Report Sections

See All Reports

Coronavirus Infections (819) Severe Acute Respiratory Syndrome (567) Infection (472) Pneumonia (366) Communicable Diseases (199) Respiratory Distress Syndrome, Adult (179) Acute Lung Injury (143) Respiratory Distress Syndrome, Newborn (143) Respiratory Insufficiency (132) Syndrome (105) Virus Diseases (90) Pneumonia, Viral (82) Depression (67) Critical Illness (62) Anxiety Disorders (41) Cardiovascular Diseases (36) Emergencies (36) Respiratory Tract Infections (36) Stress, Psychological (31) Hypoxia (30) Inflammation (30) Lung Injury (30) Neoplasms (30) Wounds and Injuries (30) Stress Disorders, Post-Traumatic (29) Thrombosis (28) Diabetes Mellitus (26) Disease (26) Respiratory Tract Diseases (26) Depressive Disorder (25) Stress Disorders, Traumatic (25) Lung Diseases (23) Acute Kidney Injury (22) Disease Progression (22) Mental Disorders (21) Olfaction Disorders (20) Respiration Disorders (20) Burnout, Psychological (19) Thromboembolism (19) Hypertension (18) Embolism (16) Arthritis (15) Blood Coagulation Disorders (15) Hemostatic Disorders (15) Pulmonary Embolism (15) Pulmonary Fibrosis (15) Lung Diseases, Interstitial (14) Stroke (14) Respiratory Aspiration (13) Diabetes Mellitus, Type 2 (12) Dyspnea (12) Fibrosis (12) Influenza, Human (12) Arthritis, Rheumatoid (11) Rheumatic Diseases (11) Venous Thrombosis (11) Burnout, Professional (9) Chronic Pain (9) Cognitive Dysfunction (9) Collagen Diseases (9) Diabetes Mellitus, Type 1 (9) Heart Failure (9) Myocardial Infarction (9) Pneumonia, Ventilator-Associated (9) Pregnancy Complications (9) Problem Behavior (9) Venous Thromboembolism (9) Vitamin D Deficiency (9) Infarction (8) Liver Diseases (8) Lung Diseases, Obstructive (8) Multiple Sclerosis (8) Myocarditis (8) Parasomnias (8) RNA Virus Infections (8) Sclerosis (8) Sepsis (8) Autoimmune Diseases (7) Convalescence (7) Depression, Postpartum (7) Dyssomnias (7) Heart Diseases (7) Hematologic Neoplasms (7) Infertility (7) Inflammatory Bowel Diseases (7) Lymphopenia (7) Pulmonary Disease, Chronic Obstructive (7) Pulmonary Valve Insufficiency (7) Shock (7) Frailty (6) Immunologic Deficiency Syndromes (6) Lung Neoplasms (6) Lupus Erythematosus, Systemic (6) Lymphoma (6) Neurologic Manifestations (6) Obesity (6) Adenoviridae Infections (5) Brain Diseases (5) Brain Injuries (5) Breast Neoplasms (5) Chronic Disease (5) Coronaviridae Infections (5) Cross Infection (5) Delirium (5) Disease Susceptibility (5) Disseminated Intravascular Coagulation (5) Fatigue (5) Feeding and Eating Disorders (5) HIV Infections (5) Immune System Diseases (5) Kidney Diseases (5) Kidney Failure, Chronic (5) Multiple Organ Failure (5) Nervous System Diseases (5) Occupational Stress (5) Parkinson Disease (5) Thrombophilia (5) Toxemia (5) Acquired Immunodeficiency Syndrome (4) Acute Coronary Syndrome (4) Anemia, Sickle Cell (4) Appendicitis (4) Arrhythmias, Cardiac (4) Arthritis, Psoriatic (4) Asymptomatic Diseases (4) Autism Spectrum Disorder (4) Carcinoma (4) Coinfection (4) Colonic Neoplasms (4) Colorectal Neoplasms (4) Coronary Artery Disease (4) Coronary Disease (4) Death (4) Embolism and Thrombosis (4) Fibromyalgia (4) Headache (4) Heart Arrest (4) Leukemia (4) Musculoskeletal Pain (4) Mycobacterium Infections (4) Postoperative Complications (4) Signs and Symptoms, Respiratory (4) Sleep Initiation and Maintenance Disorders (4) Substance-Related Disorders (4) Tuberculosis (4) Ventricular Dysfunction (4) Ventricular Dysfunction, Left (4) Ageusia (3) Alcoholism (3) Asthma (3) Attention Deficit Disorder with Hyperactivity (3) Autistic Disorder (3) Bipolar Disorder (3) Bronchiectasis (3) Cardiomyopathies (3) Chilblains (3) Cystic Fibrosis (3) Deglutition Disorders (3) Digestive System Diseases (3) Dysgeusia (3) Ganglion Cysts (3) Gastrointestinal Diseases (3) Giant Cell Arteritis (3) Head and Neck Neoplasms (3) Hemorrhage (3) Hypersensitivity (3) Hypertension, Pulmonary (3) Leukemia, Lymphocytic, Chronic, B-Cell (3) Measles (3) Melanoma (3) Metabolic Diseases (3) Migraine Disorders (3) Muscle Weakness (3) Myeloproliferative Disorders (3) Myocardial Ischemia (3) Myofascial Pain Syndromes (3) Obesity, Morbid (3) Pancreatic Neoplasms (3) Polymyalgia Rheumatica (3) Pregnancy Complications, Infectious (3) Psoriasis (3) Pulmonary Edema (3) Rare Diseases (3) Renal Insufficiency, Chronic (3) Rheumatic Fever (3) Sjogren's Syndrome (3) Sleep Wake Disorders (3) Spinal Cord Injuries (3) Spondylarthritis (3) Systemic Inflammatory Response Syndrome (3) Taste Disorders (3) Acute Disease (2) Alcohol Drinking (2) Alopecia (2) Amyotrophic Lateral Sclerosis (2) Anorexia (2) Anorexia Nervosa (2) Arteritis (2) Asymptomatic Infections (2) Atrial Fibrillation (2) Atrophy (2) Bacteremia (2) Behcet Syndrome (2) Brain Injuries, Traumatic (2) Carcinoma, Renal Cell (2) Cerebral Palsy (2) Child Development Disorders, Pervasive (2) Cholangiocarcinoma (2) Cholangitis (2) Clinical Deterioration (2) Common Cold (2) Compassion Fatigue (2) Congenital Abnormalities (2) Conjunctivitis (2) Constriction, Pathologic (2) Coronavi (2) Dementia (2) Depressive Disorder, Major (2) Developmental Disabilities (2) Diarrhea (2) Drug-Related Side Effects and Adverse Reactions (2) Encephalitis (2) Endocrine System Diseases (2) Esophageal Neoplasms (2) Eye Diseases (2) Fever (2) Fractures, Bone (2) Fractures, Stress (2) Genetic Predisposition to Disease (2) Glucose Metabolism Disorders (2) Heart Defects, Congenital (2) Hematologic Diseases (2) Hepatitis C (2) Hypothermia (2) Idiopathic Pulmonary Fibrosis (2) Infertility, Male (2) Intestinal Diseases (2) Ischemia (2) Jaundice (2) Leukemia, Lymphoid (2) Liver Cirrhosis (2) Lymphoma, Mantle-Cell (2) Macular Edema (2) Motor Neuron Disease (2) Mouth Diseases (2) Multiple Myeloma (2) Muscular Atrophy (2) Myelodysplastic Syndromes (2) Myositis (2) Neoplasm Metastasis (2) Neoplasms, Plasma Cell (2) Nerve Degeneration (2) Neuroendocrine Tumors (2) Nidovirales Infections (2) Noncommunicable Diseases (2) Obstetric Labor, Premature (2) Oral Manifestations (2) Osteoporosis (2) Overweight (2) Pediatric Obesity (2) Pneumonia, Pneumocystis (2) Precursor Cell Lymphoblastic Leukemia-Lymphoma (2) Premature Birth (2) Psychological Trauma (2) Psychotic Disorders (2) Rectal Neoplasms (2) Renal Insufficiency (2) ST Elevation Myocardial Infarction (2) Sarcopenia (2) Scleroderma, Diffuse (2) Scleroderma, Systemic (2) Seizures (2) Shock, Septic (2) Skin Diseases (2) Sleep Apnea Syndromes (2) Sleep Apnea, Obstructive (2) Stillbirth (2) Suicide (2) Thyroid Diseases (2) Uterine Cervical Neoplasms (2) Vision Disorders (2) Vision, Low (2) Abruptio Placentae (1) Acalculous Cholecystitis (1) Adenocarcinoma (1) Adjustment Disorders (1) Adrenal Insufficiency (1) Agoraphobia (1) Alcohol-Related Disorders (1) Alcoholic Intoxication (1) Alpha 1-Antitrypsin Deficiency (1) Altitude Sickness (1) Alzheimer Disease (1) Amblyopia (1) Anemia, Aplastic (1) Aneurysm (1) Angina Pectoris (1) Ankle Fractures (1) Aortic Valve Stenosis (1) Apnea (1) Arthritis, Juvenile (1) Atherosclerosis (1) Atrioventricular Block (1) Autonomic Nervous System Diseases (1) Bacterial Infections (1) Barotrauma (1) Behavior, Addictive (1) Binge-Eating Disorder (1) Blister (1) Body Weight (1) Body Weight Changes (1) Bradycardia (1) Bronchopulmonary Dysplasia (1) Brucellosis (1) Bulimia (1) Bulimia Nervosa (1) Carcinoma in Situ (1) Carcinoma, Ductal (1) Carcinoma, Ductal, Breast (1) Carcinoma, Hepatocellular (1) Carcinoma, Intraductal, Noninfiltrating (1) Cardiovascular Abnormalities (1) Cataract (1) Cellulitis (1) Central Nervous System Neoplasms (1) Cerebral Hemorrhage (1) Cholangitis, Sclerosing (1) Cholecystitis (1) Cholecystitis, Acute (1) Chronic Traumatic Encephalopathy (1) Ciliary Motility Disorders (1) Cognition Disorders (1) Colitis (1) Colitis, Ulcerative (1) Colonic Diseases (1) Com (1) Communicable Diseases, Emerging (1) Communication Disorders (1) Consciousness Disorders (1) Conversion Disorder (1) Coron (1) Coronavirus Infect (1) Cr (1) Crohn Disease (1) Deafness (1) Death, Sudden, Cardiac (1) Dental Caries (1) Depressive Disorder, Treatment-Resistant (1) Dermatitis (1) DiGeorge Syndrome (1) Diabetes Complications (1) Digestive System Neoplasms (1) Diphtheria (1) Down Syndrome (1) Dyskinesias (1) Dyspareunia (1) Dysphonia (1) Emergen (1) Emergence Delirium (1) Emphysema (1) Endocarditis (1) Endometrial Neoplasms (1) Endometriosis (1) Endophthalmitis (1) Endotoxemia (1) Epilepsy (1) Esophageal and Gastric Varices (1) Eye Infections (1) Facial Pain (1) Facies (1) Familial Mediterranean Fever (1) Fatigue Syndrome, Chronic (1) Femoral Fractures (1) Femoral Neck Fractures (1) Fetal Growth Retardation (1) Fetal Membranes, Premature Rupture (1) Fractures, Closed (1) Gambling (1) Gastroenteritis (1) Gastroesophageal Reflux (1) Gastrointestinal Neoplasms (1) Gestational Weight Gain (1) Glioblastoma (1) Headache Disorders, Secondary (1) Healthcare-Associated Pneumonia (1) Hearing Loss (1) Hearing Loss, Conductive (1) Heart Block (1) Heart Failure, Systolic (1) Hemoglobinopathies (1) Hemophilia A (1) Hepatitis (1) Hereditary Autoinflammatory Diseases (1) Herpes Labialis (1) Herpes Zoster (1) Hoarseness (1) Humeral Fractures (1) Hyp (1) Hyperaldosteronism (1) Hyperglycemia (1) Hyperkinesis (1) Hyperphosphatemia (1) Hyperplasia (1) Hypertension, Pregnancy-Induced (1) Hypertrophy (1) Hypokalemia (1) Hyponatremia (1) Hypotension (1) Hypoventilation (1) Inf (1) Infant, Newborn, Diseases (1) Infe (1) Infec (1) Infecti (1) Infertility, Female (1) Intellectual Disability (1) Intestinal Atresia (1) Intestinal Neoplasms (1) Intracranial Aneurysm (1) Intracranial Hypertension (1) Intracranial Thrombosis (1) Jaundice, Obstructive (1) Joint Diseases (1) Keratoconjunctivitis (1) Kidney Neoplasms (1) Laryngeal Neoplasms (1) Latent Tuberculosis (1) Leukemia, Myeloid, Acute (1) Liver Cirrhosis, Biliary (1) Liver Failure (1) Liver Neoplasms (1) Lymphedema (1) Lymphocytosis (1) Lymphoma, B-Cell (1) Lymphoma, Non-Hodgkin (1) Macrophage Activation Syndrome (1) Macular Degeneration (1) Malnutrition (1) Maternal Death (1) Maxillofacial Injuries (1) Memory Disorders (1) Meningitis (1) Meningitis, Meningococcal (1) Menorrhagia (1) Menstruation Disturbances (1) Metabolic Syndrome (1) Metabolism, Inborn Errors (1) Microvascular Rarefaction (1) Mitochondrial Diseases (1) Mobility Limitation (1) Monoclonal Gammopathy of Undetermined Significance (1) Mood Disorders (1) Mouth, Edentulous (1) Movement Disorders (1) Mucocutaneous Lymph Node Syndrome (1) Multiple Chronic Conditions (1) Muscular Dystrophies (1) Musculoskeletal Diseases (1) Myalgia (1) Mycoses (1) Myocardial Reperfusion Injury (1) Necrosis (1) Needlestick Injuries (1) Neonatal Sepsis (1) Neoplastic Cells, Circulating (1) Nephritis (1) Nervous System Malformations (1) Nervous System Neoplasms (1) Neurocognitive Disorders (1) Neurodegenerative Diseases (1) Neuromuscular Diseases (1) Neuromyelitis Optica (1) Nutrition Disorders (1) Obsessive Behavior (1) Oligospermia (1) Orbital Cellulitis (1) Osteoarthritis (1) Osteoarthritis, Hip (1) Osteoarthritis, Knee (1) Osteochondritis (1) Otitis Media with Effusion (1) Ovarian Neoplasms (1) Pain, Intractable (1) Pancreatitis (1) Paramyxoviridae Infections (1) Paraproteinemias (1) Paresis (1) Parkin (1) Perinatal Death (1) Periodontal Diseases (1) Periodontitis (1) Pharyngeal Diseases (1) Pn (1) Pneumon (1) Pneumonia, Bacterial (1) Pre-Eclampsia (1) Prediabetic State (1) Pregnancy in Diabetics (1) Primary Dysautonomias (1) Prostatic Hyperplasia (1) Protein Deficiency (1) Pseudomonas Infections (1) Psychophysiologic Disorders (1) Puerperal Infection (1) Pulmonary Alveolar Proteinosis (1) Pulmonary Atelectasis (1) Pulmonary Eosinophilia (1) Pulmonary Heart Disease (1) Purpura, Thrombocytopenic, Idiopathic (1) Recurrence (1) Renal Insufficie (1) Reperfusion Injury (1) Resp (1) Respi (1) Respiratory Distress Sy (1) Respiratory Syncytial Virus Infections (1) Retinal Vein Occlusion (1) Rupture (1) Sarcoidosis (1) Scleroderma, Localized (1) Se (1) Shock, Cardiogenic (1) Shoulder Fractures (1) Skin Manifestations (1) Skin Neoplasms (1) Skull Fractures (1) Somatoform Disorders (1) Spondylitis (1) Spondylitis, Ankylosing (1) Sprains and Strains (1) Status Epilepticus (1) Stomach Neoplasms (1) Stress Disorders, Traumatic, Acute (1) Subarachnoid Hemorrhage (1) Suicidal Ideation (1) Superinfection (1) Synovial Cyst (1) Tachycardia (1) Tachycardia, Ventricular (1) Tachypnea (1) Testicular Neoplasms (1) Thalassemia (1) Thoracic Diseases (1) Thrombocytopenia (1) Thrombophlebitis (1) Thrombotic Microangiopathies (1) Tobacco Use Disorder (1) Tonsillitis (1) Torsades de Pointes (1) Tourette Syndrome (1) Tracheal Stenosis (1) Trauma, Nervous System (1) Tuberculosis, Pulmonary (1) Urinary Tract Infections (1) Urogenital Neoplasms (1) Urologic Diseases (1) Uterine Neoplasms (1) Vaginal Neoplasms (1) Vascular Diseases (1) Ventricular Dysfunction, Right (1) Virus (1) Vitamin D Deficie (1) Voice Disorders (1) Vulvar Neoplasms (1) Waldenstrom Macroglobulinemia (1) Weight Gain (1) Weight Loss (1) Yellow Fever (1) beta-Thalassemia (1)

