  4. COVID
  5. Children, Adult
Interventions
  1. Other: Questionnaire
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Immunologic Deficiency Syndromes
HPO:Immunodeficiency

Primary Outcomes

Description: To describe frequency of cough, fever, diarrhoea, shortness of breath, sore throat, blocked nose, red eyes, headache, joint pain, muscle pain, fatigue, chills, nausea, vomiting, diarrhoea over a year

Measure: To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting

Time: 1 year

Secondary Outcomes

Description: Patient/parent reported positive tests for COVID19

Measure: Number of children/adults tested positive for COVID19

Time: 1 year

Description: Patient/parent reported admissions in hospital because of COVID19

Measure: Number of children/adults admitted in hospital because of COVID19

Time: 1 year

Description: Patient/parent reported effect of COVID19 on daily activities

Measure: To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children

Time: 1 year
201 A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress

The primary objective of this study is to evaluate if the addition of zanubrutinib to supportive care increases the respiratory failure-free survival rate at Day 28 in participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress.

NCT04382586
Conditions
  1. COVID-19 Pulmonary Complications
  2. COVID-19
Interventions
  1. Drug: Zanubrutinib
  2. Drug: Supportive Care
  3. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Respiratory failure-free survival rate 28 is defined as the proportion of patients who have not had respiratory failure nor died <= 28 days from randomization.

Measure: Respiratory failure-free survival rate at day 28

Time: 28 Days

Secondary Outcomes

Measure: Median reduction in days spent on supplemental oxygen

Time: Up to 28 Days

Measure: All-cause mortality

Time: Up to 28 Days

Measure: Proportion of participants experiencing respiratory failure or death

Time: Up to 28 Days

Measure: Mechanical ventilation-free survival

Time: Up to 28 Days

Measure: Days on mechanical ventilation

Time: Up to 28 Days

Measure: Duration of hospitalization

Time: Up to 28 Days

Measure: Time to discharge

Time: Up to 28 Days

Measure: PaO2:FiO2 and/or oxygenation index

Time: Up to 28 Days

Description: This scale evaluates the safety and efficacy of investigational therapeutic agents in combination with care for the treatment of hospitalized participants suffering from COVID-19 infections on a scale of scores from 0 to 8, with higher scores indicating higher level of severity of the disease. (0 = No clinical or virological evidence of disease, and 8 = Death)

Measure: Change from Baseline to Day 14 in WHO - 8 Point Ordinal Scale

Time: Up to 28 Days
202 Collaborative Outcomes Study on Health and Functioning During Infection Times During COVID-19 Pandemic

Observational, cross-sectional, multi-center, multi-wave survey, assessing characteristics and predictors of physical and mental health as well as health behaviors during COVID-19 pandemic, targeting the general population (children, adolescents and adults).

NCT04383470
Conditions
  1. Mental Health Wellness 1
  2. Pandemic
MeSH:Infection

Primary Outcomes

Description: Primary outcome in the wave 1 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms, and World Health Organization (WHO)-5 well-being in the last 2 weeks compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).

Measure: Mental health symptoms, well-being change from last 2 weeks before the pandemic to last 2 weeks during COVID-19 pandemic

Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

Description: Primary outcome in the wave 2 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms and World Health Organization (WHO)-5 well-being in the last 2 weeks six months after the COVID-19 pandemic ended, compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).

Measure: Mental health symptoms, well-being change from last 2 weeks before the pandemic to last 2 weeks 6 months after WHO declares pandemic over COVID-19 pandemic

Time: wave 2 - change from before to 6 months after pandemic

Description: Primary outcome in the wave 3 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms and World Health Organization (WHO)-5 well-being in the last 2 weeks 12 months after the COVID-19 pandemic ended, compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).

Measure: Mental health symptoms change, well-being change from last 2 weeks before the pandemic to last 2 weeks 12 months after WHO declares pandemic over COVID-19 pandemic

Time: wave 3 - change from before to 12 months after pandemic (after the pandemic outbreak has been declared from WHO, and until the pandemic outbreak has been declared conlucded by WHO)

Secondary Outcomes

Description: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic

Measure: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic

Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

Description: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic

Measure: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic

Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

Description: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic

Measure: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic

Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

Description: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic

Measure: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic

Time: wave 2 - change from before to 6 months after pandemic

Description: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic

Measure: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic

Time: wave 2 - change from before to 6 months after pandemic

Description: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic

Measure: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic

Time: wave 2 - change from before to 6 months after pandemic

Description: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic

Measure: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic

Time: wave 3 - change from before to 12 months after pandemic

Description: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic

Measure: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic

Time: wave 3 - change from before to 12 months after pandemic

Description: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic

Measure: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic

Time: wave 3 - change from before to 12 months after pandemic

Description: Change in general physical health, self-rated, on a VAS scale from 0 to 100.

Measure: Change in general physical health, self-rated, on a VAS scale from 0 to 100.

Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

Description: Change in general physical health, self-rated, on a VAS scale from 0 to 100.

Measure: Change in general physical health, self-rated, on a VAS scale from 0 to 100.

Time: wave 2 - change from before to 6 months after pandemic

Description: Change in general physical health, self-rated, on a VAS scale from 0 to 100.

Measure: Change in general physical health, self-rated, on a VAS scale from 0 to 100.

Time: wave 3 - change from before to 12 months after pandemic

Description: Change in general mental health, self-rated, on a VAS scale from 0 to 100.

Measure: Change in general mental health, self-rated, on a VAS scale from 0 to 100.

Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

Description: Change in general mental health, self-rated, on a VAS scale from 0 to 100.

Measure: Change in general mental health, self-rated, on a VAS scale from 0 to 100.

Time: wave 2 - change from before to 6 months after pandemic

Description: Change in general mental health, self-rated, on a VAS scale from 0 to 100.

Measure: Change in general mental health, self-rated, on a VAS scale from 0 to 100.

Time: wave 3 - change from before to 12 months after pandemic

Description: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.

Measure: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.

Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

Description: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.

Measure: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.

Time: wave 2 - change from before to 6 months after pandemic

Description: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.

Measure: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.

Time: wave 3 - change from before to 12 months after pandemic

Description: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.

Measure: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.

Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

Description: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.

Measure: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.

Time: wave 2 - change from before to 6 months after pandemic

Description: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.

Measure: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.

Time: wave 3 - change from before to 12 months after pandemic

Description: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.

Measure: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.

Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

Description: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.

Measure: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.

Time: wave 2 - change from before to 6 months after pandemic

Description: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.

Measure: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.

Time: wave 3 - change from before to 12 months after pandemic
203 Randomized Prospective Clinical Study for Efficacy of Anti-Corona VS2 Immunoglobulins Prepared From COVID19 Convalescent Plasma in Prevention of Infection in High Risk Groups as Well as Treatment of Early Cases of COVID19 Patients

Preparation of safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients to be used to: 1. To determine efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19 2. To determine efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection

NCT04383548
Conditions
  1. COVID19
Interventions
  1. Other: hyper immunoglobulins containing anti-Corona VS2 immunoglobulin
MeSH:Infection

Primary Outcomes

Description: efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19

Measure: Efficacy of COVID19 hyper immunoglobulins for patients

Time: 2 weeks

Description: efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection

Measure: Efficacy of COVID19 hyper immunoglobulins for high risk groups

Time: 1 month

Description: overall percentage of adverse events as hemolysis and anaphylaxis ,headache and other complains that occur during 72 hours of following infusion of anti-SARS-CoV-2 hyper immunoglobulins will be assessed by 1-vital sign 2-hemolysis by LDH and bilirubin level

Measure: Safety of anti-SARS-CoV-2 hyper immunoglobulins assessed by percentage of adverse events

Time: 72 hours
204 Role of Ibuprofen and Other Medicines on Severity of Coronavirus Disease 2019 (COVID-19) Infections: a Case-control Study

It has been suggested that ibuprofen might be associated with more severe cases of coronavirus infections, based on the observation that severe COVID cases had been exposed to ibuprofen, resulting in a warning by the French authorities. This was attributed to: 1. a suggestion that ibuprofen might upregulate ACE-2 thereby increasing the entrance of COVID-19 into the cells, 2. an analogy with bacterial soft-tissue infections where more severe infections on NSAIDs are attributed to an immune-depressive action of NSAIDs, or to belated treatment because of initial symptom suppression, 3. fever is a natural response to viral infection, and reduces virus activity: antipyretic activity might reduce natural defenses against viruses. However fever reduction in critically ill patients had no effect on survival. However, these assertions are unclear: upregulation of ACEII would increase the risk of infection, not necessarily its severity, and would only apply to the use of NSAIDs before the infection, i.e. chronic exposure. It would be irrelevant to the infection once the patients are infected, i.e., to symptomatic treatment of COVID-19 infection. Anti-inflammatory effect masking the early symptoms of bacterial infections resulting in later antibiotic or other treatment is not applicable: there is no treatment of the virus that might be affected by masking symptoms. Antipyretic effect increasing the risk or the severity of infection would apply equally to all antipyretic agents including paracetamol, which share the same mechanism of action for fever reduction. EMA remains prudent about this assertion In addition, excess reliance on paracetamol while discouraging the use of ibuprofen might increase the risk of hepatic injury from paracetamol overdose. Paracetamol is the prime drug associated with liver injury and transplantation, in voluntary and inadvertent overdose or even at normal doses. This might be increased by COVID-related liver function alterations. It is therefore proposed to conduct a case-control study in a cohort of patients admitted to hospital in France with COVID-19 infection.

NCT04383899
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: Questionnaire
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Synd Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Describe medications including ibuprofen used prior to admission associated with worse infection in COVID-19 patients in France. Thanks to a questionnaire created for the study, with 5 questions on existing pathology, drugs administrated symptom onset and when, hospitalisation. Each questions have a multiple choice.

Measure: Describe medications used prior to admission associated with worse infection in COVID-19 patients in France.

Time: At inclusion day

Description: Quantify medications including ibuprofen used prior to admission associated with worse infection in COVID-19 patients in France. Thanks to a questionnaire created for the study, with 5 questions: existing pathology, drugs administrated symptoms onset and when, hospitalisation. Each questions have a multiple choice.

Measure: Quantify medications used prior to admission associated with worse infection in COVID-19 patients in France.

Time: At inclusion day

Secondary Outcomes

Description: Describe patient characteristics thanks to the same questionnaire.

Measure: Describe other patient characteristics with worse infection in COVID-19 patients in France.

Time: At inclusion day

Description: Quantify patient characteristics thanks to the same questionnaire.

Measure: Quantify other patient characteristics with worse infection in COVID-19 patients in France.

Time: At inclusion day
205 Olfactory and Gustatory Disturbances as a Clinical Presentation of Coronavirus Disease 2019 (COVID-19) Infection in Malaysia - A Nationwide Multicentre Case-Control Study

The Malaysian COVID-19 Anosmia Study is a nationwide multicentre observational study to investigate the prevalence and characteristics of olfactory and gustatory/taste disturbances in COVID-19 infection in Malaysia, and to evaluate the predictive value of screening for these symptoms in COVID-19 infection. This study consists of two phases: the first phase is a cross-sectional study and the second phase is a case-control study. The case-control study is described here (the cross-sectional study is described in a separate ClinicalTrials.gov record).

NCT04384042
Conditions
  1. SARS-CoV Infection
  2. COVID-19
  3. Anosmia
  4. Dysgeusia
Interventions
  1. Other: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances
MeSH:Infec Infection Coronavirus Infections Severe Acute Respiratory Syndrome Olfaction Disorders Dysgeusia
HPO:Anosmia

Primary Outcomes

Description: In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances

Measure: Presence or absence of olfactory and taste disturbances in study participants

Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection

Description: The relationship between case & control status and each exposure variable will be estimated by odds ratios and their 95% confidence intervals using conditional logistic regression models.

Measure: Adjusted odds ratio of olfactory & taste disturbances in COVID-19 infection

Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection

Secondary Outcomes

Description: In the patient-reported online questionnaire, subjects will be asked regarding other symptoms they experienced when they were diagnosed with COVID-19/within the past 2 weeks of answering the questionnaire (e.g. headache, nasal congestion, fever, chills, cough, dyspnoea, gastrointestinal symptoms, eye & ear symptoms)

Measure: Clinical manifestations of study participants

Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection

Description: In the patient-reported online questionnaire, subjects will be asked regarding their pre-existing health conditions (for example, obesity, diabetes, hypertension, cardiac conditions, previous head trauma, chronic rhinosinusitis, etc.)

Measure: Other pre-existing health conditions

Time: Baseline

Description: PPV reflects the probability that the presence of olfactory and taste disturbances will have a positive diagnosis of COVID-19. This is derived from dividing the number of patients with olfactory & taste disturbances with COVID-19 infection over the total number of patients with olfactory and taste disturbances, and multiplying by 100%

Measure: Positive predictive value (PPV) of olfactory and taste disturbances in predicting diagnosis of COVID-19 infection

Time: Baseline

Description: NPV reflects the probability that the absence of olfactory and taste disturbances will have a negative diagnosis of COVID-19. This is derived from dividing the number of patients without olfactory & taste disturbances and without COVID-19 infection over the total number of patients with no olfactory and taste disturbances, and multiplying by 100%

Measure: Negative predictive value (NPV) of olfactory and taste disturbances in predicting absence of COVID-19 infection

Time: Baseline

Description: The percentage of true positives, i.e. the proportion of patients with olfactory and taste disorders with COVID-19 infection. This can be calculated by dividing the number of subjects with olfactory & taste disturbances who have COVID-19 infection with the number of patients with olfactory & taste disturbances, and multiplying by 100%

Measure: Sensitivity of olfactory and taste disturbances in predicting COVID-19 infection

Time: Baseline

Description: The percentage of true negatives, i.e. the proportion of patients without olfactory and taste disorders who do not have COVID-19 infection. This can be calculated by dividing the number of subjects without olfactory & taste disturbances who do not have COVID-19 infection with the number of patients without olfactory & taste disturbances, and multiplying by 100%

Measure: Specificity of olfactory and taste disturbances in predicting COVID-19 infection

Time: Baseline
206 Genetic Factors Influencing the Response to Infection With SARS-COV-2

We will study genetic factors causing severe disease due to infection with SARS-COV-2 which may help to find targeted therapy

NCT04384250
Conditions
  1. Genetic Basis of COVID-19 Infection
Interventions
  1. Diagnostic Test: Whole Exome Sequencing
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Genetic susceptibility to COVID-19

Measure: Mutations leading to increase susceptibility to SARS-COV-2 infection

Time: 12 months
207 A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin for the Treatment of Moderate to SARS Related to COVID-19 Infection vs Placebo

The purpose of this research study is to evaluate the safety and potential efficacy of Intravenous Infusion of Zofin for treatment of moderate to severe Acute Respiratory Syndrome (SARS) related to COVID-19 infection vs Placebo.

NCT04384445
Conditions
  1. Corona Virus Infection
  2. COVID-19
  3. SARS
  4. Acute Respiratory Distress Syndrome
Interventions
  1. Biological: Zofin
  2. Other: Placebo
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Safety will be defined by the incidence of any infusion associated adverse events as assessed by treating physician

Measure: Incidence of any infusion associated adverse events

Time: 60 Days

Description: Safety will be defined by the incidence of severe adverse events as assessed by treating physician

Measure: Incidence of Severe Adverse Events

Time: 60 Days

Secondary Outcomes

Description: Measured at day 60 or at hospital discharge, whichever comes first.

Measure: All Cause Mortality

Time: 60 Days

Description: Number of participants that are alive at 60 days post first infusion follow up

Measure: Survival Rate

Time: 60 Days

Description: Measure IL-6, TNF-alpha from serum of blood samples

Measure: Cytokine Levels

Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28

Description: D-dimer from serum of blood samples methodology using blood samples or nose / throat swab

Measure: D-dimer Levels

Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28

Description: CRP from serum of blood samples

Measure: C-reactive protein Levels

Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28

Description: Viral load by real time RT methodology using blood samples or nose / throat swab

Measure: Quantification of the COVID-19

Time: Day 0, Day 4, Day 8

Description: Improved organ failure within 30 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs using Sequential Organ Failure Assessment (SOFA) score.

Measure: Improved Organ Failure

Time: Day 30

Description: Chest imaging changes for 30 days compare to placebo: 1) Ground-glass opacity, - 2) Local patchy shadowing, 3) Bilateral patchy shadowing, and 4) Interstitial abnormalities.

Measure: Chest Imaging Changes

Time: Day o, Day 30
208 Investigational- Compassionate Use of Convalescent Plasma From COVID-19 Donors in Oncological and Non-Oncological Patients With Severity Criteria: FALP 001-2020 Trial (FALP-COVID)

COVID-19 infection has spread worldwide causing several deaths in few months Convalescent Plasma from COVID 19 donors has shown huge activity in small series from Chinese patients and currently many centers from USA and the European Union are assessing its use looking to avoid mortality and prolonged hospitalizations COVID-19-related

NCT04384588
Conditions
  1. COVID-19 Infection
  2. Cancer Patients
  3. General Population
Interventions
  1. Biological: Convalescent Plasma from COVID-19 donors
MeSH:Infection

Primary Outcomes

Description: in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma

Measure: in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma

Time: 1 year

Description: safety of convalescent plasma from COVID 19 donors (CTCAE V5.0)

Measure: safety of the use of convalescent plasma drom COVID 19 donors

Time: 1 year

Secondary Outcomes

Description: any cause of mortality during these periods

Measure: Mortality at 30 days, 90 days, 6 months and 1 year

Time: 1 year

Description: based on results from this trial comparing with official information

Measure: in-hospital Mortality COVID-19 related compared with non-treated population according to Chilean official reports

Time: through study completion, an average of 1 year

Description: number of days of hospitalization in high complexity facilities after convalescent plasma use

Measure: Number of days of hospitalization in high complexity facilities after convalescent plasma use

Time: 1 year

Description: number of days of hospitalization in intensive care unit after convalescent plasma use

Measure: Number of days of hospitalization in intensive care unit after convalescent plasma use

Time: 1 year

Description: number of days of mechanical ventilatory support in patients after convalescent plasma use

Measure: Number of days of mechanical ventilatory support in patients after convalescent plasma use

Time: 1 year

Description: total number of days of mechanical ventilatory support

Measure: Total number of days of mechanical ventilatory support

Time: 1 year

Description: total number of hospitalization days in patients treated with convalescent plasma

Measure: Total number of hospitalization days in patients treated with convalescent plasma

Time: 1 year

Description: total number of hospitalization days in patients after treatment with convalescent plasma

Measure: Number of hospitalization days in patients after treatment with convalescent plasma

Time: 1 year

Description: Viral load measuring

Measure: Viral load measuring

Time: 14 days

Description: COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies

Measure: Immunological response in treated patients (COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies)

Time: day 1 of hospitalization

Description: negativization of COVID 19 load since convalescent plasma use

Measure: Negativization of COVID 19 load since convalescent plasma use

Time: 14 days

Description: negativization of COVID 19 load since hospitalization

Measure: Negativization of COVID 19 load since hospitalization

Time: 14 days

Description: negativization of COVID 19 load since first reported symptoms COVID-19 related

Measure: Negativization of COVID 19 load since first reported symptoms COVID-19 related

Time: 14 days

Description: Interferon Gamma measurement from donor

Measure: Donor Interferon Gamma profile characterization

Time: 1 day

Description: Granulocyte Macrophage Colony Stimulating Factor measurement from donor

Measure: Donor Granulocyte Macrophage Colony Stimulating Factor characterization

Time: 1 day

Description: Tumor Necrosis Factor Alfa measurement from donor

Measure: Donor Tumor Necrosis Factor Alfa characterization

Time: 1 day

Description: Interleukin -1 beta measurement from donor

Measure: Donor Interleukin -1 beta characterization

Time: 1 day

Description: Interleukin -2 measurement from donor

Measure: Donor Interleukin-2 characterization

Time: 1 day

Description: Interleukin -4 measurement from donor

Measure: Donor Interleukin-4 characterization

Time: 1 day

Description: Interleukin -6 measurement from donor

Measure: Donor Interleukin-6 characterization

Time: 1 day

Description: Interleukin -8 measurement from donor

Measure: Donor Interleukin-8 characterization

Time: 1 day

Description: Interleukin -10 measurement from donor

Measure: Donor Interleukin-10 characterization

Time: 1 day

Description: Interferon Gamma measurement from receptor

Measure: Receptor Interferon Gamma profile characterization

Time: 1 day

Description: Granulocyte Macrophage Colony Stimulating Factor measurement from receptor

Measure: Receptor Granulocyte Macrophage Colony Stimulating Factor characterization

Time: 1 day

Description: Tumor Necrosis Factor Alfa measurement from receptor

Measure: receptor Tumor Necrosis Factor Alfa characterization

Time: 1 day

Description: Interleukin -1 beta measurement from receptor

Measure: receptor Interleukin -1 beta characterization

Time: 1 day

Description: Interleukin -2 measurement from receptor

Measure: Receptor Interleukin-2 characterization

Time: 1 day

Description: Interleukin -4 measurement from receptor

Measure: Receptor Interleukin-4 characterization

Time: 1 day

Description: Interleukin -6 measurement from receptor

Measure: Receptor Interleukin-6 characterization

Time: 1 day

Description: Interleukin -8 measurement from receptor

Measure: Receptor Interleukin-8 characterization

Time: 1 day

Description: Interleukin -10 measurement from receptor

Measure: Receptor Interleukin-10 characterization

Time: 1 day
209 Efficacy and Safety of Hyperimmune Plasma Treatment in Patients With COVID-19 Severe Infection

Passive immunotherapy through plasma infusion of convalescent subjects - convalescent plasma - or "hyperimmune" plasma was one of the most widespread and effective anti-infective treatments in the pre-antibiotic era and one of the founding pillars of immunology, and has also been used during the SARS (2002-2003) and Ebola (2014-2016) viral epidemy for which there were no alternative immunoprophylactic or therapeutic interventions. To date, there are not proven etiological therapies for SARS-CoV-2 infection, the agent responsible for the disease called Covid-19. Among those subjected to clinical studies during the current epidemic in China, hyperimmune plasma appears to be one of the most rational and promising. The objective of this study will be to evaluate the efficacy and safety of the hyperimmune plasma administered add-on to the anti-Covid-19 treatment (standard therapy) according to clinical practice in patients with severe Covid-19 infection, compared to patients with severe Covid-19 infection treated only with standard therapy.

NCT04385043
Conditions
  1. COVID-19
Interventions
  1. Other: plasma hyperimmune
  2. Drug: standard therapy
MeSH:Infection

Primary Outcomes

Description: Statistically significant reduction (P <0.05) of mortality in the group of patients treated with hyperimmune plasma vs patients treated with standard therapy.

Measure: decrease in mortality

Time: 30 days

Secondary Outcomes

Description: Statistically significant increase (P <0.05) of lymphocyte levels after 7 and 14 days after the start of treatment with hyperimmune plasma (treated group), compared to the control group.

Measure: lymphocytes

Time: 7 and 14 days

Description: Statistically significant reduction (P <0.05) of plasma levels of reactive protein C (expressed as mg/L), 7 and 14 days after the start of treatment with hyperimmune plasma vs standard therapy (group control)

Measure: PCR levels vs control

Time: 7 and 14 days

Description: Statistically significant reduction (P <0.05) of plasma levels of reactive protein C (expressed as mg/L), 7 and 14 days after the start of treatment with hyperimmune plasma vs the same patients before the beginning of the treatment

Measure: PCR levels vs before treatment

Time: 7 and 14 days

Description: Significant Correlation (P<0.05) between hyperimmune plasma antibody levels and clinical improvement time (expressed in days)

Measure: AB levels and clinical improvement

Time: 30 days

Description: Statistically significant reduction (P <0.05) of plasma levels of IL-6 (expressed as pg/mL) and TNF-alpha (expressed as pg/mL), 7 and 14 days after the start of treatment with hyperimmune plasma vs standard therapy (group control)

Measure: Inflammatory cytokines vs controls

Time: 7 and 14 days

Description: Statistically significant reduction (P <0.05) of plasma levels of IL-6 (expressed as pg/mL) and TNF-alpha (expressed as pg/mL), 7 and 14 days after the start of treatment with hyperimmune plasma vs the same patients before the beginning of the treatment

Measure: Inflammatory cytokines vs before treatment

Time: 7 and 14 days
210 A Randomised Double-blind Placebo-controlled Trial to Determine the Safety and Efficacy of Inhaled SNG001 (IFN-β1a for Nebulisation) for the Treatment of Patients With Confirmed SARS-CoV-2 Infection

SNG001 is an inhaled drug that contains a antiviral protein called interferon beta (IFN-β). IFN-β in produced in the lungs during viral lung infections. It has been shown that older people and people with some chronic diseases have an IFN-β deficiency. Many viruses inhibit IFN-β as part of their strategy to evade the immune system. Addition of IFN-β in vitro protects lung cells from viral infection. IFN-β protects cells against the MERS and SARS coronaviruses (close relatives of SARS-CoV-2, the virus that causes COVID-19). SNG001 is an inhaled formulation of interferon beta-1a it is currently in Phase II clinical trials for COPD patients. Synairgen has conducted randomised placebo controlled clinical trials of SNG001 involving >200 asthma and COPD patients. These trials have shown that SNG001 has: - been well tolerated during virus infections - enhanced antiviral activity in the lungs (measured in sputum and blood samples) - provided significant lung function benefit over placebo in asthma in two Phase II trials. Synairgen believes SNG001 could help prevent worsening or accelerate recovery of severe lower respiratory tract illness in COVID-19 patients. Patients who are in hospital or non-hospitalised but are a high risk groups (e.g. elderly or diabetics) will be invited to take part in the trial. The patient would receive either SNG001 or placebo once daily for 14 days. The severity of the patients condition would be recorded on a scale developed by the World Health Organisation and the patient would be asked questions about their breathlessness, cough and sputum every day, as well as assess their general medical condition and safety. The study will start as a Pilot phase where 100 patients will be randomised in the hospital setting and a 120 patients randomised in the home setting. Once each of the Pilot phases are complete, a Pivotal phase will be conducted. It is estimated that the size of each of the Pivotal phases (hospital and home) will be around 100 to 300 patients per arm. The actual number will be determined after the data review at the end of each of the Pilot phases. If SNG001 proves to be beneficial it would be a major breakthrough for the treatment of COVID-19.

NCT04385095
Conditions
  1. SARS-CoV-2
Interventions
  1. Drug: SNG001
  2. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period - minimum of 0 (patient is well) to a maximum of 8 (death)

Measure: Ordinal Scale for Clinical Improvement

Time: Day 1 to Days 15 and 28

Secondary Outcomes

Description: Progression to pneumonia as diagnosed by chest x-ray, if no pneumonia is present at time of enrolment

Measure: Progression to pneumonia (hospital setting only)

Time: Day 2 to Day 28

Description: Evolution of pneumonia, as diagnosed by chest x-ray, if pneumonia is present at time of enrolment

Measure: Progression to pneumonia (hospital setting only)

Time: Day 1 to Day 28

Description: Time to clinical improvement

Measure: Time to clinical improvement (hospital setting only)

Time: Time to hospital discharge OR Time to NEWS2 of ≤ 2 maintained for 24 hours

Description: NEWS2 assessment of acute-illness severity on a scale of 0 ( being well) up to 24 (requiring emergency response)

Measure: National Early Warning Score 2 (NEWS2) assessment of acute-illness severity (hospital setting only)

Time: Day 1 to Day 28

Description: Changes in daily breathlessness, cough and sputum scale (BCSS) on a scale of 0 (no symptoms) up to 4 (severe symptoms)

Measure: Changes in daily breathlessness, cough and sputum scale (BCSS)

Time: Day 1 to Day 28

Description: Looking at blood pressure measured in mmHg

Measure: Safety and tolerability - blood pressure II. Viral load

Time: Day 1 to Day 28

Description: Looking at heart rate measured in beats per minute

Measure: Safety and tolerability - heart rate II. Viral load

Time: Day 1 to Day 28

Description: Looking at temperature measured in degrees Celsius

Measure: Safety and tolerability - temperature II. Viral load

Time: Day 1 to Day 28

Description: Looking at respiratory rate measure in breaths per minute

Measure: Safety and tolerability - respiratory rate II. Viral load

Time: Day 1 to Day 28

Description: Looking at oxygen levels measured in a %

Measure: Safety and tolerability - oxygen saturation II. Viral load

Time: Day 1 to Day 28

Description: Looking at adverse events (numbers and terms)

Measure: Safety and tolerability - adverse events II. Viral load

Time: Day 1 to Day 28

Description: Looking at concomitant medications given during treatment

Measure: Safety and tolerability - concomitant medications II. Viral load

Time: Day 1 to Day 28

Description: Temperature ≤37.8 °C AND COVID-19 symptoms (breathing, cough, sputum, muscle aches, headache, fatigue, sore throat, loss or change to sense of smell and taste, rhinorrhoea and anorexia) all rated as absent or mild

Measure: Time to clinical improvement (home setting only)

Time: Day 1 to Day 28

Description: Time to improvement of COVID-19 symptoms (fever, breathing, cough, sputum, muscle aches, headache, fatigue, sore throat, loss or change to sense of smell and/or taste, rhinorrhoea and anorexia)

Measure: Time to improvement of COVID-19 symptoms (home setting only).

Time: Day 1 to Day 28

Description: Time to self-reported recover

Measure: Time to self-reported recovery (home setting only)

Time: Day 2 to Day 16

Description: Self-reported daily rating of overall feeling of wellness

Measure: Self-reported daily rating of overall feeling of wellness (home setting only).

Time: Day 1 to Day 28

Description: Quality of life measured using EQ-5D-5L

Measure: Quality of life measured using EQ-5D-5L (home setting only).

Time: Day 1 to Day 28

Description: Time to virus clearance and viral load

Measure: Virus clearance/load (if samples are available)

Time: Day 1 to Day 28

Description: Blood and sputum biomarkers

Measure: Blood and sputum biomarkers (if samples are available).

Time: Day 1 to Day 28

Description: Contact with health services

Measure: Contact with health services (home setting only

Time: Day 1 to Day 28

Description: Consumption of antibiotics

Measure: Consumption of antibiotics (home setting only

Time: Day 1 to Day 28
211 COVIDAge Study- Hospital Des Trois-Chêne

In December 2019, the first patients infected with the 2019 novel coronavirus (2019-nCoV) were diagnosed in Wuhan. The clinical presentation and course of Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection is poorly understood in older patients and is certainly different from the general population. This project is designed to better understand and to determine clinical, biological and radiological markers of poor adverse outcomes in hospitalized older patients diagnosed with COVID-19.

NCT04385212
Conditions
  1. Coronavirus Infection
  2. Sars-CoV2
  3. Elderly Infection
  4. Old Age; Debility
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: We measure functional score of comorbidities

Measure: To evaluate the relative contributions of comorbidities on intra-hospitalized death

Time: 1 month

Secondary Outcomes

Description: We measure Functional Independence Measure scale

Measure: To evaluate the relative contributions of functional characteristics on intra-hospitalized death

Time: 1 month

Description: We describe the role fo geriatric syndrome such as delirium, falls

Measure: To explore specific clinical profiles that may influence COVID-19 disease outcomes in the elderly based on geriatrics syndromes

Time: 1 month
212 Pilot Study on the Use of Sarilumab in Patients With COVID-19 Infection

Sarilumab is an anti-interleukin-6 human monoclonal antibody, such as tocilizumab, which is administered subcutaneously every two weeks for the treatment of moderate to severe active rheumatoid arthritis in adult patients. Despite the effectiveness reported for tocilizumab in the recently published experiences, the need to rapidly find alternative therapies to manage the complications of Covid-19 infection remains extremely high. The lack of clinical experience on the usage of sarilumab in such patients prevents the possibility of adopting early access programs for using commercially available sarilumab (prefilled syringe) packs in patients with severe Covid-19 pneumonia. The present study is aimed to generate a rapid, still robustly documented, evidence on the potential clinical efficacy and tolerability of a further IL-6R antagonist in Covid-19 pneumonia.

NCT04386239
Conditions
  1. COVID19
Interventions
  1. Drug: Sarilumab Prefilled Syringe
MeSH:Infection

Primary Outcomes

Description: Clinical efficacy of sarilumab in adult patients hospitalized due to severe Covid-19 pneumonia based on the proportion of patients who show an improvement of the respiratory function, described as ≥30% decrease in oxygen requirement compared to baseline (as defined as the ratio of O2 flow through the Venturi mask).

Measure: Proportion of patients who show an improvement of the respiratory function

Time: 6 weeks

Secondary Outcomes

Description: Evaluation of the time to resolution of fever, defined as body temperature ≤36.6°C axilla, ≤37.8°C rectal or tympanic for at least 48 hours without antipyretics in patients with fever at baseline.

Measure: Evaluation of the time to resolution of fever

Time: 6 weeks

Description: Evaluation of the viral load on blood and sputum for COVID-19

Measure: Evaluation of the viral load on blood and sputum for COVID-19

Time: Before administration of sarilumab, 48 hours and 96 hours after administration

Description: Evaluation of the plasma concentration of GM-CSF

Measure: Evaluation of the plasma concentration of GM-CSF

Time: Pre-treatment and 96 and 120 hours post-treatment

Description: Evaluation of the plasma concentration of Il-6

Measure: Evaluation of the plasma concentration of Il-6

Time: Pre-treatment and 96 and 120 hours post-treatment

Description: Evaluation of the plasma concentration of TNF-α

Measure: Evaluation of the plasma concentration of TNF-α

Time: Pre-treatment and 96 and 120 hours post-treatment

Description: Evaluation of the rate of progression of WBC fraction of immature granulocytes - IG - (absolute count).

Measure: Evaluation of the rate of progression of White Blood Cell (WBC) fraction

Time: 96 and 120 hours post-treatment
213 COVID-19 Infection in Healthcare Workers: a Cohort Study

Introduction: The SARS-Cov-2 outbreak in France and the concomitant massive increase in the number of cases requiring hospital management create a major risk of COVID-19 infection for hospital staff. In addition to nosocomial transmission, the health care workers (HCWs), defined as persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials, are also exposed to community transmission. Whether HCWs acquire infection at work or in the community is important to adapt protection measures. A few studies investigated COVID-19 infection among medical and nursing personnel. However, none have analyzed all categories of hospital staff. As of April 9, 2020, a total of 9,282 US HCWs with confirmed COVID-19 had been reported to CDC (US), however description of occupational activities was not available. Therefore, limited information is available about COVID-19 infection among HCWs. Thus, the objectives of the sdudy are to estimate the incidence of symptomatic SARS-CoV-2 infection in HCWs in five university hospitals (including geriatric hospitals) of the great Paris area and to estimate both nosocomial and community risk factors. Method: A prospective and retrospective cohort study that includes all hospital staff (including medical and nursing personnel, health care managers, laboratory, radiology, reception staffs, stretcher-bearers, etc.) working in different departments of five university hospitals (acute medical centers and geriatric hospitals) in the great Paris area (9 000 HCWs). Incidence of symptomatic SARS-CoV-2 infection will be estimated with its 95%CI. Individual and contextual risk factors will be analyzed using multilevel multivariate logistic regression modelling to account for clustering and confounding. Conclusion This study should make it possible to better characterize SARS-Cov-2 contamination of HCWs and to estimate the share of nosocomial transmission.

NCT04386759
Conditions
  1. COVID-19
Interventions
  1. Other: Cohort
MeSH:Infection

Primary Outcomes

Description: The primary endpoint will be the occurrence of confirmed (RT-PCR or work stopping) SARS-CoV-2 infection.

Measure: SARS-COV-2 infection

Time: At inclusion

Description: The primary endpoint will be the occurrence of confirmed (RT-PCR or work stopping) SARS-CoV-2 infection.

Measure: SARS-COV-2 infection

Time: Up to 3 months

Secondary Outcomes

Description: Individual factors collected by a self-questionnaire

Measure: Individual factors

Time: At inclusion

Description: Individual factors collected by a self-questionnaire

Measure: Individual factors

Time: Up to 3 months

Description: Weekly consumption of masks and hydroalcoholic solution

Measure: Hospital ward level

Time: Up to 3 months
214 NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study

This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

NCT04387656
Conditions
  1. Asymptomatic COVID-19 Infection Laboratory-Confirmed
  2. Hematopoietic and Lymphoid Cell Neoplasm
  3. Malignant Solid Neopl
  4. Malignant Solid Neoplasm
  5. Symptomatic COVID-19 Infection Laboratory-Confirmed
Interventions
  1. Procedure: Biospecimen Collection
  2. Other: Data Collection
MeSH:Infection Communicable Diseases Laboratory Infection Neoplasms
HPO:Neoplasm

Primary Outcomes

Description: Distinguish the likelihood of severe COVID19 (for example, requiring hospitalization, requiring intensive care unit [ICU] treatment or requiring a ventilator) and death due to COVID-19 for patients with versus without the factor. Among subgroups of at least 50 patients, evaluate using chi-square tests as well as death and hospitalization rates.

Measure: Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity

Time: Up to 2 years

Description: Describe the degree to which COVID-19 interrupts, delays, or otherwise alters cancer treatment for subgroups of patients defined by cancer type and/or treatment modality. Describe the association between changes in cancer therapy and clinical outcomes. Evaluate association of COVID-19 with outcome by comparison to historical controls in subgroups of at least 50 patients using log rank tests to assess time to survival event.

Measure: Effects of COVID-19 on cancer therapy and association with clinical outcomes

Time: Up to 2 years

Other Outcomes

Description: Analysis will include time to development of antibodies, prevalence of cytokine abnormalities, and genome-wide association study (GWAS) to define genetic polymorphisms associated with severe COVID-19 disease/mortality.

Measure: Collection of blood specimens for future biomarker studies

Time: Up to 2 years
215 Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic: a Prospective, Open-label, Pilot, Randomized Trial

In December 2019, an outbreak of pneumonia associated with a novel coronavirus named as severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) was reported in Wuhan city, China, and spread exponentially throughout China and other countries in the following weeks. It is recommended that elective endoscopies should be deferred during the COVID-19 outbreak for the potential transmission between patients and medical staff in the statements of Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Therefore, exploring an alternative for patients with the requirements of endoscopy during the outbreak is of great importance. Herein,the investigators developed an novel non-contact magnetically-controlled capsule endoscopy (Nc-MCE) system (Figure 1) adds a remote control workstation and a audio-visual exchange system to the original well-established MCE system. This study was a open-label, prospective, randomized controlled study approved by the institutional review board of Shanghai Changhai Hospital. It was designed to evaluate the diagnostic utility, safety, feasibility and patients acceptability of Nc-MCE in patients with an indication of endoscopy, and comparing it with the result of MCE.

NCT04389333
Conditions
  1. Gastrointestinal Disease
  2. Infectious Disease
  3. Capsule Endoscopy
Interventions
  1. Device: non-contact magnetically-controlled capsule endoscopy
MeSH:Communicable Diseases Infection Gastrointestinal Diseases Digestive System Diseases
HPO:Abnormality of the gastrointestinal tract

Primary Outcomes

Description: Maneuverability score was the sum of four subjective scores rated by the operator (signal transmission quality score, operating comfort score, gastric visualization score and study subject compliance score), each of which ranged from 1 to 5 denoting the lowest to the highest degree of satisfaction.

Measure: Maneuverability score

Time: During the procedure

Secondary Outcomes

Description: GET was defined as the time time taken for the endoscopist to complete the gastric examination to his or her satisfaction

Measure: Gastric examination time(GET)

Time: During the procedure

Description: The investigators use a satisfaction questionnaire to evaluate the comfort and acceptability of each patient

Measure: the comfort and acceptability of patients

Time: After the procedure(within 5 days)

Description: Diagnosis based on the data of nc- MCE by two endoscopist

Measure: diagnostic yield

Time: after the procedure(within 5 days)

Other Outcomes

Description: Adverse events during and after the procedure

Measure: Adverse events

Time: During and within 2 weeks after the procedure

Description: Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus

Measure: Clinical success

Time: During the procedure
216 PROphylaxis for paTiEnts at Risk of COVID-19 infecTion (PROTECT): a Basket Trial of Prophylactic Interventions Amongst At-risk Patients

The PROTECT open-label randomised basket trial will assess the effectiveness of hydroxychloroquine (HCQ) as chemoprophylaxis against COVID-19 in multiple vulnerable populations in the United Kingdom.

NCT04389359
Conditions
  1. COVID-19
Interventions
  1. Drug: Hydroxychloroquine Sulfate 200 MG
MeSH:Infection

Primary Outcomes

Description: The primary outcome for PROTECT is the time to confirmed COVID-19 infection from the date of randomisation. This will be captured via linkage with PHE or by direct reporting by sites.

Measure: Time to confirmed diagnosis of COVID-19

Time: To study completion, average 6 months

Secondary Outcomes

Description: Death from any cause

Measure: All-cause mortality

Time: To study completion, average 6 months

Description: Severity will be assessed by requirement for hospitalisation, HDU/ICU admission or death and Length of inpatient stay.

Measure: Severity of COVID-19 disease

Time: To study completion, average 6 months

Description: Acute respiratory distress syndrome, viral pneumonitis, myocarditis/myocardial injury, acute kidney injury.

Measure: Incidence of COVID-19 complications

Time: To study completion, average 6 months
217 The Use of Desferal and Adjuvants for Prevention of ARDS in Hospitalised Cases Documented With Covid 19 Infection: A Randomized Controlled Trial

To evaluate the efficacy of using Desferal injections for prevention of ARDS in moderate cases with fever , chest tightness and relevant chest images

NCT04389801
Conditions
  1. Covid 19
Interventions
  1. Drug: Desferal 500 MG Injection
MeSH:Infection

Primary Outcomes

Description: patient dies from ARDS

Measure: Mortality rate

Time: two weeks

Secondary Outcomes

Description: time to recovery

Measure: Duration of severe symptoms

Time: two weeks
218 Amotosalen-Ultraviolet A Pathogen-Inactivated Convalescent Plasma in Addition to Best Supportive Care and Antiviral Therapy on Clinical Deterioration in Adults Presenting With Moderate to Severe Coronavirus Disease 2019 Infectious Disease (COVID-19)

This project investigates individual treatments using convalescent severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) plasma in SARS-CoV-2 infected patients at risk for disease progression. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma. Only patients with moderate to severe disease at risk for transfer to intensive care unit or patients at the intensive care unit with limited treatment options will be treated.

NCT04389944
Conditions
  1. Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)
Interventions
  1. Other: convalescent plasma application to SARS-CoV-2 infected patients
MeSH:Communicable Diseases Infection Coronavirus Infections Clinical Deterioration

Primary Outcomes

Description: Serious adverse events during the study period include transfusion reaction (fever, rash), transfusion related acute lung injury (TRAU) , transfusion associated circulatory overload (TACO) , transfusion related infection

Measure: Serious adverse events in convalescent plasma treated patients

Time: From baseline (enrolment) to 24 hours follow-up

Description: Change in SARS-CoV2 quantitative in nasopharyngeal swab

Measure: Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients

Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28

Description: Transfer to ICU

Measure: Transfer to ICU

Time: at Baseline (admission to Covid-ward) until day 28

Description: in-hospital death

Measure: in-hospital death

Time: at Baseline (admission to Covid-ward) until day 28

Description: Change in SARS-CoV2 quantitative in plasma

Measure: Virologic clearance in plasma of convalescent plasma treated patients

Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28

Secondary Outcomes

Description: Duration of hospitalisation

Measure: Time to discharge from hospital after enrolment

Time: at Baseline (admission to Covid-ward) until discharge (approx. 28 days)

Description: Rise of SARS-CoV-2 antibody titers (on day 1, 7, 14 and 28)

Measure: Humoral immune response

Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
219 Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission

SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.

NCT04390022
Conditions
  1. Covid-19
  2. Coronavirus Infection
  3. SARS-CoV-2 Infection
Interventions
  1. Drug: Ivermectin
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment

Measure: Proportion of patients with a positive SARS-CoV-2 PCR

Time: 7 days post-treatment

Secondary Outcomes

Description: Change from baseline quantitative and semi-quantitative PCR in nasopharyngeal swab

Measure: Mean viral load

Time: Baseline and on days 4, 7, 14 and 21

Description: Proportion of patients with fever and cough at days 4, 7, 14 and 21 as well as proportion of patients progressing to severe disease or death during the trial

Measure: Fever and cough progression

Time: Up to and including day 21

Description: Proportion of participants with positive IgG at day 21

Measure: Seroconversion at day 21

Time: Up to and including day 21

Description: Proportion of drug-related adverse events

Measure: Proportion of drug-related adverse events

Time: 7 days post treatment

Description: Levels in median fluorescence intensity (MFI) of IgG, IgM and IgA against the receptor-binding domain of the spike glycoprotein of SARS-CoV-2 in plasma, measured by a Luminex assay

Measure: Levels of IgG, IgM and IgA

Time: Up to and including day 28

Description: Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry

Measure: Frequency of innate immune cells

Time: Up to and including day 7

Description: Frequency of CD4+ T and CD8+ T cells (% over total CD4+T and CD8+ T) expressing any functional marker upon in vitro stimulation of PBMC with SARS-CoV-2 peptides, measured by flow cytometry

Measure: Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T cells

Time: Up to and including day 7

Description: Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher)

Measure: Results from cytokine Human Magnetic 30-Plex Panel

Time: Up to and including day 28
220 Olfactory and Gustatory Disturbances as a Clinical Presentation of Coronavirus Disease 2019 (COVID-19) Infection in Malaysia - A Nationwide Multicentre Cross-Sectional Study

The Malaysian COVID-19 Anosmia Study is a nationwide multicentre observational study to investigate the prevalence and characteristics of olfactory and gustatory/taste disturbances in COVID-19 infection in Malaysia, and to evaluate the predictive value of screening for these symptoms in COVID-19 infection. This study consists of two phases: the first phase is a cross-sectional study and the second phase is a case-control study. The cross-sectional study is described here (the case-control study is described in a separate ClinicalTrials.gov record).

NCT04390165
Conditions
  1. SARS-CoV Infection
  2. COVID-19
  3. Anosmia
  4. Dysgeusia
Interventions
  1. Other: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Olfaction Disorders Dysgeusia
HPO:Anosmia

Primary Outcomes

Description: In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances

Measure: Presence or absence of olfactory and taste disturbances in COVID-19 patients

Time: Within 2 weeks preceding the diagnosis of COVID-19 infection

Description: Percentage of COVID-19 patients experiencing olfactory disturbances (anosmia or hyposmia)

Measure: Prevalence of olfactory disturbances in COVID-19 patients

Time: Within 2 weeks preceding the diagnosis of COVID-19 infection

Description: Percentage of COVID-19 patients experiencing taste disturbances

Measure: Prevalence of taste disturbances in COVID-19 patients

Time: Within 2 weeks preceding the diagnosis of COVID-19 infection

Secondary Outcomes

Description: In the patient-reported online questionnaire, subjects will be asked regarding other symptoms they experienced when they were diagnosed with COVID-19 (e.g. headache, nasal congestion, fever, chills, cough, dyspnoea, gastrointestinal symptoms, eye & ear symptoms)

Measure: Clinical manifestations of study participants

Time: Within 2 weeks preceding the diagnosis of COVID-19 infection

Description: In the patient-reported online questionnaire, subjects will be asked regarding their pre-existing health conditions (for example, obesity, diabetes, hypertension, cardiac conditions, previous head trauma, chronic rhinosinusitis, etc.)