D003141: Communicable Diseases

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 (476)


Name (Synonyms) Correlation
drug884 Convalescent Plasma Wiki 0.19
drug2490 Placebo Wiki 0.18
drug965 DAS181 Wiki 0.14
Name (Synonyms) Correlation
drug899 Convalescent plasma Wiki 0.14
drug1193 Enoxaparin Wiki 0.12
drug976 DWRX2003 Wiki 0.12
drug1288 Famotidine Wiki 0.12
drug1861 Losartan Wiki 0.12
drug1289 Famotidine 20 MG Wiki 0.10
drug1008 Deferoxamine Wiki 0.10
drug1068 Disulfiram Wiki 0.10
drug1141 Ebselen Wiki 0.10
drug890 Convalescent Plasma Transfusion Wiki 0.10
drug885 Convalescent Plasma (CP) Wiki 0.10
drug977 Daclatasvir Wiki 0.10
drug1256 Expressive writing Wiki 0.10
drug991 Data collection Wiki 0.10
drug1084 Doxycycline Wiki 0.10
drug1292 Favipiravir Wiki 0.09
drug956 Cyclosporine Wiki 0.08
drug3574 VPM1002 Wiki 0.08
drug1023 Dexamethasone Wiki 0.08
drug1116 EIDD-2801 Wiki 0.08
drug1507 Hydroxychloroquine Wiki 0.08
drug3697 Zinc Wiki 0.08
drug1740 Ivermectin Wiki 0.07
drug1555 Hydroxychloroquine, Doxycycline Wiki 0.07
drug2459 Personalized ambulatory training Wiki 0.07
drug887 Convalescent Plasma 1 Unit Wiki 0.07
drug944 Crisis management coaching Wiki 0.07
drug1075 Dornase Alfa Inhalation Solution Wiki 0.07
drug1243 Experimental drug Wiki 0.07
drug936 Covid-19 swab PCR test Wiki 0.07
drug3106 Single high dose vitamin D Wiki 0.07
drug279 ArtemiC Wiki 0.07
drug62 A $20 Survey Incentive Wiki 0.07
drug1097 Drugs and supportive care Wiki 0.07
drug329 Autophagy inhibitor (GNS651) Wiki 0.07
drug2497 Placebo (PBO) Wiki 0.07
drug3133 Sofosbuvir ledipsavir Wiki 0.07
drug974 DUR-928 Wiki 0.07
drug1216 Estradiol patch Wiki 0.07
drug774 Clarithromycin Wiki 0.07
drug1266 F-652 Wiki 0.07
drug1616 IgM and IgG diagnostic kits to SARS-CoV-2 Wiki 0.07
drug1099 Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) Wiki 0.07
drug3428 To assess for development of IgG antibodies against SARS-CoV2 Wiki 0.07
drug2857 Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening Wiki 0.07
drug1035 Diagnostic Test: serology test for COVID-19 Wiki 0.07
drug3584 Validation of the POCT Antigen tests Wiki 0.07
drug1192 Enisamium Iodide Wiki 0.07
drug2787 Randomized booster Wiki 0.07
drug3621 Virtual reality therapy first Wiki 0.07
drug3238 Stool collection or fecal swab Wiki 0.07
drug3324 Tap water Wiki 0.07
drug2997 Saliva based assay: crude RNA extraction Wiki 0.07
drug4147 zinc acetate Wiki 0.07
drug2037 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.07
drug937 Covid19 Wiki 0.07
drug2496 Placebo (PB0) Wiki 0.07
drug31 1: Usual practice Wiki 0.07
drug913 Core Warming Wiki 0.07
drug1522 Hydroxychloroquine Only Product in Oral Dose Form Wiki 0.07
drug1054 Digital oximeter monitoring Wiki 0.07
drug970 DECT Wiki 0.07
drug1699 Intervention for COVID-19 preventive protocols Wiki 0.07
drug4080 sofosbuvir Wiki 0.07
drug1615 IgM and IgG antibodies assay Wiki 0.07
drug1955 Maraviroc + Currently used therapy Wiki 0.07
drug1187 Endoscopic procedure Wiki 0.07
drug2779 Racial/Ethnic Frame Wiki 0.07
drug1190 Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19 Wiki 0.07
drug1597 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.07
drug1540 Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki 0.07
drug5 - Synthetic anti-malarial drugs Wiki 0.07
drug3803 convalescent plasma application to SARS-CoV-2 infected patients Wiki 0.07
drug353 Açaí palm berry extract - natural product Wiki 0.07
drug725 Centricyte 1000 Wiki 0.07
drug1482 Home-based exercise training Wiki 0.07
drug4055 revised HOME-CoV score Wiki 0.07
drug2504 Placebo (two doses), priming Wiki 0.07
drug830 Combined ART/hydroxychloroquine Wiki 0.07
drug983 Dalcetrapib Wiki 0.07
drug3538 Umbilical Cord Lining Stem Cells (ULSC) Wiki 0.07
drug4106 telemedicine Wiki 0.07
drug376 BIO101 Wiki 0.07
drug1098 Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) Wiki 0.07
drug1918 MFS Wiki 0.07
drug2321 Online instruction Wiki 0.07
drug61 A $10 Survey Incentive Wiki 0.07
drug889 Convalescent Plasma Infusion Wiki 0.07
drug2503 Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) Wiki 0.07
drug2204 Nitric Oxide-Releasing Drug Wiki 0.07
drug1276 FSD201 Wiki 0.07
drug1033 Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta Wiki 0.07
drug2718 Quantitative IgG Test Wiki 0.07
drug2551 Placebo of excipient(s) will be administered Wiki 0.07
drug1087 Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment Wiki 0.07
drug1259 Extra blood sample Wiki 0.07
drug3815 decisions of limitations and stop processing Wiki 0.07
drug1120 ELISPOT Wiki 0.07
drug114 AT-527 Wiki 0.07
drug1802 Late-Dexamethasone Wiki 0.07
drug964 D-dimer,CBC.ESR,CRP, Wiki 0.07
drug1080 Double-Blind NT-I7 Wiki 0.07
drug3483 Treatment as usual vitamin D Wiki 0.07
drug3297 T3 solution for injection Wiki 0.07
drug1086 Drug COVID19-0001-USR Wiki 0.07
drug3302 TAK-919 Wiki 0.07
drug1019 Desidustat Wiki 0.07
drug2686 Psychological and Behaviour Change Support Wiki 0.07
drug312 Atazanavir and Dexamethasone Wiki 0.07
drug7 0.12% Chlorhexidine Gluconate Wiki 0.07
drug1240 Experience of pandemic Wiki 0.07
drug790 Cliniporator Wiki 0.07
drug1841 Lopinavir Wiki 0.07
drug1048 Differential Leucocyte Count (CLDC) device and algorithm Wiki 0.07
drug4127 unfractionated heparin Wiki 0.07
drug4144 washed microbiota transplantation Wiki 0.07
drug3784 chlorine dioxide Wiki 0.07
drug679 CYNK-001 Wiki 0.07
drug3652 Walk Test Wiki 0.07
drug1081 Double-Blind Placebo Wiki 0.07
drug1639 In-person instruction Wiki 0.07
drug1774 Kukaa Salama: mHealth intervention Wiki 0.07
drug1020 Detection of anti-COVID-19 antibody level Wiki 0.07
drug1286 Family Nurture Intervention (FNI) Wiki 0.07
drug953 Current clinical practices of participating physicians Wiki 0.07
drug1181 Emphasis of Government Involvement Wiki 0.07
drug1092 Drug: Isotretinoin(Aerosolized 13 cis retinoic acid) plus Aerosolized Itraconazole Wiki 0.07
drug1553 Hydroxychloroquine, Clindamycin, Primaquine - high dose. Wiki 0.07
drug2889 Routine standard of care Wiki 0.07
drug1211 Equipment with smartwatch throughout hospital stay on the general ward Wiki 0.07
drug1041 Dialectical Behavioral Therapy (DBT) Skills Wiki 0.07
drug1255 Expression of receptors and activating proteases Wiki 0.07
drug1022 Device used to record voice for screening Wiki 0.07
drug1234 Exercise physiology Wiki 0.07
drug2507 Placebo 0.10 mg + 1.00 mg/kg Wiki 0.07
drug1902 Lung Function tests Wiki 0.07
drug1551 Hydroxychloroquine, Azithromycin Wiki 0.07
drug2109 NA-831 and Atazanavir Wiki 0.07
drug3937 mobile internet survey on self-test Wiki 0.07
drug993 Data collection and rhinopharyngeal swab Wiki 0.07
drug6 0.075% Cetylpyridinium Chloride Wiki 0.07
drug3371 Testing procedure for Binding antibodies Wiki 0.07
drug2053 Mindfulness training Wiki 0.07
drug1093 Drug: NA-831 Wiki 0.07
drug436 Bicalutamide 150 mg Wiki 0.07
drug1793 Laboratory tests Wiki 0.07
drug2873 Rintatolimod Wiki 0.07
drug1421 HOME-CoV rule implementation Wiki 0.07
drug3799 consultation Wiki 0.07
drug1040 Diagnostic test for detection of SARS-CoV-2 Wiki 0.07
drug999 Data monitoring for 48h within the first 12 hours of admission for COVID-19 Wiki 0.07
drug45 2: Usual practice + SYMBICORT RAPIHALER Wiki 0.07
drug2428 Patients admitted in Intensive Care Units Wiki 0.07
drug930 Covid-19 + patients Wiki 0.07
drug932 Covid-19 PCR , IGM Wiki 0.07
drug1897 Lower-dose prophylactic anticoagulation Wiki 0.07
drug4122 traditional communication tools Wiki 0.07
drug2530 Placebo booster Wiki 0.07
drug1738 Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment Wiki 0.07
drug747 Chest MRI Wiki 0.07
drug1963 Masked Saline Placebo Wiki 0.07
drug3150 Specimen Collection Wiki 0.07
drug1088 Drug: GS-5734 - 1.00 mg/kg Wiki 0.07
drug377 BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki 0.07
drug4031 qRT-PCR and serology Wiki 0.07
drug1130 ERUCOV-VAC Wiki 0.07
drug2906 SARS-CoV-2 IgG Wiki 0.07
drug1095 Drug: NA-831 - 0.20 mg/kg Wiki 0.07
drug1137 Early rehabilitation Wiki 0.07
drug3487 Treatment with Dexmedetomidine Wiki 0.07
drug1166 Electronic Survey questionnaire Wiki 0.07
drug891 Convalescent Plasma as Therapy for Covid-19 patients Wiki 0.07
drug1356 GLS-1027 Wiki 0.07
drug1245 Experimental: Questionnaire without precaution information Wiki 0.07
drug954 Customized questionnaire Wiki 0.07
drug635 COVID-19 positive via testing Wiki 0.07
drug1119 ELISA and Rapid test to detect antibodies against COVID-19 Wiki 0.07
drug2876 Ritonavir Wiki 0.07
drug112 AT-001 Wiki 0.07
drug1271 FFP2 Wiki 0.07
drug497 Bloodwork Wiki 0.07
drug1071 Doctor Spot Wiki 0.07
drug1059 Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care Wiki 0.07
drug1461 High volume evacuation (HVE) Wiki 0.07
drug21 1% w/v Povidone-iodide Wiki 0.07
drug3582 Validation of the LAMP assays Wiki 0.07
drug2786 Random Donor Plasma Wiki 0.07
drug1851 Lopinavir/ Ritonavir Oral Tablet Wiki 0.07
drug2709 QUANTIFERON Wiki 0.07
drug2597 Polymorphism of the HSD3B1 Wiki 0.07
drug4000 phone call Wiki 0.07
drug2175 Neutralizing antibodies Wiki 0.07
drug1464 High-Titer COVID-19 Convalescent Plasma (HT-CCP) Wiki 0.07
drug1039 Diagnostic test for SARS-Cov2 for patients and health staff Wiki 0.07
drug3954 nasopharyngeal and throat swab Wiki 0.07
drug1242 Experimental Group Wiki 0.07
drug902 Convalesscent Plasma Wiki 0.07
drug1180 Emphasis of Academic Researchers Involvement Wiki 0.07
drug697 Cannabis, Medical Wiki 0.07
drug1226 Examine the impact of COVID-19 during pregnancy Wiki 0.07
drug963 D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester Wiki 0.07
drug1091 Drug: Isotretinoin(Aerosolized 13 cis retinoic acid) Wiki 0.07
drug751 Chinese Herbal Medicine Wiki 0.07
drug1058 Dipyridamole 100 Milligram(mg) Wiki 0.07
drug1210 EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) Wiki 0.07
drug1297 Favipiravir + Currently used therapy Wiki 0.07
drug992 Data collection and clinical testing of subjects Wiki 0.07
drug909 Conventional therapy first Wiki 0.07
drug498 Bolus placebo Wiki 0.07
drug1025 Dexamethasone 2 MG/ML Wiki 0.07
drug941 Covigenix VAX-001 placebo Wiki 0.07
drug597 COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support Wiki 0.07
drug1927 MRI (heart, brain, lungs, liver) Wiki 0.07
drug1663 Inhaled nitric oxide gas Wiki 0.07
drug916 CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test Wiki 0.07
drug1045 Dietary counselling on Food Groups according to IYC Feeding practices, WHO Wiki 0.07
drug805 Cognitive testing Wiki 0.07
drug2211 No Messaging Wiki 0.07
drug1613 IgG test Wiki 0.07
drug2804 Recombinant Interferon Alfa-2b Wiki 0.07
drug1263 Extraoral vacuum aspirator (EVA) Wiki 0.07
drug957 CytoSorb Wiki 0.07
drug3971 normal saline Wiki 0.07
drug1835 Liver function tests ,serum ferritin and PCR for COVID-19 . Wiki 0.07
drug1118 ELISA Wiki 0.07
drug3905 labs Wiki 0.07
drug1185 Endoscopic intervention Wiki 0.07
drug1012 Degarelix Wiki 0.07
drug2668 Propofol Wiki 0.07
drug3130 Sofosbuvir Wiki 0.07
drug1310 FilmArray PCR on respiratory samples Wiki 0.07
drug2740 Questionnaire with precaution information Wiki 0.07
drug1103 Duty Frame Wiki 0.07
drug2510 Placebo 250 cc 24 hours continuous infusion for 15 days Wiki 0.07
drug3279 Surveys Wiki 0.07
drug3668 Whole Exome Sequencing Wiki 0.07
drug1585 IL-12 plasmid Wiki 0.07
drug3398 There is no intervention in this study Wiki 0.07
drug37 21% Ethanol plus essential oils Wiki 0.07
drug1559 Hydroxycloroquine and Azythromycine Wiki 0.07
drug1038 Diagnostic test Covid-19 Wiki 0.07
drug1217 Estrogen Therapy Wiki 0.07
drug2667 Prophylactic/Intermediate Dose Enoxaparin Wiki 0.07
drug3759 blood collection via fingerprick Wiki 0.07
drug104 ARCT-021 two higher dose priming Wiki 0.07
drug998 Data extraction from medical files Wiki 0.07
drug1667 Inspiratory training device Wiki 0.07
drug933 Covid-19 Rapid Test Kit (RAPG-COV-019) Wiki 0.07
drug1188 Endothelial damage and angiogenic biomarkers Wiki 0.07
drug951 Curently used therapy for COVID-19 non-critical patients Wiki 0.07
drug2567 Placebo- 1.00 mg/kg Wiki 0.07
drug928 Covax-19™ Wiki 0.07
drug2461 Phage Therapy Wiki 0.07
drug1285 Facial mask Wiki 0.07
drug1055 Digital problem solving tool Wiki 0.07
drug3167 Standard COVID-19 therapies Wiki 0.07
drug2238 Non-convalescent Plasma (control plasma) Wiki 0.07
drug888 Convalescent Plasma 2 Units Wiki 0.07
drug2034 Methylprednisolone Injection Wiki 0.07
drug1275 FOY-305 Wiki 0.07
drug3906 lactoferrin, green tea extract Wiki 0.07
drug576 COR-101 Wiki 0.07
drug3548 Unfractionated heparin nebulized Wiki 0.07
drug981 Daily Vitamin D3 Wiki 0.07
drug3641 VivaDiag™ COVID-19 lgM/IgG Rapid Test Wiki 0.07
drug3450 Tradipitant Wiki 0.07
drug966 DAS181 COVID-19 Wiki 0.07
drug1046 Dietary supplementation in patients with covid disease admitted to hospital Wiki 0.07
drug2565 Placebo- 0.10 mg/kg Wiki 0.07
drug3158 Stabilized hypochlorous acid Wiki 0.07
drug1072 Doctorgram Patient Kit Wiki 0.07
drug1152 Eicosapentaenoic acid gastro-resistant capsules Wiki 0.07
drug3556 Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures Wiki 0.07
drug1428 Health-related quality of life Wiki 0.07
drug925 Cospherunate/Phytomedicine/Azythromycien Wiki 0.07
drug487 Blood sample for whole genome sequencing Wiki 0.07
drug1083 Doxycyclin Wiki 0.07
drug967 DAS181 OL Wiki 0.07
drug2508 Placebo 0.20 mg + 2.00 mg/kg Wiki 0.07
drug2792 Rapid Pathogen Detection Wiki 0.07
drug1003 Ddrops® products, 50,000 IU, Oral Wiki 0.07
drug3791 collection of mucosal lining fluid Wiki 0.07
drug232 Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB) Wiki 0.07
drug2999 Saliva sample Wiki 0.07
drug1504 Hydrogen Peroxide Wiki 0.07
drug2077 Monalizumab Wiki 0.07
drug105 ARCT-021 two lower dose priming Wiki 0.07
drug2728 Querying the INSEE database Wiki 0.07
drug3717 acetylsalicylic acid Wiki 0.07
drug2110 NA-831and Dexamethasone Wiki 0.07
drug1232 Exercise brochure Wiki 0.07
drug2540 Placebo for Camostat Mesilate Wiki 0.07
drug1085 Doxycycline Hcl Wiki 0.07
drug3720 additional blood tubes Wiki 0.07
drug1197 Enoxaparin Higher Dose Wiki 0.07
drug3249 Subacute rehabilitation Wiki 0.07
drug1052 Digital Health Online Platform Wiki 0.07