Measure: Other pre-existing health conditions

Time: Prior to diagnosis of COVID-19 infection

Description: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste before their diagnosis of COVID-19 infection

Measure: Rating of baseline sense of smell & taste in COVID-19 patients prior to diagnosis of their infection

Time: Prior to 2 weeks preceding the diagnosis of COVID-19 infection (Baseline)

Description: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste at the time of diagnosis of COVID-19 infection

Measure: Rating of sense of smell & taste in COVID-19 patients at time of diagnosis of their infection

Time: Within 2 weeks preceding the diagnosis of COVID-19 infection

Description: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste at the time of answering questionnaire survey

Measure: Rating of sense of smell & taste in COVID-19 patients at time of answering questionnaire survey

Time: Up to 6 months
221 The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection

A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.

NCT04390477
Conditions
  1. COVID-19
  2. Coronavirus Infecti
  3. Coronavirus Infection
Interventions
  1. Dietary Supplement: Probiotic
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Percentage of patients with discharge to ICU.

Measure: Cases with discharge to ICU.

Time: 30-days

Secondary Outcomes

Description: Percentage of patients with home discharge.

Measure: Patients with home discharge.

Time: 30-days

Description: Percentage of deaths.

Measure: Mortality.

Time: 30-days

Description: Number of adverse events that occur during the treatment period, attributable or not to the intervention product.

Measure: Treatment safety assessed by number of adverse events.

Time: 30-days

Description: Number of new cases of positive SARS-Cov-2 infection by PCR analysis.

Measure: New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients.

Time: 30-days

Description: Percentage of patients with negative PCR for SARS-CoV-2.

Measure: Patients with negative PCR result for SARS-CoV-2 infection.

Time: 30-days
222 Efficacy and Safety of Hydroxychloroquine and Ivermectin in Hospitalized no Critical Patients Secondary to COVID-19 Infection: Randomized Controlled Trial

Background: In December 2019, patients with pneumonia secondary to a new subtype of Coronavirus (COVID-19) were identified in China. In a few weeks the virus spread and cases started practically all over the world. In February 2020, the WHO declared a pandemic. Severe symptoms have been found in patients mainly with comorbidities and over 50 years of age. At this time there is no proven therapeutic alternative. In vitro studies and observational experiences showed that antimalarial drugs (Chloroquine and hydroxychloroquine) had antiviral activity and increased viral clearance. Ivermectin, on the other hand, has been shown in vitro to reduce viral replication and in an observational cohort, greater viral clearance with promising clinical results. So far there is no standard of treatment and clinical trials are needed to find effective treatment alternatives. Objective: To evaluate the safety and efficacy of treatment with hydroxychloroquine and ivermectin for serious COVID-19 infections in no critical hospitalized patients. Material and methods: Randomized controlled trial of patients diagnosed with respiratory infection by COVID-19, who present criteria for hospitalization. Randomization will be performed to receive hydroxychloroquine at a dose of 400 mg every 12 hours for one day and then 200 mg every 12 hours, to complete a 5-day treatment schedule. Group 2: Ivermectin 12 mg every 24 hours for one day (less than 80 kg) or Ivermectin 18 mg every 24 hours for one day (greater than 80 kg) + placebo until the fifth day. Group 3: Placebo. Prior to randomization, the risk of cardiovascular complications determined by corrected QT interval, related to hydroxychloroquine intake will be assessed. If the patient is at high risk, the allocation will be to ivermectin only or to placebo in an independent randomization, if the risk is low, any of the three groups could be assigned. Outcomes: The primary outcome will be discharge from hospital for improvement. The safety outcomes will be requirement of mechanical intubation, septic shock or death. Viral clearance will also be evaluated by means of PCR, which will be taken on the 5th day after admission, day 14 and 21.

NCT04391127
Conditions
  1. COVID-19
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Ivermectin
  3. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Days from admission as a suspected case of COVID with hospitalization criteria until discharge

Measure: Mean days of hospital stay

Time: Three months

Description: Respiratory deterioration defined by respiratory rate > 25 per minute, requirement of high oxygen supply (FiO2 > 80% ) to maintain oxygen saturation > 90 %, invasive mechanical ventilation or dead.

Measure: Rate of Respiratory deterioration, requirement of invasive mechanical ventilation or dead

Time: Three months

Description: Daily delta of oxygenation index during the hospitalization

Measure: Mean of oxygenation index delta

Time: Three months

Secondary Outcomes

Description: Mean time to viral negativization of RT-qPCR SARS-CoV-2. Pre Specified time: 5, 14, 21 and 28 days after the first positive PCR.

Measure: Mean time to viral PCR negativization

Time: 5, 14, 21 and 28 days after the first positive PCR
223 Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19

The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19. This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.

NCT04391179
Conditions
  1. COVID
  2. Corona Virus Infection
  3. Covid-19
  4. SARS-CoV-2 Infection
Interventions
  1. Drug: Dipyridamole 100 Milligram(mg)
  2. Drug: Placebo oral tablet
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Increase in plasma D-dimer level compared with baseline at enrollment.

Measure: Change in D-dimer

Time: baseline, up to approximately 28 days after last study drug administration

Secondary Outcomes

Description: Global composite rank score of death, mechanical ventilation, oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2), and World Health Organization (WHO) Ordinal score.

Measure: Global composite rank score

Time: up to approximately 28 days after last study drug administration
224 The Use of Peripheral Blood Specimens From Patients Suspected of Having SARS-CoV-2 Infections in Research Studies Intended to Support the Development of COVID-19 Detection Methods, Treatments, and/or Vaccines

Invivoscribe, Inc. and its wholly owned subsidiary LabPMM, LLC are collecting peripheral blood specimens from patients with suspected SARS-CoV-2 viral infections. These donors will be from a population of patients who are already providing nasal pharyngeal (NP) swab samples in universal transport media (UTM) for COVID-19 testing at LabPMM LLC. Specimens meeting this research protocol's inclusion criteria may be evaluated with various molecular techniques in order to identify nucleic acid sequences, antibodies, and/or antigens with the potential of being used to develop novel SARS-CoV-2 detection methods and COVID- 19 treatments and/or prevention methods (e.g. drug or vaccine development).

NCT04391400
Conditions
  1. SARS-CoV-2
Interventions
  1. Diagnostic Test: nasal pharyngeal (NP) swab samples
  2. Diagnostic Test: peripheral blood draw
MeSH:Infection

Primary Outcomes

Description: This research protocol describes the collection and analysis of peripheral blood samples to: Identify nucleic acid sequences that may be used aide in the development of SARSCoV- 2 detection methods. Identify antibodies that may be used aide in the development of SARS-CoV-2 detection methods. Identify antigens that may be used aide in the development of SARS-CoV-2 detection methods. Identify nucleic acid sequences that may be used aide in the development of COVID- 19 treatments and/or vaccines. Identify antibodies that may be used aide in the development of COVID-19 treatments and/or vaccines. Identify antigens that may be used aide in the development of COVID-19 treatments and/or vaccines.

Measure: Identification of nucleic acid sequencing, antibodies and antigens to be used in detection methods or treatments and/or vaccines

Time: 2 years
225 A Phase 2 Study of COVID 19 Convalescent Plasma in High Risk Patients With COVID 19 Infection

Purpose of Study • The purpose of this study to evaluate, the effectiveness of convalescent plasma in combatting the symptoms and effects of the coronavirus disease, COVID-19. Beyond supportive care, there are no proven treatment options for COVID-19.

NCT04392232
Conditions
  1. Coronavirus
  2. COVID-19
  3. Convalescent Plasma
Interventions
  1. Drug: Convalescent Plasma
MeSH:Infection Coronavirus Infections

Primary Outcomes

Description: % patients who survived

Measure: Survival Rate

Time: At 28 Days
226 Open, Controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Cyclosporine Plus Standard Treatment vs Standard Treatment Only in Hospitalized Patients With COVID-19 Infection

The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.

NCT04392531
Conditions
  1. COVID19 Infection
Interventions
  1. Drug: Cyclosporine
  2. Drug: Standard treatment
MeSH:Infection

Primary Outcomes

Description: efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.

Measure: Severity Category

Time: 12 days

Secondary Outcomes

Description: efficacy of CsA in combination with standard treatment in reducing mortality

Measure: Mortality Rate

Time: through study completion, an average of 6 weeks

Description: efficacy of CsA in combination with standard treatment in reducing days in hospital

Measure: Number of Days in hospital

Time: through study completion, an average of 6 weeks

Description: efficacy of CsA in combination with standard treatment in reducing days in ICU beds

Measure: Number of days in ICU beds

Time: through study completion, an average of 6 weeks

Description: efficacy of CsA in combination with standard treatment in reducing FiO2 needs.

Measure: Fio2 Needs

Time: through study completion, an average of 6 weeks

Description: safety and tolerability of cyclosporine vs standard treatment administration

Measure: Adverse events rate

Time: through study completion, an average of 6 weeks

Description: change from baseline in C reactive protein levels

Measure: Change in CRP

Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)

Description: change from baseline in ferritin levels

Measure: Change in ferritin

Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)

Description: change from baseline in LDH levels

Measure: Change in LDH

Time: every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment)

Description: change from baseline in Creatin phosphokinase levels

Measure: Change in CPK

Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)

Description: change from baseline in D Dimer levels

Measure: Change in D Dimer

Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)

Description: change from baseline in IL-6 levels

Measure: Change in IL-6

Time: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)

Description: change from baseline in KL-6 levels

Measure: Change in KL-6

Time: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)

Description: COVID19 Viral load determination

Measure: Change in Viral Load

Time: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)

Description: Specific IgG and IgM determination

Measure: Change specific antibodies

Time: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
227 Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care

It might be necessary with Sars-Cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. This task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease. The lung ultrasound is an easy tool, fast (between 5 and 10 minutes) and as a limited training. In the context of the Sars-Cov2 epidemic, Buonsenso and al case report depict the first lung ultrasound for a Covid 19 patient. Peng and al in Intensive Care Medicine accentuate the usefulness of this particular technic. In the American Journal of Respiratory and Critical Care Medicine, a study has been published as a point-of-care, in which the doctors reported using the lung ultrasound with intensive and critical care patient. In Critical Care 2016, it has been showed that ultrasound allowed with neat precisions, to predict severe ARDS patient response to the prone position, all-cause. Another researchers team found a good correlation between lung ultrasound, the SOFA, APACHE II, CPIS score, and patient mortality. And a new applicability in the pulmonary recruitment by PEEP titration has been presented. The aim of this study is to evaluate the lung ultrasound in Covid19 ARDS.

NCT04393402
Conditions
  1. COVID
Interventions
  1. Procedure: lung ultrasound (LUS)
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: In dorsal position, or in prone position, the two hemithorax will be subdivided in 6 parts, and a score will be attributed with the following criteria : A-Lines (0 point), > 3 B-lines (1 point), B-Lines coalscent (2 points), and pulmonary consolidation (3 points). For the echography we can use a convexe sonde, or a "cardiac" sonde.

Measure: LUS applicability with COVID 19

Time: 10 months

Secondary Outcomes

Description: Comparison between Xray / CT scan exam and LUS

Measure: Radiographic correlation (chest Xray and tomodensitometry)

Time: 10 months

Description: according to LUS score, ventilatory mode and parameters, medical history and bood analysis results

Measure: LUS Mortality prediction

Time: 10 months

Description: comparison of LUS score depending of the position used for performing LUS

Measure: Prediction of Prone position response

Time: 10 months
228 A Phase I Study of ResCure™ to Treat COVID-19 Infection

This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.

NCT04395716
Conditions
  1. COVID
  2. Covid-19
  3. Corona Virus Infection
  4. Sars-CoV2
  5. Coronavirus-19
  6. SARS Pneumonia
  7. SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
Interventions
  1. Biological: ResCure™
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR

Measure: The rate of recovery of mild or moderate COVID-19 in patients using ResCure™

Time: 12 Weeks

Description: Reduction and/or progression of symptomatic days, reduction of symptom severity

Measure: Reduction or progression of symptomatic days

Time: 12 Weeks

Description: Pulse from baseline to 12 weeks

Measure: Assess the safety of ResCure™ via pulse

Time: 12 Weeks

Description: Oxygen saturation from baseline to 12 weeks

Measure: Assess the safety of ResCure™ via oxygen saturation

Time: 12 Weeks

Description: EKG from baseline to 12 weeks

Measure: Assess the safety of ResCure™ via EKG

Time: 12 Weeks

Description: Assess Adverse Events and Serious Adverse Events due to ResCure™

Measure: Assess Tolerability of ResCure™

Time: 12 Weeks
229 A Multi-Center Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Patients Developing Acute Kidney Injury (AKI) or Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 Infection

Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.

NCT04395911
Conditions
  1. AKI
  2. ARDS
  3. COVID
Interventions
  1. Device: SCD
MeSH:Infection

Primary Outcomes

Description: All cause mortality at Day 60

Measure: Mortality at Day 60

Time: 60 days post treatment

Description: Dialysis Dependency at Day 60

Measure: Dialysis Dependency

Time: 60 days post treatment

Description: Ventilation free survival at Day 28

Measure: Ventilation at Day 28

Time: 28 days post treatment

Secondary Outcomes

Description: Dialysis Dependency at Day 28

Measure: Dialysis Dependency

Time: 28 days post treatment

Description: All cause mortality at Day 28

Measure: Mortality at Day 28

Time: 28 days post treatment

Description: Change from baseline in urine output

Measure: Urinary output change

Time: 10 days of treatment

Description: Change from baseline in PO2/FiO2

Measure: P02/FiO2 change

Time: 10 days of treatment

Description: Assessment of SAEs, AE and UADEs

Measure: Safety Assessments

Time: 10 days of treatment

Description: Assessment of device performance

Measure: SCD Integrity

Time: 10 days of treatment
230 Phase 1b Randomized, Double-Blind, Placebo-Controlled Study Of The Safety Of Therapeutic Treatment With Immunomodulatory Mesenchymal Stem Cells In Adults With COVID-19 Infection Requiring Mechanical Ventilation

This is a phase 1b randomized, double-blind, placebo-controlled study in adult subjects with Coronavirus Disease 2019 (COVID-19). This clinical trial will evaluate the preliminary safety and efficacy of BM-Allo.MSC vs placebo in treating subjects with severe disease requiring ventilator support during COVID 19 infection.

NCT04397796
Conditions
  1. COVID
Interventions
  1. Biological: BM-Allo.MSC
  2. Biological: Placebo
MeSH:Infection

Primary Outcomes

Description: Incidence of AEs within 30 days of randomization.

Measure: Incidence of AEs

Time: 30 days

Description: Mortality within 30 days of randomization.

Measure: Mortality

Time: 30 days

Description: Cause of death within 30 days of randomization

Measure: Death

Time: 30 days

Description: Number of ventilator-free days within 60 days of randomization.

Measure: Number of ventilator-free days

Time: 60 days

Secondary Outcomes

Description: Time from randomization to an improvement of one category using the ordinal scale. The ordinal scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized, limitation on activities Not hospitalized, no limitations on activities

Measure: Improvement of one category

Time: 30 days

Description: Change in the 7-point ordinal scale from baseline. The ordinal scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized, limitation on activities Not hospitalized, no limitations on activities

Measure: 7-point ordinal scale

Time: 30 days

Description: Change in NEWS from baseline. The following 7 clinical parameters will be assessed: Respiration rate Oxygen saturation Any supplemental oxygen Temperature Systolic blood pressure Heart rate Level of consciousness Measurements within normal ranges are assigned a 0. If the measurement in each category is substantially above or below the normal range, it is given a +1, +2, or +3. The more far off than normal, the bigger the number (in each category). A higher number indicates worse outcome. Each category can be 0-3, except for supplemental oxygen which is only 0-2. The highest value a patient can get is 20.

Measure: NEWS

Time: 30 days

Description: Time from randomization to discharge or to a NEWS of ≤ 2 maintained for 24 hours, whichever occurs first.

Measure: NEWS of ≤ 2

Time: 30 days

Description: Change from baseline in Sequential Organ Failure Assessment (SOFA) score on days 8, 15, 22, and 29. System Score for each category is 0-4 with 28 is the maximum score for worst outcome. The following categories are: Respiration Coagulation Liver Cardiovascular Central Nervous System Renal

Measure: Sequential Organ Failure Assessment (SOFA)

Time: days 8, 15, 22, and 29

Description: Number of days requiring oxygen.

Measure: Oxygen

Time: 30 days

Description: Duration of hospitalization from randomization.

Measure: Hospitalization

Time: 30 days

Description: Incidence of SAEs within 30 days of randomization

Measure: Incidence of SAEs

Time: 30 days
231 A Blood Collection Study From Volunteers Who Have Recovered From COVID-19 Infection to Identify Immunogenic Viral Epitopes in SARS-CoV-2

The COVID-19 pandemic is a global emergency threatening to take millions of lives in the United States and around the world. There is no current vaccine strategy against COVID-19 infection caused by a novel coronavirus named SARS-CoV-2. Studies with a related coronavirus called SARS-CoV-1 that caused the SARS outbreak in 2003 indicated that memory CD8+ T cells recognizing viral epitopes persisted for more than 6 years post infection while neutralizing antibodies and memory B cells were short-lived and were undetectable after a short period of time (Tang et al., 2011; Peng et al., 2006; Channappanavar et al., 2014). Thus, including viral epitopes that are recognized by memory CD8+ T cells is imperative for vaccines that can provide long-term immunity against SARS-CoV-2. In this study, blood samples from COVID-19 patients who have recovered from the infection will be used to identify the viral epitopes recognized by their memory CD8+ T cells. This will be accomplished using a genome-wide, high-throughput screening technology developed at Harvard Medical School (Kula et al., 2019) and licensed by the study sponsor, TScan Therapeutics. A 24,000-member library that tiles across all ~100 viral isolates of SARS-CoV-2 that have been sequenced so far has already been synthesized at TScan. Blood samples from convalescent patients are urgently needed to identify T cell receptors and immunogenic viral epitopes on SARS-CoV-2. It is the hope that these data will inform development of a vaccine with the potential for long-lasting protection against SARS-CoV-2.

NCT04397900
Conditions
  1. Identify the Viral Epitopes of Memory CD8 T Cells From Individuals That Have Recovered From SARS-CoV-2 In
  2. Identify the Viral Epitopes of Memory CD8 T Cells From Individuals That Have Recovered From SARS-CoV-2 Infection
  3. Determine Which SARS-CoV-2 Proteins Are Frequently Recognized by T Cells in Patients With Varying HLA Types
MeSH:Infection

Primary Outcomes

Measure: Identify the viral epitopes of memory CD8+ T cells from individuals that have recovered from SARS-CoV-2 infection.

Time: JUL2020

Measure: Determine which SARS-CoV-2 proteins are frequently recognized by T cells in patients with varying HLA types.

Time: JUL2020
232 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
233 Characteristics of COVID-19 Infection Among PREGnant Women

In December 2019, Coronavirus infection (COVID-19) was identified as causing serious respiratory infection in humans. Initially COVID-19 was propagated by infected symptomatic individuals; currently the disease is disseminated by asymptomatic COVID-19 positive subjects. The prevalence of asymptomatic COVID-19 individuals is unknown. Due its physiologic immune suppression, pregnancy is a vulnerable time for severe respiratory infections including COVID-19. Limited information is available regarding the impact of COVID-19 in pregnancy and the prevalence and demographic profile of asymptomatic pregnant women. Despite reports of 15-20% positive COVID-19 tests in women admitted to Labor and Delivery, professional obstetric medical societies still recommend not prioritizing testing of patients who are asymptomatic. In the USA, COVID-19 symptomatic patients come predominantly from lower income, Black and Latino communities. No data are available on the rate and demographic distribution of asymptomatic positive COVID-19 pregnant women. To minimize the risk of inadvertent exposure asymptomatic individuals, recently our institution started COVID-19 testing in all admitted pregnant women. The investigators expect to gain knowledge on the impact of COVID-19 in pregnant women especially if asymptomatic and compare to other respiratory infections.

NCT04398264
Conditions
  1. Corona Virus Infection
  2. Pregnancy Related
Interventions
  1. Other: COVID-19 positive via testing
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Rate of asymptomatic pregnant women who test positive for COVID-19 at the time of hospital admission

Measure: Asymptomatic COVID-19 positive pregnant women

Time: Through completion of the study, an average of 1 year

Secondary Outcomes

Description: Rate of Hispanic pregnant women among those asymptomatic COVID-19 positive on admission

Measure: Asymptomatic Hispanic COVID-19 positive pregnant women

Time: Through completion of the study, an average of 1 year

Description: Rate of asymptomatic positive pregnant women who later will develop COVID-19 related symptoms

Measure: Follow up of asymptomatic COVID-19 positive pregnant women

Time: Through completion of the study, an average of 1 year

Description: Prevalence of COVID-19 positive newborns from infected mothers

Measure: COVID-19 positive newborns

Time: Through completion of the study, an average of 1 year

Description: Rate of COVID-19 positive pregnant women who develop respiratory / multi-organ complications requiring admission to Medicine or Intensive Care units / maternal death related to COVID-19

Measure: Severe COVID-19 disease in pregnant women

Time: Through completion of the study, an average of 1 year
234 The Effectiveness of Ozone Therapy in the Prevention of COVID-19 Infection

Coronavirus has already infected 4,673,809 people and killed 312,646 people worldwide, and no specific treatment or a vaccine against it has yet proven to be effective. Ozone therapy has become o promising tool for both prevention and treatment of COVID-19 infection by various possible mechanisms. The oxidative stress created by ozone in the body to stimulate the peripheral phagocytic cells, activate the antioxidant system, and restore the immune system is thought to be effective for the prevention of COVID-19 infection. In recent years, ozone therapy has become a popular alternative method for chronic pain management of various diseases such as fibromyalgia, knee osteoarthritis, and rheumatic diseases. As a result of this, there were many individuals who had received ozone therapy before the outbreak of COVID-19. This study aimed to investigate the preventive effect of ozone therapy against COVID-19 infection in these individuals.

NCT04400006
Conditions
  1. Corona Virus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: It involved questions about age, gender, height, weight, occupation, comorbidities, and concurrent medications, in addition to a detailed query for COVID-19 infection

Measure: The survey that was taken by telephone calls

Time: Day 0
235 Prevention of COVID19 Infection by the Administration of Hydroxychloroquine to Institutionalized Older People and Nursing Home Staff. A Cluster Randomized Controlled Stepped-wedge Trial (PREVICHARM Study)

Professionals and residents of nursing homes are one of the most vulnerable groups in this public health crisis of COVID-19, since they have the highest rate of positives for COVID-19, despite the restriction measures carried out, such as prohibition of family visits to these centers, the infection occurs by cross transmission with the care staff of the centers, or with other residents. At the moment, there are no clinical trials to test the hypothesis that hydroxychloroquine is effective in coronavirus treatment. Although what has been observed is a better prognosis in infected patients, since this drug inhibits the replication of the virus and its expansion to other tissues. This study is a clinical trial to test the effectiveness of hydroxychloroquine as a preventive drug for SARS-CoV-2 infection. This drug will be applied to 1050 people residing in nursing home care and 880 professionals who work in close contact with these people and who have not yet contracted the infection. This project will be carried out in the territories of Madrid, Navarra, Aragon and Andalusia (Spain). Hydroxychloroquine is a widely known drug that is used in two scenarios, against autoimmune diseases, such as lupus or rheumatoid arthritis, and as an antimalarial drug. It is also intended to demonstrate that the presumed reduction in viral load that would be obtained with hydroxychloroquine prophylaxis, would have no effect in development of immunity against the virus. This fact can create a new paradigm for the de-escalation of the confinement to which the population has been subjected to stop the virus spread, allowing the development of general immunity in controlled populations until reaching total immunity. In addition to testing the effect of this drug, a non-pharmacological intervention based on a safety record will be tested in the management of infection on nursing home, to assess its effectiveness in detecting risk areas or bad practices carried out in this vulnerable environment. The study is led by researchers of the Institute of Biomedicine of Malaga (Spain), and has obtained a financing of 1,024,199 euros from Carlos III Health Institute (Spain). The period of execution of the clinical trial is one year, and with this intervention, the intention is to reduce cross-infection in residents by a minimum threshold of 15%, as well as to decrease infection in the professionals.

NCT04400019
Conditions
  1. Sars-CoV2
  2. Coronavirus Infection
  3. Prevention
  4. Prevention &
  5. Prevention & Control
  6. Nursing Home
  7. Hydroxychloroquine
Interventions
  1. Drug: Hydroxychloroquine Only Product in Oral Dose Form
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Secondary Outcomes

Description: Dichotomous qualitative variable (1: Death 0: Survival)

Measure: Mortality

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Continous variable. It will be evaluated with the AIDS Clinical Trials Group method: investigation of medications not taken in a period of 4 days prior to the interview)% adherence = (total prescribed galenic units for that period-total units not taken) / total prescribed galenic units for that period

Measure: Compliance with treatment

Time: It will be evaluated during the five days that the chemoprophylaxis with hydorxychloroquine is administered

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at six days

Time: This outcome will be evaluated at 6 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. Participant requires hospital admission attributable to SARS-CoV-2 infection

Measure: Hospitalization

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine
236 Long-term Pulmonary Outcomes After Infection With Sars-CoV-2

The objective of this study is to assess the long-term outcomes after hospital admission with Covid-19 with respect to pulmonary function, physical capacity, imaging, quality of life and socioeconomic outcomes.

NCT04401163
Conditions
  1. Sars-CoV2
  2. Covid19
Interventions
  1. Diagnostic Test: Imaging of the lungs
MeSH:Infection

Primary Outcomes

Description: Expert evaluation

Measure: Imaging of the lungs

Time: 3 months after discharge

Description: Expert evaluation

Measure: Imaging of the lungs

Time: 12 months after discharge

Description: Liter

Measure: Pulmonary function tests

Time: 3 months after discharge

Description: Liter

Measure: Pulmonary function tests

Time: 12 months after discharge

Description: Walking distance (meters) and change in oxygen saturation.

Measure: Six-minute walk test

Time: Performed 3 months after discharge

Description: Walking distance (meters) and change in oxygen saturation.

Measure: Six-minute walk test

Time: Performed 12 months after discharge

Secondary Outcomes

Description: 0-100 scale. The lower the score, the more disability.

Measure: Short Form-36 (SF-36) questionnaire

Time: 3 months after discharge

Description: 0-100 scale. The lower the score, the more disability.

Measure: Short Form-36 (SF-36) questionnaire

Time: 12 months after discharge

Description: 10-50 score. The higher the score, the more fatigue

Measure: Fatigue Assessment Score

Time: 3 months after discharge

Description: 10-50 score. The higher the score, the more fatigue

Measure: Fatigue Assessment Score

Time: 12 months after discharge

Description: 0-30. The lower the score, the more cognitive impairment

Measure: Cognitive sore (MOCA)

Time: 3 months after discharge

Description: 0-30. The lower the score, the more cognitive impairment

Measure: Cognitive sore (MOCA)

Time: 12 months after discharge

Description: 0-21. The higher the score, the more risk of anxiety or depression.

Measure: Hospital anxiety and Depression score (HADS)

Time: 3 months after discharge

Description: 0-21. The higher the score, the more risk of anxiety or depression.

Measure: Hospital anxiety and Depression score (HADS)

Time: 12 months after discharge

Description: Any pre-COVID-19 comorbidity and treatment with immmunosuppressants will be registered.

Measure: Comorbidities

Time: 12 months after discharge

Description: Change in outcomes between discharge and follow-up visits will be evaluated

Measure: Blood sample at routine follow up.

Time: 3 months after discharge

Description: Change in outcomes between discharge and follow-up visits will be evaluated

Measure: Blood sample at routine follow up.

Time: 12 months after discharge

Description: Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.

Measure: Biobanking of blood

Time: 3 months after discharge

Description: Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.

Measure: Biobanking of blood

Time: 12 months after discharge
237 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
238 Efficacy of Tannin Specific Natural Extract for Coronavirus Disease (COVID-19): Randomized Controlled Trial

There is an urgent need to evaluate interventions that could be effective against the infection with SARS-CoV 2. Tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. This randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement ARBOX in positive COVID-19 patients.

NCT04403646
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Coronavirus Infection
Interventions
  1. Dietary Supplement: ARBOX
  2. Other: PLACEBO
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: defined as the time from first dose of polyphenol extract to hospital discharge

Measure: Time to hospital discharge

Time: Throughout the Study (Day 0 to Day 28)

Secondary Outcomes

Description: proportion

Measure: 28-day all-cause mortality

Time: Throughout the Study (Day 0 to Day 28)

Description: proportion

Measure: invasive ventilation on day 28

Time: Throughout the Study (Day 0 to Day 28)

Description: mean difference

Measure: Difference in Pro and antiinflammatory citoquine levels

Time: day 1-14

Measure: Difference in fecal intestinal microbiota composition

Time: day 1-14

Description: proportion

Measure: Negativization of COVID-PCR at day 14

Time: day 14
239 A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of EIDD-2801 to Eliminate Infectious Virus Detection in Persons With COVID-19

This is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19

NCT04405570
Conditions
  1. SARS-CoV 2
Interventions
  1. Drug: EIDD-2801
  2. Drug: Placebo (PBO)
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding stratified log-rank test (to account for the "early" versus "late" time from symptom onset randomization strata). Non detectable defined as "a viral load below the limit of quantification

Measure: Virologic Efficacy

Time: 28 days

Description: Measure the safety and tolerability of EIDD-2801 by estimating in the randomization arm the probability of 1) any adverse events (AEs) leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AE (not already present at baseline), and 4) study drug-related new grade 3 or higher AE. The cumulative probability of each safety and each tolerability endpoint (4 endpoints) by using the Kaplan-Meier approach and stratified log-rank test.

Measure: Number of Participants with any Adverse Events (AEs) as Assessed by Kaplan Meier Approach

Time: 28 days

Secondary Outcomes

Description: Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs by using the Kaplan-Meier approach and stratified log-rank test.

Measure: Number of Participants With any Adverse Events (AEs), Grade 2 or higher as Assessed by Kaplan Meier Approach

Time: 28 days
240 A Phase III Prospective, Interventional, Cohort, Superiority Study to Evaluate the Benefit of Rapid COVID-19 Genomic Sequencing (the COVID-19 GENOMICS UK Project) on Infection Control in Preventing the Spread of the Virus in United Kingdom NHS Hospitals

Hospitals are recognised to be a major risk for the spread of infections despite the availability of protective measures. Under normal circumstances, staff may acquire and transmit infections, but the health impact of within hospital infection is greatest in vulnerable patients. For the novel coronavirus that causes COVID-19, like recent outbreaks such as the SARS and Ebola virus, the risk of within hospital spread of infection presents an additional, significant health risk to healthcare workers. Infection Prevention and Control (IPC) teams within hospitals engage in practices that minimise the number of infections acquired within hospital. This includes surveillance of infection spread, and proactively leading on training to clinical and other hospital teams. There is now good evidence that genome sequencing of epidemic viruses such as that which causes COVID-19, together with standard IPC, more effectively reduces within hospital infection rates and may help identify the routes of transmission, than just existing IPC practice. It is proposed to evaluate the benefit of genome sequencing in this context, and whether rapid (24-48h) turnaround on the data to IPC teams has an impact on that level of benefit. The study team will ask participating NHS hospitals to collect IPC information as per usual practice for a short time to establish data for comparison. Where patients are confirmed to have a COVID-19 infection thought to have been transmitted within hospital, their samples will be sequenced with data fed back to hospital teams during the intervention phase. A final phase without the intervention may take place for additional information on standard IPC practice when the COVID-19 outbreak is at a low level nationwide.

NCT04405934
Conditions
  1. Covid-19
  2. Nosocomial Infection
  3. Coronavirus
  4. Coronavirus Infection
  5. SARS-CoV 2
Interventions
  1. Other: Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures
MeSH:Infection Communicable Diseases Cross Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Incidence rate of IPC-defined HOCIs, measured as incidence rate of recorded cases per week per 100 inpatients, during each phase of the study based on case report forms.

Measure: Incidence rates of IPC-defined hospital-onset COVID-19 infection (HOCIs)

Time: 6 months

Description: Identification of nosocomial transmission using sequencing data in potential HOCIs in whom this was not identified by pre-sequencing IPC evaluation, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.

Measure: Change in incidence rates of IPC-defined HOCIs with rapid vs standard sequencing

Time: 6 months

Secondary Outcomes

Description: Incidence rate of IPC-defined hospital outbreaks, defined as cases of hospital transmission linked by location and with intervals between diagnoses of no greater than 2 weeks (relevant data extracted from case report forms), measured as incidence rate of outbreak events per week per 100 inpatients during each phase of the study.

Measure: Incidence rates of IPC-defined hospital outbreaks

Time: 6 months

Description: Incidence rate of IPC+sequencing-defined hospital outbreaks, defined by retrospective review of all available sequencing and epidemiological data for identification of transmission clusters and measured as outbreak events per week per 100 inpatients during each phase of the study.

Measure: Incidence rates of IPC+sequencing-defined hospital outbreaks

Time: 6 months

Description: Changes to IPC actions implemented following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.

Measure: Changes to IPC actions following viral sequence reports

Time: 6 months

Description: Changes to IPC actions that would ideally have been implemented (given unlimited resources) following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.

Measure: Recommended changes to IPC actions following viral sequence report - not implemented

Time: 6 months

Description: Health economic benefit of standard and rapid sequencing reports to IPC measured using bespoke health economic case report data comparison between baseline, standard and rapid sequencing phases.

Measure: Health economic benefit to IPC of standard vs rapid sequencing reports

Time: 6 months

Description: Number of HCW days off work measured from sampling these data points on case report forms at all study phases.

Measure: Impact of both standard and rapid sequencing reports on number of HCW days off work

Time: 6 months
241 Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease: a Randomised Controlled Trial

This is a randomized controlled trial of the efficacy and safety evaluation of oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting patients with a new coronavirus disease

NCT04405999
Conditions
  1. Increased Risk of SARS-CoV-2 Infection
Interventions
  1. Drug: Bromhexine Hydrochloride
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Negative PCR of SARS-CoV-2 and the absence of clinical manifestations of COVID-19 infection in individuals taking Bromhexine hydrochloride 4 weeks after randomization.

Measure: Polymerase chain reaction (PCR)

Time: 4 weeks after randomization

Secondary Outcomes

Description: Time to clinical symptoms of a respiratory infection with positive PCR SARS-CoV-2

Measure: Time to symptoms

Time: 14 days after last contact

Description: Time to detect positive SARS-CoV-2 PCR

Measure: Time to positive PCR

Time: 14 days after last contact

Description: The number of asymptomatic cases of SARS-CoV-2 infection

Measure: Number of cases

Time: 14 days after last contact

Description: The number of mild, moderate and severe forms of the disease COVID-19 with Bromhexine hydrochloride

Measure: Case severity

Time: 14 days after last contact

Description: Evaluation of adverse events

Measure: Drug tolerance

Time: 14 days after last contact
242 Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection

Observational, retrospective data collection and prospective IgG analysis, and multicenter study. The main objective of the study is th description of the characteristics and evolution of patients with lung cancer who have acquired COVID-19 infection. For the identification of patients who contract COVID-19 infection, the IgG+ blood test by ELISA method will be used.

NCT04407143
Conditions
  1. Lung Cancer
  2. COVID
  3. Corona Virus Infection
Interventions
  1. Diagnostic Test: IgG test
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Lung Neoplasms
HPO:Neoplasm of the lung

Primary Outcomes

Description: Description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection.

Measure: Description of the characteristics of patients

Time: From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeks
243 Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo

Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo

NCT04408014
Conditions
  1. COVID
  2. SARS-CoV 2
Interventions
  1. Diagnostic Test: Serological test
  2. Diagnostic Test: Nasopharyngeal Swab
  3. Diagnostic Test: Oropharyngeal Swab
MeSH:Infection

Primary Outcomes

Description: IgM and IgG antibodies against SARS-CoV-2

Measure: Prevalence of antibodies against SARS-CoV-2 through serological testing

Time: 1 month

Description: Positive RT-PCR test result for SARS-CoV-2

Measure: Frequency of participants with a positive RT-PCR test result for SARS-CoV-2

Time: 1 month
244 Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection in Healthcare Personnel

This clinical trial will evaluate the safety, tolerability and effectiveness of topical GLS-1200 nasal spray to reduce the incidence of confirmed, symptomatic SARS-CoV-2 infection.

NCT04408183
Conditions
  1. SARS-CoV 2
  2. Infection
Interventions
  1. Drug: GLS-1200
  2. Drug: Placebo
MeSH:Infection Communicable Diseases

Primary Outcomes

Measure: Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0

Time: 4 weeks of treatment

Measure: Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group

Time: 4 weeks of treatment

Secondary Outcomes

Measure: Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome.

Time: 4 weeks of treatment
245 Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection - A Multicenter Phase II Trial

This is a multicenter, Phase 2 study, to assess the efficacy of the treatment with convalescent plasma in patients with severe COVID-19 infection.

NCT04408209
Conditions
  1. COVID-19 Infection
Interventions
  1. Procedure: Convalescent Plasma
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: The primary endpoint of this trial is the survival on day 21. The primary endpoint, as a dichotomous composite of survival (yes/no) and no longer fulfilling criteria of severe COVID-19, will be analyzed according their classification. Specifically, categorical variables will be analyzed by means of absolute and relative frequencies, and all continuous variables will be described using arithmetic mean, standard deviation, median, quartiles. Also, geometric means, variance and 95% confidence intervals (CI), will be calculated for all pharmacokinetics parameters.

Measure: Survival

Time: Day 21

Description: The primary endpoint of this trial is the survival on day 35.

Measure: Survival

Time: Day 35

Description: The primary endpoint of this trial is the survival on day 60.

Measure: Survival

Time: Day 60

Secondary Outcomes

Description: The secondary endpoint of this trial is that no longer fulfilling criteria of severe COVID-19 within 21 days after inclusion. This will be assessed on the basis of respiratory rate and ventilation support.

Measure: Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease

Time: Day 21
246 Immune Response and Risk of Serious Infection to SARS-Cov2

To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%. Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.

NCT04410432
Conditions
  1. SARS Cov2, Immune Response
Interventions
  1. Biological: Blood sample collection
MeSH:Infection

Primary Outcomes

Description: Flow cytometry measurement of the percentage of circulating Th1 lymphocytes

Measure: Percentage of circulating Th1 lymphocytes

Time: Until the end of the study, about 12 months.

Secondary Outcomes

Description: Immunofluorimetric measurement of serum concentrations of IFN-γ, CXCL9, CXCL10, CXCL11

Measure: Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11

Time: Until the end of the study, about 12 months.
247 Hydroxychloroquine Efficacy and Safety in Preventing SARS-CoV-2 Infection and COVID-19 Disease Severity During Pregnancy

It still unclear how SARS-CoV-2 affects pregnant women and their offspring, as well as which factors may influence obstetrical disease and outcomes, including the timing of maternal viral exposure by gestational age, the effects of parity, age, host immune responses, coexisting medical and obstetrical conditions and the effects of treatment regimens. While further information is gathered, based on the existing evidence from other infections causing pneumonia, pregnant women should be considered to be at high risk for developing severe infection during the current COVID-19 epidemic. Results from clinical trials with HCQ in nonpregnant adults may not be directly extrapolated to pregnant women given the special features of the pregnancy status. Thus, clinical research is urgently needed to improve the care and reduce the risk of poor pregnancy outcomes of women in this and in future epidemics.

NCT04410562
Conditions
  1. Pregnancy Related
  2. COVID
  3. Covid-19
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs at day 21 after treatment start

Measure: Number of PCR confirmed cases among pregnant women

Time: 21 days after intervention

Secondary Outcomes

Measure: Incidence of COVID-19 disease during pregnancy

Time: through study completion, an average of 1 year

Measure: Incidence of COVID-19-related admissions

Time: through study completion, an average of 1 year

Measure: Incidence of all-cause admissions

Time: through study completion, an average of 1 year

Measure: Incidence of all-cause outpatient attendances

Time: through study completion, an average of 1 year

Measure: Mean duration of symptoms-signs of COVID-19

Time: through study completion, an average of 1 year

Measure: Frequency and severity of adverse events

Time: through study completion, an average of 1 year

Measure: Incidence of preeclampsia

Time: through study completion, an average of 1 year

Measure: Incidence of gestational diabetes

Time: through study completion, an average of 1 year

Measure: Incidence of SARS-CoV-2 infections during pregnancy

Time: through study completion, an average of 1 year

Measure: Prevalence of intrauterine growth restriction

Time: through study completion, an average of 1 year

Measure: Maternal mortality rate

Time: through study completion, an average of 1 year

Measure: Proportion of neonates with SARS-CoV-2- intrauterine infection by PCR-confirmed SARS-CoV-2-infection in nasopharyngeal aspirate.

Time: through study completion, an average of 1 year

Measure: Proportion of neonates with clinical signs/symptoms of COVID-19

Time: through study completion, an average of 1 year

Measure: Prevalence of low birth weight (<10th centile according to local standards)

Time: through study completion, an average of 1 year

Measure: Prevalence of preterm birth (<37 weeks of gestational age)

Time: through study completion, an average of 1 year

Measure: Prevalence of embryo and foetal losses (miscarriages and stillbirths)

Time: through study completion, an average of 1 year

Measure: Frequency of congenital malformations

Time: through study completion, an average of 1 year

Measure: Proportion of adverse perinatal outcome

Time: through study completion, an average of 1 year

Measure: Neonatal morbidity

Time: through study completion, an average of 1 year

Measure: Neonatal mortality rate

Time: through study completion, an average of 1 year
248 Studies on Current and Past SARS-CoV-2 Infection (and COVID-19) in Healthcare in Stockholm, Sweden

The SARS-CoV-2 pandemic and resulting COVID-19 disease causes a substantial burden on healthcare systems. Little is known about how the infection spreads within healthcare. In order to design control strategies, knowledge of the presence of viral nucleic acid and whether an immune response to the virus has been mounted is needed. The purpose of this study is to determine whether personnel and patients/clients in healthcare in Region Stockholm have a currrent SARS-CoV-2 infection or have had an infection. This information will be used to understand how the infection spreads in healthcare, to explore the association with sick-leave among personnel, and to plan high-quality and safe care. Healthcare providers and organizations participating in the study from the greater Stockholm region include the following: Karolinska University Laboratory, Karolinska University Hospital; Intensive Care Unit, Karolinska University Hospital; SciLifeLab; KTH Royal Institute of Technology; Roo Home Healthcare Services (Roo Hemtjänst och Vård); Health Care Services Stockholm County (SLSO); Region Stockholm; Southern Hospital (Södersjukhuset); Danderyd Hospital; Capio St Göran Hospital; Södertälje Hospital; Tiohundra AB; Ersta Hospital, Sweden; and St Eriks Eye Hospital (St Eriks Ögonsjukhus).

NCT04411576
Conditions
  1. SARS-CoV 2
Interventions
  1. Diagnostic Test: Throat swab sample for measuring current infection with SARS-CoV-2
  2. Diagnostic Test: Blood sample for serology to measure past infection with SARS-CoV-2
MeSH:Infection

Primary Outcomes

Description: Ongoing and past SARS-CoV-2 infection, measured in throat samples (current infection) and serum (past infection, antibodies to SARS-CoV-2) evaluated in relation to age, gender, sickleave, address, workplace, sampling date, work tasks (for healthcare personnel) and evaluated in relation to date of hospitalization, diagnoses, and interventions for patients and healthcare clients.

Measure: SARS-CoV-2 infection

Time: Throat and blood samples are taken one time at enrollment. Other background characteristics are determined using linkages to healthcare employment databases up to two months after enrollment.

Other Outcomes

Description: Sequencing will be completed on the positive samples to determine is the virus isolate is the same. This can provide information on the spread of the infection in population.

Measure: SARS-CoV-2 sequencing

Time: Sequencing will be completed in a later phase of the study, after enrollment is complete and within 1 year.
249 Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection

The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized IVIG for patients infected with the influenza virus. He wants to find out if IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune system some help to clear the infection naturally.

NCT04411667
Conditions
  1. Sars-CoV2
Interventions
  1. Drug: Octagam
MeSH:Infection

Primary Outcomes

Description: Number of subjects requiring mechanical ventilation due to respiratory failure

Measure: Mechanical Ventilation

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Secondary Outcomes

Description: Number of days requiring oxygen therapy

Measure: Oxygen Therapy

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Description: Number of days in hospital

Measure: Length of Stay

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
250 Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory Therapy in Patients Diagnosed With COVID-19 Disease

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.

NCT04412395
Conditions
  1. Corona Virus Infection
  2. Middle East Respiratory Syndrome (MERS)
  3. Acute Respiratory Distress Syndrome
  4. Coronavirus Infection
  5. COVID-19
  6. SARS-CoV 2
Interventions
  1. Dietary Supplement: Lactoferrin (Apolactoferrin)
  2. Drug: Placebo of excipient(s) will be administered
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respira Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Comparing the influence of the intervention on the Survival rate.

Measure: Survival rate.

Time: up to 8 weeks.

Description: For mild/moderate symptoms patients: fever, cough and other symptoms relieved with improved lung CT - For severe symptoms patients: fever, cough and other symptoms relieved with improved lung CT, and oxygen saturation by pulse oximetry (SPO2 )> 93% for nonasthmatic patients, and from 88-92% in asthmatic patients.

Measure: Rate of disease remission.

Time: up to 4 weeks.

Description: Comparing the influence of the intervention on the PCR negative results.

Measure: The number of patients with PCR negative results.

Time: up to 4 weeks.

Secondary Outcomes

Description: Recording the changes from severe to moderate or mild and the time taken.

Measure: Mean change in the disease severity (clinical assessment).

Time: up to 4 weeks.

Description: Recording the changes in blood pressure mmHg.

Measure: Mean change in blood pressure.

Time: up to 4 weeks.

Description: Recording the changes in heart rate in beat/second.

Measure: Mean change in heart beats.

Time: up to 4 weeks.

Description: Recording the changes in body temperature in Celsius.

Measure: Mean change in body temperature.

Time: up to 4 weeks.

Description: Recording the changes in the respiratory rate in breath/minute.

Measure: Mean change in body respiratory rate.

Time: up to 4 weeks.

Description: Recording the changes in arterial oxygen saturation in mmHg.

Measure: Mean change in oxygen saturation.

Time: up to 4 weeks.

Description: Recording the changes in the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).

Measure: Mean change in the ratio in arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).

Time: up to 4 weeks.

Description: Recording the changes in complete blood picture (CBC) in cells per liter.

Measure: Mean change in complete blood picture (CBC).

Time: up to 4 weeks.

Description: Recording the changes in C reactive protein (CRP) in mg/L.

Measure: Mean change in C reactive protein (CRP).

Time: up to 4 weeks.

Description: Recording the changes in erythrocyte sedimentation rate (ESR) in mm/hr.

Measure: Mean change in erythrocyte sedimentation rate (ESR).

Time: up to 4 weeks.