drug2643 Probiorinse Wiki 0.07
drug3583 Validation of the NGS method Wiki 0.07
drug1357 GLS-1200 Wiki 0.07
drug3071 Serology SARS-CoV2 Wiki 0.07
drug103 ARCT-021 single dose priming Wiki 0.07
drug3966 non-contact magnetically-controlled capsule endoscopy Wiki 0.07
drug2850 Respiratory infections Wiki 0.07
drug3210 Standard screening strategy Wiki 0.07
drug895 Convalescent Serum Wiki 0.07
drug1282 Face mask sampling Wiki 0.07
drug2844 ResCure™ Wiki 0.07
drug3177 Standard Plasma (FFP) Wiki 0.07
drug924 Cospherunate/Azythromycine Wiki 0.07
drug1169 Elisa-test for IgM and IgG to SARS-CoV-2 Wiki 0.07
drug1817 Liberase Enzyme (Roche) Wiki 0.07
drug2770 RT PCR SARS-CoV-2 Wiki 0.07
drug12 0.9% (w/v) saline Wiki 0.07
drug854 Conestat alfa Wiki 0.07
drug1094 Drug: NA-831 - 0.10 mg/kg Wiki 0.07
drug1215 Essential oils Wiki 0.07
drug3632 Vitamin D supplementation Wiki 0.07
drug3375 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: Wiki 0.07
drug1884 Low or upper respiratory tract sample Wiki 0.07
drug1182 Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet Wiki 0.07
drug155 Activity Wiki 0.07
drug1031 DiaNose Wiki 0.07
drug23 1.5-2% w/v Hydrogen Peroxide Wiki 0.07
drug975 DWJ1248 Wiki 0.07
drug982 Daily placebo Wiki 0.07
drug3631 Vitamin D 1000 IU Wiki 0.07
drug1797 Lactoferrin (Apolactoferrin) Wiki 0.07
drug1257 Extended sampling and procedures Wiki 0.07
drug3382 The standard of care Wiki 0.07
drug577 CORVax Wiki 0.07
drug2267 Nutrition Wiki 0.07
drug1608 Identification of genetic variants Wiki 0.07
drug3919 lung ultrasound (LUS) Wiki 0.07
drug1155 Electric pad for human external pain therapy Wiki 0.07
drug915 Coromec Registry with ECL-19 Wiki 0.07
drug2518 Placebo Group Wiki 0.07
drug1554 Hydroxychloroquine, Clindamycin, Primaquine - low dose. Wiki 0.07
drug1208 Enzalutamide Wiki 0.07
drug2177 New screening strategy Wiki 0.07
drug1279 Face Mask + Soap Wiki 0.07
drug542 Butterfly iQ Wiki 0.07
drug940 Covigenix VAX-001 Wiki 0.07
drug1074 Dornase Alfa Wiki 0.07
drug1151 Educational meetings and visual prompts Wiki 0.07
drug3915 lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Wiki 0.07
drug2568 Placebo- 2.00 mg/kg Wiki 0.07
drug3171 Standard Donor Plasma Wiki 0.07
drug511 Breath Biopsy Wiki 0.07
drug959 CytoSorb-Therapy Wiki 0.07
drug2566 Placebo- 0.20 mg/kg Wiki 0.07
drug383 BNT162a1 Wiki 0.07
drug2199 Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Wiki 0.07
drug3170 Standard Care Therapy Wiki 0.07
drug3932 metenkefalin + tridecactide Wiki 0.07
drug1043 Diet tracking and survey Wiki 0.07
drug2237 Non-contact MCE system Wiki 0.07
drug3768 blood test for SARS-COV2 serology Wiki 0.07
drug1552 Hydroxychloroquine, Clindamycin Wiki 0.07
drug958 CytoSorb 300 mL device Wiki 0.07
drug3233 Sterile Normal Saline for Intravenous Use Wiki 0.07
drug530 Bromhexine Hydrochloride Wiki 0.07
drug2499 Placebo (carrier control) Wiki 0.07
drug387 BNT162c2 Wiki 0.07
drug1140 Eating habits Wiki 0.07
drug331 Avdoralimab Wiki 0.07
drug2298 Olfaction testing Wiki 0.07
drug369 BCG-10 vaccine Wiki 0.07
drug2148 NasoVAX Wiki 0.07
drug2119 NIVOLUMAB Wiki 0.07
drug917 CoronaVac Wiki 0.07
drug1168 Electronic survey Wiki 0.07
drug1060 Direct Antigen Tests for COVID-19 Wiki 0.07
drug1957 Maraviroc+Favipiravir+CT Wiki 0.07
drug1233 Exercise capacity Wiki 0.07
drug820 Collection of blood samples in order to create a biocollection Wiki 0.07
drug1280 Face mask Wiki 0.07
drug1258 External evacuation device (EED) Wiki 0.07
drug926 Cost-Benefit Frame Wiki 0.07
drug1495 Human Ezrin Peptide 1 (HEP1) Wiki 0.07
drug1558 Hydroxychloroquine/Chloroquine Wiki 0.07
drug1677 Interferon-Alpha2B Wiki 0.07
drug3967 non-interventional Wiki 0.07
drug2453 Personal Protective Testing Booth Wiki 0.07
drug1010 Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days Wiki 0.07
drug1281 Face mask awareness Wiki 0.07
drug499 Bolus vitamin D3 Wiki 0.07
drug1247 Expiratory training device Wiki 0.07
drug108 ART Therapy Wiki 0.07
drug1089 Drug: GS-5734 - 2.00 mg/kg Wiki 0.07
drug341 Azithromycin Wiki 0.07
drug686 Camostat Mesilate Wiki 0.07
drug210 Anakinra Wiki 0.06
drug3630 Vitamin D Wiki 0.06
drug1842 Lopinavir / Ritonavir Wiki 0.06
drug3765 blood sampling Wiki 0.06
drug2557 Placebo oral tablet Wiki 0.06
drug3633 Vitamin D3 Wiki 0.06
drug2032 Methylprednisolone Wiki 0.05
drug3628 Vitamin C Wiki 0.05
drug3191 Standard of Care Wiki 0.05
drug2152 Nasopharyngeal swab Wiki 0.05
drug759 Chloroquine Sulfate Wiki 0.05
drug536 Bucillamine Wiki 0.05
drug3437 Tocilizumab Injection Wiki 0.05
drug1539 Hydroxychloroquine Sulfate Tablets Wiki 0.05
drug1138 Early-Dexamethasone Wiki 0.05
drug3084 Sevoflurane Wiki 0.05
drug2449 Peripheral blood draw Wiki 0.05
drug1248 Exposure Wiki 0.05
drug714 Carrimycin Wiki 0.05
drug519 Brequinar Wiki 0.05
drug3197 Standard of Care Treatment Wiki 0.05
drug2103 N-Acetyl cysteine Wiki 0.05
drug1228 Exercise Wiki 0.05
drug3764 blood samples Wiki 0.05
drug3154 Spirometry Wiki 0.05
drug1009 Defibrotide Wiki 0.05
drug1237 Exercise training Wiki 0.05
drug2992 Saline solution Wiki 0.05
drug3750 basic treatment Wiki 0.05
drug2126 NORS (Nitric Oxide Releasing Solution) Wiki 0.05
drug1034 Diagnostic Laboratory Biomarker Analysis Wiki 0.05
drug762 Chloroquine or hydroxychloroquine Wiki 0.05
drug3207 Standard of care treatment Wiki 0.05
drug1195 Enoxaparin 40 Mg/0.4 mL Injectable Solution Wiki 0.05
drug886 Convalescent Plasma (anti-SARS-CoV-2 plasma) Wiki 0.05
drug1165 Electronic Health Record Review Wiki 0.05
drug1104 Duvelisib Wiki 0.05
drug2529 Placebo Vaccine Wiki 0.05
drug1752 Ivermectin Pill Wiki 0.05
drug4126 unfractionated Heparin Wiki 0.05
drug394 Bacille Calmette-Guérin (BCG) Wiki 0.05
drug1496 Human biological samples Wiki 0.05
drug1167 Electronic questionnaire Wiki 0.05
drug2985 Saline Wiki 0.04
drug2215 No intervention Wiki 0.04
drug482 Blood sample Wiki 0.04
drug2019 Mesenchymal stromal cells Wiki 0.04
drug119 AV-COVID-19 Wiki 0.04
drug476 Blood draw Wiki 0.04
drug1143 Echocardiography Wiki 0.04
drug384 BNT162b1 Wiki 0.04
drug3043 Selinexor Wiki 0.04
drug3196 Standard of Care (SoC) Wiki 0.04
drug2771 RT-PCR Wiki 0.04
drug3258 Supportive Care Wiki 0.04
drug1601 Ibrutinib Wiki 0.04
drug16 0.9% saline Wiki 0.04
drug3199 Standard of care Wiki 0.04
drug4004 placebo Wiki 0.04
drug463 Biospecimen Collection Wiki 0.04
drug385 BNT162b2 Wiki 0.04
drug1672 Interferon Beta-1A Wiki 0.04
drug3340 Telemedicine Wiki 0.04
drug3351 Telerehabilitation Wiki 0.04
drug2607 Povidone-Iodine Wiki 0.04
drug2198 Nitric Oxide Wiki 0.04
drug128 AZD1222 Wiki 0.03
drug769 Cholecalciferol Wiki 0.03
drug3871 hydroxychloroquine Wiki 0.03
drug2879 Rivaroxaban Wiki 0.03
drug776 Clazakizumab Wiki 0.03
drug3219 Standard treatment Wiki 0.03
drug2717 Quality-of-Life Assessment Wiki 0.03
drug491 Blood sampling Wiki 0.03
drug2730 Questionnaire Wiki 0.03
drug2827 Remdesivir Wiki 0.02
drug3430 Tocilizumab Wiki 0.02
drug3762 blood sample Wiki 0.02
drug1527 Hydroxychloroquine Sulfate Wiki 0.02
drug2732 Questionnaire Administration Wiki 0.02
drug2575 Placebos Wiki 0.02

Correlated MeSH Terms (122)


Name (Synonyms) Correlation
D007239 Infection NIH 0.65
D045169 Severe Acute Respiratory Syndrome NIH 0.35
D018352 Coronavirus Infections NIH 0.30
Name (Synonyms) Correlation
D012141 Respiratory Tract Infections NIH 0.27
D014777 Virus Diseases NIH 0.18
D012327 RNA Virus Infections NIH 0.18
D003333 Coronaviridae Infections NIH 0.16
D003428 Cross Infection NIH 0.16
D030341 Nidovirales Infections NIH 0.10
D058345 Asymptomatic Infections NIH 0.10
D009410 Nerve Degeneration NIH 0.10
D006526 Hepatitis C NIH 0.10
D012140 Respiratory Tract Diseases NIH 0.08
D004066 Digestive System Diseases NIH 0.08
D005767 Gastrointestinal Diseases NIH 0.08
D019965 Neurocognitive Disorders NIH 0.07
D000070627 Chronic Traumatic Encephalopathy NIH 0.07
D009080 Mucocutaneous Lymph Node Syndrome NIH 0.07
D001997 Bronchopulmonary Dysplasia NIH 0.07
D008595 Menorrhagia NIH 0.07
D013166 Spondylitis NIH 0.07
D013167 Spondylitis, Ankylosing NIH 0.07
D006929 Hyperaldosteronism NIH 0.07
D014552 Urinary Tract Infections NIH 0.07
D054559 Hyperphosphatemia NIH 0.07
D004314 Down Syndrome NIH 0.07
D011552 Pseudomonas Infections NIH 0.07
D055985 Latent Tuberculosis NIH 0.07
D018184 Paramyxoviridae Infections NIH 0.07
D015163 Superinfection NIH 0.07
D021821 Communicable Diseases, Emerging NIH 0.07
D001424 Bacterial Infections NIH 0.07
D011649 Pulmonary Alveolar Proteinosis NIH 0.07
D018357 Respiratory Syncytial Virus Infections NIH 0.07
D005879 Tourette Syndrome NIH 0.07
D003424 Crohn Disease NIH 0.07
D000309 Adrenal Insufficiency NIH 0.07
D008258 Waldenstrom Macroglobulinemia NIH 0.07
D007008 Hypokalemia NIH 0.07
D006505 Hepatitis NIH 0.07
D015535 Arthritis, Psoriatic NIH 0.07
D014808 Vitamin D Deficiency NIH 0.07
D011014 Pneumonia NIH 0.06
D007251 Influenza, Human NIH 0.06
D007945 Leukemia, Lymphoid NIH 0.05
D000070642 Brain Injuries, Traumatic NIH 0.05
D000690 Amyotrophic Lateral Sclerosis NIH 0.05
D012640 Seizures NIH 0.05
D000075902 Clinical Deterioration NIH 0.05
D050177 Overweight NIH 0.05
D009101 Multiple Myeloma NIH 0.05
D020522 Lymphoma, Mantle-Cell NIH 0.05
D016470 Bacteremia NIH 0.05
D016472 Motor Neuron Disease NIH 0.05
D003139 Common Cold NIH 0.05
D009362 Neoplasm Metastasis NIH 0.05
D000073296 Noncommunicable Diseases NIH 0.05
D004660 Encephalitis NIH 0.05
D054990 Idiopathic Pulmonary Fibrosis NIH 0.05
D054219 Neoplasms, Plasma Cell NIH 0.05
D012120 Respiration Disorders NIH 0.05
D001172 Arthritis, Rheumatoid NIH 0.04
D025241 Spondylarthritis NIH 0.04
D001289 Attention Deficit Disorder with Hyperactivity NIH 0.04
D011565 Psoriasis NIH 0.04
D006470 Hemorrhage NIH 0.04
D015451 Leukemia, Lymphocytic, Chronic, B-Cell NIH 0.04
D001714 Bipolar Disorder NIH 0.04
D011024 Pneumonia, Viral NIH 0.04
D001168 Arthritis NIH 0.04
D016638 Critical Illness NIH 0.04
D012127 Respiratory Distress Syndrome, Newborn NIH 0.04
D055371 Acute Lung Injury NIH 0.04
D005356 Fibromyalgia NIH 0.04
D007938 Leukemia, NIH 0.04
D014376 Tuberculosis NIH 0.04
D058070 Asymptomatic Diseases NIH 0.04
D009164 Mycobacterium Infections NIH 0.04
D000755 Anemia, Sickle Cell NIH 0.04
D000163 Acquired Immunodeficiency Syndrome NIH 0.04
D003327 Coronary Disease NIH 0.04
D004630 Emergencies NIH 0.04
D013577 Syndrome NIH 0.03
D015658 HIV Infections NIH 0.03
D007154 Immune System Diseases NIH 0.03
D001930 Brain Injuries, NIH 0.03
D004198 Disease Susceptibility NIH 0.03
D001927 Brain Diseases NIH 0.03
D012128 Respiratory Distress Syndrome, Adult NIH 0.03
D007676 Kidney Failure, Chronic NIH 0.03
D007674 Kidney Diseases NIH 0.03
D014115 Toxemia NIH 0.03
D008171 Lung Diseases, NIH 0.03
D007153 Immunologic Deficiency Syndromes NIH 0.03
D010300 Parkinsonian NIH 0.03
D008175 Lung Neoplasms NIH 0.03
D008223 Lymphoma, NIH 0.03
D004194 Disease NIH 0.03
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.03
D006331 Heart Diseases NIH 0.03
D015212 Inflammatory Bowel Diseases NIH 0.03
D012598 Scoliosi NIH 0.03
D018805 Sepsis NIH 0.03
D009103 Multiple Sclerosis NIH 0.03
D008173 Lung Diseases, Obstructive NIH 0.03
D002318 Cardiovascular Diseases NIH 0.02
D011248 Pregnancy Complications NIH 0.02
D059350 Chronic Pain NIH 0.02
D003095 Collagen Diseases NIH 0.02
D053717 Pneumonia, Ventilator-Associated NIH 0.02
D012216 Rheumatic Diseases NIH 0.02
D004417 Dyspnea NIH 0.02
D017563 Lung Diseases, Interstitial NIH 0.02
D020141 Hemostatic Disorders NIH 0.02
D011658 Pulmonary Fibrosis NIH 0.02
D001778 Blood Coagulation Disorders NIH 0.02
D006973 Hypertension NIH 0.02
D018450 Disease Progression NIH 0.02
D040921 Stress Disorders, Traumatic NIH 0.01
D013313 Stress Disorders, Post-Traumatic NIH 0.01
D009369 Neoplasms, NIH 0.01
D014947 Wounds and Injuries NIH 0.01

Correlated HPO Terms (44)


Name (Synonyms) Correlation
HP:0011947 Respiratory tract infection HPO 0.27
HP:0002180 Neurodegeneration HPO 0.10
HP:0002905 Hyperphosphatemia HPO 0.07
Name (Synonyms) Correlation
HP:0002900 Hypokalemia HPO 0.07
HP:0000846 Adrenal insufficiency HPO 0.07
HP:0000132 Menorrhagia HPO 0.07
HP:0006517 Intraalveolar phospholipid accumulation HPO 0.07
HP:0000859 Hyperaldosteronism HPO 0.07
HP:0100280 Crohn's disease HPO 0.07
HP:0005508 Monoclonal immunoglobulin M proteinemia HPO 0.07
HP:0100512 Low levels of vitamin D HPO 0.07
HP:0002090 Pneumonia HPO 0.06
HP:0011024 Abnormality of the gastrointestinal tract HPO 0.06
HP:0006802 Abnormal anterior horn cell morphology HPO 0.05
HP:0005526 Lymphoid leukemia HPO 0.05
HP:0002383 Encephalitis HPO 0.05
HP:0005550 Chronic lymphatic leukemia HPO 0.05
HP:0100754 Mania HPO 0.05
HP:0007354 Amyotrophic lateral sclerosis HPO 0.05
HP:0006775 Multiple myeloma HPO 0.05
HP:0001370 Rheumatoid arthritis HPO 0.04
HP:0003765 Psoriasiform dermatitis HPO 0.04
HP:0001250 Seizure HPO 0.04
HP:0007018 Attention deficit hyperactivity disorder HPO 0.04
HP:0001369 Arthritis HPO 0.04
HP:0000077 Abnormality of the kidney HPO 0.04
HP:0002665 Lymphoma HPO 0.03
HP:0001298 Encephalopathy HPO 0.03
HP:0002088 Abnormal lung morphology HPO 0.03
HP:0002721 Immunodeficiency HPO 0.03
HP:0006510 Chronic pulmonary obstruction HPO 0.03
HP:0100526 Neoplasm of the lung HPO 0.03
HP:0002037 Inflammation of the large intestine HPO 0.03
HP:0006536 Pulmonary obstruction HPO 0.03
HP:0100806 Sepsis HPO 0.03
HP:0001626 Abnormality of the cardiovascular system HPO 0.02
HP:0012532 Chronic pain HPO 0.02
HP:0001909 Leukemia HPO 0.02
HP:0002098 Respiratory distress HPO 0.02
HP:0006515 Interstitial pneumonitis HPO 0.02
HP:0001928 Abnormality of coagulation HPO 0.02
HP:0002206 Pulmonary fibrosis HPO 0.02
HP:0000822 Hypertension HPO 0.02
HP:0002664 Neoplasm HPO 0.01