Description: Recording the changes in D-dimer in ng/mL.

Measure: Mean change in D-dimer.

Time: up to 4 weeks.

Description: Recording the changes in ferritin in ng/mL.

Measure: Mean change in ferritin.

Time: up to 4 weeks.

Description: Recording the changes in liver Albumin in g/L.

Measure: Mean change in liver Albumin.

Time: up to 4 weeks.

Description: Recording the changes in total and direct Bilirubin in mg/dL.

Measure: Mean change in total and direct Bilirubin.

Time: up to 4 weeks.

Description: Recording the changes in prothrombin time (PT), partial thromboplastin time (PTT ) in seconds and calculating International Normalized Ratio (INR).

Measure: Mean change in prothrombin time (PT) and partial thromboplastin time (PTT ).

Time: up to 4 weeks.

Description: Recording the changes in aspartate aminotransferase (AST) in IU/L.

Measure: Mean change in aspartate aminotransferase (AST).

Time: up to 4 weeks.

Description: Recording the changes in Alanine Aminotransferase (ALT) in IU/L.

Measure: Mean change in Alanine Aminotransferase (ALT).

Time: up to 4 weeks.

Description: Recording the changes in Blood Urea Nitrogen (BUN) in mg/dL.

Measure: Mean change in Blood Urea Nitrogen (BUN).

Time: up to 4 weeks.

Description: Recording the changes in Serum Creatinine in mg/dL.

Measure: Mean change in Serum Creatinine.

Time: up to 4 weeks.

Description: Recording the changes in Serum Creatinine in ml/min.

Measure: Mean change in Serum Creatinine clearance.

Time: up to 4 weeks.

Description: Recording the changes in Glomerular filtration rate (GFR ) ml/min/m2.

Measure: Mean change in Glomerular filtration rate (GFR ).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-1 (IL-1) in pg/ml.

Measure: The mean change in serum interleukin-1 (IL-1).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-6 (IL-6) in pg/ml.

Measure: The mean change in serum interleukin-6 (IL-6).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-10 (IL-10) in pg/ml.

Measure: The mean change in serum interleukin-10 (IL-10).

Time: up to 4 weeks.

Description: Recording the changes in tumor necrosis factor-alpha (TNF alpha) in ng/ml.

Measure: The mean change in serum tumor necrosis factor-alpha (TNF alpha).

Time: up to 4 weeks.

Description: Recording the changes in immunoglobulin G (IgG) in ng/ml.

Measure: Mean changes in immunoglobulin G (IgG).

Time: up to 4 weeks.

Description: Recording the changes in immunoglobulin M (IgM) in ng/ml.

Measure: Mean changes in immunoglobulin M (IgM).

Time: up to 4 weeks.

Description: Recording the changes in PCR viral load in copies/mL.

Measure: The mean change in PCR viral load.

Time: up to 4 weeks.

Description: Recording the changes in lung CT.

Measure: Mean change in lung CT manifestation.

Time: up to 4 weeks.

Description: Recording any unexpected Adverse Events of the intervention.

Measure: Nature and severity of Adverse Events.

Time: up to 4 weeks.

Description: Recording the changes (the average time of lung imaging recovery), as assessed by lung CT.

Measure: Time for lung recovery.

Time: up to 8 weeks.

Description: Recording the changes the event of missed drug doses.

Measure: The number of missed drug doses among each treatment group.

Time: up to 4 weeks.
251 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
252 Study of the Efficiency and Security of NIVOLUMAB Therapy, Used in Immuno-stimulation, in Hospitalized Obese Individuals at Risk to Evolve Towards Severe Forms of COVID-19 Infection. Multicentric, Paralleled, Randomized, Controlled Trial

Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus). Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19. In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production. This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15

NCT04413838
Conditions
  1. Obesity, COVID-19 Infection
Interventions
  1. Drug: NIVOLUMAB
  2. Other: Routine standard of care
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Patient's clinical state will be evaluated by the proportion of patients able to be weaned of oxygen at D15 after randomization (randomization date is the day where the experimental treatment (i.e. NIVOLUMAB) is administered).

Measure: Patient's clinical state

Time: 15 days after randomization

Secondary Outcomes

Description: Proportion of in-coming patients in ICU at D7 and D15 post-randomization

Measure: Readmission

Time: 7 days and 15 days after randomization

Description: Proportion of death at D7 and D15 post-randomization

Measure: Mortality

Time: 7 days and 15 days after randomization

Description: Proportion of patients weaned out of oxygen at D7 post-randomization

Measure: Oxygen flow needs

Time: 7 days after randomization

Description: Mean oxygen flow needed

Measure: Requirement of oxygen

Time: 7 days and 15 days after randomization

Description: Proportion of out-coming patients from hospitalization at D7 and D15 post-randomization

Measure: Discharge from hospital

Time: 7 days and 15 days after randomization

Description: Report of all adverse events linked or not to experimental treatment during the study

Measure: Adverse events

Time: Within 15 days post-randomization and 90 days and 6 months after randomization

Description: Presence or not of nasopharyngeal SARS-CoV-2 determined by PCR response

Measure: Presence of nasopharyngeal SARS-CoV-2

Time: On day 0 before randomization and 15 days after randomization

Description: Presence or not of nasopharyngeal SARS-CoV-2 Quantified by PCR

Measure: nasopharyngeal SARS-CoV-2 viral charge

Time: On day 0 before randomization and 15 days after randomization

Description: Number of total LT (using immuno-phenotyping) will explore the immune response

Measure: Number of total Lymphocytes T

Time: On day 0 before randomization and 15 days after randomization

Description: Number of CD3+ LT (using immuno-phenotyping) will explore the immune response

Measure: Number of CD3+ Lymphocytes T(lymphocyte subpopulation of CD3+ T cells)

Time: On day 0 before randomization and 15 days after randomization

Description: Number of total CD4+ LT (using immuno-phenotyping) will explore the immune response

Measure: Number of CD4+ Lymphocytes T(lymphocyte subpopulation of CD4+ T cells)

Time: On day 0 before randomization and 15 days after randomization

Description: Evaluation of number of CD8+ LT (using immuno-phenotyping) will explore the immune response

Measure: Number of CD8+ Lymphocytes T(lymphocyte subpopulation of CD8+ T cells)

Time: On day 0 before randomization and 15 days after randomization

Description: Systemic concentration measurement of IL-6 will explore the inflammatory response

Measure: Interleukin 6 (IL-6)

Time: On day 0 before randomization and 15 days after randomization

Description: Systemic concentration measurement of IL-10 will explore the inflammatory response

Measure: Interleukin 10 (IL-10)

Time: On day 0 before randomization and 15 days after randomization

Description: Systemic concentration measurement of TNFα will explore the inflammatory response

Measure: Tumor Necrosis Factor alpha (TNFα )

Time: On day 0 before randomization and 15 days after randomization

Description: Systemic concentration measurement of IFNγ will explore the inflammatory response

Measure: Interferon gamma (IFNγ)

Time: On day 0 before randomization and 15 days after randomization

Description: Systemic concentration measurement of type I IFN will explore the inflammatory response

Measure: Type I Interferon (type I IFN)

Time: On day 0 before randomization and 15 days after randomization

Description: Evaluation of Tim3 expression on CD4+ and CD8+ lymphocytes will explore the fundamental research on obesity and COVID-19

Measure: Tim3 expression

Time: On day 0 before randomization and 15 days after randomization

Description: Evaluation of PD1 expression on CD4+ and CD8+ lymphocytes will explore the fundamental research on obesity and COVID-19

Measure: PD1 expression

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of PD-L1 expression on monocytes will explore explore the fundamental research on obesity and COVID-19

Measure: PD-L1 expression

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of HLA-DR expression on monocytes will explore explore the fundamental research on obesity and COVID-19

Measure: Human Leukocyte Antigen - DR isotype gene expression (HLA-DR expression)

Time: On day 0 before randomization and 15 days after randomization

Description: The cytotoxic LT production of IFNγ will explore the fundamental research on obesity and COVID-19

Measure: Production of IFNγ by lymphocytes T

Time: On day 0 before randomization and 15 days after randomization

Description: The cytotoxic LT production of granzyme B will explore the fundamental research on obesity and COVID-19

Measure: Production of granzyme B by lymphocytesT

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of LPS will explore the endotoxemia and perform fundamental research on obesity and COVID-19

Measure: Lipopolysaccharides (LPS)

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of LBP (endotoxin transporter) will explore the endotoxemia and perform fundamental research on obesity and COVID-19

Measure: LBP(LPS-Binding Protein)

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of sCD14 (endotoxin transporter) will explore the endotoxemia and perform fundamental research on obesity and COVID-19

Measure: sCD14

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of High Density Lipoproteins proteomic will explore the lipoprotein metabolism and perform fundamental research on obesity and COVID-19

Measure: High Density Lipoproteins

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of apolipoprotein proteomic will explore the lipoprotein metabolism and perform fundamental research on obesity and COVID-19

Measure: Apolipoprotein

Time: On day 0 before randomization and 15 days after randomization
253 Contamination and Transmission of the SARS-CoV-2 Virus in Exposed, Confined and Community-based Infants: A Cross-sectional, Multicentre, Interventional Seroprevalence Study

According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to be of the same order of magnitude, but need to be confirmed by a biological technique. Children would be susceptible to infection but often asymptomatic.

NCT04413968
Conditions
  1. Coronavirus
  2. Coronavirus Infection
  3. Covid19
  4. Sars-CoV2
Interventions
  1. Diagnostic Test: Rapid detection test
  2. Diagnostic Test: Nasopharyngeal swab
  3. Diagnostic Test: Stool collection
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of children with a positive rapid serological test (presence of anti-SARS-CoV2 antibodies (IgM or IgG)).

Measure: Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period

Time: Day of intervention (1 day)
254 Complications Risk Factors in Patients Hospitalized for COVID-19 Infection: Role of Proteins Electrophoresis

The inflammation is central in COVID-19 infections. Our aim is to evaluate the clinical value of measuring inflammation by using serum protein electrophoresis (SPE). SPE evaluation of inflammation should be able to predict outcome, follow up evolution or treatment efficacy in patients with coronavirus infection and thus anticipate their evolution to severe viral infection and allow an optimal clinical management. SPE inflammation diagnostics will be benchmarked with other diagnostics of inflammation, currently used more routinely.

NCT04414059
Conditions
  1. SARS-CoV 2
  2. Hospitalisation-Associated Infection
MeSH:Infection

Primary Outcomes

Description: hospitalisation in Intensive Care Unit OR Oxygen needs > 6 L/min OR death whatever the cause

Measure: Complications onset

Time: Up to 3 weeks

Secondary Outcomes

Description: Risk quantification

Measure: Risk value associated with each risk factor as identified at the end of the main study analysis

Time: Up to 3 weeks

Description: Correlation between complications onset (as defined by hospitalisation in Intensive Care Unit OR Oxygen needs > 6 L/min OR death whatever the cause) and individual protein fraction value

Measure: Predictive performance and risk associated with each individual protein fraction

Time: Up to 3 weeks

Description: Evolution over time of the serum quantity of each individual protein fraction (6 fractions studied)

Measure: Intra-patient kinetics evolution of the electrophoresis curves

Time: Up to 3 weeks

Description: Evolution over time of the serum quantity of each biological risk factor (as defined for the study)

Measure: Intra-patient kinetics evolution of biological risk factors

Time: Up to 3 weeks

Description: Central review of each serum protein electrophoresis curve

Measure: Inter-expert reproducibility analysis of electrophoretic inflammatory profiles centrally reviewed

Time: After study completion, estimated 10 months after first patient enrolled

Description: Urine samples at admission, every 4 days and at complications onset

Measure: Contribution of urinary electrophoresis inflammation profiles in the interpretation of serum electrophoresis curves

Time: Up to 3 weeks

Description: Biobank with serum samples for the implementation, at the end of the study, of a high-resolution capillary electrophoresis technique enabling each serum protein to be viewed individually

Measure: Exploratory biological objective: Definition of a more detailed electrophoretic inflammatory profile

Time: After study completion, estimated 10 months after first patient enrolled
255 Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial

The purpose of this study is to determine whether hydroxychloroquine is an effective prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants will be randomized into two parallel groups. The first arm will evaluate the use of hydroxychloroquine every-other-day plus standard measures of protection for the prevention of SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of COVID-19 symptoms for 8 weeks.

NCT04414241
Conditions
  1. SARS-CoV-2
Interventions
  1. Drug: Hydroxychloroquine
MeSH:Infection

Primary Outcomes

Measure: Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2

Time: Eight weeks

Measure: Safety: Proportion of participants with grade 3 or more adverse events

Time: Eight weeks

Secondary Outcomes

Measure: Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events

Time: Eight weeks
256 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)
257 Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial (PROTECT-COVID-19).

The aim of this study is to analyze if administration of conestat alfa for 72 hours in addition to standard of care (SOC) in patients hospitalized with non-critical SARS-CoV-2 pneumonia (WHO Ordinal Scale Score 3 or 4) reduces the risk of disease progression to Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).

NCT04414631
Conditions
  1. Coronavirus Infections
Interventions
  1. Drug: Conestat alfa
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Disease severity on the 7-point Ordinal World Health Organization (WHO) scale (for the current study, score 0 will be omitted and score 6 and 7 will be combined). The ordinal scale measures illness severity over time. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19.

Measure: Disease severity

Time: on day 7

Secondary Outcomes

Description: Time to clinical improvement (time from randomisation to an improvement of two points on the seven-category WHO ordinal scale or live discharge from hospital, whichever came first)

Measure: Time to clinical improvement

Time: within 14 days after enrolment

Description: Proportion of participants alive and not having required invasive or non-invasive ventilation

Measure: Proportion of participants alive and not having required invasive or non-invasive ventilation

Time: at 14 days after enrolment

Description: Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg)

Measure: Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg)

Time: within 14 days after enrolment

Other Outcomes

Description: Changes in the ordinal WHO scale

Measure: Changes in the ordinal WHO scale

Time: from baseline over 14 days

Description: Length of hospital stay in survivors

Measure: Length of hospital stay in survivors

Time: until day 28

Description: Proportion of participants progressing to mechanical ventilation

Measure: Proportion of participants progressing to mechanical ventilation

Time: on day 7 and day 14

Description: Proportion of participants requiring ICU treatment

Measure: Proportion of participants requiring ICU treatment

Time: on day 7 and 14

Description: Length of ICU stay

Measure: Length of ICU stay

Time: until day 28

Description: 28 Ventilator-free days

Measure: 28 Ventilator-free days

Time: until day 28

Description: All-cause mortality

Measure: All-cause mortality

Time: time from randomisation to death within four weeks

Description: Changes in biomarker level CRP

Measure: Changes in biomarker level CRP (mg/l)

Time: until day 14

Description: Changes in biomarker level LDH

Measure: Changes in biomarker level LDH (U/l)

Time: until day 14

Description: Changes in biomarker level D-Dimer

Measure: Changes in biomarker level D- Dimer (yg/ml)

Time: until day 14

Description: Changes in biomarker level Ferritin

Measure: Changes in biomarker level Ferritin (ng/ml)

Time: until day 14

Description: Changes in biomarker level IL-6

Measure: Changes in biomarker level Interleukin 6 (IL- 6) (pg/ml)

Time: until day 14

Description: Changes in lymphocyte count

Measure: Changes in lymphocyte count (cells per microliter of blood)

Time: until day 14

Description: Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples

Measure: Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples

Time: time from enrolment to first of 2 negative assays at least 12 hours apart

Description: Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins

Measure: Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins

Time: within 14 days

Description: Time to defervescence (temperature <38.0°C)

Measure: Time to defervescence (temperature <38.0°C)

Time: sustained for at least 48 hours

Description: Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate)

Measure: Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate) until day 28

Time: until day 28

Description: Duration of supplemental oxygen

Measure: Duration of supplemental oxygen

Time: until day 28

Description: Peak serum concentration of conestat alfa will be measured

Measure: Change in pharmacokinetics of conestat alfa

Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge date

Description: Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration)

Measure: Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration)

Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge date
258 COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study

This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

NCT04416373
Conditions
  1. Coronavirus Infection
  2. Pregnancy Complications
  3. Vertical Transmission of Infectious Disease
  4. Breastfeeding
  5. Neonatal Infection
Interventions
  1. Diagnostic Test: RT PCR SARS-CoV-2
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pregnancy Complications

Primary Outcomes

Description: Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples

Measure: SARS-CoV-2 Neonatal Infection

Time: 7 days

Secondary Outcomes

Description: stillbirths and deaths in the first week of life

Measure: Perinatal mortality

Time: 35 weeks

Description: maternal ICU admission due to COVID-19

Measure: ICU maternal admission

Time: 35 weeks

Description: Newborn 5 minute Apgar Score < 7

Measure: 5 minute Apgar Score < 7

Time: 1 day

Description: Delivery between 24 and 36 weeks

Measure: Preterm labour

Time: 35 weeks

Description: Preterm premature rupture of the membranes between 24 and 36 weeks

Measure: PPROM

Time: 35 weeks

Description: spontaneous pregnancy loss before 24 weeks

Measure: Miscarriage

Time: 14 weeks
259 Use of High Dose Inhaled Corticosteroids as Treatment of Early COVID-19 Infection to Prevent Clinical Deterioration and Hospitalisation

At the time of writing (3/4/2020), close to a million people have been infected by the SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths is now called CoVID-19. Currently, there are no effective treatments for the early or late stages of this illness. Governments worldwide have undertaken dramatic interventions to try and reduce the rate of spread of this deadly coronavirus. Early data from multiple studies in China, where the virus originated, show that severe cases of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This data has been confirmed by the Italian physicians. The investigators think that the widespread use of inhaled corticosteroids reduces the risk of CoVID-19 pneumonia in patients with chronic lung disease. Early microbiological data also shows that these corticosteroids are effective at slowing down the rate of coronavirus replication on lung cells. Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma. This type of medicine is among the top 3 most common medication prescribed around the world. Their safety is well understood, and their potential side effects are mild and reversible. The investigators propose to test this idea that, in participants early in the course of CoVID-19 illness, daily high dose inhaled corticosteroids for 28 days, will reduce the chances of severe respiratory illness needing hospitalisation. We will also study the effect of this inhaled therapy on symptoms and viral load.

NCT04416399
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Budesonide dry powder inhaler
MeSH:Infection Coronavirus Infections Severe Acut Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19

Measure: Emergency department attendance of hospitalisation related to COVID-19

Time: Day 1 to day 28

Secondary Outcomes

Description: Evaluate the effect of intervention on body temperature

Measure: Body temperature

Time: Day 1 to day 14

Description: Evaluate the effect of intervention on blood oxygen level

Measure: Blood oxygen saturation level

Time: Day 1 to day 14

Description: Evaluate the effect of intervention on patient's symptoms as determined by common cold questionnaire. Higher score meaning worse symptoms.

Measure: Symptoms as assessed by common cold questionnaire

Time: Day 1 to day 14

Description: Evaluate the effect of intervention on patient's symptoms as determined by FluPro questionnaire. Higher score meaning worse symptoms.

Measure: Symptoms as assessed by FluPro questionnaire

Time: Day 1 to day 14

Description: Evaluate the effect of intervention on nasal and throat swab SARS-CoV-2 viral load

Measure: Nasal/throat swab SARS-CoV-2 viral load

Time: Day 1, 7 and 14
260 Quality of Life and Long-term Outcomes in Patients With Pneumonia Associated With SARS-Cov2 Infection, Survivors of Intensive Care Units: a Prospective Multicenter Cohort Study

Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the Intensive Care Unit (ICU), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the ICU admission. The present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among patients recovered from SARS-COV-2 pneumonia, after discharge from the ICU, its determinants and predictors, in Portugal. It is a multicenter prospective cohort study of adult patients admitted at the ICU due to proven or suspected SARS-CoV-2 infection, included 90 days after discharge from the ICU. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. The secondary outcomes are all-cause mortality, rehospitalizations, return to work or study, the degree of dependence and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of physical activity and cognitive, renal and respiratory functions after ICU discharge. Investigators will collect data by means of structured telephone interviews, at a 12 months follow up period.

NCT04416464
Conditions
  1. Quality of Life
  2. Long-term Outcomes
  3. Coronavirus Infection
  4. Morality
  5. Rehospitalization
Interventions
  1. Other: COVID-19 Pneumonia
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).

Measure: Health-related quality of life.

Time: One-year (12 months) after ICU discharge.

Secondary Outcomes

Description: Length of stay at the ICU.

Measure: Length of stay at the ICU.

Time: The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).

Description: Incidence of all-cause mortality.

Measure: Incidence of all-cause mortality

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: Rehospitalization.

Measure: Rehospitalization.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.

Measure: Percentage of long-term ventilatory support need.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: Percentage of patients requiring any kind of renal replacement therapy.

Measure: Percentage of renal replacement therapy need.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).

Measure: Symptoms of anxiety and depression.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale, a score of instrumental activities of daily living (the score ranges from 0 to 8, with higher scores indicating less dependence).

Measure: Score of functional independence.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the The Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, in 8 domains, with higher scores indicating worse symptoms.

Measure: Score of cognitive function.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: Percentage of major cardiac events.

Measure: Percentage of major cardiac events.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: Score of Chronic obstructive pulmonary disease (COPD) assessed using the Portuguese version of the Clinical COPD Questionnaire (CCQ). The Clinical COPD, consisting of 10 items (each scored between 0 and 6), divided into three domains (symptoms, functional, mental). The total score is calculated by summing the scores of the individual items and dividing by 10 (the number of individual items) giving a total score between 0 and 6 with higher scores representing worse scenario.

Measure: Score of Chronic obstructive pulmonary disease (COPD)

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).

Measure: Symptoms of posttraumatic stress disorder

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).

Measure: Utility score of health-related quality of life at 3, 6, and 9 months.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the visual analogue scale of the Portuguese version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health).

Measure: Score of self-rated health.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
261 A Proposed Alternative to the N-95 Mask Shortage in the COVID-19 Pandemic. A Feasibility Study

The purpose of this study is to assess the safety and efficiency of an assembled modified mask in protecting health care workers against Coronavirus in case of any personal protective equipment shortage. At least 20 healthy participants will be recruited to try the modified mask. The modified masks will be made from masks that are already available as well as filters available in the pulmonary department at the Oklahoma City VA Health Care System

NCT04416919
Conditions
  1. Coronavirus Infection
  2. Disease Prevention
Interventions
  1. Other: Assembled mask
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Conduct a quantitative fit test and calculate the percentage of participants who pass the test.

Measure: Success Percentage

Time: 15 minutes

Secondary Outcomes

Description: Change in end-tidal CO2 from 0 to 15 minutes while wearing the Full or the Whole mask

Measure: End-tidal CO2 Variation. Description: mmHg.

Time: at 0 and 15 minutes

Description: Measure the change in Oxygen Pulse Oximetry from 0 to15 minutes while wearing the Full or the Whole mask

Measure: Oxygen Pulse Oximetry Variation. Description: mmHg.

Time: at 0 and 15 minutes.

Description: Evaluate the visibility (5-point Likert scale from Absent to Complete) while wearing the Full or the Whole mask for 15 minutes

Measure: Mask Visibility. Description: Likert Scale.

Time: 15 minutes

Description: When the mask is removed, participants will be asked about willingness to use this mask compared to N-95 masks using a 5-point Likert scale from 'Very unlikely' to 'Very likely'.

Measure: Willingness of usage. Description: Likert Scale.

Time: after 15 minutes
262 Acute Infection in Mitochondrial Disease: An Observational Prospective Natural History Study of Metabolism, Infection and Immunity During the COVID19 Pandemic

Background: Mitochondrial disease is a rare disorder. It can cause poor growth, developmental delays, muscle weakness, and other symptoms. The disease is usually inherited. It can be present at birth or develop later in life. Infection is a major cause of disease and death in people with this disease. Researchers want to learn more about how infection and the declining health of people who have this disease may be related to the COVID-19 pandemic. To do this, researchers will study the DNA of people who become ill with suspected or confirmed coronavirus. Their DNA will be compared to the DNA of their family members. Objective: To learn more about how genes may play a role in how COVID-19 affects people with mitochondrial disease. Eligibility: People age 2 months and older with mitochondrial disease and a suspected or confirmed diagnosis of COVID-19. Design: Participants will complete a questionnaire about their health history. Their medical records may be reviewed. They will give a blood sample. If the participant becomes ill, they may have a videoconference with a doctor or nurse at the NIH to perform a physical exam. They may be contacted after their illness to give updates on their health. They may be asked to give extra blood samples or complete extra questionnaires. Participants genetic data will be put into a database. The data will be labeled with a code and not their name. The data will be shared with other researchers. Participation lasts about 1 year. This may be extended if the participant is very ill.

NCT04419870
Conditions
  1. Mitochondrial Disease
MeSH:Infection Mitochondrial Diseases

Primary Outcomes

Description: To identify immune signatures that associate with host responses todisease that would allow improved patient stratification and identification of potential therapeutic targets to mitigate the severesymptoms and sequelae of infection in mitochondrial disease.

Measure: We will perform whole blood transcriptomic analysis, humoral response profiling and soluble mediator profiling.

Time: Undefined for natural history study

Secondary Outcomes

Description: to stratify severity of illness based on clinical factors (e.g. intensive care status, ventilatory support, clinical laboratory data, radiologyrecords)

Measure: Patient Medical Records for Data Abstraction

Time: Undefined for natural history study

Description: to understand functional status, healthcare resource access and other sociodynamic factors as they affect the mitochondrial disease community.

Measure: Patient centered outcomes data via questionnaires

Time: Undefined for natural history study
263 Scheme of Primary Prevention of Infection by COVID-19, in Health Providers: Phase II Controlled Clinical Trial, to be Carried Out in Medellín-Antioquia

Introduction: The SARS Co-2 contagious rate is high (Ro: 2.0-3.0). The infection is aggressive with high pathogenicity. Global confinement impacts all social and economic fields of human activity. Clinical behavior exceeds the capabilities of public health care. With the initial information on the pandemic, it is estimated that 20% of health personnel in direct contact with patients can acquire the disease, despite preventive self-care. The molecular relationship of COVID-19 with the subject's ACE2 protein encourages the virus to enter the host cell, and initiates replication and the immune response, causing an imbalance generating an immunological storm of cytokines, with serious damage to the host. Objective: It is proposed to supply a combined scheme of two compounds by oropharyngeal spray that capture the virus before entering the target cell and orally administer immunomodulatory compounds that regulate the inflammatory response released by the virus, in order to improve the antiviral response. Methodology: A controlled, parallel design, triple blind, phase II clinical trial will be conducted with four study groups to compare the active compounds (oropharyngeal spray and capsule) with placebo. Discussion: With the application of the combined scheme of two compounds, a 75% reduction in infection is expected in health providers in direct contact with COVID patients.

NCT04420260
Conditions
  1. COVID
Interventions
  1. Dietary Supplement: Group A: oropharygeal spray and immunostimulant
  2. Dietary Supplement: Group B: Placebo oropharyngeal spray + Active principle immunostimulant
  3. Dietary Supplement: Group C:Active principle oropharyngeal spray + Placebo taken PO
  4. Dietary Supplement: Group D:Placebo oropharyngeal spray + Placebo taken PO
MeSH:Infection

Primary Outcomes

Description: Seroconversion of IgM for COVID-19. Result of positive IgM antibodies: A previously scheduled closure visit will be conducted, the trial product will be interrupted if a case is classified as severe-critical, and clinical follow up will be continued as planned. As protocols by the Health Ministry dictate, cases will be confirmed with a PCR-RT test, for the diagnosis of COVID-19. The result of the test will be requested to document the outcome.

Measure: Seroconversion of IgM for COVID-19.

Time: 1 month

Secondary Outcomes

Description: seroconversion of IgG

Measure: Seroconversion of IgG for COVID-19.

Time: through study completion, 45 days
264 Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection: A Randomized, Double-blind, Placebo Controlled, Telemedicine Study (SynCov Study)

The investigators hypothesize that the intake of Omni-Biotic® 10 AAD can reduce the duration of diarrhea in Covid-19 disease. The investigators further hypothesize that Omni-Biotic® 10 AAD can reduce stool frequency, improve stool consistency, improve other gastrointestinal symptoms of Covid-19, reduce disease duration and severity, reduce intestinal inflammation and can improve dysbiosis. The investigators aim to perform a randomized, double blind, placebo-controlled study using telemedicine in patients with Covid-19 disease.

NCT04420676
Conditions
  1. COVID
Interventions
  1. Dietary Supplement: Omnibiotic AAD
  2. Dietary Supplement: Placebo
MeSH:Infection

Primary Outcomes

Description: Duration of diarrhea (defined as days with 3 or more loose stools)

Measure: Diarrhea

Time: 30 days

Secondary Outcomes

Description: stool evacuations per days

Measure: Stool frequency

Time: 30 days

Description: Stool consistency according to Bristol stool scale for each evacuation, score 1-7, a higher score means a lower stool consistancy

Measure: Stool consistency

Time: 30 days

Description: presence of anorexia, nausea, vomiting, abdominal pain, bloating (yes/no)

Measure: Gastrointestinal symptoms

Time: 30 days

Description: days patients feel sick, are not able to work or are on sick leave

Measure: Duration of Covid-19 disease

Time: 30 days

Description: mild/moderate/severe

Measure: Severity of Covid-19 disease

Time: 30 days

Description: measured by ELISA

Measure: Stool Calprotectin

Time: 30 days

Description: measured by ELISA

Measure: Stool Zonulin

Time: 30 days

Description: 16S RNA sequencing

Measure: Microbiome composition

Time: 30 days
265 Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)

Study Objective: To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.

NCT04421664
Conditions
  1. Corona Virus Infection
  2. SARS-CoV Infection
  3. Coronavirus
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo oral tablet
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.

Measure: Ordinal Scale of COVID19 Disease Severity at 14 days

Time: 14 days

Secondary Outcomes

Description: Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.

Measure: Incidence of Hospitalization

Time: 14 days

Description: Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.

Measure: Incidence of COVID-19 related Death

Time: 90 days

Description: Outcome reported as the number of participants in each arm who expire due to all causes.

Measure: Incidence of all-cause Death

Time: 90 days

Description: Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.

Measure: Incidence of All-Cause Study Medicine Discontinuation or Withdrawal

Time: 14 days

Description: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Measure: Overall symptom severity at 5 and 14 days

Time: 5 and 14 days

Description: Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Measure: Overall change in disease severity over 14 days among those who are symptomatic at baseline

Time: 14 days
266 Observational Study to Evaluate the Effects on the Qt Interval of COVID-19 Coronavirus Infection in Critically Ill Patients

The present study aims to evaluate the impact of COVID-19 disease and its treatment on ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to the critical care unit.

NCT04422535
Conditions
  1. Coronavirus Infection
  2. Intensive Care Patients
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The QT interval measurement will be performed on the available 12-lead ECG from the medical record. The QT interval will be measured according to the recommendations of the scientific societies of cardiology: it is considered from the beginning of the activation of the ventricular myocardium and the end of its repolarization, which are represented in the ECG respectively by the beginning of the QRS and the end of the T wave. Ideally, the QT interval should be measured in Q-wave leads in DII and V5. An average value of 3 heart cycles (beats) should be recorded. Two researchers to control inter-observer variability will perform the measurement.

Measure: Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection

Time: through study completion, an average of 1 year

Secondary Outcomes

Description: To assess the incidence of arrhythmias in critically ill patients with COVID-19 infection admitted to critical patient units. To evaluate the impact of the association of drugs administered for the treatment of COVID-19 infection in critically ill patients in the QT interval.

Measure: incidence of arrhythmias and impact of the COVI-drugs administered on QT interval

Time: through study completion, an average of 1 year
267 Bruk av Ultralyd i Evaluering av Pasienter Med Mistenkt COVID-19 Infeksjon i Norge

In light of the ongoing COVID-19 epidemic in Norway, it is paramount to develop and utilize clinical tools for assessing and risk stratifying patients with suspected coronary infection in the emergency departments. Diagnostic use of ultrasound in viral pneumonias, including COVID-19 has proved to be very useful. The use of ultrasound will assist in quick detection of lung pathology compatible with increasing severity of the COVID-19 disease. At the same time, the use of ultrasound diagnostics in the emergency department could improve logistics and reduce potential exposure of the corona virus to other health personnel. The purpose of the study is to assess whether ultrasound findings correlates with physical examination, labs, and other imaging diagnostics in patients with suspected or diagnosed COVID-19 disease, as well as assessing whether ultrasound diagnostics can assist in risk stratification. The project is conducted as a prospective multicenter study where ultrasound diagnostics will be performed on patients with suspected coronary infection in the emergency departments. Data collection takes place as part of the daily clinical evaluation of acute patients in the emergency departments. The project is planned to be completed towards the end of 2025.

NCT04422691
Conditions
  1. COVID-19
  2. Pneumonia, Viral
  3. Pulmonary Infection
Interventions
  1. Diagnostic Test: Lung ultrasound
MeSH:Infection Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: 30-day mortality

Measure: Mortality

Time: up to 30 days

Description: In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.

Measure: Level-of-care

Time: up to 7 days

Secondary Outcomes

Description: in days

Measure: In-hospital length of stay

Time: Up to 30 days

Measure: Oxygen usage in the emergency department

Time: Within 24 hours

Description: in hours

Measure: Emergency department length of stay

Time: Within 24 hours

Measure: Antibiotics usage

Time: Within 24 hours

Other Outcomes

Description: Clinical correlation between ultrasound findings and vital signs, labs, blood gas and other diagnostic modalities.

Measure: Clinical correlation

Time: Within 3 days
268 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
269 COVID-19 Related Health and Infection Control Practices Among Dentists

As dentists begin reopening their practices during a global pandemic, the risk of COVID-19 infection that dentists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. The goal of the proposed study is to understand U.S.-based dentists' health and dental-practice reactions to COVID-19. To estimate this, U.S-based dentists will be surveyed monthly. These findings could be used to describe the prevalence and incidence of COVID-19 among dentists, determine what infection control steps dentists take over time, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.

NCT04423770
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Other: No intervention
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: COVID-19 case as confirmed by clinician and/or detection of SARS-CoV-2 RNA or a specific antigen in a clinical specimen

Measure: COVID-19 probable or confirmed case

Time: 18 months

Secondary Outcomes

Description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety.

Measure: Anxiety

Time: 12 months

Description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms.

Measure: Depression

Time: 12 months

Description: Self-reports of infection control efforts in the respondents' primary dental practices

Measure: Dental practice infection control efforts

Time: 12 months

Description: Self-reports of personal protective equipment use

Measure: Dentists' use of personal protective equipment

Time: 12 months
270 Possibilities of Chest Magnetic Resonance Imaging (MRI) in Diagnostics of COVID-19. The Use of MRI to Assess Lung Damage in Patients With Coronavirus Infection

Since the onset of the COVID-19 pandemic, the importance of chest computed tomography (CT) in detecting signs of viral pneumonia has become clear from the literature. However, the increased patient flow creates an additional pressure on CT centers. We believe, the use of chest magnetic resonance imaging (MRI) can help to test patients for CОVID-19 when CT scan is not available. Lung MRI may be useful in routing a patient in a difficult epidemiological situation.

NCT04424355
Conditions
  1. Coronavirus Infections
  2. Pneumonia
Interventions
  1. Diagnostic Test: Chest MRI
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Expected number - more than two zones

Measure: Number of zones of pulmonary parenchyma corresponding to viral pneumonia detected by chest MRI in comparison with CT scan

Time: Upon completion, up to 1 year
271 Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)

People with cancer may be at higher risk of poor outcomes with COVID-19 infection. This observational study aims to describe the clinical course of COVID-19 infection in people with cancer and evaluate the utility of antibody and antigen tests for COVID-19. The results of this study will inform clinical practice in the management of cancer patients with COVID-19.

NCT04427280
Conditions
  1. Infectious Disease
  2. Cancer
  3. Coronavirus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Proportion of patients, at each sample timepoint, with a positive detection of IgM and IgG specific antibodies to SARS-CoV-2.

Time: 56 days

Secondary Outcomes

Description: Duration of clinical symptoms

Measure: Clinical course of SARS-CoV-2 infection in cancer patients.

Time: 56 days

Description: Severity of clinical symptoms

Measure: Clinical course of SARS-CoV-2 infection in cancer patients.

Time: 56 days

Description: Number of patients whose cancer treatment has been impacted by SARS-CoV-2

Measure: Clinical course of SARS-CoV-2 infection in cancer patients.

Time: 56 days

Measure: Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR.

Time: 56 days

Measure: Time from start of symptoms to Day 0 testing in the study.

Time: 56 days

Description: Proportion of samples successfully processed and result obtained, with 95% confidence interval Proportion of samples processed with a positive result by lateral flow, by the gold standard (throat/nose RT-PCR)

Measure: Feasibility of SARS-CoV-2 testing with a lateral flow assay.

Time: 56 days
272 RT-PCR SARS-CoV-2 at 1 Month of COVID-19 Infection in the Geriatric Population

Evaluation of the rate of positive RT-PCR SARS-CoV-2 test at 1 month of COVID infection among elderly people. It is unclear how long an individual with COVID-19 will remain "sick" and "contagious". It appears that SARS-CoV-2 can be transmitted before symptoms appear and throughout the course of the disease. They investigators did not find any study on a COVID + geriatric population reassessing carriage at 1 month even though age seems to be a risk factor for prolonged excretion as suggested in the study following study: Xu K, Chen Y, Yuan J, Yi P, Ding C, Wu W, et al. Factors associated with prolonged viral RNA shedding in patients with COVID-19. Clinical Infectious Diseases. 2020 Apr 9; ciaa351

NCT04427358
Conditions
  1. Covid-19
MeSH:Infection

Primary Outcomes

Measure: Analysis of the rate of RT-PCR SARS-CoV-2 positive at 1 month of COVID infection

Time: at 1 month of COVID infection
273 A Pilot Trial of Thymalfasin (Ta1) to Prevent COVID-19 Infection in Elderly Renal Dialysis Patients

Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN® injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by the thymus gland. Ta1 is a biological response modifier which activates various cells of the immune system, and is therefore expected to have clinical benefits in disorders where immune responses are impaired or ineffective, including acute and chronic viral and bacterial infections, cancers, and vaccine non-responsiveness. Patients with end-stage renal disease (ESRD) on hemodialysis, in addition to their intrinsic kidney disease and frequent burden of comorbidities, also have increased risk of exposure to communicable diseases as they are treated several times each week at hemodialysis centers with several other patients and clinic staff in attendance. The majority of patients are over 60 years of age and many are receiving immunosuppressive medications. Accordingly, ESRD patients are particularly susceptible to COVID-19 infection. Ta1 has been shown to be safely administered to hemodialysis patients. It is our hypothesis that a course of Ta1 administered to individuals with ESRD will reduce the rate and severity of infection with COVID-19.

NCT04428008
Conditions
  1. COVID-19
Interventions
  1. Drug: Thymalfasin
MeSH:Infection

Primary Outcomes

Description: Number of subjects who become infected with COVID-19 over the course of the study

Measure: Reduction in documented infection with COVID-19 Reduction in infection with COVID-19

Time: 6 months

Secondary Outcomes

Description: Number of subjects who become hospitalized

Measure: Need for hospitalization

Time: 6 months

Description: If subject becomes hospitalized, what length of time does the subject remain hospitalized

Measure: Hospital length of stay

Time: 6 months

Description: Number of subjects who are entered into the ICU

Measure: Need for ICU admission

Time: 6 months

Description: If subject is entered into the ICU, what length of time does the subject remain in the ICU

Measure: ICU length of stay

Time: 6 months

Description: Number of subjects who require mechanical ventilation

Measure: Need for mechanical ventilation

Time: 6 months

Description: If mechanical ventilation is required, what length of time the ventilation is required

Measure: Duration of mechanical ventilation

Time: 6 months

Description: If subject becomes infected with COVID-19, how long does the subject require to recover from the infection

Measure: Recovery time from COVID-19

Time: 6 months

Description: Evaluation of whether any comorbidities are changed over the course of treatment (eg., worsening of congestive heart failure)

Measure: Change in any existing comorbidities or occurrence of newly diagnosed disease

Time: 6 months

Description: Determination of whether there are more or fewer infections other than COVID-19 (other respiratory, urinary tract, cellulitis, etc.)

Measure: Incidence of non-COVID-19 infections

Time: 6 months

Description: Evaluation of the levels of CD4 and CD8 subjects

Measure: Change in lymphocyte subsets (CD4, CD8)

Time: 6 months

Description: Number of subjects who die during the course of the study

Measure: Mortality

Time: 6 months

Description: Number of subjects with mild, moderate, or severe adverse events based on perceived clinical significance of the event

Measure: Treatment-emergent adverse events

Time: 6 months

Description: Number of subjects with mild, moderate, or severe changes to vital signs based on perceived clinical significance of the event

Measure: Treatment-emergent changes in vital signs

Time: 6 months

Description: Number of subjects with mild, moderate, or severe laboratory findings based on perceived clinical significance of the event

Measure: Treatment-emergent laboratory parameters

Time: 6 months
274 Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement

This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study. The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality. The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.

NCT04429594
Conditions
  1. Coronavirus Infections
Interventions
  1. Other: blood sampling
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: number of positive serologies

Measure: positive serologies

Time: 12 months
275 Phase 2 Clinical Trial to Compare the Efficacy and Safety of Different Doses of Ivermectin in Patients Diagnosed With the New Coronavirus Infection (SARS-CoV-2)

In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 infection.

NCT04431466
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Ivermectin
  2. Other: Standard treatment for COVID-19
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab after Intervention Initiation.

Measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab.

Time: 7 days following intervention

Secondary Outcomes

Description: Viral load variation in the nasopharyngeal swab during treatment.

Measure: Viral load variation in the nasopharyngeal swab.

Time: 7 days following intervention.

Description: Variation of serum lymphocyte counts during treatment.

Measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab.

Time: 7 days following intervention.

Description: Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab at the end of follow-up.

Measure: Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab.

Time: 7 after intervention.

Description: Proportion of patients with clinical improvement, defined as the time to normalize fever, respiratory rate and oxygen saturation and cough relief at the end of follow-up.

Measure: Proportion of patients with clinical improvement.

Time: 7 after intervention.
276 Impact of SARS-CoV-2 Infection During Pregnancy on Newborns and Young Children

This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of pregnancy, and on developement of the child in early life.

NCT04432779
Conditions
  1. Pregnancy
  2. Covid-19
Interventions
  1. Other: no intervention
MeSH:Infection

Primary Outcomes

Description: Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis

Measure: Outcome of pregnancy

Time: Up to the delivery

Secondary Outcomes

Description: Measure of antibodies in maternal serum at delivery

Measure: Prevalence of positive serology to SARS-CoV-2 at delivery

Time: At the delivery

Description: Measure the ratio of cord blood antibodies on maternal antibodies titers

Measure: Transplacental transfer of antibodies to SARS-CoV-2

Time: At the delivery

Description: Placental histology will be performed in women tested positive for SARS-CoV-2 during pregnancy

Measure: To characterize placental alterations related to SARS-CoV-2 infection

Time: At the delivery

Measure: Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers

Time: At 1 month post delivery

Description: Measure of antibodies in cord blood and at the age of 1 month

Measure: To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of life

Time: Up to 1 month post delivery

Description: Occurence of infectious disease, neurological development, growth

Measure: Clinical evolution of the children

Time: Up to 3 years
277 A Phase III, Randomized, Double-blind, Placebo-controlled, Multicentre, Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in the SARS-CoV-2 Pandemic by Modulating the Immune System

The aim of this study is to investigate whether vaccination of elderly with VPM1002 could reduce hospital admissions and/or severe respiratory infectious diseases in the SARS-CoV-2 pandemic . VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG) vaccine, which has been used successfully as a vaccine against tuberculosis for about 100 years, especially in developing countries. VPM1002 has been shown in various clinical studies to be significantly safer than the BCG vaccine. VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also provide (partial) protection against COVID-19 disease caused by the "new corona virus" SARS-CoV 2.

NCT04435379
Conditions
  1. Infection, Respiratory Tract
Interventions
  1. Biological: VPM1002
  2. Biological: Placebo
MeSH:Communicable Diseases Infection Respiratory Tract Infections
HPO:Respiratory tract infection

Primary Outcomes

Measure: Number of days with severe respiratory disease at hospital and/or at home

Time: From day 0 to day 240

Secondary Outcomes

Measure: Cumulative incidence of hospital admissions

Time: From day 0 to day 240

Measure: Cumulative incidence of documented SARS-CoV-2 infection

Time: From day 0 to day 240

Measure: Number of days with self-reported fever (≥ 38 ºC)

Time: From day 0 to day 240

Measure: Number of days with self-reported acute respiratory symptoms

Time: From day 0 to day 240

Measure: Cumulative incidence of self-reported acute respiratory symptoms

Time: From day 0 to day 240

Measure: Cumulative incidence of death for any reason

Time: From day 0 to day 240

Measure: Cumulative incidence of death due to documented SARS-CoV-2 infection

Time: From day 0 to day 240

Measure: Cumulative incidence of ICU admission for any reason

Time: From day 0 to day 240

Measure: Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection

Time: From day 0 to day 240

Measure: Cumulative incidence of hospital admission due to documented SARSCoV- 2 infection

Time: From day 0 to day 240
278 Comparative Efficacy of Ivermectin Versus Combination of Hydroxychloroquine Plus Darunavir/ Ritonavir for Shortening Duration of SARS-CoV2 Detection From Respiratory Secretion Among Asymptomatic or Afebrile COVID-19 Infection

This is an open label randomised controlled study of oral ivermectin (600 mcg/kg/d* 3 day) versus combined of hydroxychloroquine plus darunavir/ ritonavir for 5 days treatment among asymptomatic carrier of SAR-CoV2 adult Thai population. Outcomes include safety and duration of detectable of SAR-CoV2 in nasopharyngeal/ throat (NP) swab by polymerase chain reaction amplification (PCR) after treatment. 40-50 patients in each treatment arm is planned, with an interim analysis when approximately 50% of cases is enrolled.

NCT04435587
Conditions
  1. Asymptomatic Infections
  2. SARS-CoV2 Infection
Interventions
  1. Drug: Ivermectin Pill
  2. Drug: Combined ART/hydroxychloroquine
MeSH:Infection Communicable Diseases Asymptomatic Infections

Primary Outcomes

Description: Comparison of adverse event rates between treatment arms

Measure: Adverse event rates

Time: after first dose until day 28 of follow up

Description: comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm

Measure: Efficacy for shortening duration of SAR-CoV2 detection by PCR

Time: weekly after treatment until 4th week

Secondary Outcomes

Description: comparison of median duration for total antibody detection in each arm

Measure: Antibody detection rates

Time: weekly after treatment until 4th week
279 Use of Convalescent Plasma for Treatment of Patients With COVID-19 Infection

The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection. An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP). Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).

NCT04438694
Conditions
  1. COVID19
Interventions
  1. Drug: Convalescent Plasma
MeSH:Infection

Primary Outcomes

Description: Decrease of hospital days of safety until discharge

Measure: Duration of hospitalization/Recovery status

Time: 2-3 weeks
280 A Randomized, Double-blind, Placebo-controlled Phase 3 Study: Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 Infection Rate and COVID-19 Severity

Bacille Calmette-Guerin (BCG) is a live attenuated vaccine administered for prevention of tuberculosis. Recently, several groups have hypothesized that BCG may "train" the immune system to respond to a variety of unrelated infections, including viruses and in particular the coronavirus responsible for COVID-19. Trials are currently being conducted in Australia, Netherlands, Germany and the United Kingdom to evaluate its effectiveness. Front line workers includes members of municipal and provincial police services, emergency medical personnel, firefighters, public transport employees, health service workers and food manufacturing employees. They are at high risk of infection from COVID-19, with potentially high infection rate. The investigators propose an interventional trial to evaluate the effectiveness of BCG vaccination to prevent COVID-19 infection and reduce its severity in front-line employees in Ontario.

NCT04439045
Conditions
  1. SARS-CoV-2 Infection
Interventions
  1. Biological: VPM1002
  2. Other: Placebo
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: To compare the self-reported incidence of SARS-CoV-2 infection (confirmed by positive test) following vaccination with either VPM1002 or placebo.

Measure: COVID-19 infection

Time: 7 months

Secondary Outcomes

Description: Compare the incidence of hospitalization in participants with positive COVID-19 test treated with either VPM1002 or placebo

Measure: Incidence of hospitalization for COVID-19

Time: 7 months

Description: Compare the incidence of hospitalization requiring intensive care (ICU admission) in participants with positive COVID-19 test treated with either VPM1002 or placebo

Measure: Incidence of ICU admission for COVID-19

Time: 7 months

Description: Compare the incidence of acute respiratory distress syndrome (ARDS) in participants with positive COVID-19 test treated with either VPM1002 or placebo.

Measure: Incidence of ARDS

Time: 7 months

Description: Compare the incidence of the need for mechanical ventilation in participants with positive COVID-19 test treated with either VPM1002 or placebo.

Measure: Mechanical ventilation for COVID-19

Time: 7 months

Description: To compare the incidence of secondary infection in participants with positive COVID-19 test treated with either VPM1002 or placebo.

Measure: Secondary infection in COVID-19

Time: 7 months

Description: To compare the mortality in participants with positive COVID-19 test treated with either VPM1002 or placebo.

Measure: COVID-19-related Mortality

Time: 7 months

Description: Compare the incidence of deep vein thrombosis, pulmonary embolism, or stroke in participants with positive COVID-19 test treated with either VPM1002 or placebo.

Measure: Incidence of DVT

Time: 7 months

Other Outcomes

Description: Compare the incidence of COVID-19 in participants who have received BCG vaccination previously.

Measure: Incidence of COVID-19 in Participants with Past BCG Vaccination

Time: 7 months

Description: To measure cardiac troponin, B-type natriuretic peptide, N-terminal pro b-type natriuretic peptide, C reactive protein, serum amyloid A, and procalcitonin identified as potential biomarkers of COVID-19 infection using blood samples collected prior to the vaccination and at the end of the 7-month follow-up.

Measure: Measure cardiac troponin, B-type natriuretic peptide, N-terminal pro b-type natriuretic peptide, C reactive protein, serum amyloid A, and procalcitonin as biomarkers of COVID-19

Time: 7 months

Description: Adverse events following administration of VPM1002 when used for prevention of COVID-19.

Measure: Adverse events following BCG vaccine

Time: 7 months

Description: Compare the priming of the innate trained immunity (i.e. induction of Th1 and Th17 responses to unrelated stimuli) to participants administered placebo.

Measure: Innate Trained Immunity

Time: 7 months
281 Prognostication of Oxygen Requirement in Non-severe SARS-CoV-2 Infection

Note that this is a study that is co-sponsored by Medecins Sans Frontieres, Spain, and the University of Oxford. The primary objective of this study is to identify clinical and biochemical prognostic markers in adults with virologically confirmed COVID-19 who do not require oxygen supplementation, with a focus on: aiding safe discharge from a healthcare facility (i.e. a high NPV); near-term impact on COVID-19 interventions in resource-limited settings (i.e. simple clinico-demographic variables and biochemical markers for which near-patient / POCTs are commercially available or in late-stage development). The secondary objective of this study is to evaluate the field-based performance of near-patient lateral flow assays for suPAR and IL-6 in adults with non-severe SARS-CoV-2 infection

NCT04441372
Conditions
  1. SARS-CoV2
  2. COVID
MeSH:Infection

Primary Outcomes

Description: Identify clinical and biochemical prognostic markers in adults with non-severe COVID-19. This is assessed through the ability of the markers to predict progression to subsequent supplemental oxygen requirement - sensitivity, specificity, NPV, PPV and AUROC, and discrimination (c-index) and calibration (plots of observed probabilities against predicted probabilities) of a prognostic model combining up to four markers.

Measure: Clinical and biochemical prognostic markers

Time: 14 days

Secondary Outcomes

Description: To evaluate the field-based performance of near-patient lateral flow assays for suPAR and IL-6 in adults with non-severe SARS-CoV-2 infection. This is assessed through looking at correlation of the near-patient lateral flow assays and the instrumented multi-analyte immunoassaygold standard.

Measure: Evaluate field-based performance of POC

Time: 14 days
282 Bicentric, Phase 2, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc Associated With Standard Treatment in Hospitalized Patients With Pulmonary SARS-CoV-2 Infection (COVID-19).

This is a bicentric, phase 2, randomized, open-label study to evaluate the efficacy and safety of maraviroc associated with standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (COVID-19).

NCT04441385
Conditions
  1. COVID-19
Interventions
  1. Drug: Maraviroc 300 mg
  2. Other: Standard care therapy
MeSH:Infection

Primary Outcomes

Description: A patient with a saturation of 90% or less despite the use of a reservoir mask without rebreathing with a flow of 7 liters per minute (FiO2 0.6 or higher), will be considered to have severe ARDS. These oximetric criteria have a close correlation with a PaO2 / FiO2 of 100 or less, which defines severe ARDS.

Measure: Proportion of patients developing severe ARDS.

Time: 28 days

Secondary Outcomes

Measure: All-cause mortality.

Time: 28 days

Measure: Percentage of patients requiring tracheal intubation, use of Non-invasive Ventilation NIV or High Flow Nasal Cannula (HFNC) devices during the study period

Time: 28 days

Measure: Percentage of patients who progress to severe ARDS, death or ICU admission.

Time: 28 days

Description: Defined as the time (in hours) from the start of the treatment under study to the normalization of temperature, normalization of respiratory rate and SpO2. Axillary temperature < 37.5ºC (oral < 37.2ºC) for 48 hours, without antipyretic treatment. Breathing rate < 24 rpm during the clinical evaluation and at least two consecutive daily evaluations (48 hours). SpO2 > 93% breathing ambient air during clinical assessment and at least two consecutive daily assessments (48 hours).

Measure: Differences in Time to Clinical Improvement

Time: 28 days

Description: The ordinal scale of 7 categories of patient health status ranges from: Death. Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Hospitalized, with non-invasive ventilation or high flow oxygen devices. Hospitalized, requiring supplemental oxygen. Hospitalized, not requiring supplemental oxygen. Non-hospitalized, activity limitation. Non-hospitalized, no activity limitation.

Measure: Change in clinical status of subject on a 7-point ordinal scale.

Time: 28 days

Measure: Percentage of patients requiring immunosuppressive/immunomodulatory treatment as a rescue medication.

Time: 28 days

Description: Classification according to the WHO toxicity scale

Measure: Proportion of patients developing adverse effects, serious adverse reactions, laboratory or physical examination findings, EKG abnormalities acquired during the trial, death and adverse events leading to early discontinuation of treatment.

Time: 28 days
283 COV-IMMUNO: A Randomized, Phase III Trial of Immunization With IMM-101 Versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure

The purpose of this study is to find out if immunization with IMM-101 will reduce the incidence of severe respiratory and COVID-19 infections in cancer patients.

NCT04442048
Conditions
  1. Cancer
  2. Covid-19
Interventions
  1. Biological: IMM-101
  2. Other: Observation
MeSH:Infection

Primary Outcomes

Description: WHO definition of "influenza-like illness" (ILI) [Fitzner 2018] or confirmed viral/bacterial respiratory infection AND Results in a change or delay in cancer treatment or requirement for and unscheduled medical assesment, hospitalization or death.

Measure: The rate of "flu-like illness" which includes:

Time: 1 year

Secondary Outcomes

Measure: The incidence of documented COVID-19 infection (confirmed by any Health Canada approved COVID-19 test. Both symptomatic and asymptomatic infections will be documented

Time: 1 year

Measure: The rate of severe respiratory and COVID-19 infection defined as a confirmed COVID-19 infection leading to hospitalization, ICU admission or death

Time: 1 year

Measure: The number of events that meet the definition of the primary endpoint, as measured within the one-year follow-up (patients may meet the primary endpoint more than once and be counted multiple times).

Time: 1 year

Measure: The incidence of COVID-19 seroconverted patients between baseline, 3 months, 6 months and 12 months

Time: 3, 6, and 12 months

Measure: The incremental cost-effectiveness ratio (in the unit of CAD$ per life-years gained) measured with EQ-5D-5L

Time: 1 year

Measure: Failure-free survival, as time from enrollment to recurrence or progression declared by the investigator on the basis of objective standard evaluation consistent with the disease site or death

Time: 1 year

Measure: Overall survival (OS), as time from enrollment to death from any cause

Time: 1 year

Measure: Incidence, frequency, and severity of AEs considered possibly, probably or definitely related to receipt of IMM-101

Time: 1 year

Measure: Incidence and frequency of local injection site reactions subsequent to IMM-101 administration

Time: 1 year

Measure: Incidence and duration of ICU admission related to documented COVID-19 infection

Time: 1 year
284 Phase 2, Double-blind, Randomized, Placebo-controlled Study of NasoVAX in the Prevention of Clinical Worsening in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)

The purpose of this study is to evaluate the safety and effectiveness of NasoVAX in preventing worsening of symptoms and hospitalization in patients with early COVID-19.

NCT04442230
Conditions
  1. Coronavirus Infection
Interventions
  1. Biological: NasoVAX
  2. Other: Placebo
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Decrease from baseline in mean resting SpO2

Measure: Proportion of patients with clinical worsening

Time: Day 1 to Day 14

Secondary Outcomes

Description: Proportion of patients requiring hospitalization

Measure: Maximal severity of COVID-19 after treatment

Time: Day 1 to Day 42

Measure: All-cause mortality

Time: Day 1 to Day 42
285 Characterizing the Perioperative Epidemiology of SARS-CoV-2 (COVID-19) Spread for Quality Improvement of Perioperative Infection Control Program

In a case-series analysis, 9 patients undergoing elective or urgent/emergent surgery that are COVID-19 positive will be approached for patient consent. OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) collection kits will be utilized for sampling of 48 sampled time/locations per patient. Patient sampling locations will include the nasopharynx and oropharynx. Operating room environmental locations will include areas in the patient care arena such as the anesthesia machine. Samples of each location will be obtained before and after treatment with UV-C (Helios, Surfacide), germicidal, ultraviolet light and other infection control practices that are currently in place, such as utilization of preoperative chlorhexidine wipes, nasal iodine, improved hand hygiene, and improved vascular care. UV-C light for environmental cleaning is not regulated by the FDA. Samples will be processed by RT-PCR for presence of SARS-CoV-2 nucleic acid. Positive samples will be sent to Dr. Stanley Perlman's lab to assess viability. Samples will also be assessed for S. aureus as a process control. We will characterize the epidemiology of perioperative SARS-CoV-2 spread as a quality improvement initiative to improve our current perioperative infection control bundle and to serve as the platform for national dissemination of a perioperative COVID-19 defense strategy.

NCT04443803
Conditions
  1. COVID-19
MeSH:Infection

Primary Outcomes

Description: Sars-CoV-2 transmission event

Measure: Perioperative transmission of SARS-CoV-2

Time: 24 hours
286 Multi-Center, Double-Blinded, Placebo-Controlled, Phase II Clinical Efficacy Study Evaluating NORS To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Mild COVID-19

This is a multi-center, double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating NORS for the treatment of COVID-19 in individuals with Suspected mild COVID-19 Infection.

NCT04443868
Conditions
  1. SARS-CoV Infection
Interventions
  1. Drug: Nitric Oxide-Releasing Drug
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms in NORS vs placebo group

Measure: To Measure the efficacy of NORS compared to saline placebo in the hospitalization of participants with mild COVID-19 infection

Time: 28 Days

Secondary Outcomes

Description: Measure the change in mean Modified Jackson Cold Score Diary Score

Measure: To Measure reduction of clinical symptoms as compared to saline placebo in participants with mild COVID-19 infection

Time: 7, 14, 21 and 28 days

Description: Number of participants lost-to-follow-up,discontinuing study treatment or number of treatments due to intolerance

Measure: To measure the tolerance of NORS compared to saline placebo in participants with mild COVID-19 infection

Time: 14 days

Description: Severity and frequency of adverse events, pain, discomfort or discontinuations of treatment.

Measure: To measure the tolerance of NORS compared to saline placebo in participants with mild COVID-19 infection

Time: 14 days
287 An Observational Study to Assess the Effectiveness of the Standard of Care (Hydroxychloroquine+Azythromicin or Chloroquine+Azythromicin) Recommended by the Ministry of Health for the Treatment of the Coronavirus Infection in Burkina Faso

This is an observational study to evaluate the effectiveness of the combinations Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the treatment of Coronavirus (Covid-19) infection in Burkina Faso.

NCT04445441
Conditions
  1. Coronavirus Infection
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The impact of the treatment on virological clearance (viral load) post-treatment

Measure: Clearance of viral load

Time: 14 days

Secondary Outcomes

Description: This outcome will include the occurrence of adverse events including significant changes in the relevant biological parameters

Measure: Safety of the treatment

Time: 14 days
288 Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.

NCT04445454
Conditions
  1. Coronavirus Infection
Interventions
  1. Biological: Mesenchymal stromal cells
MeSH:Infection Communicable Diseases Coronavirus I Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To assess the infusional toxicity

Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: To assess the number of Adverse events of special interest : Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events.

Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: Group A (patients not under mechanical ventilation): to determine the pourcentage of patients requiring mechanical ventilation

Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: Group B (patients under mechanical ventilation): to determine the vital status (dead/alive)

Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Secondary Outcomes

Description: To assess the clinical status (on a 7-point WHO ordinal scale)

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the duration of oxygen therapy and/or mechanical ventilation

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the length of stay at the intensive care unit and of hospitalization

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the number of organ failures

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the intensity of the inflammatory response

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the evolution of coagulation parameter

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the presence of Biomarker of lung lesion, repair and scarring

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the v iral load over the 28 days after inclusion and seroconversion to COVID-19 over the 90 days after inclusion

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the pulmonary function

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the number of adverse reactions (ARs), ARs grade > 3, serious adverse events (SAEs), serious ARs (SARs), suspected expected and unexpected SARs (SESARs and SUSARs).

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Other Outcomes

Description: To determine the FACS analysis of regulatory T-cell (Treg) levels and Treg and Tconv sub-populations

Measure: To investigate immune modulation

Time: Day 28

Description: To assess the cytotoxic activity by MLR

Measure: To compare the cytotoxic activity of PBMCs from healthy control and COVID-19 patients (divided in responders / non-responders to MSC therapy) against MSCs in vitro

Time: Day 28
289 An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection

This is a randomised placebo controlled phase II trial to examine the efficacy of antivirals to treat COVID-19 infection compared to placebo for virological cure and improved clinical outcomes. Individuals will be randomised to the candidate antiviral which in the first instance is Favipiravir or matched placebo and randomisation will be stratified according to whether the participant requires hospitalisation or not. This treatment will be given in addition to the usual standard of care in the participating hospital.

NCT04445467
Conditions
  1. COVID
Interventions
  1. Drug: Favipiravir
MeSH:Infection

Primary Outcomes

Description: Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing

Measure: Time to virological cure

Time: 14 days

Secondary Outcomes

Description: All adverse events definitely, probably or possibly related to study treatment.

Measure: Safety

Time: 28 days

Description: Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale

Measure: Clinical improvement

Time: 28 days

Description: Time from randomization to resolution of clinical symptoms (fever, cough, shortness of breath, cough). Resolution defined as the start of the first 24 hour period when all symptoms are rated as mild or absent and remained this way for 24 hours

Measure: Clinical symptoms

Time: 28 days

Description: Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.

Measure: Biomarkers

Time: 28 days
290 Randomized, Doubled-blind Phase II Trial Evaluating the Use of Ivermectin Plus Losartan for Prophylaxis of Severe Events in Cancer Patients With Recent Diagnosis of COVID-19

Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19

NCT04447235
Conditions
  1. Cancer
  2. COVID
  3. Coronavirus Infection
Interventions
  1. Drug: Placebo
  2. Drug: Ivermectin
  3. Drug: Losartan
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death

Measure: Incidence of severe complications due COVID-19 infection

Time: 28 days

Secondary Outcomes

Description: Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%

Measure: Incidence of Severe Acute Respiratory Syndrome

Time: 28 days

Description: Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute

Measure: Incidence of Severe Acute Respiratory Syndrome

Time: 28 days

Description: Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)

Measure: Adverse events

Time: 28 days

Description: Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)

Measure: Adverse events

Time: 28 days

Description: Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)

Measure: Adverse events

Time: 28 days

Description: Incidence of symptomatic postural hypotension, diagnosed by clinical assessment of reduction of > 20 mmHG of arterial systolic pressure after measurement in prone position and orthostatic position.

Measure: Adverse events

Time: 28 days

Description: Death of any cause since protocol enrollment

Measure: Overall survival

Time: 28 days
291 Role of Circulating Microparticles in Covid-19 Infection

Among the distinctive features of Covid-19, numerous reports have stressed the importance of vascular damages associated with coagulopathy onset. Microparticles (MPs) shed by apoptotic/stimulated cells are reliable markers of vascular damage released upon pro-inflammatory conditions and behave as active participants in the early steps of clot formation. In addition, MPs carry ACE1 and ACE2, the cell-entry receptor for SARS-Cov2 in the vasculature and up-regulate ACE1 expression in neighbouring endothelial cells. This may contribute to unopposed angiotensin II accumulation which further exacerbate tissue injury and promote both inflammation and thrombosis. The aim of the study is to evaluate the impact of circulating MPs on ACE2 expression, the cell-entry receptor for SARS-Cov2 on endothelial cells.

NCT04448743
Conditions
  1. COVID-19
Interventions
  1. Other: Blood sample
MeSH:Infection

Primary Outcomes

Measure: Western blot measurement of ACE2 receptor expression in porcine cells

Time: Through study completion, an average of 1 year
292 Knowledge, Attitude and Practice About COVID-19 and Awareness of Infection Control to Prevent COVID-19 Transmission in Clinics and Perception About Online Learning During Lock Down Period: A Cross-sectional Study

Coronavirus disease 2019 (abbreviated "COVID- 19") is a pandemic respiratory disease that is caused by a novel coronavirus and was first detected in December 2019 in Wuhan, China. The disease is highly infectious, and its main clinical symptoms include fever, dry cough, fatigue, myalgia, and dyspnoea.1 In China, 18.5% of the patients with COVID-19 developed to the severe stage, which is characterized by acute respiratory distress syndrome, septic shock, difficult-to-tackle metabolic acidosis, and bleeding and coagulation dysfunction. After China, COVID-19 spread across the world and many governments implemented unprecedented measures like suspension of public transportation, the closing of public spaces, close management of communities, and isolation and care for infected people and suspected cases. The Malaysian government had enforced Movement Control Order (MCO) from 18th March to 4th May 2020 and henceforth Conditional Movement Control Order (CMCO) until 9th June 2020. The battle against COVID-19 is still continuing in Malaysia and all over the world. Due to the CMO and CMCO in the country, public and private universities have activated the e-learning mode for classes and as the government ordered, universities are closed and no face-to-face activities allowed. This has forced students of all disciplines including dentistry to stay at home which are wide-spread across Malaysia and shift to e- learning mode. To guarantee the final success for fight against COVID-19, regardless of their education status, students' adherence to these control measures are essential, which is largely affected by their knowledge, attitudes, and practices (KAP) towards COVID-19 in accordance with KAP theory. Once the restrictions are eased students have to come back and resume their clinical work in the campus. Hence, in this study we assessed the Knowledge, Attitude, and Practice (KAP) towards COVID-19 and the students preference for online learning.

NCT04449081
Conditions
  1. Acute Respiratory Distress Syndrome
  2. Corona Virus Infection
  3. Acute Lung Injury
  4. Fever
  5. Myalgia
  6. Cough
  7. Dyspnea
  8. Septic Shock
  9. Bleeding
Interventions
  1. Behavioral: Knowledge, Attitude, Practice, Awareness, Preference
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Myalgia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lun Acute Lung Injury Dyspnea Lung Injury
HPO:Dyspnea Myalgia Respiratory distress

Primary Outcomes

Description: KAP towards COVID-19 was assessed using validated questionnnaire

Measure: Knowledge, Attitude, Practice of dental students towards COVID-19

Time: 4 months

Secondary Outcomes

Description: Awareness level about Infection control to prevent COVID-19 transmission in clinics was assesed using a standardized questionnaire

Measure: Awareness level about Infection control to prevent COVID-19 transmission in clinics

Time: 4 months

Description: Preference towards online learning. was assessed using a standard questionnaire

Measure: Preference towards online learning.

Time: 4 months
293 Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection: a Retrospective-prospective Cohort Study

The study cohort will be enrolled among all Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts. Participants will be asked consent for the research use of blood, pharyngeal swab, and for those hospitalized for COVID-19, also for the bronchoalveolar lavage and fecal samples. Biological samples will be used to perform cellular, microbial and molecular analyses aimed at better understanding the disease pathogenesis and the individual differences in susceptibility to the disease.

NCT04451577
Conditions
  1. COVID
Interventions
  1. Other: No intervention
MeSH:Infection

Primary Outcomes

Description: COVID-19 infection will be assessed by serological analysis of the presence of IgG anti-Covid-19 antibodies, an a subsequent pharyngeal swab. Symphtoms and possible hospitalization will be considered in clinical response.

Measure: Clinical response to COVID-19

Time: 36 months

Description: PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome (symptoms aggressiveness).

Measure: Immunological response to COVID-19

Time: 36 months

Description: Genetic variants analysis potentially related with COVID-19 susceptibility/severity in different subgroups of patients, ranging from individuals positive for the virus but asymptomatic to individuals affected by COVID-19 with ARDS requiring admission to ICU

Measure: Genetic predisposition to COVID-19

Time: 36 months

Description: Microbiota analysis (using 16S rDNA sequencing technology) of residual BAL, pharyngeal swab, plasma and saliva/sputum to evaluate whether different microbial or metabolome profiles are associated to worsen disease or to protection

Measure: Microbiome-related response to COVID-19

Time: 36 months
294 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2

Primary Objective: - To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (strict-term) confirmed by RT-qPCR - To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing asymptomatic or symptomatic SARS-CoV-2 infection confirmed by RT-qPCR - To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo

NCT04452318
Conditions
  1. Healthy Participants
Interventions
  1. Drug: REGN10933 + REGN10987
  2. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

Measure: Proportion of participants who have a positive SARS-CoV-2 RT-qPCR (based on central lab test) and signs and symptoms (strict-term) of SARS-CoV-2 infection during the Efficacy assessment period (EAP)

Time: Up to 1 month

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

Measure: Proportion of participants who have a RT-qPCR confirmed SARS-CoV-2 infection (either symptomatic or asymptomatic) during the EAP

Time: Up to 1 month

Description: Primary: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Secondary: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Incidence and severity of treatment-emergent adverse events (TEAEs)

Time: Up to 8 months

Secondary Outcomes

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

Measure: Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad term) during the EAP

Time: Up to 1 month

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

Measure: Proportion of participants who have a positive SARS-CoV-2 RT-qPCR and absence of signs and symptoms (strict term) during the EAP

Time: Up to 1 month

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

Measure: Proportion of participants who have a positive SARS-CoV-2 RT-qPCR and absence of signs and symptoms (broad term) during the EAP

Time: Up to 1 month

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

Measure: Number of days of symptomatic SARS-CoV-2 infection (strict-term) from the first day of the first sign or symptom until the last day of the last sign or symptom associated with the first positive SARS-CoV-2 RT-PCR that occurs during the EAP

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

Measure: Number of days of symptomatic SARS-CoV-2 infection (broad-term) from the first day of the first sign or symptom until the last day of the last sign or symptom associated with the first positive SARS-CoV-2 RT-PCR that occurs during the EAP

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

Measure: Time-weighted average of viral shedding (log10 copies/mL) from the first positive SARS CoV-2 RT-qPCR Nasopharyngeal (NP) swab sample (with an onset during the EAP) until the visit within the window including 22 days after the positive test during the EAP

Time: Up to 1 month

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

Measure: Maximum SARS-CoV-2 RT-qPCR log10 viral copies/mL in Nasopharyngeal (NP) swab samples among individuals with ≥1 RT-qPCR positive that has an onset during the EAP

Time: Up to 1 month

Description: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Maximum SARS-CoV-2 RT-qPCR log10 viral copies/mL in NP swab samples

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Area under the curve (AUC) in viral shedding (log10 copies/mL) from the first positive SARS-CoV-2 RT-qPCR NP swab sample until the first confirmed negative test, that has an onset during the EAP

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Number of medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection that has an onset during the EAP

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Number of days of hospital and intensive care unit (ICU) stay in subjects hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP

Time: Up to 8 months

Description: Daily responsibilities including work (employed adults) or school (matriculating students), or family obligations/responsibilities (childcare or eldercare) Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Number of days missed for daily responsibilities due to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP

Time: Up to 8 months

Description: Pharmacokinetic (PK) parameters may include, but are not limited to: - Maximum observed plasma concentration (Cmax) - Cmax/Dose - Time of maximum observed plasma concentration (tmax) - Time of Clast (tlast) - Last measurable plasma concentration (Clast) - Area under plasma concentration-time curve from time 0 to infinity (AUCinf) - AUCinf/Dose - Elimination half-life (t1/2) - Concentration in serum 28 days (C28) after dosing) Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Concentrations of REGN10933 in serum over time and selected PK parameters

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Concentrations of REGN10987 in serum over time and selected PK parameters

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 over time

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 over time

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

Measure: Incidence and severity of TEAEs in baseline seropositive participants (based on central lab test)

Time: Up to 8 months

Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Incidence and severity of symptomatic SARS-CoV-2 infection

Time: Up to 8 months

Description: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Proportion of participants who subsequently develop signs and symptoms (strict-term) of symptomatic SARS-CoV-2 infection during EAP

Time: Within 14 and 28 days of a positive RT-qPCR

Description: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Proportion of participants who subsequently develop signs and symptoms (broad-term) of symptomatic SARS-CoV-2 infection during EAP

Time: Within 14 and 28 days of a positive RT-qPCR

Description: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Number of days of symptomatic SARS CoV-2 infection (strict-term)

Time: Up to 8 months

Description: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Number of days of symptomatic SARS CoV-2 infection (broad-term)

Time: Up to 8 months

Description: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Measure: Time-weighted average change from baseline in viral shedding in NP swab samples until the visit within the window including day 23

Time: Until day 23
295 Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments

This survey is performed to examine if during the Covid's crisis, the practitionner's have respected the modalities of the law about the end of life, in particular concerning limitations and stop of therapeutics

NCT04452487
Conditions
  1. Patient Hospitalized in Disease Infecti
  2. Patient Hospitalized in Disease Infectious Unit
  3. Patient Hospitalized in Intensive Reanimation Unit
  4. Patient Hopsitalized in Internal Medicine Unit
Interventions
  1. Behavioral: decisions of limitations and stop processing
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: The conformity of the modalities of the decisions of limitations and therapeutic stops will be evaluated by a composite criterion defined by the simultaneous presence of the 3 main modalities imposed by the Clayes-Leonetti law to achieve a limitation that are : An outside consultant's opinion ( required if no advance directives), the caregiver collegial discussion or adherence to patient advance directives, notification of decision in the medical record

Measure: decisions of limitations and therapeutic stops

Time: at the end of patient's hospitalization, an average of one month

Secondary Outcomes

Description: notification of the decision, the conclusions of the discussions, the opinion of the consultant and the arguments given to justify the LAT

Measure: Characteristics of the notification of LAT procedure

Time: at the end of patient's hospitalization, an average of one month

Description: number and status of caregivers who participated to the collegial discussion

Measure: Characteristics of the LAT procedure (persons who participated to the collegial discussion)

Time: at the end of patient's hospitalization, an average of one month

Description: formal elements of the consultant's reasoned opinion ( legal term) in the file

Measure: Characteristics of consultant's reasoned opinion for the LAT procedure

Time: at the end of patient's hospitalization, an average of one month

Description: formal elements of advance directives

Measure: Characteristics of the LAT procedure

Time: at the end of patient's hospitalization, an average of one month

Description: number of beds, number of caregivers (medical, paramedical, internal external), number of admissions during periods of study

Measure: Characteristics of units

Time: day 0

Description: measured in year

Measure: Age of physicians

Time: Day 0

Description: male or female

Measure: gendrer of physicians

Time: Day 0

Description: Measured in year of experience

Measure: Exparience of physicians

Time: Day 0

Description: professional status

Measure: Characteristics of physicians

Time: Day 0

Description: measured in year

Measure: Age of patients

Time: day 0

Description: comorbidities

Measure: patient's history

Time: day 0

Description: COVID19 infection (yes or no)

Measure: COVID-19 patient's status

Time: day 0

Description: hospitalization reason

Measure: Characteristics of hospitalization's patients

Time: day 0

Description: organ failure

Measure: Characteristics of affected organ

Time: day 0

Description: severity score

Measure: Characteristics of patients

Time: day 0

Description: fate

Measure: final patient status

Time: day 0

Description: family presence or relatives

Measure: patient's environnement

Time: day 0
296 Randomized Controlled Phase 2/3 Clinical Trial of NA-831 Alone or With Atazanavir, or NA-831 With Dexamethasone, or Atazanavir With Dexamethasone in the Treatment of COVID-19 Infection

This Phase 2/3 trial evaluates four treatment strategies for non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, in which participants will receive NA-831 or Atazanavir with or without Dexamethasone.

NCT04452565
Conditions
  1. Coronavirus Infection
  2. Severe Acute Respiratory Infection
  3. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Drug: Drug: NA-831
  2. Combination Product: NA-831 and Atazanavir
  3. Combination Product: NA-831and Dexamethasone
  4. Combination Product: Atazanavir and Dexamethasone
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome
HPO:Respiratory tract infection

Primary Outcomes

Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death

Measure: 1. Time (Hours) to recovery

Time: [ Time Frame: 36 days ]

Secondary Outcomes

Description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications

Measure: Time fever resolution

Time: [ Time Frame: 36 days ]
297 Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel

The purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets, as is the case with healthcare personnel.

NCT04452643
Conditions
  1. Covid19
Interventions
  1. Biological: BACMUNE (MV130)
  2. Other: Placebo
MeSH:Infection

Primary Outcomes

Description: Incidence of subjects with COVID-19, defined by the presence of: Fever Any of the respiratory signs and/or symptoms: cough, dyspnea, respiratory failure, runny nose/nasal obstruction. Positive test for SARS-COV-2 (PCR o serology)

Measure: Incidence of subjects with COVID-19

Time: 60 days

Description: Incidence of severe COVID-19, defined by CURB > 2 and/or death

Measure: Severity of COVID-19

Time: 60 days

Secondary Outcomes

Description: Rate of subjects with seroconversion to SARS-CoV-2 (negative serology at the beginning of the study and positive at the end of the study

Measure: Seroconversion to SARS-CoV-2

Time: 60 days

Description: Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition

Measure: Subjects with symptoms

Time: 60 days

Description: The effect of the treatment on the severity of the disease will be measured based on the rate of subjects requiring hospital admission for COVID-19

Measure: Hospital admission due to COVID-19

Time: 60 days

Description: The effect of the treatment on the severity of the disease will be measured based on the rate of subjects who require admission to an intensive care unit for COVID-19 • Time from confirmation of SARS-CoV-2 infection to the appearance of symptoms.

Measure: Admission to an intensive care unit due to COVID-19

Time: 60 days

Description: Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.

Measure: Elapsed time until hospitalization

Time: 60 days

Description: Elapsed time until the first symptoms of COVID-19 appears to admission into an intensive care unit pro COVID-19.

Measure: Elapsed time until admission into an care unit for COVID-19

Time: 60 days

Description: Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19.

Measure: Elapsed time until death not related to COVID-19

Time: 60 days
298 Acceptability of Telehealth Triage Using Robotic Systems in COVID-19

The overall objective of this investigation is to understand the patient response to a robotic platform used to facilitate telehealth triage in the emergency department during the COVID-19 pandemic. The COVID-19 pandemic has altered the manner in which emergency department triage is completed. Attempts at cohorting individuals with potential COVID-19 disease in order to prevent disease transmission to healthcare workers and minimize the use of personal protective equipment (PPE) have renewed interest in telemedical solutions as a method to triage and manage individuals with COVID-19. This investigation deploys a legged robotic platform to facilitate agile, highly mobile telemedicine to manage COVID-19 patients in the emergency department. The primary objective is to measure the patient response to interacting with these systems.

NCT04452695
Conditions
  1. COVID-19
  2. Telemedicine
  3. Robotics
  4. Emergencies
  5. Emerging Infectious Disease
Interventions
  1. Device: Doctor Spot
MeSH:Communicable Diseases Infection Communicable Diseases, Emerging Emergencies

Primary Outcomes

Description: Quantitative questionnaire on the acceptance of virtual robotic care graded on a likert scale (higher scores better)

Measure: Acceptance of robotic telehealth system

Time: Immediately after completion of triage

Description: Quantitative questionnaire on the willingness to use this system again based on a likert scale (higher scores better)

Measure: Willingness to interact with robotic telehealth system

Time: Immediately after completion of triage

Description: Quantitative questionnaire on the user satisfaction with their triage experience (How satisfied were you with your experience interacting with the robotic system today?)

Measure: Satisfaction of interacting with a robotic telehealth system

Time: Immediately after completion of triage

Secondary Outcomes

Description: Quantitative questionnaire comparing robotic triage process with in-person triage: Do you think your interaction with the robotic system was better, the same or no different than an in-person evaluation?)

Measure: Use of robotic system versus in-person triage

Time: Immediately after completion of triage
299 Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of the Manremyc® Food Supplement to Prevent SARS-CoV-2 Infection

The purpose of this study is to assess the efficacy of Manremyc® food supplement for reduce the incidence of SARS-CoV-2 infection in a high risk population, as healthcare workers.

NCT04452773
Conditions
  1. COVID19
Interventions
  1. Dietary Supplement: Manremyc
  2. Dietary Supplement: Placebo
MeSH:Infection

Primary Outcomes

Description: % of positive serology at the end of the study or positive PCR test in the course of routine clinical practice

Measure: Documented cumulative incidence of SARS-CoV-2 infection

Time: up to 4 months

Secondary Outcomes

Description: Number of days Documented as sick leave for SARS-CoV-2

Measure: Documented sick leave for SARS-CoV-2

Time: up to 4 months (cumulative)

Description: Number of days off work due to the quarantine imposed as a consequence to have acute respiratory symptoms, fever or infection documented by SARS-CoV-2

Measure: days off work due to the quarantine

Time: up to 4 months

Description: Number of days in quarantine imposed by close contact outside the center with SARS-CoV-2 positive

Measure: Quarantine imposed by close contact outside the center with SARS-CoV-2 positive

Time: up to 4 months

Description: Number of days of self-reported fever (≥38 ºC)

Measure: Fever

Time: Up to 4 months

Description: Cumulative incidence of self-reported acute respiratory symptoms

Measure: Cumulative incidence of self-reported acute respiratory symptoms

Time: up to 4 months

Description: Number of days of self-reported acute respiratory symptoms

Measure: Number of days of self-reported acute respiratory symptoms

Time: up to 4 months

Description: Number of participants with pneumonia confirmed by X-ray

Measure: Incidence of pneumonia

Time: up to 4 months

Description: Cumulative incidence of death from documented SARS-CoV-2 infection

Measure: Cumulative incidence of death from documented SARS-CoV-2 infection

Time: Up to 4 months

Description: Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection

Measure: Incidence of admission to ICU

Time: Up to 4 months

Description: Number of days admitted to the ICU for documented SARS-CoV-2 infection

Measure: Days in IUC

Time: Up to 4 months

Description: Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection

Measure: Incidence of mechanical ventilation

Time: Up to 4 months

Description: Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection

Measure: Incidence of hospital admissions

Time: Up to 4 months

Description: Number of days of hospitalization for documented SARS-CoV-2 infection

Measure: Days of hospitalization

Time: Up to 4 months

Description: Levels of IgG

Measure: Levels of IgG

Time: Up to 4 months

Description: Levels of IgM

Measure: Levels of IgM

Time: Up to 4 months

Description: Levels of SARS-CoV-2 antibodies at the end of the study period

Measure: Levels of SARS-CoV-2 antibodies at the end of the study period

Time: Up to 4 months

Other Outcomes

Description: All adverse events reported by the subjects, both serious and non-serious, will be collected. All events related to a SARS-CoV-2 infection will be exempted from collection, as they will be collected as part of the associated symptoms

Measure: AEs

Time: Up to 4 months

Description: All thoseAdverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.

Measure: SAEs

Time: Up to 4 moths
300 Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of the RUTI® Vaccine to Prevent SARS-CoV-2 Infection

The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.

NCT04453488
Conditions
  1. Covid-19
  2. Sars-CoV2
Interventions
  1. Biological: RUTI® vaccine
  2. Biological: Placebo
MeSH:Infection

Primary Outcomes

Description: % positive serology at the end of the study or positive PCR test in the course of routine clinical practice

Measure: Documented cumulative incidence of SARS-CoV-2 infection

Time: Up to 4 months

Secondary Outcomes

Description: Number of days of documented sick leave for SARS-CoV-2

Measure: Sick leave for SARS-CoV-2

Time: Up to 4 months

Description: The number of days off work due to the quarantine imposed as a consequence to have acute respiratory symptoms, fever or infection documented by SARS-CoV-2

Measure: Days off work due to the quarantine

Time: Up to 4 months

Description: Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive

Measure: Quarantine imposed by close contact outside the center with SARS-CoV-2 positive

Time: Up to 4 months

Description: Number of MD, nursing, personnel management and services, etc.

Measure: Professional category

Time: Up to 4 months

Description: Number of days of self-reported fever (≥38 ºC)

Measure: Fever

Time: Up to 4 months

Description: Cumulative incidence of self-reported acute respiratory symptoms

Measure: Incidence of self-reported acute respiratory symptoms

Time: Up to 4 months

Description: Number of days of self-reported acute respiratory symptoms

Measure: Days of self-reported acute respiratory symptoms

Time: Up to 4 months

Description: Number of participants with pneumonia confirmed by X-ray

Measure: Incidence of pneumonia

Time: Up to 4 months

Description: Cumulative incidence of death from documented SARS-CoV-2 infection

Measure: Incidence of death from SARS-CoV-2 infection

Time: Up to 4 months

Description: Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection

Measure: Incidence of admissions to Intensive Care Unit (ICU)

Time: Up to 4 months

Description: Number of days admitted to the ICU for documented SARS-CoV-2 infection

Measure: Days in ICU

Time: Up to 4 months

Description: Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection

Measure: Incidence of mechanical ventilation

Time: Up to 4 months

Description: Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection

Measure: Incidence of hospital admissions

Time: Up to 4 months

Description: Number of days of hospitalization for documented SARS-CoV-2 infection

Measure: Days of hospitalization

Time: Up to 4 months

Description: Incidence of SARS-CoV-2 antibodies at the end of the study period

Measure: Incidence of SARS-CoV-2 antibodies

Time: Final visit

Description: Frequency and levels of immunoglobulin IgG and immunoglobulin IgM

Measure: Types of antibodies detected

Time: Final visit

Description: Levels of SARS-CoV-2 antibodies at the end of the study period

Measure: Levels of SARS-CoV-2 antibodies

Time: Final visit

Other Outcomes

Description: All adverse events reported by the subjects, both serious and non-serious, will be collected. All events related to a SARS-CoV-2 infection will be exempted from collection as part of the associated symptoms.

Measure: AEs

Time: Up to 4 months

Description: All those Adverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.

Measure: SAEs

Time: Up to 4 months
301 Impact of the Syndromic PCR System FilmArray on Management of ICU Patients With Severe Pulmonary Disease in the Context of the Covid-19 Pandemic.

The research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalized in ICU for severe respiratory disease. During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria of covid-19 interfere with the standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with COVID-19 are at higher risk of developing other associated infections and thus, patients have therefore often been treated with antibiotics, adequately or not, due to difficulty to quickly identify the etiology of their symptoms with conventional methods. In order to improve their treatment, both diagnostic and therapeutic, we set up a new syndromic molecular test in our laboratories to accelerate and improve the pneumonia management and antibiotic stewardship. This research will include 100 to 150 adult patients hospitalized in ICU during the first half of 2020. It will take place within the Nancy University Hospital and the Reims University Hospital, France.

NCT04453540
Conditions
  1. Infectious Disease
  2. Pneumonia
  3. Molecular Diagnosis
  4. Covid-19
  5. Antibiotic Stewardship
Interventions
  1. Diagnostic Test: FilmArray PCR on respiratory samples
MeSH:Communicable Diseases Infection Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Antibiotic prescription modification following the FilmArray results as: No prescription No change in antibiotic utilization Antibiotic initiation Antibiotic escalation Antibiotic de-escalation Antibiotic discontinuation

Measure: Therapeutic decision

Time: 24 h following the FilmArray results
302 COVID-19 in Pain Perspective

In our hospital's Infectious Diseases and Clinical Microbiology service, patients who have been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during this process, and 466 patients will be recruited to compare them with the pre-disease state of the patients and to evaluate the pain status of the patients after treatment.

NCT04454333
Conditions
  1. Infection
  2. COVID
  3. Pain
MeSH:Infection

Primary Outcomes

Description: Evaluation of severity of pain for head, back-neck and extremities by Numeric Rating Scale. Scoring will be done between 0 minimum and 10 maximum values. Higher scores mean worse outcome.

Measure: Numeric Rating Scale for Pain

Time: up to 10 weeks

Description: Evaluation of patient's anxiety and depression level in hospital by Hospital Anxiety and Depression Scale (HADS). The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report screening scale. It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. Higher scores mean a worse outcome.

Measure: Hospital Anxiety and Depression Scale (HADS)

Time: up to 10 weeks

Description: Evaluation of patient's quality of life by SF-12 Health assesment Questionaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). Higher scores mean a better outcome.

Measure: SF-12 Health assesment Questionaire

Time: up to 10 weeks
303 Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19

Approximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical course. This leads to hospitalization and potentially life threatening complications such as pneumonia and respiratory failure. Predictors for early detection and risk stratification are urgently needed. Moreover, only scarce information is available for long-term follow-up and late complications associated with infection. We therefore aimed to find predictors for severe courses of the novel disease as well as to establish strategies for therapeutic monitoring and follow-up.

NCT04456075
Conditions
  1. SARS-CoV2
  2. COVID
MeSH:Infection

Primary Outcomes

Description: Transfer factor for carbon monoxide

Measure: TLCO

Time: 3-5 days intervals (inpatients)

Description: Transfer factor for carbon monoxide

Measure: TLCO

Time: 1-6 months (outpatients, follow up)

Description: frequency dependence of resistance as measured by oscillometry

Measure: D5-20

Time: 3-5 days intervals (inpatients

Description: frequency dependence of resistance as measured by oscillometry

Measure: D5-20

Time: 1-6 months (outpatients, follow up)

Description: forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)

Measure: FEV1/FVC

Time: 3-5 days intervals (inpatients)

Description: forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)

Measure: FEV1/FVC

Time: 1-6 months (outpatients, follow up)

Secondary Outcomes

Description: structured questionnaire

Measure: comorbidities

Time: at hospital admission and each follow (every 1-6 months)

Description: structured qualitative questionnaire

Measure: clinical symptoms

Time: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)

Description: validated questionnaire (scores range from 0 to 100, with higher scores indicating more limitations)

Measure: St. George's Respiratory Questionnaire total score

Time: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
304 Phase II Randomized Study of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects With Early COVID-19 Infection

- This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. - Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. - Subjects will be randomized to receiving convalescent plasma or best supportive care. - Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. - The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

NCT04456413
Conditions
  1. COVID-19
Interventions
  1. Biological: Convalescent Plasma
  2. Other: Best Supportive Care
MeSH:Infection

Primary Outcomes

Description: The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.

Measure: Hospitalization Rate

Time: 10 Days

Secondary Outcomes

Description: The time to symptoms resolution is defined as the time in days from therapies initiation to the first documented symptoms resolution as assessed by a local site. Patients whose symptoms are not resolved, or result in death, or lost follow-up on the designed follow-up date, will be censored on that date.

Measure: Time to symptoms resolution

Time: 2 Months

Description: Overall survival (OS) will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.

Measure: Overall survival

Time: 2 Months

Measure: Rate of virologic clearance by nasopharyngeal swab at 2 and 4 weeks

Time: 2 and 4 Weeks

Measure: Rate of nasopharyngeal swab positivity in donors

Time: 2 Months

Measure: Rate of donor titers level

Time: 2 Months

Measure: Impact of donor titers level on efficacy

Time: 2 Months

Measure: Patients' anti-SARS-CoV2 titer assessment pre-infusion for the Treatment group, at 2 weeks , 4 weeks and 2 months.

Time: Prior to treatment, 2 Weeks, 4 Weeks, and 2 Months

Other Outcomes

Description: Univariate test will be performed in terms of identifying the association between exploratory objective and the hospitalization rate, Mantel-Haenszel test for categorical variables, and t-test or its non-parametric version for the continuous variables based on the normalized of the data.

Measure: Plasma product's cytokine level assessment

Time: Day 0

Measure: Plasma product's mannose-binding lectin (MBL) level assessment

Time: Day 0

Measure: Plasma product's procalcitonin (PCT) level assessment

Time: Day 0

Measure: Plasma product's C-reactive protein (CRP) level assessment

Time: Day 0

Measure: Plasma product's Human neutrophil lipocalin (HNL) level assessment

Time: Day 0

Measure: Plasma product's Annexin V level assessment

Time: Day 0

Measure: Plasma product's Surfactant protein D (SP-D) level assessment

Time: Day 0

Measure: Plasma product's microRNA level assessment

Time: Day 0

Measure: Plasma product's immunoglobulin level assessment

Time: Day 0

Measure: Patients' cytokines levels assessment at +2 and +4 weeks post randomization

Time: 2 Weeks and 4 Weeks

Measure: Patients' chemokines levels assessment at +2 and +4 weeks post randomization

Time: 2 Weeks and 4 Weeks

Description: Safety assessment will be performed on infusion day for the Treatment group (immediately post infusion), and for all patients on randomization day +3 and +7 days (by telephone, closest business day is acceptable), +2 weeks (+/- 3 days), +4 weeks (+/- 3 days).

Measure: Rates of adverse events associated with convalescent plasma infusion.