Clinical Trials

Navigate: Correlations   HPO

There are 199 clinical trials


1 An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections

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

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

Primary Outcomes

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

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

Time: 26 Days

Secondary Outcomes

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

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

Time: Day 5,12,19 and 26

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

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

Time: Day 19 and 26

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

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

Time: Day 19 and 26

Other Outcomes

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

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

Time: Day 26

Description: Measured by death from all causes

Measure: Efficacy in reduction of mortality

Time: Day 26

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

Measure: Antiviral effect

Time: Day 26

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

Measure: Efficacy on clinical improvement

Time: Day 26

Description: Measured by change in the Modified Jackson Cold Score

Measure: Efficacy on the respiratory symptoms

Time: Day 26
2 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
3 Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

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

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

Primary Outcomes

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

Measure: Prevention of COVID-19

Time: Five years

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

Measure: Treatment of COVID-19

Time: Five years

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

Measure: Treatment of Symptoms

Time: Five years

Secondary Outcomes

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

Measure: Cannabis Impact on Quality of Life

Time: Five years

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

Measure: Cannabis Route and Dosing

Time: Five years

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

Measure: Monitoring Adverse Events

Time: Five years
4 RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study

Lower Respiratory Tract infections are a common cause of admission to the intensive care unit. Children routinely receive antibiotics until the tests confirm whether the infection is bacterial or viral. The exclusion of bacterial infection may take 48 hours or longer for culture tests on biological samples to be completed. In many cases, the results may be inconclusive or negative if the patient has already received antibiotics prior to the sample being taken. A rapid assay to detect the most likely cause of infection could improve the speed with which antibiotic therapy is rationalised or curtailed. This study aims to assess whether a new genetic testing kit which can identify the presence of bacteria and viruses within hours rather than days is a feasible tool in improving antibiotic prescribing and rationalisation of therapy in critically ill children with suspected lower respiratory tract infection.

NCT04233268
Conditions
  1. Lower Respiratory Tract Infection
  2. Ventilator Associated Pneumonia
  3. COVID19
Interventions
  1. Diagnostic Test: Rapid Pathogen Detection
MeSH:Infection Communicable Diseases Respiratory Tract Infections Pneumonia, Ventilator-Associated Pneumonia
HPO:Pneumonia Respiratory tract infection

Primary Outcomes

Description: Performance of novel pathogen detection assays compared to standard microbiology, in regard to sensitivity, specificity and likelihood ratios

Measure: Performance of the novel pathogen detection assay

Time: 3 years

Secondary Outcomes

Description: Time to reportable test results

Measure: Time to results

Time: 3 years

Description: Where routine culture is negative, what proportion of tests have a positive detection using the novel assay?

Measure: Negative cultures

Time: 3 years

Description: Duration of therapy and number of antibiotic classes during paediatric intensive care unit admission

Measure: Antibiotic therapy

Time: 3 years

Description: Number of critically ill children requiring mechanical ventilation with COVID19 compared to those without

Measure: Prevalence of COVID19 in children admitted to PICU

Time: 2 years
5 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
6 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
7 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

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

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

Primary Outcomes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
8 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
9 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
10 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
11 Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID19 Infection: a Randomized Clinical Trial

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

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

Primary Outcomes

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

Measure: Reduction in the incidence of intubation and mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Mortality from all causes

Measure: Mortality

Time: 28 days

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

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

Time: 7 days

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

Measure: Time to clinical recovery

Time: 28 days
12 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
13 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
14 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
15 Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization

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

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

Primary Outcomes

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

Measure: Hospital Admission

Time: 15 days

Secondary Outcomes

Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported shortness of breath in general, intensity, frequency and duration on a 0-10 scale, with 0 being no symptoms and 10 being the most severe. Finally, the patient answers the question "I've been short of breath" using a 0-4 scale, 0 being none and the most severe. There is no validated, unified single score and each item is evaluated individually.

Measure: Change in PROMIS Dyspnea scale

Time: 10 days

Description: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Physical score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.

Measure: Change in SF-12 Physical Composite Score

Time: 10 days

Description: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Mental composite score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Measure: Change in SF-12 Mental Composite Score

Time: 10 days

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

Measure: Daily Maximum Temperature

Time: 10 days

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

Measure: Emergency Department/Clinic Presentations

Time: 28 days

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

Measure: Disease Severity Rating Day 7

Time: 7 days

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

Measure: Disease Severity Rating Day 15

Time: 15 days

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

Measure: Disease Severity Rating Day 28

Time: 28 days

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

Measure: Viral Load by Oropharyngeal Swab Day 9

Time: 9 days

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

Measure: Viral Load by Oropharyngeal Swab Day 15

Time: 15 days

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

Measure: Ventilator-Free Days

Time: 28 days

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

Measure: Therapeutic Oxygen-Free Days

Time: 28 days

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

Measure: Need for Hospital Admission at 15 Days

Time: 15 days

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

Measure: Need for Oxygen Therapy at 15 Days

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

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

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

Primary Outcomes

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

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

Time: 7 days

Secondary Outcomes

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

Measure: Daily Hypotensive Episodes

Time: 10 days

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

Measure: Hypotension Requiring Vasopressors

Time: 10 days

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

Measure: Acute Kidney Injury

Time: 10 days

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

Measure: Sequential Organ Failure Assessment (SOFA) Total Score

Time: 10 days

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

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

Time: 10 days

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

Measure: 28-Day Mortality

Time: 28 days

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

Measure: 90-Day Mortality

Time: 90 days

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

Measure: ICU Admission

Time: 10 days

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

Measure: Number of Ventilator-Free Days

Time: 10 days

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

Measure: Number of Therapeutic Oxygen-Free Days

Time: 10 days

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

Measure: Number of Vasopressor-Free Days

Time: 10 days

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

Measure: Length of ICU Stay

Time: 10 days

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

Measure: Length of Hospital Stay

Time: 10 days

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

Measure: Incidence of Respiratory Failure

Time: 10 days

Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported shortness of breath in general, intensity, frequency and duration on a 0-10 scale, with 0 being no symptoms and 10 being the most severe. Finally, the patient answers the question "I've been short of breath" using a 0-4 scale, 0 being none and the most severe. There is no validated, unified single score and each item is evaluated individually.

Measure: Change in PROMIS Dyspnea scale

Time: 10 days

Description: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Physical score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Measure: Change in SF-12 Physical Composite Score

Time: 10 days

Description: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Mental composite score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Measure: Change in SF-12 Mental Composite Score

Time: 10 days

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

Measure: Disease Severity Rating

Time: 10 days

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

Measure: Viral Load by Nasopharyngeal Swab Day 9

Time: 9 days

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

Measure: Viral Load by Nasopharyngeal Swab Day 15

Time: 15 days

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

Measure: Viral Load by Blood Day 9

Time: 9 days

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

Measure: Viral Load by Blood Day 15

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

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

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

Primary Outcomes

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

Measure: COVID-19 diagnosis

Time: 14 days

Secondary Outcomes

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

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

Time: 14 days

Other Outcomes

Description: Mean/ Median in the two groups

Measure: Total number of quarantine days

Time: 14 days

Description: Percentage in the two groups

Measure: Proportion of healthcare providers requiring quarantine

Time: 14 days
18 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
19 Pandemic Response Network: Duke Community Health Watch

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

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

Primary Outcomes

Measure: Number of participants who experience inpatient admission

Time: 2 months

Secondary Outcomes

Measure: Number of participants admitted to the intensive care unit

Time: 2 months

Measure: Number of participants requiring mechanical ventilation

Time: 2 months

Measure: Number of deceased participants

Time: 2 months
20 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
21 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
22 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
23 Proactive Prophylaxis With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19

This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.

NCT04322396
Conditions
  1. Virus Diseases
  2. Infection Viral
  3. Corona Virus Infection
Interventions
  1. Drug: Azithromycin
  2. Drug: Hydroxychloroquine
  3. Drug: Placebo oral tablet
  4. Drug: Placebo oral tablet
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of days alive and discharged from hospital within 14 days

Time: 14 days

Secondary Outcomes

Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".

Measure: Categorization of hospitalization status

Time: 14 days

Measure: Admitted to intensive care unit, if admitted to ICU then length of stay

Time: 14 days

Measure: Have used Non-invasive ventilation (NIV) during hospitalization

Time: 14 days

Measure: Mortality

Time: 30 days

Measure: Length of hospitalization

Time: 14 days

Measure: Days alive and discharged from hospital

Time: 30 days

Measure: Mortality

Time: 90 days

Measure: Mortality

Time: 365 days

Measure: Number of readmissions (all causes)

Time: 30 days

Measure: Number of days using non-invasive ventilation (NIV)

Time: 14 days

Description: Delta PaO2 measured in arterial puncture

Measure: Change in patient's oxygen partial pressure

Time: 4 days

Description: Delta PaCO2 measured in arterial puncture

Measure: Change in patient's carbondioxid partial pressure

Time: 4 days

Description: pH measured in arterial puncture

Measure: Level of pH in blood

Time: 4 days

Measure: Time for no oxygen supplement (or regular oxygen supplement "LTOT")

Time: 14 days
24 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

25 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
26 Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection

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

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

Primary Outcomes

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

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 1 month

Secondary Outcomes

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

Measure: Pulmonary Function Analysis

Time: baseline, 3 Month, 6 months

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

Measure: Digital Oximetry

Time: 3 months, 6 months
27 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
28 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
29 ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection

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

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

Primary Outcomes

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

Time: 14 days or discharge

Secondary Outcomes

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

Time: 14 days or discharge

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

Time: 14 days or discharge

Measure: In-hospital mortality

Time: 14 days or discharge

Measure: Mean change in NEWS2 score from baseline

Time: 14 days or discharge

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

Time: 14 days or discharge

Measure: Reduction from baseline of NRS for cough

Time: 14 days or discharge

Measure: Reduction from baseline of NRS for nausea

Time: 14 days or discharge

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

Time: 14 days or discharge

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

Time: 14 days or discharge
30 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
31 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
32 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
33 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
34 A Prospective, Controlled, Randomized, Multicenter Study of the Efficacy of an Autophagy Inhibitor (GNS561), an Anti-NKG2A (Monalizumab) and an Anti-C5aR (Avdoralimab) Compared to the 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 an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) 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-NKG2A vs standard of care (randomization ratio 1:1:1). - COHORT 2 (moderate/severe symptoms): anti-C5aR vs standard of care (randomization ratio 1:1).