Time: Day 3 and 7, Weeks 2 and 4
305 Randomised Single Blinded Clinical Study of Efficacy of Intranasal Probiotic Treatment to Reduce Severity of Symptoms in COVID19 Infection

Randomised, single-blinded trial. Patients with a diagnosis of COVID-19 infection within the past 96 hours and not requiring hospitalization will be recruited into a trial of BID Nasal irrigation for 14 days, followed by a 14 day observation period. Irrigation will be performed with either Probiorinse probiotic nasal irrigation solution or NeilMed Sinus rinse. Patients will be able to identify their treatments, but study staff will be blinded as to assignment.

NCT04458519
Conditions
  1. COVID-19 Infection
Interventions
  1. Other: Probiorinse
  2. Other: Saline solution
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Change in severity of COVID-19 infection as assessed by number of days with any symptoms of COVID-19 infection greater than or equal to 35 as measured on VAS scale as assessed at the 28 day endpoint.

Measure: Change in severity of COVID-19 infection

Time: 4 weeks

Secondary Outcomes

Description: Number of days with any symptom of anosmia

Measure: Number of days with any symptom of anosmia

Time: 4 weeks

Description: Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS). VAS scale from 0 to 100, with a higher score indicating a worse outcome.

Measure: Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS).

Time: 4 weeks

Description: Number of days where rescue medication is required

Measure: Number of days where rescue medication is required

Time: 4 weeks
306 PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs

PHENOTYPE is an investigator-led, observational cohort study which aims to explore the long-term outcomes of patients with COVID-19 infection and to identify potential risk factors and biomarkers that can prognosticate disease severity and trajectory.

NCT04459351
Conditions
  1. Coronavirus
  2. Corona Virus Infection
  3. COVID-19
  4. 2019nCoV
  5. 2019 Novel Coronavirus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary purpose is to characterise the different presentations and features of COVID-19 and outcomes.

Measure: Identification of baseline characteristics which correlate with disease severity

Time: Based on clinical need - Up to 1 year follow up.

Description: Relationship between changes in markers of inflammation (CRP, D dimer, ferritin, fibrinogen, pro-calcitonin) and pulmonary, renal and cardiac complications post hospitalisation for Covid-19 infection.

Measure: Identification of blood biomarkers which correlate with disease severity

Time: Based on clinical need - Up to 1 year follow up.

Description: Genomic, proteomic and transcriptomic analysis of blood samples to look for genetic susceptibility to severe disease presentations and to identify new biomarkers that predict disease severity or disease trajectory

Measure: Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations

Time: Based on clinical need - Up to 1 year follow up.

Secondary Outcomes

Description: Incidence of: Interstitial lung disease Pulmonary embolism Pulmonary hypertension as determined by pulmonary artery systolic pressure on echocardiogram or mean pulmonary artery pressure on right heart catheterisation if performed Renal dysfunction (as defined by new persistent impairment of egfr or new sustained protenuria measured using urinary protein-creatinine ratio) Cardiac dysfunction (new LV or RV systolic dysfunction on echocardiogram) Psychological distress as measured using Hospital anxiety and depression scale

Measure: Incidence

Time: Based on clinical need - Up to 1 year follow up.

Description: Assessed through Leicester Cough Questionnaire: Domain scores 1-7; Total scores 3-21

Measure: Change in respiratory symptom scores

Time: Based on clinical need - Up to 1 year follow up.

Description: Assessed through the modified Medical Research Council Dyspnoea Scale: Scores range from 0-4.

Measure: Change in respiratory symptom scores

Time: Based on clinical need - Up to 1 year follow up.

Description: Assessed thought the Short Form Survey (36): 8 scales, each scored between 0-100.

Measure: Change in frailty and quality of life scores

Time: Based on clinical need - Up to 1 year follow up.

Description: Assessed through the Clinical Frailty Scale: Scores range from 1-9.

Measure: Change in frailty and quality of life scores

Time: Based on clinical need - Up to 1 year follow up.

Description: D dimer/ fibrinogen and new pulmonary embolism

Measure: Relationship between serum markers and clinical outcomes

Time: Based on clinical need - Up to 1 year follow up.

Description: Troponin/ BNP and cardiac disease

Measure: Relationship between serum markers and clinical outcomes

Time: Based on clinical need - Up to 1 year follow up.

Description: Markers of inflammation (CRP, procalcitonin, ferritin, fibrinogen, D dimer, ESR) and persistent radiological abnormalities

Measure: Relationship between serum markers and clinical outcomes

Time: Based on clinical need - Up to 1 year follow up.

Other Outcomes

Description: Changes in health behaviours such as alcohol consumption and tobacco use Mental health and psychological wellbeing Factors affecting compliance with Public Health England guidelines The impact of cultural and religious beliefs on behaviours during the pandemic

Measure: Thematic analysis of semi-structured interviews exploring the following areas:

Time: Up to 1 year follow up.
307 Psychiatric Disturbances in Patients Infected With COVID-19: A Cross Sectional Study

This observational study aims at Assessment of the prevalence and types Psychiatric disturbances that affects patients with COVID-19 infection with and without previous psychiatric diseases. in addition to, Assessment of the types of Psychiatric disturbances in patients with COVID-19 infection in correlation to age, disease severity, co-morbid conditions and treatments applied

NCT04459403
Conditions
  1. Corona Virus Infection
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: The General Health Questionnaire: To measure psychiatric well-being. Taylor Manifest Anxiety Scale: To determine the level of anxiety. Beck Depression Inventory: To assess symptoms of depression. The Brief-COPE scale: To assess coping responses. These questionnaires are combined in one questionnaire filled by the patients. it needs from 15-20 minutes.

Measure: Psychiatric well-being, level of anxiety, symptoms of depression and coping strategies questionnaire

Time: 3 months

Description: prevalence of each type and correlation with age, disease severity, co-morbid conditions and treatments applied

Measure: Prevalence and types of Psychiatric disturbances in patients with COVID-19 infection

Time: 3 months
308 A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection

This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.

NCT04459702
Conditions
  1. COVID
  2. COVID-19
  3. Corona Virus Infection
  4. Coronavirus Infection
  5. Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
  6. Coronavirus-19
  7. SARS-CoV 2
  8. SARS Pneumonia
Interventions
  1. Drug: hydroxychloroquine
  2. Drug: Azithromycin
  3. Drug: Ritonavir
  4. Drug: Lopinavir
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores

Time: 6 months

Description: Time to non-infectivity as measured by PCR testing

Measure: Efficacy of Treatment by Time to Non-Infectivity

Time: 10 days

Secondary Outcomes

Description: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores

Time: 6 months

Description: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.

Time: 6 months

Description: Changes in blood parameters measured in a Complete Blood Count (CBC).

Measure: Safety of Dual Therapy as Measured by Complete Blood Count

Time: 6 months

Description: Changes in blood parameters measured in a Complete Metabolic Panel.

Measure: Safety of Quadruple Therapy as Measured by Complete Blood Count

Time: 6 months

Description: Changes in serum albumin levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel -Albumin

Time: 6 months

Description: Changes in serum albumin levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin

Time: 6 months

Description: Changes in serum albumin/globulin ratio

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio

Time: 6 months

Description: Changes in serum albumin/globulin ratio

Measure: Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio

Time: 6 months

Description: Changes in serum alkaline phosphatase levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase

Time: 6 months

Description: Changes in serum alkaline phosphatase levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase

Time: 6 months

Description: Changes in serum AST levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - AST

Time: 6 months

Description: Changes in serum AST levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - AST

Time: 6 months

Description: Changes in serum ALT levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT

Time: 6 months

Description: Changes in serum ALT levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel ALT

Time: 6 months

Description: Changes in serum BUN/Creatinine Ratio

Measure: Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio

Time: 6 months

Description: Changes in serum BUN/Creatinine Ratio

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio

Time: 6 months

Description: Changes in serum Blood Urea Nitrogen levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN

Time: 6 months

Description: Changes in serum Blood Urea Nitrogen levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - BUN

Time: 6 months

Description: Changes in serum calcium levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Calcium

Time: 6 months

Description: Changes in serum calcium levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium

Time: 6 months

Description: Changes in serum carbon dioxide levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide

Time: 6 months

Description: Changes in serum carbon dioxide levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide

Time: 6 months

Description: Changes in serum chloride levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Chloride

Time: 6 months

Description: Changes in serum chloride levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride

Time: 6 months

Description: Changes in serum creatinine levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine

Time: 6 months

Description: Changes in serum creatinine levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine

Time: 6 months

Description: Changes in serum globulin levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Globulin

Time: 6 months

Description: Changes in serum globulin levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin

Time: 6 months

Description: Changes in blood glucose levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose

Time: 6 months

Description: Changes in blood glucose levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Glucose

Time: 6 months

Description: Changes in blood potassium levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Potassium

Time: 6 months

Description: Changes in blood potassium levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium

Time: 6 months

Description: Changes in serum total bilirubin levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin

Time: 6 months

Description: Changes in serum total bilirubin levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin

Time: 6 months

Description: Changes in serum total protein levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein

Time: 6 months

Description: Changes in serum total protein levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein

Time: 6 months

Description: Presence or absence of treatment related serious adverse events Grade III or higher

Measure: Safety of Dual Therapy as Measured by Treatment Related SAE

Time: 6 months

Description: Presence or absence of treatment related serious adverse events Grade III or higher

Measure: Safety of Quadruple Therapy as Measured by Treatment Related SAE

Time: 6 months
309 Breath Test Feasibility Trial for Covid-19 Infection Diagnosis

Can Nanotechnology Biomarker Tagging (NBT) be used to detect COVID-19 infection in people presenting for COVID-19 testing? NBT can be used to detect the substances present in a person's breath. In this study the breath of people presenting for COVID-19 testing is going to be analysed. Analysing a large number of samples from people with COVID-19 (as confirmed by the standard swab test used by the NHS) will enable a breath profile to be produced, ie the substances present in the breath when someone has COVID-19. After the profile has been validated, NBT can be used to test whether or not a person has COVID-19 by seeing if their breath matches the profile. Using this technology for COVID-19 testing has advantages over the current standard test. The sample can be analysed immediately in the clinical setting and the results are available in 5-10 minutes, so if the person tests negative they can go back to their normal life straight away. The current swab test takes around 72 hours for the results to be available, and the person needs to self-isolate during this time in case they test positive, resulting in potentially unnecessary days of work missed and inconvenience. The breath test is non-invasive and is unlikely to cause any discomfort, as the person is only required to breath normally into the device. This study will also review the practicalities of using this test. It is quick and easy to train people in how to carry out the test, so it could potentially easily be rolled out to testing sites.

NCT04459962
Conditions
  1. Covid-19 Infection
Interventions
  1. Diagnostic Test: Breath Test & Cheek Swab
MeSH:Infection

Primary Outcomes

Description: This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample. These will be combined to provide a COVID-19 positive profile

Measure: To investigate/ examine the effectiveness of Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients with COVID-19 symptoms

Time: 6 Months

Secondary Outcomes

Description: This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample using ML. These will be combined to provide a COVID-19 positive profile.

Measure: -To profile the unique pattern of Volatile Organic Compounds (VOCs) found in the expired breath of COVID-19 patients using the NBT system (VOC analysis and ML).

Time: 6 months

Description: The patient samples that return COVID-19 negative will be used as controls for identification of VOCs and relative concentrations that are common to all samples.

Measure: To differentiate this unique profile from the patients that are found to be negative for COVID-19

Time: 6 months
310 Efficacy and Safety of Sirolimus for Treating COVID-19 Infection

This research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection

NCT04461340
Conditions
  1. COVID 19
Interventions
  1. Drug: Sirolimus
MeSH:Infection

Primary Outcomes

Description: The duration from start of treatment to normalization of pyrexia, respiratory rate ,O2 saturation and relief of cough that is maintained for at least 72 hours.

Measure: Time to clinical recovery

Time: 14-28 days

Description: Two successive negative COVID-19 PCR analysis tests 48-72 hours apart

Measure: Viral clearance

Time: 14 days

Secondary Outcomes

Description: Evaluate the lung extension of pneumonia at day 14

Measure: radiological lung extension

Time: 14 days

Description: incidence and type of adverse events

Measure: drug adverse events

Time: 28 days

Description: number of deaths to total number of patients

Measure: 28 day mortality

Time: 28 day

Description: deteriorated patients who need admission to intensive care unit

Measure: intensive care unit (ICU) admission rate

Time: 28 days

Description: duration from hospitalization to discharge

Measure: Duration of hospital stay

Time: 28 days
311 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
312 Effects of SARS-CoV-2 Infection on Beta-cell Function in Euglycemic Patients

In recent months, a new coronavirus, SARS-CoV-2, has been identified as the cause of a serious lung infection named COVID-19 by the World Health Organization. This virus has spread rapidly among the nations of the world and it is the cause of a pandemic and a global health emergency. There is still very little scientific evidence on the virus, however epidemiological data suggest that one of the most frequent comorbidities is diabetes, along with hypertension and heart disease. There is no scientific evidence on the possible effects of this infection on the function of the β cell and on glycemic control. Clinical evidence seems to suggest that COVID-19 infection mostly affects the respiratory system, and an acute worsening of glycemic compensation is not described as generally observed in bacterial pneumonia. However, previous work on acute respiratory syndromes (SARS) caused by similar coronaviruses, had described that the infection has multi-organ involvement related to the expression of the SARS coronavirus receptor, the angiotensin 2 converting enzyme, in different organs, especially at the level of endocrine pancreatic tissue. In the population of this previous work, glucose intolerance and fasting hyperglycaemia have been described and in 37 of 39 diabetic patients examined, a remission of diabetes was observed three years after the infection. It is possible that the coronaviruses responsible for SARS may enter the pancreatic islets using the angiotensin 2 converting enzyme receptor, expressed at the level of the endocrine pancreas, thus causing diabetes. Additionally, previous literature on coronavirus infections (SARS and MERS or Middle-East Respiratory Syndrome) suggested that diabetes could worsen the evolution of the disease. In particular, in case of Middle-East Respiratory Syndrome-CoV infection, diabetic mice had a more prolonged serious illness and a delay in recovery regardless of the viremic titer. This could probably be due to a dysregulation of the immune response, which results in more serious and prolonged lung disease. There are currently no data on pancreatic beta cell function in patients with COVID-19.

NCT04463849
Conditions
  1. COVID19
  2. BETA-CELL FUNCTION
Interventions
  1. Diagnostic Test: Stimulation test with arginine infusion in order to verify the possible existence of damage to the beta cell function induced by COVID-19 infection
MeSH:Infection

Primary Outcomes

Description: Difference in insulin levels during and after COVID-19 infection and compared to patients in the control group

Measure: Serum β - cellular function index insulin levels

Time: 12 months

Description: Difference in C-peptide levels during and after COVID-19 infection and compared to patients in the control group

Measure: Serum β - cellular function index C-peptide levels

Time: 12 months

Description: Difference in HOMA-β index during and after COVID-19 infection and compared to patients in the control group

Measure: Serum β - cellular function HOMA-β index

Time: 12 months

Description: Difference in pro-insulin/insulin ratio during and after COVID-19 infection and compared to patients in the control group

Measure: Serum β - cellular function pro-insulin/insulin ratio

Time: 12 months

Description: Check for the existence of damage to the beta cell function induced by COVID-19 infection, clinically observable with changes in the secretory response of insulin

Measure: Evaluation of the secretory response of insulin to the arginine stimulation test

Time: 12 months

Description: Presence of SARS-CoV-2 viral particles in β cells in COVID-19 patient samples

Measure: Viral SARS-CoV-2 particles in β cells

Time: 12 months

Description: Evidence of impairment of β cell function in the serum of COVID-19 patients

Measure: Percentage of patients with preserved β cells function

Time: 12 months

Secondary Outcomes

Description: Changes in glucose values in COVID-19 patients and healthy volunteers

Measure: Glucose values

Time: 12 months

Description: Changes in the values of continuous glucose monitoring in both COVID-19 patients and healthy volunteers

Measure: Values of continuous glucose monitoring

Time: 12 months

Description: Comparison of interleukin 1-β levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interleukin 1-β

Time: 12 months

Description: Comparison of interleukin IL-2 levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interleukin IL-2

Time: 12 months

Description: Comparison of interleukin IL-6 levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interleukin IL-6

Time: 12 months

Description: Comparison of interleukin IL-7 levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interleukin IL-7

Time: 12 months

Description: Comparison of interleukin IL-10 levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interleukin IL-10

Time: 12 months

Description: Comparison of interleukin tumor necrosis factor-α levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker tumor necrosis factor-α

Time: 12 months

Description: Comparison of interferon gamma levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interferon gamma

Time: 12 months

Description: Comparison of macrophage inflammatory protein-1β levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker macrophage inflammatory protein-1β

Time: 12 months

Description: Comparison of macrophage inflammatory monocyte chemoattractant protein-1 in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker monocyte chemoattractant protein-1

Time: 12 months

Description: Comparison of macrophage inflammatory granulocyte-macrophage colony-stimulating factor in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker granulocyte-macrophage colony-stimulating factor

Time: 12 months

Description: Comparison of macrophage inflammatory granulocyte colony-stimulating factor in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker granulocyte colony-stimulating factor

Time: 12 months
313 Cross-sectional Study of COVID-19 Infection in Hospital Health Personnel

The objective of the study is to determine the percentage of past SARS-CoV-2 infections in hospital health personnel involved in the care of people with COVID-19 in HUGTiP and in Badalona Serveis Assistencials de Badalona.

NCT04466462
Conditions
  1. SARS-CoV-2 Infection
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Number of participants with past SARS-CoV-2 infection

Measure: Number of participants with past SARS-CoV-2 infection

Time: Day 0

Secondary Outcomes

Description: Number of infections in health personnel who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection

Measure: Number of infections in health personnel who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection

Time: Day 0

Description: Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19.

Measure: Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19.

Time: Day 0

Description: Number of infected participants who are active smokers and/or have chronic lung disease and/ or have history of hypertension.Relationship of degree of exposure to participants infected with SARS-CoV-2 admitted to the hospital.Professional category.

Measure: Number of infected participants who are active smokers and/or have chronic lung disease and/ or have history of hypertension.Relationship of degree of exposure to participants infected with SARS-CoV-2 admitted to the hospital.Professional category.

Time: Day 0

Description: Number of participants infected with SARS-CoV-2 that presented symptoms and their grade. Number of participants infected with SARS-CoV-2 who required hospitalization. Number of participants infected with SARS-CoV-2 who received treatment.

Measure: Number of participants infected with SARS-CoV-2 that presented symptoms and their grade. Number of participants infected with SARS-CoV-2 who required hospitalization. Number of participants infected with SARS-CoV-2 who received treatment.

Time: Day 0

Description: Number of family members infected from each participant with SARS-CoV-2 infection

Measure: Number of family members infected from each participant with SARS-CoV-2 infection

Time: Day 0
314 Antiviral for Adult Patients Hospitalized for SARS-CoV-2 Infection: a Randomized, Phase 2/3, Multicenter, Double Blinded, Placebo Controlled, Adaptive, Multi-arm, Multi-stage Clinical Trial - Coalition Brazil COVID-19 IX: REVOLUTIOn

A key strategy in the treatment of COVID-19 would be to find an effective antiviral agent that would decrease the peak viral load and, consequently, the associated degree of immunopathological damage that follows this phase. The clinically approved substances considered for this study are used for treatment of other virus diseases, like HIV (atazanavir) and HCV (sofosbuvir and daclatasvir). Severe progression of COVID-19 among patients under treatment for these aforementioned viruses is empirical less common. Besides, the clinical rationale, there are pre-clinical evidence pointing out that patients with COVID-19 could benefit from treatments with atazanavir, sofosbuvir and daclatasvir.

NCT04468087
Conditions
  1. COVID-19
Interventions
  1. Drug: Atazanavir
  2. Drug: Daclatasvir 60 mg
  3. Drug: Sofusbuvir + Daclastavir 60 mg
  4. Drug: Placebo Atazanavir
  5. Drug: Placebo Daclatasvir 60 mg
  6. Drug: Placebo Sofusbuvir + Daclatasvir 60 mg
  7. Drug: Daclatasvir 120 mg
  8. Drug: Sofosbuvir + Daclatasvir 120 mg
  9. Drug: Placebo Daclatasvir 120
  10. Drug: Placebo Sofosbuvir/Daclatasvir 120
MeSH:Infection

Primary Outcomes

Description: Change in the slope of the SARS-COV 2 log viral load evaluated by nasopharyngeal swab samples assessed at baseline and days 3, 6 and 9 after randomization (isolated antiviral).

Measure: Phase II first step: Change in area under the curve of SARS-COV 2 viral load

Time: days 3, 6 and 9 after randomization

Description: Change in the slope of the SARS-COV 2 log viral load curve evaluated by nasopharyngeal swab samples assessed at baseline and days 3, 6 and 9 after randomization (combined antiviral).

Measure: Phase II second step: Change in area under the curve of SARS-COV 2 viral load

Time: days 3, 6 and 9 after randomization

Description: Number of days without oxygen, non-invasive ventilation/high flow nasal cannula or need for mechanical ventilation in 15 days.

Measure: Phase III: Number of free days from respiratory support

Time: 15 days
315 Evaluation of Clinical Parameters Following COVID-19 Infection in Pregnancy (COpregVID)

Coronavirus infection, also known as COVID-19, has become a global pandemic with over 3 million cases and 250,000 deaths worldwide. Coronaviruses (CoV) belong to a family of viruses that predominately infect mammals and birds, affecting their lungs, intestinal tract, liver and nervous systems. Prior to the discovery of the current novel coronavirus strain (SARS-CoV-2), there were six different strains that are known to infect humans, which includes the virus that caused the severe acute respiratory syndrome (SARS) pandemic in 2002. In humans, the majority of severe illness from SARs and COVID-19 is due to inflammation of the lungs and pneumonia. Pregnancy poses a significantly increased risk of viral pneumonia and during SARS more pregnant women required intensive care and breathing support, and the proportion of deaths was higher when compared to non-pregnant adults. Furthermore, kidney failure and development of abnormal blood clotting disorders, which occurs during severe infection, is more common in pregnancy and the associated changes in blood vessels extend to the placentas of infected pregnant women, thus potentially affecting the fetus. This makes pregnant women affected by the virus at high risk of developing severe complications. Fortunately, there have been a number of biomarkers identified that are associated with illness severity. These include, specialised white blood cells, blood clotting cells and constituents, as well as other measures of heart and kidney function. We propose that these biomarkers are important correlates of clinical disease severity and prognosis in pregnant and postnatal women. This knowledge has the potential to help clinicians during this pandemic to better manage and care for their patients.

NCT04470583
Conditions
  1. COVID-19
  2. 2019 Novel Coronavirus Infection
  3. COVID-19 Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Data collection and analysis on the proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive patients during acute infection and recovery.

Measure: Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women.

Time: From the start of the study up until one month prior to study end.

Description: Data collection and analysis on the concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive patients during acute infection and recovery.

Measure: Concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive women.

Time: From the start of the study up until one month prior to study end.

Secondary Outcomes

Description: Data collection and analysis on profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.

Measure: Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.

Time: From the start of the study up until one month prior to study end.
316 COVID-19 Infection at Samusocial in Paris: Descriptive and Serological Survey

Study of COVID-19 seroprevalence in precarious population living in shelters of Samusocial de Paris and in staff working in these centers during COVID-19 epidemic.

NCT04470648
Conditions
  1. SARS-COV2 Infection
Interventions
  1. Diagnostic Test: blood test for SARS-COV2 serology
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Primary objective is to evaluate SARS-COV2 seroprevalence in people hosted and health care workers of 3 centers of Samusocial de Paris where COVID19 epidemics occured

Measure: SARS-COV-2 seroprevalence in 3 centers for homeless and people in social distress

Time: 6 months

Secondary Outcomes

Description: Measure of morbidity in the participating population in the 3 centers

Measure: Morbidity rate

Time: 6 months

Description: Number of deaths related to Covid-19 during the epidemic in the 3 centers

Measure: Covid-19 related death rate in the 3 centers from March to May 2020

Time: 6 months

Measure: Ratio of negative serology rate and positive serology rate in the 3 centers

Time: 6 months

Measure: Ratio of SARS-COV2 seroprevalence obtained in these centers to the estimated seroprevalence in the Ile de France region

Time: 6 months
317 Cellular Immune Profile Changes in Individuals With Active or Past COVID-19 Infection

Clinical specimens are collected from individuals either recovered from or with active SARS-CoV-2 infection to support process and analytical development for a potential cell-based immunotherapy in preclinical research, SRPH-CVD-01. SRPH-CVD-01 is an allogeneic cell-based immunotherapy candidate to be investigated in a subsequent clinical trial under a future FDA IND to treat people suffering from COVID-19. Enrolled participants provide a venous blood specimen (up to 40mL) to be used in preclinical studies and research and development of SRPH-CVD-01. Subjects may eventually be asked to undergo leukapheresis for peripheral blood mononuclear cell (PBMC) collection and their specimens will be used to further develop the SRPH-CVD-01 cell product, including a cGMP compliant process to be applied under the future FDA IND.

NCT04470999
Conditions
  1. Covid19
  2. SARS-CoV-2
Interventions
  1. Other: Leukapheresis
MeSH:Infection

Primary Outcomes

Description: After the initial venous blood draw, the blood samples will be tested to measure the absolute count and percentage of B cells, monocytes, CD4+ and CD8+ T cells, gammadelta T (gdT) cells, CD3+CD56+ natural killer T (NKT) cells, and natural killer (NK) cells in total PBMCs. Data will describe the range of each cell population across participants.

Measure: Cellular immune system profiling

Time: Up to 20 days

Secondary Outcomes

Description: Innate immune system cells (gdT, NKT, and NK) will be assessed for their SARS-CoV-2 antiviral activity by stimulation and immunophenotyping. Data will report the antiviral phenotypic characteristics of these cells.

Measure: Innate immune system profiling

Time: Up to 100 days

Description: Virus-specific innate immune cells that are relevant to SRPH-CVD-01 clinical product candidate will be expanded under various conditions to assess their therapeutic and protective potential against COVID-19. Data will report the expansion rate of SRPH-CVD-01 cells. These cell will also help validate the assays and processes for the development of the SRPH-CVD-01 cell product to be used in a future clinical trials.

Measure: Expansion of virus-specific innate immune cells

Time: Up to 100 days
318 Epidemiologic Assessment of SARS-CoV-2 Prevalence in Minnesota

The purpose of this epidemiologic study is to estimate the prevalence and incidence of anti-SARS-CoV-2 antibodies in at-risk, exposed, affected populations. The study will also estimate the risk of SARS-CoV-2 exposure in target population.

NCT04473183
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. SARS-CoV-2
  4. Corona Virus Infection
Interventions
  1. Diagnostic Test: Specimen Collection
  2. Diagnostic Test: Surveys
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Prevalence of symptomatic infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report symptoms of SARS-CoV-2 infection.

Measure: Prevalence of Symptomatic Infection

Time: 1 year

Description: Prevalence of subclinical infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report no symptoms of SARS-CoV-2 infection.

Measure: Prevalence of Subclinical Infection

Time: 1 year
319 An Epidemiological Investigation on the Prevention of Respiratory Infectious Diseases by Wearing Mask Correctly

The purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. The research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. It is of great significance to COVID-19 's practical prevention and control.

NCT04474028
Conditions
  1. Respiratory Infectious Diseases
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Whenever the subject feels bitter, it means that the mask does not fit well with the subject's face. If the subjects do not feel bitter all the time, it means that the mask is suitable for the subjects' face and can be worn.

Measure: can or can't fell bitterness

Time: Immediately after spray test
320 Reducing Asymptomatic Infection With Vitamin D in Coronavirus Disease

This study is intended to address whether oral daily vitamin D supplementation reduces infection with SARS-CoV-2 in healthy young adults. The primary aim of the study is to demonstrate a reduction in 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population following 24 weeks of taking oral vitamin D supplemented at a dose of 1000 I.U. daily, versus matching placebo. The secondary aims of this study are to explore: 1. Any effect on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.

NCT04476680
Conditions
  1. SARS-CoV Infection
  2. Vitamin D D
  3. Vitamin D Deficiency
  4. Covid19
  5. Acute Respiratory Tract Infection
Interventions
  1. Dietary Supplement: Vitamin D 1000 IU
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Vitamin D Deficiency Asymptomatic Infections
HPO:Low levels of vitamin D Respiratory tract infection

Primary Outcomes

Description: asymptomatic seroconversion for SARS-CoV-2

Measure: Seroconversion

Time: 24 weeks

Description: asymptomatic seroconversion for SARS-CoV-2

Measure: Interim analysis - seropositivity at 12 weeks

Time: 12 weeks

Secondary Outcomes

Description: Sensitivity and specificity of dried blood spot assay compared with venous blood serology

Measure: Dried Blood Spot performance

Time: 24 weeks

Description: Sensitivity and specificity of salivary IgA compared with venous blood serology

Measure: Salivary IgA performance

Time: 24 weeks

Description: The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.

Measure: Prevalence of SARS-CoV-2

Time: 24 weeks

Description: The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time

Measure: Change in seropositivity

Time: 24 weeks

Description: The effect of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity

Measure: Change in seroconversion rate

Time: 24 weeks
321 Immune Profiles in CF Fungal Infection

This study is investigating the role of allergic (Th2) inflammation in patients with Cystic Fibrosis (CF) and history of fungal infection and/or Allergic Bronchopulmonary Aspergillosis. Little is known about fungal infection in CF and conflicting results exist on whether this results in worse lung function over time. There is concern that persistent fungal infection can result in worse clinical outcome measures in patients with CF. Also, it is unclear how ABPA develops, but may be related to the amount of fungus a patient with CF is infected with. This study looks at inflammatory patterns and allergic responses to fungal elements to help identify biomarkers and signs of allergic disease in fungally infected patients with CF.

NCT04476758
Conditions
  1. Cystic Fibrosis
  2. Fungal Infection
  3. Allergic Bronchopulmonary Aspergillosis
MeSH:Infection Communicable Diseases Mycoses Aspergillosis Pulmonary Aspergillosis Aspergillosis, Allergic Bronchopulmonary Cystic Fibrosis Fibrosis

Primary Outcomes

Description: Difference in sputum Th2 biomarkers (ECP, IL4, IL5, IL10, IL13, and eosinophil count) in patients with CF with fungal infection with expected elevation of sputum Th2 biomarkers in patients with CF and ABPA compared to those without fungal infection and without ABPA.

Measure: Difference in Th2 Sputum Markers

Time: Average of 24 months

Secondary Outcomes

Description: Serum Th2 biomarkers in patients with fungal infection and ABPA (Table 3). Serum Th1 biomarkers in patients with fungal infection and ABPA (Table 3). Serum sensitization markers to fungal allergens in patients with fungal infection and ABPA (Table 4). Baseline and historic lung function, historical comorbid diagnoses and BMI measurements in patients with fungal infection and ABPA. Environmental factors that are possibly related to fungal infection and ABPA in patients with CF. Immune profile: A profile of each group will be based upon their findings of each set of biomarkers: Th1, Th2, mold allergy panel, and systemic markers of inflammation. Based upon findings in each of these categories (elevated, depressed), we will be able to formulate a profile based upon the type of marker/inflammatory pathway.

Measure: Other markers of fungal inflammation and allergic reaction in patients with CF

Time: Average of 24 months

Other Outcomes

Description: Banking of both sputum and serum to potentially utilize microbiome and transcriptome techniques for further immunotyping and infection characterization.

Measure: Biobanking of specimens

Time: Average of 24 months
322 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
323 Microbial Infections and Antimicrobial Resistance (AMR) Patterns Associated With Hospitalized Patients With 2019 Novel Coronavirus Disease (COVID 19)

To detect microbial infection and AMR associated with COVID 19 infection. To correlate risk factors of COVID 19 patients with microbial infections and their effects on disease.

NCT04479982
Conditions
  1. Covid19
MeSH:Infection

Primary Outcomes

Description: The correlation between microbial infection and COVID 19 infection and their effect on prognosis and disease outcome.

Measure: Microbial infections and antimicrobial resistance (AMR) patterns associated with hospitalized patients with 2019 novel coronavirus disease (COVID 19)

Time: baseline
324 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
325 Real-life Evaluation of the Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection in Patients Receiving Long-term Treatment for Systemic Lupus Erythematosus and/or Gougerot's Disease

There is a pandemic in the world by COVID-19. Currently, the pharmacological curative or prophylactic treatments for this infection are not known. Recent studies have suggested that Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. The main objective of this study is to assess in patients with autoimmune disease treated with long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had an independent protective effect on the risk or the severity of infection with COVID-19.

NCT04481633
Conditions
  1. COVID-19
Interventions
  1. Diagnostic Test: COVID 19 serology
  2. Other: COVID 19 Self-Questionnaire
MeSH:Infection

Primary Outcomes

Description: Rate of patients with positive anti-COVID19 serology with or without Hydroxy-Chloroquine.

Measure: Rate of patients with positive anti-COVID19 serology

Time: Day 1

Secondary Outcomes

Description: Rate of patients with symptomatic or severe (hospitalization) form of infection.

Measure: Rate of patients with symptomatic or severe (hospitalization) form of infection

Time: Day 1
326 SERO-EPIDEMIOLOGY OF SARS-COV2 INFECTION IN THE AUTONOMOUS CITY OF BUENOS AIRES

The pandemic of a new coronavirus SARS-COV-2, which causes COVID-19 disease, has spread rapidly and is a major public health challenge. While the focus is primarily on containing the number of cases and finding alternative therapies, information is still lacking to elucidate the dynamics of viral circulation and to understand the distribution of the infection in the population. The cases reported in Argentina and worldwide could plausibly represent only a small proportion of the number of asymptomatic or poorly symptomatic cases that exist in society. However, the magnitude of this dissociation between symptomatic cases and asymptomatic persons is unknown. Knowing this information is of strategic importance as it will allow the estimation of a community prevalence and the evaluation of the best containment strategy. In fact, although all social distancing measures are now indispensable, the feasibility of prolonging the measure over time is a complex issue and in any case will require population-based information. The best way to approach the estimation of a true population prevalence is to take representative samples from the population and test them periodically. These experiences were carried out in other contexts showing heterogeneous results within the community studied. In Spain, for example, the range of antibodies present in the population varied from 1.1% to 14.2%, also showing that an important part of the population had had contact with the virus without symptoms. Studies in Switzerland and the United States also show similar findings. However, these estimates are not automatically transferable to other settings. The city of Buenos Aires has a particular demographic composition with an important group of the population living in shantytowns (it is estimated that between 7% and 10% of the population lives in shantytowns) and with much heterogeneity among the different communes of the city. In the villas, the incidence rates of COVID-19 infection differ significantly from those present in the group "outside the village". However, there is also an important difference in the incidence rates by commune, even without considering the villas. Thus, it is important to know the sero-epidemiology of antibodies against SARS-COV2 in a representative sample of the city of Buenos Aires. For this purpose, a nationally produced test (COVIDAR IgG) developed by professionals from CONICET and Instituto Leloir will be used. The aim of this initiative is to estimate the true dimension of the COVID-19 epidemic in the City of Buenos Aires, by studying the immunological status of the Buenos Aires population in relation to SARS-Cov2, as well as to observe the evolution of the infection among the population, since this information is essential to guide future public health measures related to the control of COVID-19. To achieve this objective, a comprehensive sero-epidemiological study will be carried out to provide estimates of past SARS-Cov2 infection with sufficient precision to be representative of the sero-epidemiological status of the Buenos Aires city population.

NCT04482361
Conditions
  1. COVID-19
Interventions
  1. Diagnostic Test: Presence of specific anti-SARS-CoV-2 antibodies
MeSH:Infection

Primary Outcomes

Description: To estimate the prevalence of SARS-Cov2 infection in the city of Buenos Aires, by means of the determination of IGG-type antibodies in a representative and randomized sample of adult residents of the city.

Measure: Prevalence of IGG for COVID-19

Time: 4 months

Measure: Changes in prevalence of IGG for COVID-19

Time: 4 months
327 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
328 A Phase II Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection

In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.

NCT04482686
Conditions
  1. COVID
  2. Covid-19
  3. Corona Virus Infection
  4. Coronavirus Infection
  5. Coronavirus-19
  6. SARS-CoV2
  7. SARS-CoV Infection
Interventions
  1. Drug: Ivermectin
  2. Drug: Doxycycline Hcl
  3. Dietary Supplement: Zinc
  4. Dietary Supplement: Vitamin D3
  5. Dietary Supplement: Vitamin C
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time to negative RT-PRC result indicating that patient is no longer infective

Measure: Time to Non-Infectivity by RT-PCR

Time: 6 months

Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score)

Time: 6 months

Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score)

Time: 6 months

Description: Patients will have serum stored for titer testing to compare antibody levels over time

Measure: Efficacy of Treatment as measured by Titer

Time: 6 months

Description: Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment

Measure: Efficacy of Treatment as measured by RT-PCR

Time: 10 days

Secondary Outcomes

Description: Blood D-Dimer levels

Measure: Safety of Treatment as Measured by D-Dimer

Time: 6 Months

Description: Blood Pro-Calcitonin levels

Measure: Safety of Treatment as Measured by Pro-Calcitonin

Time: 6 Months

Description: Blood CRP levels

Measure: Safety of Treatment as Measured by C-Reactive Protein

Time: 6 Months

Description: Blood ferritin levels

Measure: Safety of Treatment as Measured by Ferritin

Time: 6 Months

Description: Blood enzyme levels

Measure: Safety of Treatment as Measured by Liver Enzymes

Time: 6 Months

Description: CBC

Measure: Safety of Treatment as Measured by Complete Blood Count

Time: 6 Months

Description: Blood electrolytes

Measure: Safety of Treatment as Measured by Electrolyte Levels

Time: 6 Months

Description: Presence or absence of Grade 3 or high treatment related adverse events

Measure: Safety of Treatment as Measured by Treatment Related Adverse Events

Time: 6 months
329 Immunoglobulin G Antibody Immune Response Profile Following Infection With SARS-CoV-2 in COVID-19 Egyptian Patients

The objective of this study is to detect the evidence on the immune response following acute SARS-CoV-2 infections. the study will report the profile of IgG specific antibodies levels to SARS-CoV-2 infection found in recovered coronavirus disease (COVID-19) patients after infection for both symptomatic and asymptomatic patients.

NCT04483622
Conditions
  1. Covid19
MeSH:Infection

Primary Outcomes

Description: it's expected to have COVID-19 antibodies within 1month of infection the antibody titre expected to rise the fall to a lower levels

Measure: rising titre of IGg antibodies

Time: first month
330 COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses (SERO-BL-COVID-19)

The study is to investigate the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.

NCT04483908
Conditions
  1. COVID-19 Infection
Interventions
  1. Diagnostic Test: blood draw
  2. Diagnostic Test: fingertip tests for POC assays
  3. Diagnostic Test: saliva collection
  4. Diagnostic Test: collection of swabs
MeSH:Infection

Primary Outcomes

Description: Qualitative method validation: qualitative result of the ELISA (Patient does / does not have immunity) as the gold standard compared to the POC using univariate measures to derive sensitivity and specificity of the POC.

Measure: Qualitative method validation (yes/ no)

Time: at baseline

Description: Quantitative method validation: antibody concentration from the ELISA are related to the dichotomous result from POC.

Measure: Quantitative method validation (antibody concentrations)

Time: at baseline

Secondary Outcomes

Description: Antibody and T cell repertoires and transcriptional profiles of cells will be used to identify potential antibody and T cell clones correlated with COVID-19 protection.

Measure: Immune cell repertoire sequencing

Time: at baseline
331 An International Multi-Centre Randomised Clinical Trial to Assess the Clinical, Virological and Immunological Outcomes in Patients Diagnosed With SARS-CoV-2 Infection (COVID-19)

An International Multi-Centre Randomised Clinical Trial to Assess the Clinical, Virological and Immunological Outcomes in Patients Diagnosed with SARS-CoV-2 Infection (COVID-19).

NCT04483960
Conditions
  1. SARS-CoV-2 Infection (COVID-19)
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Lopinavir / Ritonavir
  3. Biological: Convalescent plasma
MeSH:Infection

Primary Outcomes

Description: Morbidity

Measure: Proportion of participants alive and not having required new intensive respiratory support (invasive or non-invasive ventilation) or vasopressors/inotropic support in the 28 days after randomisation.

Time: 28 days

Secondary Outcomes

Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: World Health Organization (WHO) 7-point outcome scale (clinician assessed)

Time: 28 days

Description: All cause mortality

Measure: Mortality

Time: 7, 15, 28, and 90 days

Description: Number of days

Measure: Time to death

Time: 90 days

Description: Number of days

Measure: Length of hospital stay

Time: 90 days

Description: Yes/No

Measure: Receipt of invasive or non-invasive ventilation

Time: 28 days

Description: Number of days

Measure: Length of receipt of invasive or non-invasive ventilation

Time: 28 days

Description: Number of days

Measure: Length of intensive care unit (ICU) stay

Time: 90 days

Description: Yes/No

Measure: Presence of chest infiltrates on chest x-ray (CXR) or CT

Time: 3 and 7 days

Description: Number of days

Measure: Time to defervescence from randomisation

Time: 28 days

Description: C-reactive protein (CRP) and Lactate dehydrogenase (LDH) and D-dimer

Measure: Biomarker levels

Time: 28 days

Description: number of days of use in first 10 days

Measure: Antibiotic use

Time: 10 days

Description: Recording of the following adverse events: Diarrhoea, Nausea, Vomiting, Pancreatitis, QTc prolongation (>500ms) 24 hours, serious allergic reaction or anaphylaxis, transfusion-related acute lung injury, transfusion-associated circulatory overload

Measure: Adverse Events

Time: 10 days

Description: Yes/No

Measure: Serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death in hospital

Time: 28 days

Description: Yes/No - based on the modified Kidney Disease Improving Global Outcomes (KDIGO) criteria; serum creatinine increase by≥ 26.5mol/L within 48 hours OR to ≥1.5 times baseline, known or presumed to have occurred within the prior 7 days

Measure: Acute Kidney Injury (AKI)

Time: 28 days

Description: Confirmed deep vein thrombosis, pulmonary embolus, ischemic cerebrovascular event, acute myocardial infarction or other thrombotic event during index hospitalisation.

Measure: Thrombotic events

Time: 28 days

Description: Proportion of patients with negative SARS-CoV-2 real time - polymerase chain reaction (RT-PCR) at day 3 and day 7 from upper or lower respiratory tract samples.

Measure: Viral clearance

Time: 3 and 7 days
332 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Severe COVID-19 Patients

The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.

NCT04483973
Conditions
  1. Covid19
  2. Coronavirus
  3. Coronavirus Infection
  4. Corona Virus Infection
Interventions
  1. Drug: Ebselen
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respirator Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of participants with treatment-related adverse events

Time: 30 days

Secondary Outcomes

Description: Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement

Measure: WHO Ordinal Scale

Time: 30 days

Description: Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)

Measure: Degree of supplemental oxygen

Time: 30 days

Description: Peripheral oxygen saturation measured by pulse oximetry

Measure: Peripheral Oxygen Saturation (SpO2)

Time: 30 days
333 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Moderate COVID-19 Patients

The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.

NCT04484025
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Coronavirus
  4. Coronavirus Infection
Interventions
  1. Drug: Ebselen
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infecti Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of participants with treatment-related adverse events

Time: 30 days

Secondary Outcomes

Description: Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement

Measure: WHO Ordinal Scale

Time: 30 days

Description: Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)

Measure: Degree of supplemental oxygen

Time: 30 days

Description: Peripheral oxygen saturation measured by pulse oximetry

Measure: Peripheral Oxygen Saturation (SpO2)

Time: 30 days
334 Prognostic Factors in Patients Admitted to an Urban Teaching Hospital With COVID-19 Infection

As of 27th May 2020, approximately 5.7 million people worldwide are known to have been infected with COVID-19 coronavirus and more than 350,000 have died (1). The severity of this viral disease for an individual is associated with a widespread perturbation of immune, physiological and metabolic parameters (2, 3). These whole body changes could be considered characteristic of a systemic inflammatory response to tissue injury and it has been long recognised that a large and ongoing systemic inflammatory response is associated with the development of multiple organ failure and infective disease (4, 5). One of the cardinal signs of severe COVID-19 infection is a marked systemic inflammatory response (2). This response bears striking similarity to the systemic inflammatory response experienced by patients undergoing major elective surgical resections for cancer (6, 7). Indeed, the systemic inflammatory response and the associated metabolic stress has been most well characterised in major elective surgery, where the relationship between the magnitude of the post-operative systemic inflammatory response and the development of post-operative complications is now well recognised, as is the effect of patient comorbidity on this relationship (8, 9). Such work has informed therapeutic manoeuvres including minimally invasive surgery, pre-operative optimisation (e.g. anaesthesia, nutrition and steroids) and enhanced recovery protocols. The aim of the present study was to examine whether routinely collected clinicopathological characteristics of patients with COVID-19 on admission were informative on the immune and metabolic stress experienced by patients with COVID-19 and whether such characteristics were informative on subsequent outcome.

NCT04484545
Conditions
  1. COVID-19
Interventions
  1. Diagnostic Test: Prognostic score
MeSH:Infection

Primary Outcomes

Description: 30-day mortality and prognostic score

Measure: mortality

Time: 30-day
335 Pediatric COVID-19 Infection; Do Clinical Features and Hematological Parameters Predict the Need for ICU Admission?

This study is to discuss the different clinical presentations, hematological and laboratory abnormalities in pediatric COVID-19 infection.

NCT04487119
Conditions
  1. Covid19
MeSH:Infection

Primary Outcomes

Description: hematological indices; TLC, absolute lymphocytic count, absolute neutrophil count platelet count, N/L ratio and CRP in pediatric COVID-19 infection

Measure: hematological findings

Time: at time of admission

Secondary Outcomes

Description: proportion of patients with respiratory and GIT symptoms, proportion of patients needs ICU admission relation between severity and hematologic indices

Measure: clinical presentations

Time: at time of admission
336 A Pilot Trial of Thymalfasin (Ta1) to Treat COVID-19 Infection in Patients With Lymphocytopenia

It is our hypothesis that a course of Ta1 administered to hospitalized individuals with COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective) and severity of infection (secondary objectives) compared to untreated individuals in the same hospital with comparable lymphocytopenia. After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1 week. Individuals in the control arm will be followed on the identical protocol but will not receive daily Ta1.

NCT04487444
Conditions
  1. Covid19
Interventions
  1. Drug: Thymalfasin
MeSH:Infection

Primary Outcomes

Description: Length of time for patient to no longer require supplemental oxygen and can sustain a good oxygen saturation (SpO2) on room air

Measure: Time to recovery (free of respiratory failure)

Time: Day 28

Secondary Outcomes

Description: Evaluation of CD4 and CD8 levels

Measure: Lymphopenia

Time: Day 14

Description: Percentage of subjects still alive

Measure: Survival

Time: Day 28

Description: Length of time before hospital discharge

Measure: Hospital length of stay

Time: Day 28

Description: Number of subjects that require high flow oxygen

Measure: Requirement for high flow oxygen supplementation

Time: Day 28

Description: Number of days that each subject requires high flow oxygen

Measure: Duration of high flow oxygen supplementation

Time: Day 28

Description: Number of subjects that are admitted to the ICU

Measure: ICU admission

Time: Day 28

Description: Number of days that each subject remains in the ICU

Measure: ICU length of stay

Time: Day 28

Description: Number of subjects that require mechanical ventilation

Measure: Mechanical ventilation

Time: Day 28

Description: Number of days that each subject requires the mechanical ventilation

Measure: Duration of mechanical ventilation

Time: Day 28

Description: Number of subjects that have decreases or increases in comorbidities existing at time of enrollment

Measure: Change in any existing comorbidities (e.g., worsening congestive heart failure) or occurrence of newly diagnosed disease

Time: Day 28

Description: Number of subjects who get infections other than COVID-19

Measure: Incidence of non-COVID-19 infections (other respiratory, urinary tract, cellulitis, etc.)

Time: Day 28

Description: Adverse events and serious adverse events experienced by the subjects

Measure: AEs/SAEs

Time: Day 60

Description: Mild, moderate, or severe changes to vital signs (heart rate, blood pressure, temperature, number of respirations per minute) based on perceived clinical significance of the change

Measure: Changes to vital signs

Time: Day 28

Description: Mild, moderate, or severe changes to laboratory parameters (complete blood count and standard chemistry surveys) based on perceived clinical significance of the change

Measure: Changes in laboratory parameters

Time: Day 28
337 A Phase 2 Double-blind Placebo-controlled Study Investigating the Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With SARS-CoV-2 Infection

Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection

NCT04488575
Conditions
  1. Covid19
Interventions
  1. Drug: EDP1815
  2. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]

Measure: Change from baseline to the lowest S/F oxygen ratio

Time: 14 days

Secondary Outcomes

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day.

Measure: Change in S/F Ratio

Time: 14 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day.

Measure: Percentage change in S/F Ratio

Time: 14 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42

Measure: Percentage of participants at each level on the WHO OSCI score

Time: 42 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42

Measure: Percentage of participants with shifts from each level of the WHO OSCI score at baseline

Time: 42 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42

Measure: Percentage of participants remaining at their baseline score on the WHO OSCI (or lower)

Time: 42 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day

Measure: Percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day

Time: 42 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death).

Measure: The time in days spent at each participant's worst reported WHO OSCI score (excluding death).

Time: 42 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more.

Measure: Intubation and mechanical-ventilation free survival

Time: 42 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause

Measure: Overall survival

Time: 42 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy

Measure: Number of days requiring oxygen therapy

Time: 42 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C

Measure: Number of days with pyrexia

Time: 42 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature

Measure: Maximum daily temperature

Time: 42 days

Description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels

Measure: SpO2 level

Time: 42 days

Description: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less.

Measure: Time to discharge

Time: 42 days

Description: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy.

Measure: Time to oxygen saturation (SpO2) ≥94%

Time: 42 days

Description: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms.

Measure: Time to recovery

Time: 42 days

Description: The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness and relationship to treatment

Measure: Number of participants experiencing AEs by seriousness and relationship to treatment

Time: 42 days

Description: The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters

Measure: Incidence of clinically significant abnormal lab parameters

Time: 42 days
338 Sildenafil for Treating Patients With COVID-19 and Perfusion Mismatch: A Pilot Randomised Trial

This randomised trial aims to assess the role of sildenafil in improving oxygenation amongst hospitalised patients with COVID19.

NCT04489446
Conditions
  1. Covid19
  2. SARS-COV2 Infection
Interventions
  1. Drug: Sildenafil
  2. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Mean difference in alveolar oxygen pressure to inspired oxygen fraction (Pa/Fi) ratios.

Measure: Arterial Oxygenation

Time: One hour after sildenafil administration

Description: Mean difference in alveolar oxygen pressure to inspired oxygen fraction (Pa/Fi) ratios.

Measure: Arterial Oxygenation

Time: Daily until the end of follow-up (up to 15 days after randomisation)

Description: Mean difference in the alveolo-arterial gradient between study groups.

Measure: Alveolo-arterial gradient

Time: One hour after sildenafil administration

Description: Mean difference in the alveolo-arterial gradient between study groups.

Measure: Alveolo-arterial gradient

Time: Daily until the end of follow-up (up to 15 days after randomisation)

Secondary Outcomes

Description: Proportion of patients requiring admission to an intensive care unit in each study group

Measure: Intensive care unit admission

Time: Up to two weeks after randomisation

Description: Proportion of patients requiring noninvasive mechanical ventilation o high-flow nasal cannula unit in each study group

Measure: Noninvasive Mechanical Ventilation or Requirement of High-Flow Nasal Cannula

Time: Up to two weeks after randomisation

Description: Proportion of patients requiring invasive mechanical ventilation in each study group

Measure: Invasive mechanical ventilation

Time: Up to two weeks after randomisation

Description: Proportion of patients that survived COVID19 in each study group

Measure: Survival

Time: Up to two weeks after randomisation

Other Outcomes

Description: Adverse events attributable to sildenafil use.

Measure: Adverse events

Time: Up to two weeks after randomisation
339 A Phase I, Open-label, Randomized, Single-dose Study of Acalabrutinib in Healthy Subjects to Evaluate the Effect of Proton-pump Inhibitor (Rabeprazole) on Acalabrutinib Capsule When Administered Orally With COCA-COLA

This study is being conducted to support the clinical development of acalabrutinib in participants who need treatment with proton pump inhibitors while taking acalabrutinib.

NCT04489797
Conditions
  1. Infectious Disease
Interventions
  1. Drug: Acalabrutinib
  2. Drug: Rabeprazole
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Assessment of AUCinf for acalabrutinib and ACP-5862 (metabolite of acalabrutinib) following administration of capsule with and without rabeprazole.

Measure: Area under plasma concentration-time curve from time zero to infinity (AUCinf)

Time: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2

Description: Assessment of AUClast for acalabrutinib and ACP-5862 following administration of capsule with and without rabeprazole.

Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)

Time: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2

Description: Assessment of Cmax for acalabrutinib and ACP-5862 following administration of capsule with and without rabeprazole.

Measure: Maximum observed plasma concentration (Cmax)

Time: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2

Secondary Outcomes

Description: Assessment of the safety and tolerability of acalabrutinib capsule when administered with COCA-COLA and rabeprazole.

Measure: Number of participants with adverse events and serious adverse events

Time: From screening until Follow-up visit (Upto 5 to 6 Weeks)
340 Effectiveness of a Novel Respirator With Chitosan Nanoparticles to Reduce the Incidence of SARS-CoV-2 Infection in Healthcare Professionals: Randomized Controlled Trial (VESTA Trial)

The use of nanomaterials in facial respirators could decrease the permeability of particles and promote a biocidal effect compared to conventional respirators (N95) and, therefore, enhance the filtering power, aiming to mitigate harmful effects of bacteria and viruses. Chitosan is a natural cationic polymer derived from chitin, with important characteristics such as being biodegradable, biocompatible, non-toxic, and presenting antimicrobial activity. This polymer shows virucidal activity in several types of viruses, including other coronavirus serotypes, given the attractive factor of its cationic charge for negative charges. The effectiveness of a novel individual protection semi facial respirator (called VESTA) will be investigated, compared to a conventional N95 respirator. The respirators will be tested in healthcare professionals working in hospital environments and the effectiveness will be attributed to the lower incidence rate of infection by the SARS-CoV-2. The effectiveness of respirators will also be attributed to the ability to filter these viruses after use by healthcare professionals exposed to potentially contaminated environments. The study will be carried out in two stages: i) Pilot Randomized Clinical Trial with reduced sample and ii) Controlled Randomized Clinical Trial (RCT). This RCT will be conducted with healthcare professionals who have contact with environments/patients infected by SARS-CoV-2 in hospital sectors with greater vulnerability to infection (urgency, emergency and intensive care units). The pilot trial will be conducted initially with a group of fifty participants (n = 25 in each group) for initial investigation of the potential for efficacy with the use of the respirators (VESTA and conventional N95) in two sectors (emergency and ICU) of a Hospital. The RCT will consist of two parallel groups: (1) Experimental Group (GExp) that will use the novel respirator (VESTA) and (2) Control Group (CG) that will use the standard respirator (N95). Participants will be recruited from participating centers and will be accompanied by eight consecutive shifts (each shift lasting 6 to 12 hours, followed by approximately 36 hours of rest). Participants will be accompanied during 21 days, and will be assessed at baseline (T0), at the end of the 10th day (T1) and at the end of the 21st day (T2). The respirators will be assessed after the end of the 1st hospital shift for morphological characterization (virus quantity and inactivation).

NCT04490200
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Worker-Patient Transmission, Healthcare
Interventions
  1. Device: VESTA respirator
  2. Device: Conventional N95 respirator
MeSH:Infecti Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of professionals infected, confirmed by reverse-transcription polymerase chain reaction (RT-PCR)

Measure: Incidence of laboratory-confirmed COVID-19

Time: 21 days

Description: Electron microscopy technique will be used, to identify if there is viruses present (through its direct visualization and morphological recognition) and they are inactive. This assessment will occur after the end of the first hospital shift.

Measure: Ability of the filtering element to inactivate the SARS-Cov-2

Time: 24 hours

Secondary Outcomes

Description: 11-point Likert scale ranging from -5 ("extremely unsatisfied"), 0 ("neutral"), to 5 ("completely satisfied")

Measure: Usability and comfort of the respirator

Time: Assessments at T1 (day 10) and T2 (day 21)

Description: quantified based on the activities and procedures performed by the participants. Adherence will be measured by a self-report recorded in a diary, estimating the percentage of use referring to the total workhours.

Measure: Adherence to the use of the Respirator

Time: Assessments at the end of the first and second weeks of intervention

Description: Measured by the Job Stress Scale Questionnaire (17 questions composed by 4-point Likert scales)

Measure: Stress

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by the Maslach Burnout Inventory

Measure: Burnout

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by the Six-dimensional short form quality of life questionnaire (SF-6D), with scores ranging from 0 to 1 (in which 0 is equal to the worst health state and 1 is equal to the best health state).

Measure: Self-reported quality of life

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by the Nordic Musculoskeletal Questionnaire, which assess the self-report of musculoskeletal symptoms in the last 12 months and last 7 days. Identification of areas of the body causing musculoskeletal problems in a body map (possible sites being neck, shoulders, upper back, elbows, low back, wrist/hands, hips/thighs, knees and ankles/feet).

Measure: Musculoskeletal discomfort

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by a VAS-scale ranging from 0 to 10, being 0 the worst work ability and 10 the best work ability, considering the present time.

Measure: Work ability

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)
341 Characteristics and Outcomes of Gastrointestinal Manifestations of COVID-19

Patients confirmed COVID-19 with gastrointestinal manifestations will be included. Characteristics and outcomes will be described for them.

NCT04490772
Conditions
  1. Infectious
Interventions
  1. Diagnostic Test: Laboratory tests
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Clinical characteristics of age, sex, comorbidities and symptoms.

Measure: Clinical data questionnaire

Time: 2 months

Description: Laboratory characters

Measure: Tests such as CBC

Time: 2 months

Description: Laboratory characters

Measure: liver function test

Time: 2 months
342 COVID-19 Seroprevalence Study in French Guiana

Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.

NCT04490850
Conditions
  1. Coronavirus Infection
  2. Severe Acute Respiratory Syndrome
  3. SARS-CoV Infection
  4. Covid19
Interventions
  1. Procedure: Blood sample
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The COVID-19 immunity of the population will be assessed by evaluating the anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies

Measure: Measure of the COVID-19 immunity of the population

Time: 1 year

Secondary Outcomes

Description: The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population

Measure: Evaluation of the level of asymptomatic and pauci-symptomatic infections

Time: 1 year
343 Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)

Patients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in ICU. This infection seems to cause widespread organ injury (i.e acute renal injury, neurological disorders, pulmonary embolism,…). It is therefore necessary to provide a framework for the follow up of patients. Moreover SARS-CoV-2 infection consequences remain unknow at this time. Study hypothesis is that COVID alters determining factors (physical or psychological) of quality of life after ICU hospitalisation. The aim of the study is to assess quality of life 3 months after ICU hospitalization. Secondary purposes of the study are 1) assessment of quality of life 6 months and the evolution between the third and the sixth months after ICU hospitalization 2) description patients care after 3 and 6 months ICU left and their clinical status 3) convening and providing a "platform" within several physicians (neurologist, biologist, pneumologist…) will be able to follow up patients and perform complementary investigations according to patients injuries.

NCT04491214
Conditions
  1. Covid19
  2. Follow up
  3. Rehabilitation
Interventions
  1. Other: quality of live assessment
MeSH:Infection

Primary Outcomes

Description: assess different dimensions of quality of life: physical and mentaland social dimensions

Measure: assess quality of life after severe COVID infection

Time: measured at 3 months after ICU left.

Secondary Outcomes

Description: Clinical status of patients and assessment of quality of life. collects crucial elements of care based on doctors' prescriptions

Measure: Quality of life and Clinical status

Time: measured at 3 and 6 months after ICU left.
344 COVID-19 INFECTION IN MULTIPLE MYELOMA PATIENTS: AN EUROPEAN OBSERVATIONAL STUDY

Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe.

NCT04492371
Conditions
  1. Multiple Myeloma
  2. Covid19
  3. Corona Virus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Multiple Myeloma Neoplasms, Plasma Cell
HPO:Multiple myeloma

Primary Outcomes

Description: The duration of infection.

Measure: Nature of COVID19

Time: 1 years

Description: Costs related to Covid in terms of health resource needs.

Measure: Costs related to COVID-19

Time: 1 years

Description: Number of infection recovery for each systemic anti-cancer subgroup.

Measure: Systemic anti-cancer therapy subgroup

Time: 1 years

Description: Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.

Measure: Laboratory values collected at hospitalization

Time: 1 years

Description: Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.

Measure: COVID-19 infection in myeloma patient subgroups

Time: 1 years

Description: Number of frail patients with COVID-19 infection and resolution of it.

Measure: Incidence of COVID-19 infection in frail patients

Time: 1 years

Description: Number of infection and outcome per country.

Measure: Infection outcome in different countries

Time: 1 years
345 Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients

Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 infection in adults.

NCT04492384
Conditions
  1. Covid19
  2. SARS-CoV-2 Infection
  3. Pneumonia
  4. Copd
  5. CKD
  6. Cardiac Event
  7. Overweight and Obesity
  8. Cardiovascular Diseases
  9. Diabetes
  10. Hypertension
  11. Coronary Heart Disease
Interventions
  1. Other: non-interventional
MeSH:Infection Communicable Diseases Cardiovascular Diseases Heart Diseases Coronary Disease Overweight Noncommunicable Diseases
HPO:Abnormality of the cardiovascular system

Primary Outcomes

Description: percentage of patients with non-infectious diseases relating to overall number of patients registered in study

Measure: rate of non-infectious diseases

Time: 12 month since a moment of request of medical help

Description: correlation between number of patients with COVID-19 of various severity and number of pre-existing conditions and their severity among these groups

Measure: severity of COVID-19 depending on pre-existing diseases

Time: 12 month since a moment of request of medical help

Description: Registration of disability or change of disability status

Measure: disability registration / change of disability status

Time: 12 month since a moment of request of medical help

Description: rate of deaths among registered participants

Measure: rate of letal outcomes

Time: 12 month since a moment of request of medical help

Description: correlation between number of deaths and pre-existing diseases

Measure: rate of letal outcomes depending on pre-existing disease

Time: 12 month since a moment of request of medical help
346 COVID-19 Infection Screening in Cancer Patients (NEOSCREENCOVID)

Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. Cancer patients seem to be at higher risk of infection and evolution to severe forms related to immunosuppression, according to the first published data from Chinese experience. However, the role of confounding factors such as age and smoking habits cannot be independently assessed. Supplementary data from a large retrospective Italian cohort suggest that the proportion of cancer patients with severe form of COVID-19 could be lower than expected. In addition, the proportion of asymptomatic SARS-Cov-2 infected cancer patients is unknown. Based on academic and expert's recommendations, most of cancer units have already modified cancer treatment during the pandemic, in order to limit the number of outpatient visits / inpatient admissions and then reduce or avoid cross infection of COVID-19, although the negative impact on patient's outcome (cancer recurrence or mortality) has not been established. Thus, a large screening for SARS-Cov-2 infection in treated cancer patients could help to: - Define an accurate prevalence of COVID-19 immunization in this population - Aggregate data on the relationship between clinical characteristics in cancer patients and COVID-19 risk. - Provide information about asymptomatic COVID-19 cases. - Organize effectively cancer units to separate infected and non-infected patients. The RT-PCR gold-standard test for COVID-19 on nasal and pharyngeal swabs has limitations, as the test is not universally available, turnaround times can be lengthy, and reported sensitivities vary. It does not provide information about immunization status. Serological assays may be important for understanding the epidemiology of emerging SARS-Cov-2, including the burden and role of asymptomatic infections. Thus, the development of new devices or techniques for accurate diagnosis of SARS-CoV-2 infections, of fast and safe use, that could be spread in the local hospitals and clinics, would be a major advance for identifying and treating patients. In addition, information about the immunization of fragile people, such as cancer patients, could help to plan a safe strategy for anti-cancer treatment schedule and for the end of quarantine.

NCT04492410
Conditions
  1. Cancer
Interventions
  1. Other: rapid serological test
MeSH:Infection

Primary Outcomes

Description: The rate of prevalence will be defined as the ratio of the number of positive patients to the number of patients tested based on the rapid serological test (presence of IgM and/or IgG).

Measure: To evaluate the prevalence of COVID-19

Time: Day 1

Secondary Outcomes

Description: The assessment of the perception of the rapid serological test for patient and health care professional will be measured in terms of Pain, simplicity, rapidity and satisfaction, reported on a questionnaire: • Pain: The pain assessment will be performed using a visual analog scale (VAS). The score will be graded between 0 (absence of pain) to 10 (maximum pain) • Simplicity: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good". • Rapidity: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good". • Satisfaction with care: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good"

Measure: To evaluate patient's and health care professional's perception about the rapid serological test.

Time: Day 1

Description: Diagnostic performance: sensibility, specificity, positive and negative predictive values, positive and negative likelihood ratio and area under the ROC curve, will be assessed to evaluate the rate of COVID-19 positive and COVID-19 negative serological rapid test on whole blood compared to the gold-standard RT-PCR on nasal swab.

Measure: To evaluate the concordance of COVID-19 positivity by the rapid serological test compared to the gold-standard RT-PCR on nasal swab for eligible patients

Time: Day 1

Description: Diagnostic performance: sensibility, specificity, positive and negative predictive values, positive and negative likelihood ratio and area under the ROC curve, will be assessed to evaluate the rate of COVID-19 positive and COVID-19 negative serological rapid test on whole blood compared to an ELISA serological test on whole blood.

Measure: To evaluate the concordance of COVID-19 positivity by the rapid serological test compared to a classic serological test (ELISA method) from whole blood

Time: Day 1

Description: The rate of patients with at least one positive test among all the methods applied (rapid serological test and/or serological ELISA test and/or RT-PCR and/or ddPCR) will be defined.

Measure: To evaluate the proportion of the patients who will have at least one positive testing among all the methods applied.

Time: 6 months

Description: The proceedings of additional COVID-19 testing for corresponding patients will be described in terms of: Time interval between the tests Type and results of the subsequent tests

Measure: To evaluate the number of patients who will get at least one new testing after the rapid serological test has been performed.

Time: 6 months

Description: The clinical and biological characteristics between positive and negative COVID-19 will be compared in term of: Age, gender, BMI, performance status, smoking history, alcohol consumption, medical history and concomitant medication clinical stage, location, type of treatment. blood group, hematology, coagulation parameters and serum clinical chemistry

Measure: To compare the clinical and biological characteristics between positive and negative tested COVID-19 patients

Time: 6 months

Description: The rate of hospital admission for severe COVID-19 form and death will be assessed.

Measure: To describe the outcome of COVID-19 positive patients

Time: 6 months

Description: A change on the anti-cancer treatment Schedule induced by the result of COVID-19 test will be defined as : a medical treatment delay decision or a treatment discontinuation decision

Measure: To evaluate the impact of COVID-19 rapid serological test on the anti-cancer treatment schedule

Time: 6 months
347 Evaluation of Systemic and Oral Conditions of Pregnant Women and Their Babies, With Exposure to Coronavirus SARS-CoV-2

This research aims to investigate the incidence, clinical condition, mode of transmission and laboratory data of women and their babies, who were exposed to COVID-19 infection during pregnancy. This project will consist of 4 subprojects, being that Subprojects 1 and 2, will be of the observational, longitudinal type of prospective Cohort; Subproject 3 will be of prevalence; Subproject 4 will be case-control. Subproject 1- This study aims to assess periodontal condition and quality of life before and after delivery of women with excess weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2- Identify the proteins differentially expressed in saliva associated with COVID-19 infection during the 3rd trimester of pregnancy in obese and eutrophic patients. Subproject 3- Assess the prevalence of congenital syndrome in babies associated with the presumed maternal infection with SARS-CoV-2. Subproject 4- Case-control study in which newborns are submitted to clinical examination, being a group with congenital malformations and their respective controls and an interview with the mother was carried out.

NCT04492449
Conditions
  1. Exposure During Pregnancy
  2. Corona Virus Infection
Interventions
  1. Other: congenital malformation
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Probing pocket depth (PPD) and clinical attachment level (CAL) will be assessed. The PPD will be measured from the free gingival margin to the bottom of the periodontal pocket, and CAL will be measured from the cementoenamel junction to the base of the periodontal pocket, at six dental sites (mesial buccal/lingual, cervical buccal/lingual, distal buccal/lingual) excluding the third molars.

Measure: Periodontal status

Time: Interdental CAL is detectable at ≥2 non-adjacent teeth, or buccal CAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth. After, periodontitis will be classified in stages I, II, III and IV of periodontitis.

Secondary Outcomes

Description: Quality of live will be investigated by a questionnaire (OHIP-14), the impact of oral health on patients' quality of life.

Measure: Quality of life of pregnants

Time: Subjects will be asked how often (0=never, 1=rarely, 2=occasionally, 3=often, and 4=very often) experienced impacts. Scores will be: no impact (0); low impact (0 < OHIP≤ 9); moderate impact (9 < OHIP≤ 18); and high impact (18 < OHIP≤ 28).

Other Outcomes

Description: IgM and IgG serology test for COVID19

Measure: Maternal infection

Time: Serological tests for IgG and IgM, considering positive IgM means that she has already been exposed and is in the active phase of the disease and, positive IgG indicates that the person has antibodies work as a protection.
348 A Pharmacokinetic, Multi-cohort Study in Healthy Adult Subjects to Assess Gepotidacin as Victim and as Perpetrator of Drug-Drug Interactions Via CYP450, Renal and Intestinal Transporters, and to Assess Gepotidacin Pharmacokinetics in Japanese Healthy Adults

This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability study in adult healthy participants, including Japanese cohort. This study is designed to assess co-administration of probe substrates with gepotidacin in study cohorts 1 to 3 and establishing PK and safety in Japanese participants in cohort 4. Food effect will also be evaluated in cohort 4.

NCT04493931
Conditions
  1. Bacterial Infections
  2. Infections, Bacterial
Interventions
  1. Drug: Gepotidacin
  2. Drug: Cimetidine
  3. Drug: Rifampicin
  4. Drug: Midazolam
  5. Drug: Digoxin
  6. Other: Placebo matching to gepotidacin
MeSH:Infection Communicable Diseases Bacterial Infections

Primary Outcomes

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Maximum observed concentration (Cmax) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Time to reach maximum observed plasma concentration (Tmax) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Terminal phase half-life (t1/2) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC [0-t]) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: AUC from time 0 (predose) extrapolated to infinite time (AUC[0-infinity]) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Cmax of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Lag time before observation of drug concentrations (Tlag) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Tmax of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-t) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-infinity) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: Cmax of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: Tlag of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: Tmax of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: AUC(0-t) of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: AUC(0-infinity) of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: Cmax of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: Tlag of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: Tmax of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: AUC(0-t) of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: AUC(0-infinity) of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Cmax of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tmax of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC from time 0 (predose) to 24 hours post dose administration (AUC [0-24]) of gepotidacin after a single 1500 mg dose

Time: Up to 24 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC from time 0 (predose) to 48 hours post dose administration (AUC [0-48]) of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-t) of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-infinity) of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Cmax of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tmax of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC from time 0 (predose) to time tau (AUC[0-tau]) of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Cmax of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tmax of gepotidacin after the second dose of 3000 mg gepotidacin (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-tau) of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Accumulation ratio for Cmax (RoCmax) of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of morning dose up to 48 hours post evening dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Accumulation ratio for AUC (RoAUC) of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of morning dose up to 48 hours post evening dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-24) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 24 hours post morning dose (first dose) in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-48) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 48 hours post morning dose (first dose) in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-t) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: AEs will be collected.

Measure: Cohort 4: Number of participants with non-serious adverse events (non-SAEs)

Time: Up to Day 16

Description: SAEs will be collected.

Measure: Cohort 4: Number of participants with serious adverse events (SAEs)

Time: Up to Day 16

Description: Number of participants with abnormal vital signs will be assessed.

Measure: Cohort 4: Number of participants with abnormal vital signs

Time: Up to Day 16

Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.

Measure: Cohort 4: Number of participants with abnormal electrocardiogram (ECG) findings

Time: Up to Day 16

Description: Blood samples will be collected for the assessment of hematology parameters.

Measure: Cohort 4: Number of participants with abnormal hematology parameters

Time: Up to Day 16

Description: Blood samples will be collected for the assessment of chemistry parameters.

Measure: Cohort 4: Number of participants with abnormal clinical chemistry parameters

Time: Up to Day 16

Description: Urine samples will be collected for the assessment of urinalysis parameters.

Measure: Cohort 4: Number of participants with abnormal urinalysis findings

Time: Up to Day 16

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Cmax of gepotidacin after a single 1500 mg dose under fed conditions

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tlag of gepotidacin after a single 1500 mg dose under fed conditions

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tmax of gepotidacin after a single 1500 mg dose under fed conditions

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-t) of gepotidacin after a single 1500 mg dose under fed conditions

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-infinity) of gepotidacin after a single 1500 mg dose under fed conditions

Time: Up to 48 hours post dose in Period 1 and Period 2

Secondary Outcomes

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: AUC(0-24) of gepotidacin

Time: Up to 24 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: AUC(0-48) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Tlag of a gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Apparent volume of distribution (Vz/F) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Apparent oral clearance (CL/F) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Total unchanged drug (Ae total) of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: AUC(0-24) of gepotidacin in urine

Time: Up to 24 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: AUC(0-48) of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Renal clearance of drug (CLr) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Amount of drug excreted in urine in a time interval (Ae[t1-t2]) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Percentage of the given dose of drug excreted in urine (fe%) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: AEs will be collected.

Measure: Cohort 1: Number of participants with non-SAEs

Time: Up to Day 14

Description: SAEs will be collected.

Measure: Cohort 1: Number of participants with SAEs

Time: Up to Day 14

Description: Blood samples will be collected for the assessment of hematology parameters.

Measure: Cohort 1: Number of participants with abnormal hematology parameters

Time: Up to Day 14

Description: Blood samples will be collected for the assessment of chemistry parameters.

Measure: Cohort 1: Number of participants with abnormal clinical chemistry parameters

Time: Up to Day 14

Description: Urine samples will be collected for the assessment of urinalysis parameters.

Measure: Cohort 1: Number of participants with abnormal urinalysis findings

Time: Up to Day 14

Description: Number of participants with abnormal vital signs will be assessed.

Measure: Cohort 1: Number of participants with abnormal vital signs

Time: Up to Day 14

Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.

Measure: Cohort 1: Number of participants with abnormal ECG findings

Time: Up to Day 14

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-24) of gepotidacin

Time: Up to 24 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-48) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: T1/2 of a gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Vz/F of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: CL/F of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Ae total of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-24) of gepotidacin in urine

Time: Up to 24 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-48) of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: CLr of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Ae(t1-t2) of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: fe% of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: AEs will be collected.

Measure: Cohort 2: Number of participants with non-SAEs

Time: Up to Day 20

Description: SAEs will be collected.

Measure: Cohort 2: Number of participants with SAEs

Time: Up to Day 20

Description: Blood samples will be collected for the assessment of hematology parameters.

Measure: Cohort 2: Number of participants with abnormal hematology parameters

Time: Up to Day 20

Description: Blood samples will be collected for the assessment of chemistry parameters.

Measure: Cohort 2: Number of participants with abnormal clinical chemistry parameters

Time: Up to Day 20

Description: Urine samples will be collected for the assessment of urinalysis parameters.

Measure: Cohort 2: Number of participants with abnormal urinalysis findings

Time: Up to Day 20

Description: Number of participants with abnormal vital signs will be assessed.

Measure: Cohort 2: Number of participants with abnormal vital signs

Time: Up to Day 20

Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.

Measure: Cohort 2: Number of participants with abnormal ECG findings

Time: Up to Day 20

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Cmax of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Tmax of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Tlag of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-tau) of gepotidacin first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Cmax of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in each Period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Tmax of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: RoCmax of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of morning dose up to 48 hours post evening dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: RoAUC of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of morning dose up to 48 hours post evening dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-tau) of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-24) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 24 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-48) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 48 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-t) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Vz/Fof gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: CL/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: T1/2 of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: Trough concentration (Cmin) of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: t1/2 of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: Vz/F of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: CL/F of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: Cmin of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: t1/2 of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: Vz/F of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: CL/F of midazolam

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Ae total of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Ae(t1-t2) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-tau) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-24) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 24 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-48) of gepotidacin in urine following two 3000 mg doses (urine)

Time: From start of morning dose up to 48 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: fe% of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 48 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: CLr of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: AEs will be collected.

Measure: Cohort 3: Number of participants with non-SAEs

Time: Up to Day 30

Description: SAEs will be collected.

Measure: Cohort 3: Number of participants with SAEs

Time: Up to Day 30

Description: Blood samples will be collected for the assessment of hematology parameters.

Measure: Cohort 3: Number of participants with abnormal hematology parameters

Time: Up to Day 30

Description: Blood samples will be collected for the assessment of chemistry parameters.

Measure: Cohort 3: Number of participants with abnormal clinical chemistry parameters

Time: Up to Day 30

Description: Urine samples will be collected for the assessment of urinalysis parameters.

Measure: Cohort 3: Number of participants with abnormal urinalysis

Time: Up to Day 30

Description: Number of participants with abnormal vital signs will be assessed.

Measure: Cohort 3: Number of participants with abnormal vital signs

Time: Up to Day 30

Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG findings will be assessed.

Measure: Cohort 3: Number of participants with abnormal ECG findings

Time: Up to Day 30

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: T1/2 of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Vz/F of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: CL/F of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tlag of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Vz/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: CL/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: t1/2 of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Ae total of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Ae(t1-t2) of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-tau) of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-24) of gepotidacin in urine after a single 1500 mg dose

Time: Up to 24 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-48) of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: fe% of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: CLr of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Ae total of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Ae(t1-t2) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-tau) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-24) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 24 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-48) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 48 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: fe% of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: CLr of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3
349 Phase 1/2a Study of Umbilical Cord Lining Stem Cells (ULSC) in Patients With ARDS Due to COVID-19

ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (MSC), with intravenous (IV) administration in hospitalized patients with acute respiratory distress syndrome (ARDS) due to COVID-19.

NCT04494386
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. SARS-CoV Infection
  4. ARDS
  5. Coronavirus
Interventions
  1. Biological: Umbilical Cord Lining Stem Cells (ULSC)
  2. Other: Placebo (carrier control)
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of subjects with a DLT event during or within 24 hours after ULSC infusion [Dose Limiting Toxicities are treatment-emergent suspected adverse reactions graded as severe, such as severe infusion-related hypersensitivity toxicities of grade ≥3, and any treatment-emergent serious adverse event (SAE) will be investigated to determine if DLT.]

Measure: Incidence of Dose Limiting Toxicity (DLT)

Time: 24 hours

Description: Number of subjects with a DLT event, suspected adverse reaction, or any serious adverse event (SAE) within 1 week of each ULSC infusion

Measure: Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE)

Time: 1 week

Description: Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study up to 1-month follow-up

Measure: Treatment-emergent adverse events (AE) and serious adverse events (SAE)

Time: 1 month

Description: Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study and up to the 12-month follow-up

Measure: Treatment-emergent adverse events (AE) and serious adverse events (SAE)

Time: 12 months

Secondary Outcomes

Description: Times to transitions between levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS

Measure: Levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS

Time: 1 month

Description: Changes in SpO2/FiO2 ratio or pAO2/FiO2 ratio compared to baseline, measured daily at a minimum; oxygenation index daily when on ventilator

Measure: Changes from baseline pulse oximetric saturation SpO2/FiO2 ratio or arterial oxygen pressure pAO2/FiO2 ratio

Time: 1 month

Description: Number of ventilator-free days (VFD) in period of 1 month from study treatment

Measure: Number of ventilator-free days (VFD)

Time: 1 month

Description: Changes in CBC with differential from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in Complete Blood Count (CBC) with differential from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in blood glucose (mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of blood glucose (mg/dL) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in levels of sodium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of sodium (mEq/L) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in levels of potassium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of potassium (mEq/L) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in levels of alanine transaminase (ALT; U/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of alanine transaminase (ALT; U/L) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Change in Urinalysis (UA) at baseline and 1 month after study treatment to assess for presence and qualitative proteinuria

Measure: Change in Urinalysis (UA) from baseline

Time: 1 month
350 A Phase 2 Trial to Evaluate the Safety and Tolerability of Clazakizumab® [Anti-Interleukin (IL)-6 Monoclonal] Compared to Placebo for the Treatment of COVID-19 Infection

The purpose of this study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody (immune system protein) that blocks certain inflammatory processes. The treatment plan is to attempt to inhibit or block these inflammatory processes in order to try to limit the damage COVID-19 causes to the lungs.

NCT04494724
Conditions
  1. COVID-19 Infection
Interventions
  1. Drug: Clazakizumab
  2. Drug: Placebo
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Proportion of participants who experience treatment-related adverse events (TEAE) ≥ Grade 3 (CTCAE v5.0) during the first 24 hours after infusion of clazakizumab or placebo

Measure: Primary Endpoint

Time: 24 hours

Secondary Outcomes

Description: Proportion of participants who need mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) after the first dose of clazakizumab or placebo

Measure: Requirement for mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO)

Time: 14 days

Description: Proportion of participants who experience infusion-related reactions during the first 24 hours after infusion of clazakizumab or placebo

Measure: Infusion-related reactions during 24 hours from the time of infusion

Time: 24 hours

Description: Proportion of participants alive at day 28 after the first dose of clazakizumab or placebo

Measure: Patient survival at 28 days

Time: 28 days

Description: Proportion of participants alive at day 60 after the first dose of clazakizumab or placebo

Measure: Patient survival at 60 days

Time: 60 days

Description: Proportion of participants who require an open-label dose of clazakizumab

Measure: Requirement for open-label clazakizumab

Time: 14 days

Description: Number of days in the ICU following the first dose of clazakizumab or placebo

Measure: Time in the intensive care unit (ICU)

Time: 60 days

Description: Number of days in the hospital following the first dose of clazakizumab or placebo

Measure: Time in the hospital

Time: 60 days

Description: Number of days from first dose of clazakizumab or placebo to requiring mechanical ventilation

Measure: Time to mechanical ventilation

Time: 60 days

Description: Difference in WHO Clinical Progression Scale between clazakizumab and placebo

Measure: Clinical status improvement assessed by the World Health Organization (WHO) Clinical Progression Scale at day 14

Time: 14 days

Description: Difference in WHO Clinical Progression Scale between clazakizumab and placebo

Measure: Clinical status improvement assessed by World Health Organization (WHO) Clinical Progression Scale at day 28

Time: 28 days

Description: Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 14 from baseline between clazakizumab or placebo

Measure: Change in Radiologic Assessment of Lung Edema (RALE) at day 14

Time: 14 days

Description: Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 28 from baseline between clazakizumab or placebo

Measure: Change in Radiologic Assessment of Lung Edema (RALE) at day 28

Time: 28 days
351 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Infection (COVID-19) in Kidney Transplant Recipients: a Brazilian Multicenter Study

COVID-19 is the pandemic disease caused by the SARS-CoV-2 coronavirus. It is a highly contagious viral disease, the condition of which main clinical symptoms are characterized by fever and respiratory symptoms. Evidence indicates to worse outcomes in patients with pre-existing diseases, such as diabetes, arterial hypertension, heart disease, pneumopathies, chronic kidney disease, and immunodeficiencies. Recipients of kidney transplants make prolonged use of immunosuppressive drugs to inhibit the acquired immune response, notably the activity of lymphocytes. Due to this potential to modulate the immune and inflammatory response, it is speculated that the clinical and laboratory condition of COVID-19 in these patients is atypical. Preliminary evidence suggests worse outcomes of COVID-19 in immunosuppressed patients, as carriers of cancer. However, information on kidney transplant recipients is insufficient. So far, only reports of the case are available in the literature with different clinical presentations and outcomes. The aim of this study is, therefore, to characterize the demographics, clinical and laboratory conditions, and the outcomes of COVID-19 in kidney transplant recipients in a national multicenter cohort.

NCT04494776
Conditions
  1. SARS-CoV-2 Infection
  2. Kidney Tran
  3. Kidney Transplant Infection
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Death within 3 months after infection (Yes/No).

Measure: Death

Time: Up to 3 months after resolution

Description: Graft loss up to 3 months after infection (Yes/No).

Measure: Graft loss

Time: Up to 3 months after resolution

Secondary Outcomes

Description: Composite outcomes: Mechanical ventilation (Yes/No); Need for dialysis (Yes/No); Need for ICU admission during evolution (Yes/No).

Measure: Hospitalization

Time: Until discharge date, an average of 1 month
352 Registry of Sustained Immunity to COVID-19 Among ESKD Patients

This is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center. The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.

NCT04495764
Conditions
  1. SARS-CoV-2 Infection
  2. Anti-SARS-CoV-2 Infection
MeSH:Infection Communicable Diseases

Primary Outcomes

Measure: Anti-SARS-CoV-2 antibodies

Time: Through study completion (5 visits), an average of 6 months

Measure: Incidence and severity of COVID-19

Time: Through study completion (5 visits), an average of 6 months
353 COVID-19 Progression in End-Stage Kidney Disease

The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2.

NCT04495907
Conditions
  1. SARS-CoV-2 Infection (Asymptomatic)
  2. SARS-CoV-2 Infection (Symptomatic)
MeSH:Infection Communicable Diseases Kidney Diseases Kidney Failure, Chronic
HPO:Abnormality of the kidney Nephropathy

Primary Outcomes

Measure: SARS-CoV-2 IgG

Time: An average of 6 months

Measure: Anti-SARS-CoV-2 IgG

Time: An average of 6 months
354 Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI)

This is a standardized protocol for the rapid, coordinated clinical investigation of severe or potentially severe acute infections by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Participants with acute illness suspected to be caused by SARS-CoV-2 (COVID-19) will be enrolled. This protocol has been designed to enable data and biological samples to be prospectively collected and shared rapidly in a globally-harmonized sampling schedule. Multiple independent studies can be easily aggregated, tabulated and analyzed across many different settings globally. The protocol is the product of many years of discussion among international investigators from a wide range of scientific and medical. Recruitment under this protocol has been initiated in response to Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV) in 2012-2013, Influenza H7N9 in 2013, viral hemorrhagic fever (Ebolavirus) in 2014, Monkeypox & MERS-coronavirus in 2018, Tick-borne encephalitis virus (TBEV) in 2019 and COVID-19 in 2020. Participants may be newly identified through healthcare system or public health access, under quarantine, or in isolation care in outpatient or inpatient settings relevant to the Johns Hopkins University School of Medicine. Other locations may adopt this study concurrently, under a deferred review, or cooperatively. The existence of this protocol would ensure a timely, comprehensive epidemiologic and clinical characterization of the initial cases of COVID-19 in a mounting pandemic. The World Health Organization (WHO) recognized the need for standardized data collection for the epidemiology, immunology and clinical characteristics of these novel pathogens, and established the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) network in 2011. At the core of the protocol are a standardized schedule, structure and content of clinical, laboratory and microbiologic data collection, supplemented by domain-specific components (e.g., acute respiratory infection, viral hemorrhagic fever). The timepoints of this protocol will also be aligned with a separate multi-center institutional review board (IRB) approved protocol to describe patients with emerging infectious diseases that present to military treatment facilities within the United States.

NCT04496466
Conditions
  1. Coronavirus
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: SARS-CoV-2 Reverse transcription polymerase chain reaction (RT-PCR) and viral culture will be performed on prospectively collected samples to determine presence and Ct of viral RNA and presence or absence of cultivable virus in assessing how long virus is shed (in days).

Measure: Duration of viral shedding

Time: 3 months

Secondary Outcomes

Description: Incidence of comorbidities (chronic kidney disease, lung disease, cardiovascular disease, venous thromboembolism) will be determined.

Measure: Incidence of comorbidities

Time: 12 months

Description: Survival with the use of treatment with off-label therapeutics or management strategies will be assessed.

Measure: Treatment response as assessed by survival

Time: 1 month

Description: Survival with the use of treatment with off-label therapeutics or management strategies will be assessed.

Measure: Treatment response as assessed by survival

Time: 3 months

Description: Survival rates overall will be determined in assessing the mortality of COVID-19.

Measure: Mortality of COVID-19

Time: 12 months

Description: Changes in a lung ultrasound score (LUS) over time will be calculated and evaluated for prediction of disease severity defined by the World Health Organization COVID-19 ordinal scale (clinical status on an ordinal scale from 0 to 8 with higher scores meaning worse outcome).

Measure: Change in lung ultrasound score

Time: Baseline and 1 month

Description: Change in IgM antibody levels in serum will be determined for description of host response.

Measure: Change in immunoglobulin M (IgM) antibody levels in serum

Time: Baseline, one month, and every three months up to 12 months

Description: Change in IgG antibody levels in serum will be determined for description of host response.

Measure: Change in immunoglobulin G (IgG) antibody levels in serum

Time: Baseline, one month, and every three months up to 12 months

Description: Change in IgA antibody levels in serum will be determined for description of host response.

Measure: Change in immunoglobulin A (IgA) antibody levels in serum

Time: Baseline, one month, and every three months up to 12 months
355 An Epidemiological Investigation on Correct Wearing of Mask by Direct Spray Test

The purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. The research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. It is of great significance to COVID-19 's practical prevention and control.

NCT04497675
Conditions
  1. Respiratory Infectious Diseases
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Whenever the subject feels bitter, it means that the mask does not fit well with the subject's face. If the subjects do not feel bitter all the time, it means that the mask is suitable for the subjects' face and can be worn.

Measure: can or can't fell bitterness

Time: Immediately after spray test
356 An Epidemiological Investigation on Correct Wearing of Mask by Hood Test

The purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. The research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. It is of great significance to COVID-19 's practical prevention and control.

NCT04497753
Conditions
  1. Respiratory Infectious Diseases
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Whenever the subject feels bitter, it means that the mask does not fit well with the subject's face. If the subjects do not feel bitter all the time, it means that the mask is suitable for the subjects' face and can be worn.

Measure: can or can't fell bitterness

Time: Immediately after spray test
357 Evaluation of Coronavirus Disease 19 (COVID-19) Convalescent Plasma

Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or prophylactic approach in COVID-19 patients. The goal of this study is to help develop a bank of convalescent plasma in California, especially in medically underserved communities particularly affected by the disease. In parallel, CCP administered to COVID-19 patients will be collected and analyzed to determine whether the antibody profile correlates with clinical outcome. The purpose of this non-therapeutic study is to learn more about the CCP antibody profile and the effect it may have in treating COVID-19 infection.

NCT04497779
Conditions
  1. Asymptomatic COVID-19 Infection Laboratory-Confirmed
  2. Symptomatic COVID-19 Infection Laboratory-Confirmed
Interventions
  1. Procedure: Biospecimen Collection
  2. Other: Diagnostic Laboratory Biomarker Analysis
  3. Other: Electronic Health Record Review
  4. Other: Questionnaire Administration
MeSH:Infection Communicable Diseases Laboratory Infection

Primary Outcomes

Description: Will be assayed for severe acute respiratory syndrome (SARS-CoV-2) immunoassay, coronavirus (CoV) PepSeq assay, and SARS-CoV-2 lenti-based neutralizing antibody titer.

Measure: Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients

Time: Up to 12 months after enrollment

Description: Will naturally be compared to reported data from the other studies. Analysis will focus on demonstrating that the antibody content of donor plasma increases the odds of surviving past day 28. Will also develop a nomogram for the probability of success (alive at day 28), accounting for patient, donor material and donor antibody characteristics measurable covariates.

Measure: All-cause mortality

Time: At day 28 post-CCP infusion

Description: Will be examined to see how this relates to the duration of hospitalization.

Measure: Donor antibody levels

Time: Up to 28 days post-CCP infusion

Secondary Outcomes

Description: Will be assessed on a 7-point ordinal scale, as recommended by the WHO patient outcome R&D Blueprint Group.

Measure: Incidence of adverse events

Time: Up to 28 days post-CCP infusion

Description: Will be assessed on a 7-point ordinal scale. The scale is as follows: Death; Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring low flow supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol RDV administration); Not hospitalized

Measure: CCP recipient outcomes

Time: Up to 28 days post-CCP infusion

Other Outcomes

Description: Patient can stay at the hospital for up to 28 days post-CCP infusion

Measure: Duration of hospitalization (days)

Time: Up to 28 days post-CCP infusion

Description: Will be assessed on a 7-point ordinal scale.

Measure: Time to clinical improvement (days)

Time: Up to 28 days post-CCP infusion
358 A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study

The purpose of this study is to evaluate whether LY3819253 prevents severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19) in facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure. Participants with a high risk of SARS-CoV-2 exposure will receive LY3819253 or placebo via an injection into a vein. Samples will be taken from the nose. Blood samples will be drawn. Participation could last up to 25 weeks and may include up to 19 visits.

NCT04497987
Conditions
  1. COVID-19
  2. SARS-CoV2
Interventions
  1. Drug: LY3819253
  2. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Percentage of Participants with SARS-CoV-2 Infection

Measure: Percentage of Participants with SARS-CoV-2 Infection

Time: Week 4

Secondary Outcomes

Description: Percentage of Participants with Moderate or Worse Severity COVID-19

Measure: Percentage of Participants with Moderate or Worse Severity COVID-19

Time: Week 8

Description: Percentage of Participants with Mild or Worse Severity COVID-19

Measure: Percentage of Participants with Mild or Worse Severity COVID-19

Time: Week 8

Description: Percentage of Participants Who are Hospitalized due to COVID-19

Measure: Percentage of Participants Who are Hospitalized due to COVID-19

Time: Week 8

Description: Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death

Measure: Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death

Time: Week 8

Description: Percentage of Participants Who Die Due to COVID-19

Measure: Percentage of Participants Who Die Due to COVID-19

Time: Week 8
359 Elderly Patients and COVID-19 Infection: a Cohort of Fifty Patients Over Ninety Years of Age

SARS-CoV2 or CoVid19 disease is a newly described pathology linked to a subtype of the coronavirus family identified in China in December 2019. This pathology can present multiple clinical facets, ranging from asymptomatic forms to more commonly critical pulmonary forms called "Acute Respiratory Distress Syndrome". The elderly population is more at risk for this infection due to the senescence of the immune system, co-morbidities and poly medications. They also often present a greater state of fragility. This study aims to report the epidemiology of the first 50 patients over 90 years of age hospitalized within the CHU Brugmann hospital.