NCT04333914
Conditions
  1. SARS-CoV-2 (COVID-19) Infection
  2. Advanced or Metastatic Hematological or Solid Tumor
Interventions
  1. Drug: Autophagy inhibitor (GNS651)
  2. Other: Standard of care
  3. Drug: Avdoralimab
  4. 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. If vital status at 28 days post randomisation is not available due to early transfer in an external resuscitation unit, patients will be considered as failure at the date of the transfer. Comparison of each experimental arm (GNS561 then monalizumab for cohort1 and avdoralimab for cohort2) to control arm will be performed using a Fisher exact test.

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: The NEWS2 score (National Early Warning Score) allocates a score based on six physiological parameters (respiratory rate / oxygen saturation / systolic blood pressure / heart rate / consciousness / temperature). It Determines the degree of illness of a patient and prompts critical care intervention. The total possible score ranges from 0 to 21. The higher the score, the greater the clinical risk. A total score close to 0 corresponds to a low risk and a total score higher than 7 corresponds to a high risk.

Measure: Clinical status

Time: Day 7, Day 14, Day 28

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

Measure: Mean change in the ranking on the ordinal scale from baseline to D7, D14 and D28

Time: Day 7, Day 14, Day 28

Description: Mean change in clinical status from baseline will be assessed by using the NEWS2 score (National Early Warning Score). The NEWS2 score (National Early Warning Score) allocates a score based on six physiological parameters (respiratory rate / oxygen saturation / systolic blood pressure / heart rate / consciousness / temperature). It Determines the degree of illness of a patient and prompts critical care intervention. The total possible score ranges from 0 to 21. The higher the score, the greater the clinical risk. A total score close to 0 corresponds to a low risk and a total score higher than 7 corresponds to a high risk.

Measure: Mean change in the ranking of the NEWS2 score from baseline to D7, D14 and D28

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 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 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 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 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: The rate of secondary infection by other documented pathogens (bacteria, fungi)

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 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 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 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)

Measure: The rate of patients with SARS-CoV-2 IgG antibodies at D7, D14 and D28

Time: Day 7, Day 14, Day 28
35 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
36 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

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

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

Primary Outcomes

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

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

Time: 24 weeks

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

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

Time: 24 weeks
37 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
38 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
39 French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study

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

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

Primary Outcomes

Description: Mortality at day 28

Measure: Mortality at day 28

Time: day 28

Secondary Outcomes

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

Measure: severe complications

Time: up to day 28

Description: Delay in imaging in hours

Measure: Imaging

Time: day 1

Description: delay in microbiological diagnosis in hours

Measure: Delay in Microbiological diagnosis

Time: day 1

Description: Antiviral therapy Yes / no

Measure: Antiviral therapy

Time: up to day 28

Description: Antibiotic therapy Yes / No

Measure: Antibiotic therapy

Time: day 28

Description: Covid-19 treatments Yes / No

Measure: Covid-19 treatments

Time: up to day 28

Description: number

Measure: Patients receiving renal replacement therapy

Time: up to day 28

Description: number

Measure: Patients receiving mechanical ventilation

Time: up to day 28

Description: Patient alive at day 28 : yes / No

Measure: Vital status

Time: day 28
40 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
41 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
42 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
43 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
44 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
45 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
46 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
47 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
48 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
49 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
50 Assessment of COVID-19 Diagnostic Self-testing Using Virtual Point-of-care

The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic antigen tests, like Artron Laboratories Inc. rapid COVID-19 antigen 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
51 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
52 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
53 Austrian COVID-19 Registry (AGMT_COVID-19)

The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2. Data will be collected from all sites in Austria willing to participate. Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF.

NCT04351529
Conditions
  1. Infectious Disease
  2. COVID-19
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF. Treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations, and response assessments shall be exclusively based on the risk/benefit estimation of the treating physician.

Measure: Documentation of natural course and the therapeutic landscape of patients with COVID-19.

Time: 2 years
54 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
55 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
56 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
57 suPAR-guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE Open-label, Non-randomized Single-arm Trial

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

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

Primary Outcomes

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

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

Time: Visit study day 14

Secondary Outcomes

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

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

Time: Visit study day 14

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

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

Time: Visit study day 1, visit study day 7

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

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

Time: Visit study day 1, visit study day 14

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

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

Time: Visit study day 1, visit study day 7

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

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

Time: Visit study day 1, visit study day 14

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

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

Time: Visit study day 1, visit study day 7

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

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

Time: Visit study day 1, visit study day 7

Description: Mortality on day 30

Measure: Rate of Mortality

Time: Visit study day 30

Description: Mortality on day 90

Measure: Rate of Mortality

Time: Visit study day 90

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

Measure: Change of gene expression between days 1 nad 7

Time: days 1 and 7
58 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
59 Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection

It is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study. Patients with severe ARDS-CoVid19 will be included in the trial within the first 24 hours. Patients will be randomized to one of the treatment groups: - SEV group: 25 patients with Sevoflurane sedation by inhalation, starting at 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved (BIS 40-50) - PRO group: 25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)

NCT04359862
Conditions
  1. Acute Respiratory Distress Syndrome
  2. COVID19 Infection
Interventions
  1. Drug: Sevoflurane
  2. Drug: Propofol
MeSH:Infection Communicable Diseases Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19

Measure: PaO2/FiO2

Time: Day 2

Secondary Outcomes

Description: To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19

Measure: TNFα

Time: Day 2

Description: To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19

Measure: IL-1b

Time: Day 2

Description: To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19

Measure: IL-6

Time: Day 2

Description: To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19

Measure: IL-8

Time: Day 2

Description: To evaluate the 30-day mortality.

Measure: Mortality

Time: Day 30
60 A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity

In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.

NCT04361253
Conditions
  1. COVID
  2. Inf
  3. Infectious Disease
Interventions
  1. Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP)
  2. Biological: Standard Plasma (FFP)
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: The primary outcome will be the MOS numerical score (score 0-9) where a score of 0 attributes to 'no clinical evidence of infection' and a score of 9 attributes to 'death'. The eligibility requirements for this trial select individuals at level 3 or higher on the modified scale, but the day 14 outcome can be any one of 10 levels.

Measure: Modified WHO Ordinal Scale (MOS) score

Time: Day 14
61 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).
62 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
63 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
64 A Phase I/II Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) for the Treatment of Adults With COVID-19

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

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

Primary Outcomes

Description: Number and severity of adverse events

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

Time: Up to 6 months

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

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

Time: Up to 6 months

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

Measure: Phase 1: Rate of clinical improvement

Time: Up to 6 months

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

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

Time: Up to 28 days

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

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

Time: Up to 28 days

Secondary Outcomes

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

Measure: Rate of Clearance of SARS-CoV-2

Time: Up to 6 months

Description: Number and severity of adverse events

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

Time: up to 6 months

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

Measure: Overall Clinical Benefit by time to medical discharge

Time: up to 6 months

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

Measure: Overall Clinical Benefit by hospital utilization

Time: up to 6 months

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

Measure: Overall Clinical Benefit by measuring mortality rate

Time: up to 6 months

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

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

Time: Up to 28 days

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

Measure: Time to Pulmonary Clearance

Time: Up to 28 days

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

Measure: Supplemental oxygen-free days

Time: Up to 28 days

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

Measure: Proportion of subjects requiring ventilation

Time: Up to 28 days
65 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 12 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 12 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 12 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 12 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 12 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 12 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 12 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 12 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 12 months
66 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
67 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
68 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
69 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
70 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
71 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
72 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
73 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
74 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
75 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
76 A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19

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

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

Primary Outcomes

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

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

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

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

Time: 14 days

Secondary Outcomes

Measure: Time to negative COVID-19 PCR

Time: 14 days

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

Time: 14 days

Measure: COVID-19 related survival

Time: 14 days

Measure: Incidence and duration of mechanical ventilation

Time: 14 days

Measure: Incidence of Intensive Care Init (ICU) stay

Time: 14 days

Measure: Duration of ICU stay

Time: 14 days

Measure: Duration of time on supplemental oxygen

Time: 14 days
77 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
78 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
79 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
80 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
81 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
82 Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission

SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.

NCT04390022
Conditions
  1. Covid-19
  2. Coronavirus Infection
  3. SARS-CoV-2 Infection
Interventions
  1. Drug: Ivermectin
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment. PCRs were performed using two target genes (E and N).

Measure: Proportion of Patients With a Positive SARS-CoV-2 PCR

Time: 7 days post-treatment

Secondary Outcomes

Description: Quantitative and semi-quantitative PCR in nasopharyngeal swab. PCRs were performed using two target genes (E and N).

Measure: Median Viral Load

Time: Baseline and on days 4, 7, 14 and 21

Description: Proportion of patients with fever and cough

Measure: Fever and Cough Progression

Time: Days 4, 7, 14 and 21

Description: Proportion of participants with positive IgG at day 21

Measure: Seroconversion at Day 21

Time: Up to and including day 21

Description: Proportion of drug-related adverse events

Measure: Proportion of Drug-related Adverse Events

Time: 7 days post treatment

Description: Levels in median fluorescence intensity (MFI) of IgG, IgM and IgA against the receptor-binding domain of the spike glycoprotein of SARS-CoV-2 in plasma, measured by a Luminex assay. [Results not yet available]

Measure: Levels of IgG, IgM and IgA

Time: Up to and including day 28

Description: Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry. [Results not yet available]

Measure: Frequency of Innate Immune Cells

Time: Up to and including day 7

Description: Frequency of CD4+ T and CD8+ T cells (% over total CD4+T and CD8+ T) expressing any functional marker upon in vitro stimulation of PBMC with SARS-CoV-2 peptides, measured by flow cytometry. [Results not yet available]

Measure: Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T Cells

Time: Up to and including day 7

Description: Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher). [Results not yet available]

Measure: Results From Cytokine Human Magnetic 30-Plex Panel

Time: Up to and including day 28
83 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
84 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
85 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
86 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
87 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
88 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
89 Prevention of COVID19 Infection by the Administration of Hydroxychloroquine to Institutionalized Older People and Nursing Home Staff. Controlled Clinical Trial, Randomized Triple Blind by Clusters (PREVICHARM Study)