NCT04499300
Conditions
  1. Covid19
Interventions
  1. Other: Data collection from medical files
MeSH:Infection

Primary Outcomes

Description: Age, sex, ethnicity

Measure: Demographic data

Time: 5 minutes

Description: Smoking, Obesity, Diabetes, Arterial hypertension, Coronary pathology, Cerebrovascular disease, chronic renal failure, chronic obstructive pulmonary disease, Neoplasia, Autoimmune disease, Chronic liver disease

Measure: Comorbidities

Time: 5 minutes

Description: CIRS-G quantifies burden of disease in elderly patients (comorbidity scale). Higher scores indicate higher severity (maximum score = 56 points).

Measure: Cumulative Illness Rating Scale-Geriatric (CIRS-G)

Time: 5 minutes

Description: Under Chronic corticosteroid therapy or Immunosuppressive therapy

Measure: Treatments

Time: 5 minutes

Description: Presence and date of first apparition: Fever, Cough, Dyspnea, Chest pain, Nausea or vomiting, Diarrhea, Fatigue, Anosmia, ageusia, inappetence, Confusion, Fall, Fracture

Measure: Signs and symptoms

Time: 5 minutes

Description: Vital signs at hospital admission: Fever

Measure: Fever

Time: 5 minutes

Description: Vital signs at hospital admission: Hypoxemia

Measure: Hypoxemia

Time: 5 minutes

Description: Vital signs at hospital admission:Tachycardia

Measure: Tachycardia

Time: 5 minutes

Description: Vital signs at hospital admission: Hypotension

Measure: Hypotension

Time: 5 minutes

Description: Vital signs at hospital admission: Gasometry

Measure: Gasometry

Time: 5 minutes

Description: Contact with confirmed covid person before admission, lives in a retirement home with other cases, Initial bacterial or viral co-infection, Bacterial or viral co-infection during the hospital stay

Measure: Infectious data

Time: 5 minutes

Description: Blood count at hospital admission or first recorded

Measure: Blood count

Time: 5 minutes

Description: Ionogram at hospital admission or first recorded

Measure: Ionogram

Time: 5 minutes

Description: Liver function at hospital admission or first recorded

Measure: Liver function

Time: 5 minutes

Description: Coagulation at hospital admission or first recorded

Measure: Coagulation

Time: 5 minutes

Description: Renal function at hospital admission or first recorded

Measure: Renal function

Time: 5 minutes

Description: Albumin at hospital admission or first recorded

Measure: Albumin

Time: 5 minutes

Description: CRP at hospital admission or first recorded

Measure: CRP

Time: 5 minutes

Description: Fibrinogen at hospital admission or first recorded

Measure: Fibrinogen

Time: 5 minutes

Description: D-dimers

Measure: D-dimers at hospital admission or first recorded

Time: 5 minutes

Description: NTproBNP at hospital admission or first recorded

Measure: NTproBNP

Time: 5 minutes

Description: CK at hospital admission or first recorded

Measure: CK

Time: 5 minutes

Description: Troponin at hospital admission or first recorded

Measure: Troponin

Time: 5 minutes

Description: Ferritin at hospital admission or first recorded

Measure: Ferritin

Time: 5 minutes

Description: Procalcitonin at hospital admission or first recorded

Measure: Procalcitonin

Time: 5 minutes

Description: Highest rate of CRP, D-Dimers, Urea, Creatinin, Fibrinogen, CK, Troponins

Measure: Biology - highest rate

Time: 5 minutes

Description: Lowest rate of hemoglobin, platelets, leucocytes, lymphocytes, albumin, Na+, K+

Measure: Biology - lowest rate

Time: 5 minutes

Description: Percentage of pulmonary involvement on chest CT scan

Measure: Percentage of pulmonary involvement on chest CT scan

Time: 5 minutes

Description: Number of pulmonary lobes affected

Measure: Number of pulmonary lobes affected

Time: 5 minutes

Description: Type of lesions as reflected on the CT scan images: 'Ground glass' or 'Crazy paving'

Measure: Type of lesions

Time: 5 minutes

Description: Need for oxygenotherapy (yes/no)

Measure: Need for oxygenotherapy

Time: 5 minutes

Description: Means of ventilation

Measure: Means of ventilation

Time: 5 minutes

Description: Hydroxychloroquine or Azithromycin

Measure: Treatment received

Time: 5 minutes

Description: Length of ICU Stay

Measure: Length of ICU Stay

Time: 5 minutes

Description: One of the following choices: death, went back home, went back to a retirement home, was placed in a revalidation unit.

Measure: Status at hospital exit

Time: 5 minutes

Description: 28-day mortality after PCR / CT scan / diagnosis

Measure: Mortality

Time: 5 minutes
360 Genetic Mechanisms Underlying SARS-CoV-2 Infection and the Impact of COVID-19 on Cognitive Function

There is a considerable variation in the disease behavior in terms of contracting the infection, manifesting none to a range of symptoms and severity of the infection among individuals exposed to or infected with SARS-CoV-2 virus, the causative organism of COVID-19. Although the respiratory system appears to be the primary target of this virus infection, emerging evidences suggests involvement of extra-pulmonary organs including central nervous system. We aim to compare the genetic profile of individuals with vs without COVID-19 after being exposed to infected cases. Additionally, we will assess the cognitive function in covid-19 positive cases with vs. without neurological symptoms at the time of infection and 1-month follow-up using the Montreal Cognitive Assessment (MoCA) questionnaire.

NCT04506229
Conditions
  1. Covid19
Interventions
  1. Genetic: Whole exome sequencing
MeSH:Infection

Primary Outcomes

Description: Evaluate variants in the following known COVID-associated genes, ACE2R, IFITM, HLA-B 46, HLA-B 15, Toll Like Receptor and IFN-1, LIST, Perforin and mutations in Chromosome 3p21.31 along with novel genetic variants.

Measure: Genetic variants with vs without COVID-19

Time: 1 day

Description: Assess the cognitive status at baseline using MoCA survey in patients with vs without neurological symptoms

Measure: Cognitive function at baseline

Time: 1 day

Secondary Outcomes

Description: change in the MoCA score from baseline in patients with vs without neurological symptoms

Measure: Change in cognitive function at 1 month

Time: 1 month

Description: compare the genetic variants in patients with no or mild to moderate vs severe symptoms

Measure: Genetic analysis

Time: 1 day
361 A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia

This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation

NCT04508075
Conditions
  1. SARS-CoV2 Infection
Interventions
  1. Biological: SARS-CoV-2 vaccine (inactivated)
  2. Biological: Placebo
MeSH:Infection

Primary Outcomes

Description: Percentage of laboratory-confirmed COVID-19 cases

Measure: Incidence of laboratory-confirmed COVID-19 after the second dose

Time: 14 days to 6 months after the second dose

Secondary Outcomes

Description: Percentage of suspected COVID-19 cases

Measure: Incidence of suspected COVID-19 cases

Time: within 14 days to 6 months after the second dose.

Description: Percentage of laboratory-confirmed cases (severe, critical, death)

Measure: Incidence of laboratory-confirmed cases (severe, critical and death)

Time: within 14 days to 6 months after the second dose

Description: Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches

Measure: Seroconversion rate anti-S antibody IgG titer (ELISA)

Time: 14 days after two doses of vaccination

Description: Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches

Measure: Seroconversion rate anti-S antibody IgG titer (ELISA)

Time: 6 months after two doses of vaccination

Description: Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches

Measure: Seropositive rate of neutralizing antibodies

Time: 14 days after two doses of vaccination

Description: Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches

Measure: Seropositive rate of neutralizing antibodies

Time: 6 months after two doses of vaccination

Other Outcomes

Description: Number of Local reactions and systemic events

Measure: Local reaction and systemic events

Time: 30 minutes to 14 days after each vaccination

Description: Number of Local reactions and systemic events

Measure: Local reaction and systemic events occurring after the last vaccination

Time: 14 days to 28 days following last vaccination

Description: Number of any SAE occur

Measure: Serious adverse events during study

Time: 6 months after the last dose
362 A Rapid Research Platform to Inform Prevention & Improve the Clinical Management of COVID-19 Illness for Priority Older Adult Groups: The McMaster Multi-regional Hospital Coronavirus Registry

The McMaster Multi-Regional Hospital Coronavirus Registry (COREG) is a platform that is collecting detailed case data on laboratory confirmed COVID-19 hospital inpatients and outpatients. The COREG platform will provide rapid high-quality evidence to improve the prevention and clinical management of COVID-19 for older adults in Canada, and internationally. The COREG platform will also provide researchers and partners with complete regional level clinical data on COVID-19 cases to inform rapid decision-making and projections, sub-studies, extensions, and linkage for all affected populations.

NCT04508959
Conditions
  1. Coronavirus Infection
  2. Coronavirus
  3. SARS-CoV-2 Infection
  4. Covid19
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Defined as symptomatic hospital outpatients with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) through the COREG platform.

Measure: Serious COVID-19 infection

Time: through study completion, an average of 1 year

Description: Defined as persons admitted with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform. We will also conduct sub analyses of hospital acquired COVID-19 also captured in the COREG platform.

Measure: Severe infection (requiring admission)

Time: through study completion, an average of 1 year

Description: Defined as persons who died with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform.

Measure: COVID-19 related death

Time: through study completion, an average of 1 year

Secondary Outcomes

Description: Days from admission to discharge.

Measure: Length of stay

Time: through study completion, an average of 1 year

Description: New or increased severity of conditions and syndromes from pre-morbid state.

Measure: Complications

Time: through study completion, an average of 1 year

Description: Rate of intensive interventions during hospital stay.

Measure: Intensive interventions

Time: through study completion, an average of 1 year
363 Randomized Trial of Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

COVID-19 outcomes are worse in male patients. Androgen signaling, therefore, is a target for clinical exploration. TMPRSS2 is a membrane protease required for COVID pathogenesis that is regulated by androgens. Blocking TMPRSS2 with bicalutamide may reduce viral replication and improve the clinical outcome. Therefore, the study proposes to test bicalutamide at 150 mg oral daily dosing in a double-blind placebo-controlled randomized trial in male patients with early symptomatic COVID-19 disease.

NCT04509999
Conditions
  1. COVID-19
Interventions
  1. Drug: Bicalutamide 150 Mg Oral Tablet
  2. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: COVID-19 symptom relief at day 28, and % of COVID-19 symptom relief and its 95% confidence interval (CI) will be calculated using the exact binomial distribution and compared using Fisher's exact test.

Measure: Proportion x 100 = percent of patients with improved COVID-19 symptoms

Time: Day 28
364 CT Abnormalities Evocative of Lung Infection Are Associated With Lower 18F-FDG Uptake in Confirmed COVID-19 Patients

CT signs that are evocative of lung COVID-19 infections have been extensively described, whereas 18F-FDG-PET signs have not. Our current study aimed to identify specific COVID-19 18F-FDG-PET signs in patients that were (i) suspected to have a lung infection based on 18F-FDG-PET/CT recorded during the COVID-19 outbreak and (ii) whose COVID-19 diagnosis was definitely established or excluded by appropriate viral testing.

NCT04512118
Conditions
  1. Presence of COVID-19 Compatible CT Abnormalities
Interventions
  1. Diagnostic Test: PET-CT of 18F-FDG
MeSH:Infection Congenital Abnormalities

Primary Outcomes

Description: Visual analysis of the pulmonary lobes by calculating a extent score for each patient

Measure: Visual analysis of pulmonary lobes

Time: 1 day

Secondary Outcomes

Description: Measurement of metabolic activity with SUV max of lung areas with CT abnormalities

Measure: Measurement of metabolic activity

Time: 1 day
365 Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection

This study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.

NCT04513158
Conditions
  1. Covid19
Interventions
  1. Biological: Convalescent Plasma
MeSH:Infection

Primary Outcomes

Description: Measured by respiratory rate >30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration <300 and received a medical diagnosis of respiratory failure, septic shock or multiple

Measure: Determine the therapeutic efficacy (response rate) of convalescent plasma infusion in patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19).

Time: Through study completion, an average of 30 days

Secondary Outcomes

Description: SARS-CoV-2 Ag levels through RT-PCR

Measure: Determine the immunologic effects of convalescent plasma infusion

Time: Through study completion, an average of 14 days

Description: Measure normalization of laboratory parameters for risk

Measure: Absolute lymphocyte count (10*3/uL)

Time: Through study completion, an average of 14 days

Description: Measure normalization of laboratory parameters for risk

Measure: reatinine kinase (mg/dL)

Time: Through study completion, an average of 14 days

Description: Measure normalization of laboratory parameters for risk

Measure: C-reactive protein (mg/dl)

Time: Through study completion, an average of 14 days

Description: Measure normalization of laboratory parameters for risk

Measure: D-Dimer (ng/ml FEU)

Time: Through study completion, an average of 14 days

Description: Measure normalization of laboratory parameters for risk

Measure: Interleukin-6 (pg/ml)

Time: Through study completion, an average of 14 days

Description: Measure normalization of laboratory parameters for risk

Measure: Ferritin (ng/mL)

Time: Through study completion, an average of 14 days
366 Reliability of Standardized Protocol of Ultrasound of the Lungs in Prediction of Severity, Length of Hospitalization and Long-term Complications and of Covid-19 Infection

Ultrasound can reliably detect morphologic changes associated with pneumonia. Additionally, protocols were elaborated which unify the investigation procedure and improve the intra- and interrater reliability. Moreover, ultrasound is a time and cost-effective and widely available method. The aim of this study is to evaluate the efficacy of the ultrasound of the lungs in predicting the length of hospitalization, of intensive care and of mechanical ventilation in Covid-19 pneumonia. Further aims are the evaluation of the efficacy of the ultrasound of the lungs in predicting the risk of death and of long-term pulmonary complications as consequences of Covid-19 pneumonia.

NCT04513210
Conditions
  1. Covid19
MeSH:Infection

Primary Outcomes

Description: Comparison of percentage of patients with oxygenation index drop below 300 mmHg during 14 after inclusion between group with and without changes in the ultrasound on admission.

Measure: Relation of changes in ultrasound and progression to respiratory failure

Time: Through study completion, an average of 1 year.

Description: Comparison of frequency of intensive care, ventilator use and of the number of days of hospital stay, between group with signs of pneumonia vs. group without signs of pneumonia in the ultrasound, on the day of admission.

Measure: Impact of ultrasonographic pneumonia signs on the day of admission on severity of COVID-19 infection

Time: Through study completion, an average of 1 year.

Secondary Outcomes

Description: Correlation of the score reflecting severity of ultrasonographic pneumonia signs with oxygen saturation of arterial blood and with oxygen and carbon dioxide partial pressure in repetitive measurements.

Measure: Sensitivity of ultrasonographic pneumonia signs in detecting respiratory failure

Time: Through study completion, an average of 1 year.

Description: Correlation of the score reflecting severity of ultrasonographic pneumonia signs with the volume of lung interstitium affected by pneumonia, measured in high resolution computer tomography scans.

Measure: Sensitivity of ultrasound in detecting interstitial changes in the lungs

Time: Through study completion, an average of 1 year.

Description: Comparison of frequency of intensive care, ventilator use and of the number of days of hospital stay, between group which improved and which did not improve in the score reflecting severity of ultrasonographic pneumonia signs from the measurement on the day of admission to measurement five days later.

Measure: Impact change in severity of ultrasonographic pneumonia signs on severity of COVID-19 infection

Time: Through study completion, an average of 1 year.
367 Cross Sectional Survey Of Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COV-2) Infection And Seroprevalence In A Cohort Of HIV-Infected Children, Youth, And Adolescents Receiving Care At A Single Tertiary Care Medical Center In Miami-Dade County, Florida

The main purpose of this research study is to learn the rate of SARS COV-2 on HIV infected children, adolescents, and youth receiving their primary HIV care at the University of Miami Miller School of Medicine. We will be using a Real Time Polymerase Chain Reaction (RT-PCR) assay collected by a nasopharyngeal (nose) swab. RT-PCR is a real time test that can detect the amount of genetic material of a specific virus.The study is funded by The Miami Center for AIDS Research (CFAR)

NCT04514016
Conditions
  1. SARS-CoV Infection
  2. Covid19
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: SARS COV-2 Infection will be analyzed from nasopharyngeal swab samples via RT-PCR assay

Measure: Number of participants who tested positive with SARS COV-2 Infection

Time: month 3

Description: SARS COV-2 antibody will be analyzed from blood samples via serological assay

Measure: Number of participants who tested positive with SARS COV-2 antibody

Time: month 3
368 Efficacy and Safety of Edoxaban and or Colchicine for Patients With SARS-CoV-2 Infection Managed in the Out of Hospital Setting

There is emerging evidence that patients with SARS-CoV-2 are affected by increased coagulopathy, including in the most advanced forms, a fully blown disseminated intravascular coagulation, leading to multi organ failure (MOF). Post-Morten observations from patients who died because of SARS-CoV-2 infection in Bergamo, Italy and other places have revealed the presence of diffuse venous, arterial and microcirculatorythrombosis, not only restricted to the lung but also involving the kidneys, heart and gut. Thrombin plays a central role in mediating clot forming as well as in mediating inflammation. A direct factor X inhibitor, namely edoxaban can act as prophylactic measure to mitigate the risk of venous and arterial thrombotic complications. Colchicine is an inexpensive (generic drug), orally administered, and a potent anti-inflammatory medication. It might accelerate SARS-CoV-2 clearance. The aim of the CONVINCE study is therefore to assess the safety and efficacy of edoxaban and/or colchicine administration in SARS-CoV-2 infected patients who are managed outside the hospital with respect to the occurrence of fatalities, hospitalisation, major vascular thrombotic events or the SARS-CoV-2 clearance rate under RT PCR.

NCT04516941
Conditions
  1. SARS-CoV Infection
  2. COVID-19
Interventions
  1. Drug: Edoxaban Tablets
  2. Drug: Colchicine Tablets
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To assess the effect of edoxaban versus no active treatment on the composite endpoint of asymptomatic proximal deep-vein thrombosis, symptomatic proximal or distal deep-vein thrombosis, symptomatic pulmonary embolism or thrombosis, myocardial infarction, ischemic stroke, non-CNS systemic embolism or death at day 25 (+/-3) after randomization.

Measure: Edoxaban vs. no active treatment

Time: Baseline to day 25

Description: To assess the effect of colchicine versus no active treatment on the SARS-CoV-2 clearance rates under RT PCR or freedom from death or hospitalisation at day 14 (+/-3) after randomization.

Measure: Colchicine vs no active treatment

Time: Baseline to day 14

Secondary Outcomes

Description: An intraluminal filling defect on CT scan or MR venography in the IVC or iliac veins.

Measure: Number of patients with asymptomatic proximal deep-vein thrombosis

Time: Baseline to day 25

Description: Typical symptoms of DVT associated with non-compressible vein segment on ultrasonography or an intra-luminal filling defect on venography, CT venography or MRI venography,located in the inferior vena cava (IVC), the iliac vein, the common femoral vein, the femoral or the popliteal vein.

Measure: Number of patients with symptomatic proximal or distal deep-vein thrombosis

Time: Baseline to day 25

Description: Typical symptoms of PE associated with an intra-luminal filling defect in (sub) segmental or more proximal branches on spiral computed tomography scan (CT) or computerized tomographic pulmonary angiography (CTPA). a considerable perfusion defect (~ 75% of a segment) with a local normal ventilation result (high probability) during perfusion-ventilation lung scan (PLS, VLS or V/Q scan). an intraluminal filling defect or a sudden cut-off of vessels (~more than 2.5 mm in diameter) on a catheter guided pulmonary angiogram. In case of an inconclusive CTPA, inconclusive V/Q scan or inconclusive angiography demonstration of DVT in the lower extremities e.g. by compression ultrasound or venography will be required

Measure: Number of patient with symptomatic pulmonary embolism or thrombosis

Time: Baseline to day 25

Description: For the primary analysis, MI endpoint will be defined based on the third universal definition of myocardial infarction with the exception of periprocedural MI after PCI, which will be defined according to the SCAI definition.

Measure: Number of patients with myocardial infarction

Time: Baseline to day 25

Measure: Number of patients with ischemic stroke

Time: Baseline to day 25

Description: Ischemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by CNS infarction

Measure: Number of patients with non-CNS systemic embolism

Time: Baseline to day 25

Description: Death will be classified in 5 categories with respect to cause. Thromboembolism, cardiovascular, bleeding, Pulmonary other known cause. In general, all deaths will be assumed to be due to thromboembolism or pulmonary in nature unless another cause is obvious

Measure: Number of deaths

Time: Baseline to day 25

Description: Need for non-invasive or invasive ventilation

Measure: Ventilation need

Time: Baseline to day 25
369 Acute Kidney Injury In Subjects With Severe Acute Respiratory Syndrome Due to SARS-CoV2 Infection

Severe pneumoniae related to Coronavirus Disease (COVID-19), had a high in-hospital mortality; this condition are worst in subjects with acute kidney disease (AKI); conditioning increased mortality, days of assisted mechanical ventilation (AMV), increased nosocomial infections and high costs. We need many studies for determinated the risk factors for AKI in subjects with COVID-19. This study pretends identify the incidence of AKI in subjects with severe pneumoniae by COVID-19, describe the role of some biomarkers in the physiopathology of AKI-COVID-19; and determine the evolution of urinary biomarkers during hospitalization, like neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor binding protein-7 (IGFBP7), and interleukin-6 (IL-6) and the progression of viruria of Severe Acute Respiratory Syndrome (SARS) related to CoronaVirus 2 (CoV2) in subjects with or without AKI.

NCT04517630
Conditions
  1. Coronavirus Infection
  2. Covid19
  3. SARS (Severe Acute Respiratory Syndrome)
  4. AKI
Interventions
  1. Diagnostic Test: urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: To estimate the strength of association between the elevation of urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 and the development of AKI associated with SARS-CoV-2 pneumonia

Measure: Urinary levels of renal biomarkers

Time: Seven days

Secondary Outcomes

Description: Describe the incidence of AKI in critically ill patients with severe COVID-19 pneumonia

Measure: Incidence of AKI

Time: One month

Description: Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with mortality

Measure: Urinary levels of renal biomarkers and mortality

Time: 30 days

Description: Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with teh severity of the disease.

Measure: Urinary levels of renal biomarkers and severity of the disease.

Time: 30 days

Description: Identify possible risk factors (epidemiological, clinical, paraclinical, use of nephrotoxic agents) for the development of AKI in critically ill patients with COVID-19 pneumonia.

Measure: Risk factors for AKI in severe COVID-19

Time: 30 days

Description: Compare the evolution over time of renal function markers (NGAL, TIMP-2 and IGFBP7) in patients with and without kidney injury.

Measure: Evolution renal biomarkers

Time: 7 days

Description: Compare the evolution over time of the SARS-CoV-2 viral load in patients with and without acute kidney injury.

Measure: Evolution of viral load

Time: 7 days

Description: Analyze the complement pathway in urine and compare its evolution over time in patients with and without acute kidney injury and SARS-CoV-2 infection.

Measure: Evolution of complement pathway

Time: seven days

Description: Analyze the metabolomic profile in urine in patients with and without acute kidney injury with SARS-CoV-2 infection.

Measure: Metabolomic profile

Time: 7 days

Description: Describe partial arterial oxygen concentration/inspired oxygen faction (PaO2/FiO2) ratio and radiologic evolution in patients with severe SARS COV2 pneumonia.

Measure: Respiratory changes

Time: 30 days

Other Outcomes

Description: Stablish the nosocomial infections in subjects with or without AKI

Measure: Nosocomial Infections

Time: 30 days
370 Retrospective Pilot Study of Vitamin D Status and Immune-inflammatory Status in Different UK Populations With COVID-19 Infection

Our hypothesis: Serum Vitamin D (25(OH)D) is significantly lower in severe versus non-severe COVID-19 infections and that this is a function of ethnicity. There is an association between vitamin D status and various cytokines (pro-inflammatory molecules). The primary objective of this research is to provide a snap shot of vitamin D status in patients from the South-East London area by age, sex, ethnicity and BMI and demonstrate ethnic differences in vitamin D status as well as its associations with severe vs non-severe COVID-19 infections. The secondary objective is to determine if there is an association between vitamin D status and various cytokines (pro-inflammatory molecules) and severity of disease.

NCT04519034
Conditions
  1. Covid19
Interventions
  1. Other: no intervention
MeSH:Infection

Primary Outcomes

Description: All vitamin D results performed by the Nutristasis Unit at St. Thomas' since January 2020 (N= ~15000) together with age, weight and height if available, ethnicity and other relevant laboratory markers (Ca, adjusted calcium, PTH, Mg, phosphate, liver and renal profile, Covid-19 screening, CRP, Haematinics, FBC) if they were tested within two weeks of the sample being measured for vitamin D will be acquired. The results of this audit will provide us with a snap shot of vitamin D status in patients from the South-East London area by age, sex, ethnicity and BMI (weight in kg/height2). Correlation analysis will also be undertaken with other laboratory parameters.

Measure: Collecting vitamin D results in patients from the South-East London area together with age, sex, ethnicity and BMI and other relevant laboratory results.

Time: January-June 2020

Secondary Outcomes

Description: All Covid-19 screening results together with vitamin D (nmol/L), ethnicity, age (yrs), weight (m) and height to obtain BMI, length of stay in hospital including ICU in days (if applicable), type of illness, recovered or not (y or no), associated health conditions, CRP, Ferritin, Haematinics, vitamin A and E, procalcitonin, LDH, INR, fibrinogen, FBC, D-dimers, CK, Troponin-T, cytokines, renal function and electrolytes will be collected from patients tested at GSTT NHS Trust. We expect that only a small number of patients who had Covid-19 screening performed would have had vitamin D, cytokines and other markers measured. However, we estimate that we will be able to identify a sufficient number of Covid-19 patients for regression and correlation analysis from this data.

Measure: Collecting Covid-19 screening results together with age, sex, ethnicity and BMI and other relevant laboratory results.

Time: March-June 2020
371 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
372 Antibodies Responses to SARS-CoV 2 Infection (COVID-19) in Hospitalized Patients. A Prospective Observational Study

1.5. Why this clinical study? The prevalence of seropositivity following SARS-CoV 2 infection might have its own potential benefits in terms of predicting the end of pandemic and the validity of herd immunity. It is not clear if SARS-CoV 2 infection would have a long-lasting antibody-mediated immunity, and if the antibodies' persistence is dependent on disease severity.depends on the severity of illness. If evidence is provided about the persistence of antibodies that is reflective of the protective immune response, serodiagnosis will be an important tool to identify individuals with various risk for infection, and those who are in need of receiving the forthcoming vaccines. The here proposed prospective clinical study will test the prevalence of seropositivity following SARS-CoV 2 infection in critically ill patients compared to those who do not require intensive care unit (ICU) admission or invasive ventilation with respect to the IgM and IgG levels.

NCT04520880
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV 2 Infection)
  2. Hospitalized Patients
  3. Laboratory-confirmed SARS-CoV 2 Infection
Interventions
  1. Diagnostic Test: Testing procedure for Binding antibodies
  2. Diagnostic Test: Neutralizing antibodies
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The measurements are dependent on epitope recognitions for synthetic, adsorbed S proteins

Measure: Changes in the levels of S specific antibodies in severely ill patients compared to mild cases.

Time: Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: The measurements are dependent on epitope recognitions for synthetic, adsorbed N proteins

Measure: Changes in the levels of N specific antibodies in severely ill patients compared to mild cases.

Time: Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infection

Secondary Outcomes

Description: Titers of the S specific binding antibodies of SARS-CoV-2 would be assayed as described in the interventions

Measure: S specific binding antibodies of SARS-CoV-2

Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: Titers of the N specific binding antibodies of SARS-CoV-2 would be assayed as described in the interventions

Measure: N specific binding antibodies of SARS-CoV-2

Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: Titers of the neutralizing antibodies directed against S protein of SARS-CoV-2 would be assayed as described in the interventions

Measure: Neutralizing antibodies directed against S protein of SARS-CoV-2

Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: The severity category of critically ill patients would be estimated using an APACHI II score. Minimum score = 0; maximum score = 71.

Measure: The severity category of critically ill

Time: Day 0, 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: Length of ICU stay from the admission day to the ICU

Measure: Length of ICU

Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: Length of hospital stay from the hospital admission day

Measure: Length of hospital stays

Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: If the patients alive or dead through a telephone interview.

Measure: Alive status at 28-days

Time: For 28 days after the onset of symptoms of SARS-Cov2 infection

Description: If the patients alive or dead through a telephone interview.

Measure: Alive status at 90-day

Time: For 90 days after the onset of symptoms of SARS-Cov2 infection

Description: To correlate the levels of S neutralizing antibodies in severely ill patients compared to mild cases.

Measure: Correlation between the levels of S neutralizing antibodies and disease severity

Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: To correlate the levels of N neutralizing antibodies in severely ill patients compared to mild cases.

Measure: Correlation between the levels of N neutralizing antibodies and disease severity

Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infection
373 A Double-blind, Placebo-controlled, Phase 2 Trial of Sublingual Low-Dose Thimerosal in Adults With Symptomatic SARS-CoV-2 Infection

Clinical trial to compare sublingual low does thimerosal in adults that have symptoms of SARS-CoV-2 Infection against placebo to show a difference in physical characteristics and viral levels.

NCT04522830
Conditions
  1. SARS-CoV-2 Infection
Interventions
  1. Drug: BTL-TML-COVID
  2. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Change from baseline in the physical component summary of the short form-36 Quality of Life Instrument

Measure: Mean duration and severity of disease

Time: Two days

Secondary Outcomes

Description: AEs will be assessed by the investigator as to severity, duration and relationship to treatment

Measure: Number of participants with treatment related adverse events

Time: Baseline through 14 days
374 COVID19-OR (SARS-CoV-2):Observation, Risk & Recovery. An Observational Study Exploring Risk Assessment and Recovery From COVID-19 (SARS-CoV-2) Infection in Hospitalised Patients

A novel coronavirus, designated corona virus disease 2019 (COVID-19) has resulted in a Pandemic at the time of writing (27th April) the reported number of confirmed cases exceeding 3 million and over 200000 associated deaths. The burden on global critical care has been considerable. As of 24th April there have been 8752 UK critical care admissions with services under considerable strain, and a mortality rate over 50%. Survivors of critical illness will require significant input. This study will perform mixed methods to provide rich data on risk stratification and recovery from critical illness. Recovery from a novel disease requires documenting and the study reports physical and psychological changes following hospital discharge in survivors. In addition qualitative interviews are being conducted with patients who have survived and been discharged from critical care along with their relatives and treating professionals, to better understand their needs during recovery.

NCT04524520
Conditions
  1. Exploring Risk Assessment and Recovery From COVID-19 Infection in Hospitalised Patients
MeSH:Infection

Primary Outcomes

Description: Chelsea critical care physical assessment tool

Measure: Physical

Time: through study completion , an average of 1 year

Description: Incremental Shuttle Walk Test (ISWT)

Measure: Physical

Time: through study completion , an average of 1 year

Description: 1- minute Sit to Stand, Grip strength

Measure: Physical

Time: through study completion , an average of 1 year

Description: Short Form Survey on health related quality of life (SF-12). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. Higher scores indicate better outcome.

Measure: Health Related Quality of life

Time: at 3 months

Description: Short Form Survey on health related quality of life (SF-36). Scores can range from 0 to 100 and a higher score indicates better outcome.

Measure: Health Related Quality of life

Time: at 1 year

Description: Depression Test Questionnaire (PHQ-9). Scores range from 1 to 27 and higher scores indicate worse outcome.

Measure: Psychological

Time: through study completion , an average of 1 year

Description: Anxiety Test Questionnaire (GAD-7). Scores range from 0 to 21 and higher scores indicates worse outcome.

Measure: Psychological

Time: through study completion , an average of 1 year

Description: Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30 and higher scores indicate a better outcome.

Measure: Psychological

Time: through study completion , an average of 1 year

Description: Post-traumatic stress disorder (PTSD) Trauma Screening (TSQ). A screening tool with 10 items. If 6 items are endorsed then the outcome is 'positive' for PTSD.

Measure: Psychological

Time: at 1 year

Secondary Outcomes

Description: escalation to critical care (Yes/No)

Measure: risk stratification

Time: through study completion and average of 1 year

Description: mechanical ventilation (Yes/No)

Measure: risk stratification

Time: through study completion and average of 1 year

Description: critical care stay hospital stay (number of days)

Measure: risk stratification

Time: through study completion and average of 1 year
375 MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients

While many people with COVID-19 suffer from respiratory disease, there is growing evidence that the virus also affects other organs. The purpose of this study is to better understand the effects of COVID-19 on the lungs and other organs. The study investigators have developed new techniques in Magnetic Resonance Imaging (MRI) to scan the lungs, heart, brain and liver. The study investigators hope to learn more about how the virus causes inflammation in these organs and how this inflammation changes over time as people recover from COVID-19 illness. The study aims to enroll 228 people in Alberta. Participants will undergo one or more MRI scans and have blood testing at one or more time points to assess for inflammation, kidney function, liver function and possible heart injury. Participants will also undergo testing to assess sense of smell, cognition (thinking and memory), spirometry (breathing test for lung function) and and exercise tolerance (walk test). The study investigators hope this study will help us learn more about the long-term risks of COVID-19 disease.

NCT04525404
Conditions
  1. Covid19
  2. Coronavirus Infection
  3. SARS-CoV Infection
Interventions
  1. Diagnostic Test: MRI (heart, brain, lungs, kidney)
  2. Diagnostic Test: Bloodwork
  3. Other: Cognitive testing
  4. Other: Olfaction testing
  5. Diagnostic Test: Spirometry
  6. Other: Walk Test
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Myocardial T1 is a surrogate marker of myocardial edema and the most sensitive MRI measure of acute myocarditis. We will show that myocardial T1 at baseline is significantly higher than myocardial T1 at 12 weeks follow-up. At 12 weeks, we will also compare native myocardial T1 in patients with baseline elevated troponin to those with baseline normal troponin as well as healthy controls

Measure: Native myocardial T1 relaxation time

Time: 12 weeks post COVID-19 diagnosis

Secondary Outcomes

Description: Similar within group and between group comparisons of MRI derived lung water content, liver water content, and the presence of brain inflammation on FLAIR imaging

Measure: FLAIR imaging

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week cognitive testing (NIH toolbox score) to the corresponding findings on MRI of brain, heart and lung at baseline

Measure: Compare 12-week cognitive testing to the corresponding findings on MRI of brain, heart and lung at baseline

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week spirometry (FEV1, FVC and FEV1:FVC) to the corresponding findings on MRI of brain, heart and lung at baseline

Measure: Compare 12-week spirometry to the corresponding findings on MRI of brain, heart and lung at baseline

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week walk test results (distance and time) to the corresponding findings on MRI of brain, heart and lung at baseline

Measure: Compare 12-week walk test results to the corresponding findings on MRI of brain, heart and lung at baseline

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI

Measure: Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI

Time: 12 weeks post COVID-19 diagnosis

Description: Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic

Measure: Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic

Time: 12-24 weeks post COVID-19 diagnosis
376 High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study

The world is currently facing a pandemic with the coronavirus (SARS-CoV-2) which leads to the disease of COVID-19. Risk factors for a poor outcome of COVID-19 have so far been identified as older age and co-morbidity including chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and current smoking status. Previous studies found, that vitamin D deficiency is more prevalent among patients with these risk factors. There are observational studies reporting independent associations between low serum concentrations of 25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute respiratory tract infection. Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should therefore be investigated for efficacy and safety. The study is designed as a randomized, placebo-controlled, double blind study. The objective of the study is to test the hypothesis that patients with vitamin D deficiency suffering from COVID-19 treated under standardized conditions in hospital will recover faster when additionally treated with a single high dose of vitamin D compared to standard treatment only.

NCT04525820
Conditions
  1. Covid19
  2. Vitamin D Deficiency
  3. Corona Virus Infection
  4. ARDS
  5. Coronavirus
  6. SARS-CoV Infection
Interventions
  1. Drug: Single high dose vitamin D
  2. Drug: Placebo
  3. Drug: Treatment as usual vitamin D
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Vitamin D Deficiency
HPO:Low levels of vitamin D

Primary Outcomes

Description: Overall duration of the hospitalization from day of admission until the day of discharge or fatality

Measure: Length of hospitalization

Time: Administration to Discharge from hospital care (mean duration is between 14 and 22 days for Patients with COVID 19)

Secondary Outcomes

Description: Did the patient need a intensive care treatment during the hospitalization (yes/no)

Measure: Need of intensive care

Time: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: Day of admission to ICU until discharge or fatality

Measure: Lenght of the Intensive Care Treatment

Time: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: Percentage of patient died during hospitalization

Measure: Overall mortality

Time: During the length of hospitalisation (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: percentage of patients with 25-hydroxyvitamin D > 50nmol/L (>20ng/mL) at day 7 - The values of calcium, phosphorus, 24-hydroxyvitamin D, 1.25-dihydroxyvitamin D, parathyroid hormone.

Measure: Development of vitamin D levels

Time: Day 1 (Baseline) and Day 7 after the first administration of the high dose vitamin D or the placebo and at discharge (mean hospital stay is between 14 and 22 days for Patients with COVID-19)

Description: percentage of patients developing a sepsis

Measure: Development of sepsis

Time: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)

Other Outcomes

Description: We assess every other complications which occurs due to COVID-19

Measure: Complications due to COVID-19

Time: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: The BP will be assessed daily in mmHg

Measure: Blood pressure (BP)

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: The heart rate will be assessed daily in bpm

Measure: Heart rate

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: The SpO2 will be assessed daily in %

Measure: Peripheral oxygen saturation (SpO2)

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)

Description: Requirement for oxygen will be assessed daily (yes/no) if yes how many liters per minute

Measure: Percentage of patients who require oxygen

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)

Description: Breathing frequence will be assessed daily in breaths per minute

Measure: Breathing frequency

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)

Description: GCS will be assessed daily 3 to 15 points. It describes the extent of impaired consciousness. 15 points means no impairment, 3 points means severe impairment of consciousness.

Measure: Glasgow Coma Scale (GCS)

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)

Description: Assessing the history of smoking in pack years (PY). the assessment will be made with the following options for answering Current smoker: Smoking for how many years? Cigarettes per day? Former smoker, how many years smoked? How many cigarettes per day Life-long non-smoker

Measure: Percentage of patients are smokers, former smokers or lifelong non-smokers

Time: Assessing of the smoking Status at Basleine

Description: Assessed in No/ Mild/ Moderate /Severe

Measure: Current Symptoms

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)

Description: Temperature will be assessed daily in degrees celsius

Measure: Temperature

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)
377 Phase 1, Open Label, Single Arm Study to Evaluate the Safety, Tolerability and Efficacy of MPT0B640 in Patients With COVID-19 Infection

Indication : Treatment of Subject with COVID-19 infection Phase : Phase I Duration of Study : 12 day Sample size : at least 15 subjects Methodology : Classical 3+3 design Investigational Product : MPT0B640, 15, 30, 60, 80 and 100mg, oral suspension Study Objective 1. Primary Objective To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640 2. Secondary Objectives To evaluate the safety and tolerability of MPT0B640 during entire study period To assess the efficacy of MPT0B640 To characterize the 48 hours PK of MPT0B640

NCT04526717
Conditions
  1. Covid19
Interventions
  1. Drug: MPT0B640
MeSH:Infection

Primary Outcomes

Description: MTD is defined as highest dose level in which 6 subjects have been treated with less than 2 instances of DLT. DLT assessed during the study treatment period (28 ± 2 days) refers to a medically significant event which meets one of the criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Measure: MTD

Time: 28days(+/-2days)

Secondary Outcomes

Description: Viral load change (log10 viral load assessed by reverse transcription-qPCR)

Measure: Viral load

Time: Time Frame: Day 1, 3, 5, 7, 9 and 12

Description: Assessed TTCI with WHO clinical progression scale by measuring clinical status daily. TTCI is defined as the time (in days) from initiation of study treatment until a decline of one category on WHO clinical progression scale which ranges from 0 (uninfected; no viral RNA detected) to 10 (death)

Measure: Time to clinical improvement

Time: Time Frame: dialy up to Day 10

Other Outcomes

Description: Cmax

Measure: Pharmacokinetic (PK)

Time: Day 1,3 and 5.

Description: Ctrough

Measure: Pharmacokinetic (PK)

Time: Day 1,3 and 5.

Description: AUCτ

Measure: Pharmacokinetic (PK)

Time: Day 1,3 and 5.
378 Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel at All Levels of Care, During the 2020 Pandemic: A Randomized Clinical Controled Trial

It will be performed a randomized, multicenter, triple-masked, placebo-controlled clinical experiment to determine the effectiveness and safety of the administration to of ivermectin at a dose of 200 mcg/kg once a week for 7 weeks in a prophylactic treatment against SARS COV-2 infection in 550 Colombian health workers during the COVID-19 pandemic.

NCT04527211
Conditions
  1. Covid19
  2. Healthcare Worker Patient Transmission
Interventions
  1. Drug: Ivermectin
MeSH:Infection

Primary Outcomes

Description: Development of of the disease according to the definitions of cases found in the guidelines from the Colombian National Institute of Health

Measure: Clinical development of covid-19 disease during the intervention period

Time: 8 weeks

Secondary Outcomes

Description: Indicate if the patient had positive serological antibodies at the end of the study

Measure: Seroconversion

Time: 8 weeks

Description: Need for hospitalization independent of the level of complexity due to covid-19

Measure: Hospitalization requirement

Time: 8 weeks

Description: ICU need due to Covid-19

Measure: Intensive Care Unit Requirement

Time: 8 weeks

Description: Adverse effect due to medication or placebo

Measure: Safety of the intervention

Time: 8 weeks
379 Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection (PICOV) A Multicentre Academic Prospective Cohort Study in Nursing Home During the Winter Season 2020-2021

Background: Each Belgian winter season is characterized by a wave of influenza like and respiratory symptoms. Especially, the elderly people are more vulnerable to be infected by influenza, but also RSV. The recent COVID-19 pandemic and eventually a next wave, will increase the prevalence of influenza like and respiratory symptoms. Method: A multicentre non-commercial cohort study will be conducted in nursing home staff and residents during the Winter season 2020-2021. Objectives: Primary objective is the difference in incidence of influenza like and respiratory symptoms between cases (cases have evidence of past infection with SARS-CoV-2, referred to as Covid +) and controls (controls have no evidence of previous infection and are referred to as Covid -). The primary outcome analysis as well as the secondary outcome analyses will use two strata: nursing home staff and nursing home residents. The secondary objectives are the difference in incidence of COVID-19, influenza, RSV infections confirmed by PCR between cases and controls, to define a correlate of protection in the covid + group against re-infection with SARS-CoV-2 based on the study of the pre-existing antibody profile (antigen specificity, antibody type and antibody level) at the time of re-exposure. A multiplex assay will be used to assess the antibody profile. Finally, to study the COVID-19 disease severity (7 point WHO ordinal scale, this includes a.o. hospitalisation, mechanical ventilation need and ICU admission, mortality) based on the presence/absence of pre-existing antibodies and the pre-existing antibody profile. For other respiratory infections we will study the need for hospitalization and mortality.

NCT04527614
Conditions
  1. Influenza, Human
  2. SARS Vi
  3. SARS Virus
  4. COVID-19
  5. Espiratory Tract Infections
Interventions
  1. Diagnostic Test: qRT-PCR and serology
MeSH:Infection Communicable Diseases Respiratory Tract Infections Influenza, Human
HPO:Respiratory tract infection

Primary Outcomes

Description: This study will assess the time to the occurrence of influenza-like illness (ILI) or acute respiratory infection (ARI) in subjects previously COVID+ compared to subjects known as COVID- (controls), more specifically subjects will belong to two subgroups: nursing home residents (65+) and nursing home staff (18-65y). COVID+ is defined as a past SARS-CoV-2 infection.

Measure: Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls

Time: up to 8 months

Secondary Outcomes

Measure: Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV

Time: up to 8 months

Measure: Validation of (SimplySpiro) to replace nasopharyngeal swabs

Time: up to 8 months

Measure: Identify the antibody characteristics in participants with reinfection with SARS-CoV-2

Time: up to 8 months

Description: Disease severity will be measured by hospitalization and mortality

Measure: Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity.

Time: up to 8 months

Measure: Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection

Time: up to 8 months
380 Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection. A Multicenter, Interventional, Randomized, Three Arms Study Design

SARS-CoV-2 infection seems to induce in most critical cases an excessive and aberrant hyper-inflammatory host immune response that is associated with a so-called "cytokine storm", moreover pro-thrombotic derangements of haemostatic system is another common finding in most severe forms of COVID19 infections, which may be explained by the activation of coagulative cascade primed by inflammatory stimuli, in line with what is observed in many other forms of sepsis. Targeting inflammatory responses exploiting steroids' anti-inflammatory activity along with thrombosis prevention may be a promising therapeutic option to improve patients' outcome. Despite the biological plausibility, no good evidence is available on the efficacy and safety of heparin on sepsis patients, and many issues have to be addressed, regarding the proper timing, dosages and administration schedules of anticoagulant drugs. The primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin (UFH) or with steroids and low molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days. The study is designed as a multicenter, national, interventional, randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned in a ratio 1:1:1 to one of the three treatment groups: LMWH group, LMWH+steroids or UFH+steroid group. A possible result showing the efficacy of the composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease.

NCT04528888
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Pneumonia, Viral
  4. Coagulopathy
Interventions
  1. Drug: Enoxaparin
  2. Drug: Methylprednisolone
  3. Drug: unfractionated heparin
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Critical Illness
HPO:Pneumonia

Primary Outcomes

Description: All-cause mortality at day 28, defined as the comparison of proportions of patients death for any cause at day 28 from randomization.

Measure: All-cause mortality at day 28

Time: Day 28 from randomization

Secondary Outcomes

Description: All-cause mortality at ICU discharge, defined as the comparison of proportions of patients death for any cause at ICU discharge.

Measure: All-cause mortality at ICU discharge

Time: from randomization to ICU discharge, censored at day 30

Description: All-cause mortality at Hospital discharge, defined as the comparison of proportions of patients death for any cause at hospital discharge

Measure: All-cause mortality at hospital discharge

Time: from randomization to ICU discharge, censored at day 90

Description: Occurrence of rescue administration of high-dose steroids or immune-modulatory drugs

Measure: Need of rescue administration of high-dose steroids or immune-modulatory drugs

Time: from randomization to ICU discharge, censored at day 28

Description: Occurrence of new organ dysfunction during ICU stay. Organ dysfunction is defined as a Sequential Organ Failure Assessment (SOFA) score ≥3 for the corresponding organ occurring after randomization.

Measure: New organ dysfunction during ICU stay

Time: From randomization to ICU discharge, censored at day 28

Description: Grade of organ dysfunction during ICU stay, grade of dysfunction is measured with Sequential Organ Failure Assessment (SOFA) score daily from randomization to day 28 or ICU discharge.

Measure: Grade of organ dysfunction during ICU stay

Time: From randomization to ICU discharge, censored at day 28

Description: Total number of days between ICU discharge and day 28. If death occurs during the ICU stay before day 28 the ICU free days calculation will be 0. The ICU readmission before day 28 after randomization will be considered.

Measure: ICU free days at day 28

Time: From randomization to day 28

Description: Occurrence of new infections including bacterial infections, fungal infections by Candida, Aspergillus, and viral reactivations including Adenovirus, Herpes Virus e Cytomegalovirus

Measure: Occurrence of new infections

Time: from randomization to day 28

Description: Total number of days that patient is alive and free of ventilation between randomisation and day 28. Ventilation is considered as positive pressure ventilation, either invasive or non-invasive. Periods of assisted breathing lasting less than 24 hours for surgical procedures will not count against the ventilation free days calculation.

Measure: Ventilation free days at day 28

Time: From randomization to day 28, censored at hospital discharge

Description: Total number of days that patient is alive and free of vasopressors between randomisation and day 28.

Measure: Vasopressors free-days at day 28

Time: From randomization to day 28, censored at hospital discharge

Description: Occurrence of switch from non-invasive to invasive mechanical ventilation

Measure: Switch from non-invasive to invasive mechanical ventilation

Time: from randomization to ICU discharge, censored at day 28

Description: Total number of hours from start of non-invasive to invasive ventilation to switch to invasive ventilation

Measure: Delay from start of non-invasive ventilation to switch to invasive ventilation

Time: from randomization to ICU discharge, censored at day 28

Description: Adverse events occurred from randomization to day 28. Events that are part of the natural history of the primary disease process or expected complications of critical illness will not be reported as adverse events.

Measure: Occurrence of protocol related adverse events

Time: From randomization to day 28

Description: Occurrence of objectively confirmed venous thromboembolism, stroke or myocardial infarction

Measure: Occurrence of venous thromboembolism, stroke or myocardial infarction

Time: from randomization to ICU discharge, censored at day 28

Description: Occurrence of major bleeding defined as transfusion of 2 or more units of packed red blood cells in a day, bleeding that occurs in at least one of the following critical sites [intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal], bleeding that necessitates surgical intervention and bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death)

Measure: Occurrence of major bleeding (safety end point)

Time: from randomization to ICU discharge, censored at day 28

Description: Occurrence of clinically relevant non-major bleeding defined ad acute clinically overt bleeding that does not meet the criteria for major and consists of any bleeding compromising hemodynamic; spontaneous hematoma larger than 25 cm2, or 100 cm2, intramuscular hematoma documented by ultrasonography, haematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures; haemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention or any other bleeding requiring temporary cessation of a study drug.

Measure: Occurrence of clinically relevant non-major bleeding (safety end point)

Time: from randomization to ICU discharge, censored at day 28

Other Outcomes

Description: Mean arterial pressure will be measured in millimeters of mercury

Measure: Mean arterial pressure

Time: Daily from inclusion until ICU discharge, censored day 28

Description: hearth rate will be measured in beats per minute

Measure: hearth rate

Time: Daily from inclusion until ICU discharge, censored day 28

Description: respiratory rate will be measured in breaths per minute

Measure: respiratory rate

Time: Daily from inclusion until ICU discharge, censored day 28

Description: diuresis will be measured daily in milliliters of urine output in the previous 24 hours

Measure: diuresis

Time: Daily from inclusion until ICU discharge, censored day 28

Description: systemic body temperature will be measured in celsius degrees

Measure: systemic body temperature

Time: Daily from inclusion until ICU discharge, censored day 28

Description: fluid balance will be measured in milliliters of fluids input and output in the previous 24 hours

Measure: fluid balance

Time: Daily from inclusion until ICU discharge, censored day 28

Description: Haemoglobin will be measured in mg/dl

Measure: Haemoglobin concentration

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: platelets count will be measured in U 10^3/mm^3

Measure: platelets count

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: white blood cells count will be measured in U per 10^9/L

Measure: white blood cells count

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: troponin will be measured in µg/L

Measure: troponin

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: coagulative function will be measured with parameters INR, PT, aPTT

Measure: coagulative function

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: D-dimer will be measured in µg/ml

Measure: D-dimer

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: anti-thrombin will be measured as a percentage

Measure: anti-thrombin

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: liver function will be assessed through measurement of AST, ALT in U/L

Measure: Liver function

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Bilirubin will be measured in mg/dL

Measure: Bilirubin

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Creatinine will be measured in mg/dL

Measure: Creatinine

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Blood cells count will be measured in Units per x 10^9/L of blood

Measure: Blood cells count

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: C-reactive protein (CRP) will be measured in mg/dl

Measure: C-reactive protein (CRP)

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: procalcitonin(PCT) wiull be measured in ng/ml

Measure: procalcitonin(PCT)

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: interleukin 6 (IL-6) will be measured in pg/ml

Measure: interleukin 6 (IL-6)

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: Ventilation mode will be cathegorized in spontaneous breathing, invasive or non invasive ventilation

Measure: Ventilation mode

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: inspired oxygen fraction will be measured in percentage of oxygen in inspired air

Measure: inspired oxygen fraction

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Gas exchanges will be assessed by measurement of PaO2, PaCO2 in mmHg by arterial blood gas analysis

Measure: Gas exchanges

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: lactates will be measured in mMol/L

Measure: lactates

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: pH will be measured in pH scale

Measure: pH

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: oxygen saturation in blood will be measured in arterial and venous samples in percentage values

Measure: oxygen saturation in blood

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: New blood, respiratory and urinary-tract infections will be recorded

Measure: New infections

Time: From randomization to day 28

Description: Viral reactivation measured by CMV DNA titres will be recorded.

Measure: Viral reactivation

Time: From randomization to day 28

Description: Need of new renal replacement therapy (intermittent haemodialysis or continuous veno-venous hemofiltration) will be recorded.

Measure: Need of new renal replacement therapy

Time: from randomization to day 28

Description: Adjunctive treatment such as pronation cycles, Nitric Oxide or ECMO will be recorded

Measure: Adjunctive treatments

Time: from randomization to ICU discharge (censored at day 28);
381 Relationship Between In-person Instruction and COVID-19 Incidence Among University Students: A Prospective Cohort Study

Whether university teaching on campus with infection control measures in place is associated with higher risk of COVID-19 than online instruction, is unknown. The investigators will assess this by conducting repeated surveys among students at universities and university colleges in Norway, where some instruction is given in-person, and some is provided online (hybrid model). The investigators will ask about the students' COVID-19 status, and how much in-person and online instruction the students are getting. The investigators will estimate the association between in-person instruction and COVID-19-risk using multivariate regression, controlling for likely confounders. The investigators will also assess whether type of instruction is associated with how satisfied the students are with the instruction the students are offered, their quality of life, and learning outcomes.

NCT04529421
Conditions
  1. Infection
  2. Infection Control
Interventions
  1. Behavioral: Online instruction
  2. Behavioral: In-person instruction
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Self-reported positive test results

Measure: COVID-19 incidence

Time: Through study completion, i.e. 4 months.

Secondary Outcomes

Description: Self-reported ("Overall, how satisfied are you with life right now?")

Measure: Quality of life

Time: Through study completion, i.e. 4 months.

Description: Self-reported ("Overall, how satisfied have you been with the teaching you have received in the past 14 days?")

Measure: Satisfaction with teaching

Time: Through study completion, i.e. 4 months.

Description: Self-reported

Measure: COVID-19 testing incidence

Time: Through study completion, i.e. 4 months.

Description: Exam results from Common Student System

Measure: Learning outcome

Time: End of term, December 2020.
382 Recombinant Human C1 Esterase Inhibitor (Ruconest®) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial in the United States (PROTECT-COVID-19-US)

The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC) in patients admitted for stage II COVID-19 infection may reduce the risk of disease progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster clinical improvement compared to SOC alone.

NCT04530136
Conditions
  1. Confirmed Coronavirus Disease
Interventions
  1. Drug: Ruconest
MeSH:Infection Coronavirus Infections

Primary Outcomes

Description: The primary endpoint will be the disease severity on the 7-point WHO Ordinal Scale on day 7. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19

Measure: Disease Severity on the 7-Point WHO Ordinal Scale

Time: Assessed on each day after enrollment (worst status) with the use of the WHO Ordinal Scale and the score on day 7 will be analyzed stratified by its baseline value

Secondary Outcomes

Description: at least 2 points Ordinal Scale for Clinical Improvement, clinical severity will be assessed.

Measure: Clinical improvement

Time: Daily until day 14

Description: Admission to ICU with invasive or non-invasive ventilation or death will be assessed.

Measure: Invasive or non-invasive ventilation

Time: Daily until day 14.

Description: Patients with ALI within 14 days after enrollment, PaO2/FiO2 will be determined daily. This is only relevant for patients with arterial blood gas sampling performed in the ICU or rarely in the medical unit.

Measure: Acute Lung Injury

Time: Daily until day 14.
383 Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus

This is a Brazilian version of the Clinical Characterization Protocol for Serious Emerging Infections (ISARIC/WHO ). This is a standardized protocol for the rapid, coordinated clinical investigation of Coronavirus disease (COVID-19). Patients with acute illness suspected to be caused by emerging will be enrolled. This protocol has been designed to enable data to be prospectively collected.

NCT04531202
Conditions
  1. Coronavirus Infection (COVID-19)
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Describe the clinical features of the illness or syndrome and complications, and determinants of severity. Assessment daily for 14 days, then hospital discharge.

Measure: Clinical characterization of coronavirus disease-2019 (COVID-19)

Time: 1 year
384 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
385 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
386 Pegylated Interferon Lambda for Treatment of COVID-19 Infection- A Randomized Open Label Pilot Trial

A randomized, open-label, 2 arm, pilot trial of Lambda 180 mcg administered subcutaneously once weekly, for up to two weeks (2 injections at most), in addition to standard supportive care, compared to standard supportive care alone, in a population of COVID-19 infected patients. patients will be randomized according to 1:1 ratio to one of the 2 trial arms: Lambda 180 mcg S.C + standard care (intervention arm) or standard care only (control arm).

NCT04534673
Conditions
  1. COVID-19
Interventions
  1. Drug: Lambda 180 mcg S.C
MeSH:Infection

Primary Outcomes

Description: The duration of viral shedding in days since initial diagnosis, as determined by RT-PCR to COVID-19.

Measure: Viral shedding in days since initial diagnosis

Time: 21 days

Description: Rate of treatment-emergent and treatment-related severe adverse events (SAEs)

Measure: Rate of adverse events and severe adverse events

Time: 21 days from entry

Secondary Outcomes

Description: the time (in hours) from initiation of trial treatment (Lambda or standard care) until normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours.

Measure: Time to clinical recovery

Time: 72 Hours

Description: Requirement for non-invasive (bipap) or mechanical ventilation

Measure: Rate of non-invasive or mechanical ventilation

Time: 28 Days

Description: length of hospital stay from admission to discharge

Measure: Length of hospital stay

Time: 28 Days

Description: All-cause mortality

Measure: All-cause mortality

Time: At day 28 following admission to the hospital

Description: Rate of undetectable COVID-19 virus levels at different days

Measure: Undetectable COVID-19 virus levels

Time: At days 7,14 and 21 from admission
387 Bacillus Calmette-Guérin Vaccination To Prevent Serious Respiratory Tract Infection And Covid-19 In Vulnerable Elderly - An Adaptive Randomized Controlled Trial

On March 11 2020 the World Health Organization (WHO) declared the coronavirus (SARS-CoV-2) outbreak a pandemic. Worldwide, the number of confirmed cases continues to rise, leading to significant morbidity and mortality. In the Netherlands, although the incidence is currently low due to social distancing measures, recurrence of infections is expected once measures are going to be lifted. Although individuals of any age can acquire SARS-CoV-2, adults of middle and older age are at highest risk for developing severe COVID-19 disease. Moreover, recent reports demonstrate that mortality rates rise significantly among patients 60 years and older. Therefore, strategies to prevent SARS-CoV-2 infection or to reduce its clinical consequences in vulnerable populations are urgently needed. Bacille Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but also induces protection against various respiratory infections, including those with a viral etiology. We hypothesize that BCG vaccination reduces clinically relevant respiratory tract infections requiring medical intervention, including COVID-19, in vulnerable elderly. The objective of this trial is to determine the impact of BCG vaccination on the incidence of clinically relevant respiratory infections or COVID-19 in vulnerable elderly. The trial is designed as an adaptive multi-center double-blind randomized placebo-controlled trial. The attempt is to include 5,200 to 7,000 vulnerable elderly, defined as ≥60 years of age being discharged from hospital in the last 6 weeks, or visiting a medical outpatient clinic, thrombosis care services, or chronic renal replacement departments. Patients with contraindications to BCG vaccination as stipulated in the Summary of Product Characteristics (SPC) and patients with a history of COVID-19 will be excluded. Participants will be randomized between intracutaneous administration of BCG vaccine (Danish strain 1331) or placebo (0.1ml 0.9% NaCl) in a 1:1 ratio.The trial has an adaptive primary endpoint. Based on accrual of the two endpoints, the primary endpoint will be either (a) COVID-19 or (b) clinically relevant respiratory tract infection requiring medical intervention, potentially including COVID-19 episodes. The other will be declared secondary endpoint. Other secondary endpoints include: all SARS-CoV-2 infections (including asymptomatic infections), influenza infection, acute respiratory infection (ARI; all infections regardless of medical intervention), ARI-related hospital admission, COVID-19 related hospital admission, pneumonia, mental, physical and social functioning, serious adverse events and adverse events, and death.

NCT04537663
Conditions
  1. Respiratory Tract Infections
  2. Covid19
Interventions
  1. Drug: Bacille Calmette-Guérin (BCG)
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Tract Infections
HPO:Respiratory tract infection

Primary Outcomes

Description: Clinically relevant relevant respiratory tract infection is composed of clinical symptoms in combination with the need for medical intervention. Exact criteria for clinically relevant respiratory tract infection and COVID-19 are described in the protocol. A blinded adjudication committee will determine the status of the primary endpoints of all participants with a potential primary endpoint, based on information provided in a standardized narrative using data reported by the participant and from GP and hospital medical records when relevant. For detection of ARI, symptoms are checked on a weekly (from week 1-4) or bi-weekly basis (from week 4 onward).

Measure: The trial has an adaptive primary endpoint. Based on predefined objective and quantitative criteria the primary endpoint will be either a clinically relevant respiratory tract infection, or COVID-19.

Time: 180 days

Secondary Outcomes

Description: Cumulative incidence of SARS-CoV-2 infection regardless of symptomatology defined as having had COVID-19 as described under primary endpoints above and/or SARS-CoV-2 positive test in real time as part of the test-and-trace program of the Dutch government and/of documented SARS-CoV-2 seroconversion at 6 months. Seroconversion will be defined as antibody-positive at 6 months but negative at baseline.

Measure: Cumulative incidence of SARS-CoV-2 infection (irrespective the presence of symptoms)

Time: 180 days

Measure: Cumulative incidence of asymptomatic, mild/moderate, and severe (requiring hospitalization) SARS-CoV-2 infection.

Time: 180 days

Description: Defined as either of 1) ARI + microbiological evidence of influenza infection, 2) seroconversion of influenza between enrolment and month 6.

Measure: Influenza infection

Time: 180 days

Description: Meeting the definition stated in the primary outcome. Irrespective of requiring an intervention.

Measure: An acute respiratory tract infection

Time: 180 days

Description: Meeting the definition stated in the primary outcome including the requirement of an intervention.

Measure: Medically attended acute respiratory tract infection

Time: 180 days

Description: Meeting the definition stated in the primary outcome including the need of hospitalization.

Measure: Acute respiratory tract infection related hospital admission

Time: 180 days

Measure: Pneumonia diagnosed by a GP or medical specialist

Time: 180 days

Description: Using the Katz Activities of Daily Living (ADL) scale, from A (fully independent) to G (dependent in feeding, continence, transferring, going to toilet, dressing, and bathing)

Measure: Functioning in daily activities

Time: 180 days

Measure: Serious adverse events and adverse events.

Time: 180 days

Measure: Major cardiovascular events

Time: 180 days

Measure: All cause 6-month mortality

Time: 180 days

Measure: History of falls

Time: 180 days

Description: Using the EQ5D quality of life instrument, with questions on 4 domains (mobility, self-care, usual activities, pain discomfort) and the percepted health of the participant with 100 meaning the best health you can imagine, and 0 meaning the worst health you can imagine

Measure: Quality of life using the EQ5D quality of life instrument

Time: 180 days

Description: Using the 6-item Lawton Activities of Daily Living questionnaire, with scores ranging from 0 (low function, dependent) to 8 (high function, independent) for women (0 through 5 for men)

Measure: Activities in daily living

Time: 180 days
388 The Prevalence of SARS-CoV-2 IgG Antibody Formation in Physicians at Advocate Lutheran General Hospital and Their Household Members

This study is a community hospital-based study that will enhance information being obtained in similar studies taking place in France, Denmark, and China. These studies are designed to assess risk of healthcare workers during outbreaks of Coronavirus 2019 (COVID-19) also known as sudden acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). This will be a prospective, single-center observational study involving human subjects. IgG (Immunoglobulin G) antibody will be tested in the serum of physicians working at Advocate Lutheran General Hospital (ALGH). IgG antibodies are the antibodies that form in response to viral or bacterial infections and typically reflect protection against said infection. To date, there have been no studies confirming that IgG antibody formation confers immunity, but studies are ongoing. Furthermore, data is lacking showing conclusive persistence of (possibly protective) antibodies over time. Attending physicians on the medical staff, fellow physicians, and house staff residents who worked at ALGH from March 1st, 2020 and on, will be eligible for the study. Testing will involve a venipuncture to obtain approximately 3mL of blood to be sent to ACL Laboratories for SARS-CoV-2 IgG testing. For physician subjects, this will be performed on four separate occasions, once at the onset of the study, a second test 3 months after the first test, a third test 6 months from the time of the first test, and a fourth and final test 12 months after the initial test. Two household members (defined below), one-time testing will occur within 2 weeks of the physician subject testing positive. All testing will be performed in a two-week window. All physician subjects will be tested at a centralized site that is only serving these subjects, by appointment. We will be offloading testing for household members to one localized commercial ACL site on the ALGH campus at the Center for Advanced Care. The household member testing will be extended to an additional two-week period after the two week window in which physicians are tested for a total of four weeks maximum. One-time testing for IgG antibodies to COVID-19 will be offered to a maximum of two household members, as defined as, any person over the age of 18 years old who has lived at home with the physician, who has tested positive for IgG antibodies, for at least 2 weeks in total duration since March 1st, 2020. The physician will be permitted to choose who gets tested, and the chosen adult subject will provide their independent consent to be tested.

NCT04540484
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Communicable Disease
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Identifying positive COVID-19 IgG formation

Time: up to 1 year

Secondary Outcomes

Description: The prevalence of COVID-19 serum IgG in physician participants at study entry, 3 months, 6 months, and 12 months after enrollment.

Measure: Physician Prevalence of COVID-19 serum IgG

Time: up to 1 year

Description: The prevalence of COVID-19 serum IgG in household members (as defined above) of physician participants that are positive at the time the associated physician tested positive.

Measure: Household Member Prevalence of COVID-19 serum IgG

Time: up to 1 year

Description: The differences in prevalence of COVID-19 IgG in physician participants that are deemed to be at minimum, moderate or high risk of COVID-19 exposure.

Measure: Physician Risk of Exposure

Time: up to 1 year

Description: The differences in prevalence of COVID-19 IgG in household members of physician participants that are positive for COVID-19 IgG.

Measure: Physician and Household Member Transmission

Time: up to 1 year

Description: The correlation between IgG prevalence and previous COVID-19 symptoms - a means of quantifying the presence of asymptomatic carriers amongst the medical staff, an important and heretofore poorly described vector of transmission.

Measure: Asymptomatic Infection

Time: 1 year

Description: The correlation between the prevalence of seropositivity and adherence to best practices regarding the use of personal protective equipment.

Measure: PPE Use and Positivity

Time: up to 1 year

Description: The development of COVID19 infections in physicians at our hospital over the test period of 12 months, and its correlation to Covid19_IgG positivity. This will allow us to understand the persistence of the antibody and its potential neutralizing power, over time.

Measure: Antibody Persistence

Time: up to 1 year
389 Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection: An Open Label Feasibility Study

The emergence of asymptomatic patients poses a significant challenge to the prevention and treatment of the epidemic.There have not been any treatment options that reduce the viral load or preventive options that reduce the risk of developing severe conditions.Therefore, present feasibility study of the safety and efficacy of Guduchi Ghan Vati was conducted in asymptomatic patients with COVID-19

NCT04542876
Conditions
  1. Covid19
Interventions
  1. Drug: Guduchi Ghan Vati
MeSH:Infection

Primary Outcomes

Description: Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result

Measure: Virologic clearance

Time: 14 days

Secondary Outcomes

Description: Total duration of stay in hospital for complete recovery

Measure: Hospital Stay

Time: 14 days

Description: Clinically relevant adverse effects of Guduchi Ghan Vati were reported using Adverse Drug Reaction reporting form

Measure: Clinically relevant adverse effects

Time: 14 days

Description: Routine blood tests were performed to assess complete blood counts, blood biochemistry parameters {Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Urea, C-reactive protein (CRP), as well as Albumin} and immunoglobulines.

Measure: Laboratory tests

Time: change from baseline to 14 days
390 COVID-19-Related Health and Practices Among Dental Hygienists

As dental practices reopen their practices during a global pandemic, the risk of 2019 novel coronavirus (COVID-19) infection that dental hygienists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. These findings could be used to describe the prevalence and incidence of COVID-19 among dental hygienists, determine what infection control steps dental hygienists take over time, describe dental hygienists' employment during the COVID-19 pandemic, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.

NCT04542915
Conditions
  1. SARS-CoV Infection
  2. Anxiety
  3. Depression
  4. Occupational Problems
  5. Severe Acute Respiratory Syndrome
  6. Coronavirus Infection
Interventions
  1. Other: No intervention
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: 2019 novel coronavirus (COVID-19) case as confirmed by clinician and/or detection of SARS-CoV-2 antigen or antibody

Measure: COVID-19 probable or confirmed case

Time: 18 months

Secondary Outcomes

Description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety.

Measure: Anxiety

Time: 12 months

Description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms.

Measure: Depression

Time: 12 months

Description: Self-reports of infection control efforts in the respondents' primary dental practices.

Measure: Dental practice infection control efforts

Time: 12 months

Description: Availability, frequency of use, and frequency of reuse of personal protective equipment

Measure: Personal protective equipment

Time: 12 months

Description: Self-descriptions of current level of employment as a dental hygienist and reasons for non-employment.

Measure: Employment status

Time: 12 months
391 A Prospective Analysis of the Quality and Quantity of Antibiotic Prescriptions for Bacterial Respiratory Tract Superinfection in Patients Hospitalized in COVID-19 Wards of a Tertiary University Hospital During the COVID-19 Pandemic

In this prospective observational study, a quantitative and qualitative analysis of antibiotic prescriptions for presumed respiratory tract (super)infection in patients hospitalized on COVID-19 wards will be made. Drivers of antibiotic prescription for presumed respiratory tract infection in patients suspected of being infected with COVID-19 or with definite COVID-19 infections will be identified.

NCT04544072
Conditions
  1. SARS-CoV Infection
  2. Antimicrobial Stewardship
  3. Respiratory Tract Infections
  4. Antibiotic Resistance
MeSH:Infection Communicable Diseases Respiratory Tract Infections Superinfection Coronavirus Infections Severe Acute Respiratory Syndrome
HPO:Respiratory tract infection

Primary Outcomes

Description: The total antibiotic use, expressed as Daily Defined Doses (DDD) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDD/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/hospitalization'.

Time: 7 months

Description: The total antibiotic use, expressed as Daily Defined Doses (DDD) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDD/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general. 1000 hospitalised patient days for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/1000 hospitalized patient days'.

Time: 7 months

Description: The total antibiotic use, expressed as Daily Doses of Administration (DDA) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDA/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily doses of administration/hospitalization'.

Time: 7 months

Description: The total antibiotic use, expressed as Daily Doses of Administration (DDA) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDA/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards, expressed as 'Daily doses of administration (DDA)/1000 hospitalized patient days'.

Time: 7 months

Secondary Outcomes

Description: The degree of appropriateness for each antibiotic (AB) formulation separately but also for all prescribed antibiotics in general, with distinction between 'Appropriate', 'Unnecessary', 'inappropriate' and 'suboptimal' AB choice. Results will be expressed as DDD or DDA of appropriate AB/1000 patient days, DDD or DDA of unnecessary AB/1000 patient days, DDD or DDA of inappropriate AB/1000 patient days and DDD or DDA of suboptimal AB/1000 patient days. Used units: g/1000 hospitalized patients days

Measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection

Time: 7 months

Description: The degree of appropriateness for each antibiotic (AB) formulation separately but also for all prescribed antibiotics in general, with distinction between 'Appropriate', 'Unnecessary', 'inappropriate' and 'suboptimal' AB choice. Results will be expressed as DDD or DDA of appropriate AB/hospitalization, DDD or DDA of unnecessary AB/hospitalization, DDD or DDA of inappropriate AB/hospitalization and DDD or DDA of suboptimal AB/hospitalization. Used units: g/hospitalization

Measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection, denominator 2

Time: 7 months

Description: The number of C. Difficile infections in the inpatient setting

Measure: Rate of Clostridioides Difficile infections

Time: 7 months

Description: median or mean age (number) , comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in age comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: median or mean weight (kg), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in weight comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of comorbidities expressed as mean Charlson Comorbidity Index score, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in amount of comorbidities comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of chronical pulmonary disease, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in rate of chronical pulmonary disease as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of haematological or solid neoplasia, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in rate of haematological or solid neoplasia as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of diabetes mellitus, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in rate of diabetes mellitus as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of patients with fever (t°>38°c), dyspnea, cough, runny nose, throat pain, thoracic pain, myalgia, fatigue, anosmia, confusion at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: significant difference in rate of patients with presence or not of at least one suggestive symptom of COVID-19 symptomatology, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of patients rate of patients having received an antibiotic prescription for a suspicion of respiratory tract infection during the 3 weeks before hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 surinfection and the group without antibiotics?

Measure: significant difference in rate of patients with recent AB prescription, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of patients with significant positive respiratory cultures, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in the rate of patients having had at least one positive significant respiratory germ culture, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of patients with oxygen suppletion need, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in the rate of patients needing oxygen supletion at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean duration of hospitalization on a COVID-ward, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: significant difference in the mean duration of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of ICU admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: significant difference in the rate of ICU admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean SatO2/FiO2 ratio (number ranging from 50-500), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in the mean value of oxygen saturation percentage over fractional oxygen percentage, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean/median qSOFA score at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in qSOFA score level at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: Rate of lymphopenia (<1250/mcl), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in the rate of lymphopenia, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean CRP values (mg/dl) at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of C-reactive protein measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean WBC count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of white blood cell count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean neutrophil count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of neutrophil count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean lymphocyte count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 surinfection and the group without antibiotics

Measure: significant difference in the mean value of lymphocyte count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean creatinine (mg/dl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of creatinine measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean LDH (U/L) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of LDH measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean bilirubin (mg/dl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of bilirubin measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean ferritin (mcg/l) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of ferritin (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean troponin (mcg/l) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of troponins (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean D-dimer (ng/ml) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of D-dimers (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months
392 Clinical and Biological Characteristics of Critically Ill Patients With COVID-19 Admitted to Pediatric Intensive Care Unit

In this prospective longitudinal cohort the investigators reported the clinical, and biological characteristics of all critically ill patients admitted in the pediatric intensive care unit (PICU) of Bicêtre Hospital during the 2019 coronavirus disease (COVID-19) pandemics. Patients were older than 37 weeks of gestational age. No upper limit was set as the unit was transiently converted into a pediatric "adult COVID-19" intensive care unit.

NCT04544878
Conditions
  1. Covid19
  2. Pediatric ALL
  3. Infection
  4. Critical Illness
  5. SARS-CoV Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Critical Illness

Primary Outcomes

Description: Secondary infection will include healthcare associated infections as well as sepsis, and septic shock

Measure: Number of patient with secondary infection

Time: 2 weeks

Secondary Outcomes

Description: mortality

Measure: Number of patients dying

Time: 7-day, 28-day and 60-day

Description: Description of the variable clinical phenotypes of COVID-19 in adults and children. This include COVID-19 respiratory failure, acute myocarditis and multi system inflammatory syndrome in children (MIS-C)

Measure: Description of clinical phenotypes

Time: through study completion, an average of 4 weeks

Description: Measure circulating cell phenotypes (relative percentage and monocyte classII histocompatibility complex

Measure: Description of immunological phenotypes

Time: through study completion, an average of 4 weeks
393 Efficacy of Dexamethasone Treatment for Patients With Acute Hypoxemic Respiratory Failure (Including ARDS) Caused by Infections (Including COVID-19)

Background: There are no proven therapies specific for pulmonary dysfunction in patients with acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial. Methods: This is a multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established AHRF (including ARDS) caused by confirmed pulmonary or systemic infections, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone: either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.

NCT04545242
Conditions
  1. Acute Hypoxemic Respiratory Failure
Interventions
  1. Drug: Dexamethasone
MeSH:Infection Respiratory Insufficiency

Primary Outcomes

Description: All-cause mortality at 60 days after randomization

Measure: 60-day mortality

Time: 60 days

Secondary Outcomes

Description: Number of ventilator-free days (VFDs) at Day 28 (defined as days being alive and free from mechanical ventilation at day 28 after randomization. For patients ventilated 28 days or longer and for subjects who die, VFD is 0.

Measure: Ventilator-free days

Time: 28 days
394 P-pVAC-SARS-CoV-2: Phase I Single-center Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults

Part I: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). No more than one subject per day will be enrolled. 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the data safety monitoring board (DSMB) as well as an amendment to the regulatory authorities (Paul-Ehrlich Institute and Ethics Committee) before proceeding to Part II. Part II: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study investigational medicinal product (IMP) (CoVac-1). 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the DSMB whether to proceed to next Part III. Part III: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). The aim of the clinical is to evaluate the safety and immunogenicity of a single use of a SARS-CoV-2-derived multi-peptide vaccine in combination with the toll like receptor (TLR)1/2 ligand XS15 in adults

NCT04546841
Conditions
  1. COVID-19 Vaccine
Interventions
  1. Biological: multipeptide cocktail
MeSH:Infection

Primary Outcomes

Description: ECOG (Scale 0-5)

Measure: Safety- Eastern Cooperative Oncology Group (ECOG) Status

Time: Day 28

Description: temperature (in grade centigrade)

Measure: Safety -Vital Signs 2

Time: Day 28

Description: blood pressure/pulse mmHg and bpm Follow-Up Days:Signs/symptoms, as assessed on volunteer's diary and visit

Measure: Safety -Vital Signs 3

Time: Day 28

Description: Alkaline phosphatase (AP) Unit: U/l

Measure: Safety-Blood Chemistry and Coagulation 1

Time: Day 28

Description: aspartate transaminase (AST/ SGOT) Unit: U/l

Measure: Safety-Blood Chemistry and Coagulation 2

Time: Day 28

Description: hemoglobin (Hb) Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing Unit: g/dl

Measure: Safety-Hematology 1

Time: Day 28

Description: red blood cells (RBC) Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing Unit: Mio/µl

Measure: Safety-Hematology 2

Time: Day 28

Description: platelet count (PLT) Unit: 1000/µl Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing

Measure: Safety-Hematology 3

Time: Day 28

Description: white blood cells (WBC) Unit: 1/µl Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing.

Measure: Safety-Hematology 4

Time: Day 28

Secondary Outcomes

Description: 60 ml of heparin blood for immunomonitoring and analysis of peptide specific T-cell response will be analyzed by the Walz lab, KKE Translational Immunologie at the Department of Immunology, Tuebingen (central laboratory). Blood will be taken before peptide vaccination on V1, and during vaccination phase and follow-up at each visit. Unit:Counts

Measure: CoVac-1 specific T-cell response

Time: Day 28
395 Recovery of Exertion Ability Following COVID-19 Infection in Military Staff

The Paris Fire Brigade staff have been particularly exposed to COVID-19 due to rescue and care activities for victims at risk in Paris area (where the virus was actively circulating). In addition, when the pandemic began in France, they had to take care of patients before procedures to protect caregivers were implemented. The contamination of young military personnel, whose physical capacity was put into strain at work, raises the question of the consequences of COVID-19 on their physical fitness. At the time, the medium- and long-term evolution of this disease and its possible repercussions on physical fitness are unknown. Moreover, like any soldiers who have been confined, they may present at least a cardio-respiratory deconditioning (sometimes independent of the disease making it difficult to distinguish between a sequelae of the infection or rehabilitation). Based on previous coronavirus epidemics (Sars-Cov 1 and Mers-Cov), it appears that long-term sequelae are possible even in mild forms and can result in an alteration of exertion ability. In the current context and in the absence of national or international recommendations on the return to physical activity, the French Armed Forces Health Service has proposed a simple management plan aiming at: i) allowing mass screening for possible exercise intolerance and targeting at-risk personnel, ii) allowing individualized re-training and iii) guaranteeing that military personnel can carry out their mission without jeopardizing their health.

NCT04548505
Conditions
  1. SARS-CoV Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Aerobic performance will be assessed through a test called VAMEVAL. VAMEVAL consists of running around a track marked out every 50 meters to the rhythm of a soundtrack that accelerates at a rate of 0.5 km/h in 2-minute increments until exhaustion or inability to maintain the pace of the race. The result of the test made on return to work will be compared to the last result on the same test performed before COVID-19 infection.

Measure: Magnitude of the decrease in aerobic performance on return to work

Time: Up to 18 months
396 A Pilot, Randomized, Placebo-Controlled Trial of GC4419 (Avasopasem Manganese) in Patients With Critical Illness Due to SARS-CoV-2 Infection (COVID-19)

A Trial of GC4419 in Patients with Critical Illness due to COVID-19

NCT04555096
Conditions
  1. Covid19
  2. SARS-CoV-2 Infection
Interventions
  1. Drug: GC4419
  2. Drug: Placebo
MeSH:Infection Critical Illness

Primary Outcomes

Measure: 28 day all-cause mortality

Time: 28 days
397 Clinical, Radiological, Lung Function, and Quality of Life Characterization of Patients With Severe/Critical Infection by SARS-COV-2 (COVID-19) Virus, After 6 and 12 Months of Hospital Discharge

A descriptive study to characterize clinical, radiological, lung function and quality of life alterations in patients who survived a severe or critical disease caused by SARS-COV-2 virus, who were treated in the intensive care unit of a high complexity institution in Cali, Colombia.

NCT04559100
Conditions
  1. Covid19
Interventions
  1. Radiation: chest radiography
  2. Radiation: thoracic computed tomography scan
  3. Diagnostic Test: spirometry
  4. Diagnostic Test: Diffusing capacity of carbon monoxide
  5. Diagnostic Test: 6 minute walk test
  6. Diagnostic Test: saint george respiratory questionnaire
MeSH:Infection

Primary Outcomes

Description: Spirometry in Liters

Measure: Lung function

Time: 6 months after hospital discharge

Description: Spirometry in Liters

Measure: Lung function

Time: 12 months after hospital discharge

Description: Diffusing capacity of carbon monoxide (% predicted)

Measure: Lung function

Time: 6 months after hospital discharge

Description: Diffusing capacity of carbon monoxide (% predicted)

Measure: Lung function

Time: 12 months after hospital discharge

Description: 6 min walk test in Meters

Measure: Lung function

Time: 6 months after hospital discharge

Description: 6 min walk test in Meters

Measure: Lung function

Time: 12 months after hospital discharge

Description: Alterations in chest radiography

Measure: Radiological alterations

Time: 6 months after hospital discharge

Description: Alterations in chest radiography

Measure: Radiological alterations

Time: 12 months after hospital discharge

Description: Alterations in thoracic CT scan

Measure: Radiological alterations

Time: 6 months after hospital discharge

Description: Alterations in thoracic CT scan

Measure: Radiological alterations

Time: 12 months after hospital discharge

Description: Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)

Measure: Quality of life alterations

Time: 6 months after hospital discharge

Description: Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)

Measure: Quality of life alterations

Time: 12 months after hospital discharge
398 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.
399 Identifying Functional and Psycho-social Complaints After Hospitalization for Severe SARS-CoV-2 Infection (COVID19)- REPERCOV

Since December 2019, China and then the rest of the world have been affected by the rapid spread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratory syndrome coronavirus), the clinical expression of which is called Covid-19 (Coronavirus Disease 2019). It is estimated that around 20% of symptomatic patients will be severe enough to warrant hospitalization, of which around 5% will be in intensive care. Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological, cardiovascular due to the infection or its care. There is also a psychological and social impact of the infection or of the care that should be measured. In this context, investigator will assess the physical and psychological complaints of patients who have presented a severe form of SARS-CoV-2 infection. The final objective being to identify the needs to offer follow-up adapted to this emerging pathology.

NCT04561154
Conditions
  1. SARS-COV2
  2. COVID19
Interventions
  1. Other: questionnaire
MeSH:Infection

Primary Outcomes

Description: the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Modified Medical Research Council"

Measure: Identify functionnal and psychosocial complaints

Time: 3 months after last hospitalization

Description: the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"

Measure: Identify functionnal and psychosocial complaints

Time: 3 months after last hospitalization

Description: the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by FRIED criteria

Measure: Identify functionnal and psychosocial complaints

Time: 3 months after last hospitalization

Description: the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"

Measure: Identify functionnal and psychosocial complaints

Time: 3 months after last hospitalization

Secondary Outcomes

Description: complaints will be assessed by questionnaire "Modified Medical Research Council"

Measure: description of functionnal and psychosocial complaints

Time: 3 months after last hospitalization

Description: complaints will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"

Measure: description of functionnal and psychosocial complaints

Time: 3 months after last hospitalization

Description: complaints will be assessed by FRIED criteria

Measure: description of functionnal and psychosocial complaints

Time: 3 months after last hospitalization

Description: complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"

Measure: description of functionnal and psychosocial complaints

Time: 3 months after last hospitalization

Description: Risk factors are defined according to age, concomitant treatment, comorbidities before hospitalization

Measure: Identify the factors favoring the persistence of complaints

Time: 3 months after last hospitalization

Description: Complaints will be assessed by questionnaire"Modified Medical Research Council"

Measure: Describe functional, neuropsychological and social complaints at a distance

Time: 3 months after last hospitalization

Description: Complaints will be assessed by questionnaire"Medical Outcome Study Short Form 36 (MOS SF-36)"

Measure: Describe functional, neuropsychological and social complaints at a distance

Time: 3 months after last hospitalization

Description: Complaints will be assessed by FRIED criteria

Measure: Describe functional, neuropsychological and social complaints at a distance

Time: 3 months after last hospitalization

Description: Complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"

Measure: Describe functional, neuropsychological and social complaints at a distance

Time: 3 months after last hospitalization

Description: Medical and surgical consultations after discharge will be measured as percentage

Measure: Describe the needs for medical and surgical consultations after discharge from hospital

Time: 3 months after last hospitalization

Description: neuropsychological support, dietetics, social assistance after discharge will be measured as percentage

Measure: Describe the needs for neuropsychological support, dietetics, social assistance after discharge from hospital.

Time: 3 months after last hospitalization

Description: Describe the factors of inequalities in access to care and study their impact on the occurrence of a SARS-CoV-2 infection, its severity and the occurrence of a functional or psycho-social complaint.

Measure: Describe the factors of inequalities in access to care

Time: 3 months after last hospitalization
400 Follow-up and Rehabilitation of Survivors of Severe Covid-19 Infection

Infection with covid-19 is associated with respiratory failure, which when related to other etiologies can lead to reduced quality of life, physical, cognitive and mental dysfunction. There is no knowledge of the possible consequences of severe covid-19 infection. Our objective is to describe these repercussions, identifying risk factors and assessing the impact of physical training. At least 100 patients over 18 years of age who survive severe Covid-19 infection will be evaluated. Assessments after 1, 4, 6 and 12 months after hospital discharge. Quality of life, dyspnea, activity of daily living, muscle strength, mental and cognitive dysfunction will be evaluated, as well as pulmonary function test, cardiopulmonary stress test and chest tomography. Return to work, thromboembolic events and mortality up to 12 months will also be monitored. Hospitalization data will be used to identify factors related to quality of life, fatigue and respiratory dysfunction. Predefined risk factors will be evaluated: age, sex, smoking, previous comorbidities index, previous clinical frailty, serum C-reactive protein and leukocyte / lymphocyte ratio in the first 24 hours of hospitalization, time between onset of symptoms and hospitalization, ICU and mechanical ventilation, time on mechanical ventilation, compliance corrected by the ideal weight at the start of mechanical ventilation, driving pressure, tidal volume corrected by the ideal weight and PEEP (positive end expiratory pressure) after 24 hours of intubation in controlled ventilation, tidal volume corrected by the ideal weight after 24 hours of spontaneous ventilation, inspiratory muscle training and pulmonary rehabilitation after hospital discharge.

NCT04563156
Conditions
  1. Covid19
Interventions
  1. Diagnostic Test: Lung Function Test
MeSH:Infection

Primary Outcomes

Description: EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually. Assessment at 6 months after discharge

Measure: Quality of life assessment of a survivor of severe COVID-19 infection 6 months after hospital discharge;

Time: 6 months after discharge

Secondary Outcomes

Measure: Quality of life questionnaire EQ-5D

Time: 30, 120 days and 12 months after hospital discharge

Measure: Evaluation of dyspnea by the Modified Medical Research Council Scale (mMRC)

Time: 30, 120 days, 6 months and 12 months after hospital discharge

Measure: The Hospital Anxiety and Depression Scale

Time: 6 months and 12 months after hospital discharge

Measure: Baseline and Transition Dyspnea Indexes (BDI-TDI)

Time: 30 days, 120 days, 6 and 12 months after hospital discharge;

Measure: Clinical frailty scale measured after discharge from the ICU,

Time: 30, 120 days, 6 and 12 months after hospital discharge

Measure: Lawton-Brody Instrumental Activities of Daily Living (iADL) scale

Time: 30, 120 days, 6 months and 12 months after hospital discharge

Measure: Muscle strength according to the Medical Research Council (MRC) scale

Time: 30, 120 days, 6 and 12 months after hospital discharge;

Measure: Maximum inspiratory pressure, diaphragmatic mobility and diaphragm thickness

Time: 30, 120 days, 6 and 12 months after hospital discharge

Measure: Sit-to-stand test in 1 minute

Time: 30 days, 120 days, 6 and 12 months after hospital

Measure: Cognitive dysfunction measured using the Montreal Cognitive Assessment (MoCA) test

Time: 6 months and 12 months after hospital discharge

Measure: Pulmonary function test with Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements

Time: 30, 120 days and 6 and 12 months after hospital discharge

Measure: Hemoglobin, hematocrit, creatinine and Fasting plasma glucose (FPG)

Time: 6 and 12 months after hospital discharge;

Measure: Quantitative computerized tomography scan

Time: 6 months after hospital discharge

Measure: Maximum VO2 during Cardiopulmonary exercise testing

Time: 6 and 12 months after hospital discharge

Measure: Return to work

Time: 6 months and 12 months after hospital discharge

Measure: Occurrence of thromboembolic events after

Time: 6 and 12 months after hospital discharge

Measure: Occurrence of falls

Time: 6 and 12 months after hospital discharge

Measure: Need for readmission

Time: 6 and 12 months after hospital discharge

Measure: Mortality

Time: 6 and 12 months after hospital discharge
401 Comorbidities And Complications Associated With Covid-19 Infection

To evaluate the spectrum of comorbidities and complications and its impact on the clinical outcome in hospitalized patients with coronavirus disease 2019 (COVID-19).

NCT04563442
Conditions
  1. Covid19
Interventions
  1. Other: complication
MeSH:Infection

Primary Outcomes

Description: Identifying and management of different co-morbidities and complications of covid-19 infection.

Measure: Identifying different co-morbidities and complications of covid-19 infection.

Time: baseline
402 Physiopathology and Sequelae of COVID-19 Infection

The data obtained from Covid-19 infections seem to suggest that the immunogenesis of Covid-19 could in some cases be the result of immune dysregulation. On the other hand, endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal, and hypothalamus). These disorders are autoimmune or linked to degeneration. The main objective is to assess the thyroid function (thyrotropic axis) as well as the corticotropic adrenal function of patients who have had Copvid-19 pneumonia. The secondary objectives is to describe the pathophysiological mechanisms of pulmonary and vasculothrombotic involvement of Covid-19

NCT04563676
Conditions
  1. Covid19
  2. TSH
  3. Cortisol
Interventions
  1. Biological: blood test
MeSH:Infection

Primary Outcomes

Description: 8-hour cortisol level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.

Measure: 8-hour cortisol level in patients with Covid19 pneumonia

Time: day 0

Description: TSH level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.

Measure: TSH level in patients with Covid19 pneumonia

Time: day 0
403 An Observational Study of Neurologic Function After COVID-19 Infection

Background: COVID-19 is an infection caused by a coronavirus. It can affect different parts of the body. For most people, it causes fevers or trouble breathing. Some people can have symptoms long after they recover. Researchers want to learn if there are signs of changes in the nervous system that may be related to COVID-19. Objective: To test the nervous system (the brain and nerves) in people who have had COVID-19 yet still have certain symptoms even after recovering. Eligibility: People age 18 and older who had COVID-19 and still have neurologic symptoms after they recovered from the initial infection. Design: Participants will be screened with a medical record review. Participants will have a neurological exam. They will complete pen-and-paper tests of their memory and thinking. They will complete a smell test with 'scratch-and-sniff' booklets. They will give blood samples. Participants will have magnetic resonance imaging (MRI) of the brain. Soft padding or a coil will be placed around their head. They will lie on a table that slides in and out of the MRI scanner. They will get a contrast dye through an intravenous (IV) catheter. Participants blood pressure, blood flow, skin temperature, sweating, and breathing will be monitored. Participants will have an electrocardiogram to measure heart function. Participants will blow into a mouthpiece for several seconds. Participants will lie on a table that has a motor. The motor tilts the table. Participants will have blood drawn through an IV as the table tilts. Participants will have a lumbar puncture. A small needle will be inserted into the spinal canal to obtain fluid. Participants may repeat some tests 8 weeks to 1 year later.

NCT04564287
Conditions
  1. COVID-19
MeSH:Infection

Primary Outcomes

Description: The number and character of brain MRI abnormalities on a dedicated research MRI protocol optimized to detect Covid-19-associated disease.

Measure: MRI brain abnormalities

Time: at NIH Clinical Center Visit

Secondary Outcomes

Description: Neurologic examination: The number and character of abnormalities associated with both central and peripheral nervous system disease.

Measure: Neurological Examination

Time: At NIH Clinical Center Visit

Description: Autonomic testing: The number and character of test results indicating autonomic nervous system disease as evidenced by abnormal heart rate and blood pressure responses during tilt table testing.

Measure: Autonomic Testing

Time: At NIH Clinical Center Visit
404 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

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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.

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