Professionals and residents of nursing homes are one of the most vulnerable groups in this public health crisis of COVID-19, since they have the highest rate of positives for COVID-19, despite the restriction measures carried out, such as prohibition of family visits to these centers, the infection occurs by cross transmission with the care staff of the centers, or with other residents. At the moment, there are no clinical trials to test the hypothesis that hydroxychloroquine is effective in coronavirus treatment. Although what has been observed is a better prognosis in infected patients, since this drug inhibits the replication of the virus and its expansion to other tissues. This study is a clinical trial to test the effectiveness of hydroxychloroquine as a preventive drug for SARS-CoV-2 infection. This drug will be applied to 1050 people residing in nursing home care and 880 professionals who work in close contact with these people and who have not yet contracted the infection. This project will be carried out in the territories of Madrid, Navarra, Aragon and Andalusia (Spain). Hydroxychloroquine is a widely known drug that is used in two scenarios, against autoimmune diseases, such as lupus or rheumatoid arthritis, and as an antimalarial drug. It is also intended to demonstrate that the presumed reduction in viral load that would be obtained with hydroxychloroquine prophylaxis, would have no effect in development of immunity against the virus. This fact can create a new paradigm for the de-escalation of the confinement to which the population has been subjected to stop the virus spread, allowing the development of general immunity in controlled populations until reaching total immunity. In addition to testing the effect of this drug, a non-pharmacological intervention based on a safety record will be tested in the management of infection on nursing home, to assess its effectiveness in detecting risk areas or bad practices carried out in this vulnerable environment. The study is led by researchers of the Institute of Biomedicine of Malaga (Spain), and has obtained a financing of 1,024,199 euros from Carlos III Health Institute (Spain). The period of execution of the clinical trial is one year, and with this intervention, the intention is to reduce cross-infection in residents by a minimum threshold of 15%, as well as to decrease infection in the professionals.

NCT04400019
Conditions
  1. Sar
  2. Sars-CoV2
  3. Coronavirus Infection
  4. Prevention
  5. Prevention &
  6. Prevention & Control
  7. Nursing Home
  8. Hydroxychloroquine
Interventions
  1. Drug: Hydroxychloroquine Only Product in Oral Dose Form
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Secondary Outcomes

Description: Dichotomous qualitative variable (1: Death 0: Survival)

Measure: Mortality

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Continous variable. It will be evaluated with the AIDS Clinical Trials Group method: investigation of medications not taken in a period of 4 days prior to the interview)% adherence = (total prescribed galenic units for that period-total units not taken) / total prescribed galenic units for that period

Measure: Compliance with treatment

Time: It will be evaluated during the five days that the chemoprophylaxis with hydorxychloroquine is administered

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at six days

Time: This outcome will be evaluated at 6 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. Participant requires hospital admission attributable to SARS-CoV-2 infection

Measure: Hospitalization

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine
90 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
91 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
92 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
93 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. Increase
  2. 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
94 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
95 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
96 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
97 Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory Therapy in Patients Diagnosed With COVID-19 Disease

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.

NCT04412395
Conditions
  1. Corona Virus Infection
  2. Middle East Respiratory Syndrome (MERS)
  3. Acute Respiratory Distress Syndrome
  4. Coronavirus Infection
  5. COVID-19
  6. SARS-CoV 2
Interventions
  1. Dietary Supplement: Lactoferrin (Apolactoferrin)
  2. Drug: Placebo of excipient(s) will be administered
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Comparing the influence of the intervention on the Survival rate.

Measure: Survival rate.

Time: up to 8 weeks.

Description: For mild/moderate symptoms patients: fever, cough and other symptoms relieved with improved lung CT - For severe symptoms patients: fever, cough and other symptoms relieved with improved lung CT, and oxygen saturation by pulse oximetry (SPO2 )> 93% for nonasthmatic patients, and from 88-92% in asthmatic patients.

Measure: Rate of disease remission.

Time: up to 4 weeks.

Description: Comparing the influence of the intervention on the PCR negative results.

Measure: The number of patients with PCR negative results.

Time: up to 4 weeks.

Secondary Outcomes

Description: Recording the changes from severe to moderate or mild and the time taken.

Measure: Mean change in the disease severity (clinical assessment).

Time: up to 4 weeks.

Description: Recording the changes in blood pressure mmHg.

Measure: Mean change in blood pressure.

Time: up to 4 weeks.

Description: Recording the changes in heart rate in beat/second.

Measure: Mean change in heart beats.

Time: up to 4 weeks.

Description: Recording the changes in body temperature in Celsius.

Measure: Mean change in body temperature.

Time: up to 4 weeks.

Description: Recording the changes in the respiratory rate in breath/minute.

Measure: Mean change in body respiratory rate.

Time: up to 4 weeks.

Description: Recording the changes in arterial oxygen saturation in mmHg.

Measure: Mean change in oxygen saturation.

Time: up to 4 weeks.

Description: Recording the changes in the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).

Measure: Mean change in the ratio in arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).

Time: up to 4 weeks.

Description: Recording the changes in complete blood picture (CBC) in cells per liter.

Measure: Mean change in complete blood picture (CBC).

Time: up to 4 weeks.

Description: Recording the changes in C reactive protein (CRP) in mg/L.

Measure: Mean change in C reactive protein (CRP).

Time: up to 4 weeks.

Description: Recording the changes in erythrocyte sedimentation rate (ESR) in mm/hr.

Measure: Mean change in erythrocyte sedimentation rate (ESR).

Time: up to 4 weeks.

Description: Recording the changes in D-dimer in ng/mL.

Measure: Mean change in D-dimer.

Time: up to 4 weeks.

Description: Recording the changes in ferritin in ng/mL.

Measure: Mean change in ferritin.

Time: up to 4 weeks.

Description: Recording the changes in liver Albumin in g/L.

Measure: Mean change in liver Albumin.

Time: up to 4 weeks.

Description: Recording the changes in total and direct Bilirubin in mg/dL.

Measure: Mean change in total and direct Bilirubin.

Time: up to 4 weeks.

Description: Recording the changes in prothrombin time (PT), partial thromboplastin time (PTT ) in seconds and calculating International Normalized Ratio (INR).

Measure: Mean change in prothrombin time (PT) and partial thromboplastin time (PTT ).

Time: up to 4 weeks.

Description: Recording the changes in aspartate aminotransferase (AST) in IU/L.

Measure: Mean change in aspartate aminotransferase (AST).

Time: up to 4 weeks.

Description: Recording the changes in Alanine Aminotransferase (ALT) in IU/L.

Measure: Mean change in Alanine Aminotransferase (ALT).

Time: up to 4 weeks.

Description: Recording the changes in Blood Urea Nitrogen (BUN) in mg/dL.

Measure: Mean change in Blood Urea Nitrogen (BUN).

Time: up to 4 weeks.

Description: Recording the changes in Serum Creatinine in mg/dL.

Measure: Mean change in Serum Creatinine.

Time: up to 4 weeks.

Description: Recording the changes in Serum Creatinine in ml/min.

Measure: Mean change in Serum Creatinine clearance.

Time: up to 4 weeks.

Description: Recording the changes in Glomerular filtration rate (GFR ) ml/min/m2.

Measure: Mean change in Glomerular filtration rate (GFR ).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-1 (IL-1) in pg/ml.

Measure: The mean change in serum interleukin-1 (IL-1).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-6 (IL-6) in pg/ml.

Measure: The mean change in serum interleukin-6 (IL-6).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-10 (IL-10) in pg/ml.

Measure: The mean change in serum interleukin-10 (IL-10).

Time: up to 4 weeks.

Description: Recording the changes in tumor necrosis factor-alpha (TNF alpha) in ng/ml.

Measure: The mean change in serum tumor necrosis factor-alpha (TNF alpha).

Time: up to 4 weeks.

Description: Recording the changes in immunoglobulin G (IgG) in ng/ml.

Measure: Mean changes in immunoglobulin G (IgG).

Time: up to 4 weeks.

Description: Recording the changes in immunoglobulin M (IgM) in ng/ml.

Measure: Mean changes in immunoglobulin M (IgM).

Time: up to 4 weeks.

Description: Recording the changes in PCR viral load in copies/mL.

Measure: The mean change in PCR viral load.

Time: up to 4 weeks.

Description: Recording the changes in lung CT.

Measure: Mean change in lung CT manifestation.

Time: up to 4 weeks.

Description: Recording any unexpected Adverse Events of the intervention.

Measure: Nature and severity of Adverse Events.

Time: up to 4 weeks.

Description: Recording the changes (the average time of lung imaging recovery), as assessed by lung CT.

Measure: Time for lung recovery.

Time: up to 8 weeks.

Description: Recording the changes the event of missed drug doses.

Measure: The number of missed drug doses among each treatment group.

Time: up to 4 weeks.
98 Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19

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

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

Primary Outcomes

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

Measure: Identification of requirement of mechanical ventilation

Time: 3 weeks

Secondary Outcomes

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

Measure: Prediction of requirement of mechanical ventilation

Time: 3 weeks

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

Measure: Association of LUS to clinical parameters

Time: 3 weeks

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

Measure: Description of findings on LUS

Time: 3 weeks
99 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
100 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
101 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
102 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
103 Observational Study to Evaluate the Effects on the Qt Interval of COVID-19 Coronavirus Infection in Critically Ill Patients

The present study aims to evaluate the impact of COVID-19 disease and its treatment on ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to the critical care unit.

NCT04422535
Conditions
  1. Coronavirus Infection
  2. Intensive Care Patients
MeSH:Inf Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The QT interval measurement will be performed on the available 12-lead ECG from the medical record. The QT interval will be measured according to the recommendations of the scientific societies of cardiology: it is considered from the beginning of the activation of the ventricular myocardium and the end of its repolarization, which are represented in the ECG respectively by the beginning of the QRS and the end of the T wave. Ideally, the QT interval should be measured in Q-wave leads in DII and V5. An average value of 3 heart cycles (beats) should be recorded. Two researchers to control inter-observer variability will perform the measurement.

Measure: Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection

Time: through study completion, an average of 1 year

Secondary Outcomes

Description: To assess the incidence of arrhythmias in critically ill patients with COVID-19 infection admitted to critical patient units. To evaluate the impact of the association of drugs administered for the treatment of COVID-19 infection in critically ill patients in the QT interval.

Measure: incidence of arrhythmias and impact of the COVI-drugs administered on QT interval

Time: through study completion, an average of 1 year
104 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
105 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
106 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
107 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
108 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
109 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
110 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: To 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: To 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: To 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: To 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: To 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: To compare the incidence of COVID-19 in participants who have received BCG vaccination previously vs those not previously vaccinated

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: To compare adverse event profile in participants following administration of VPM1002 or placebo 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) in participants following administration of VPM1002 or placebo when used for prevention of COVID-19.

Measure: Innate Trained Immunity

Time: 7 months
111 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
112 Double-Blinded, Placebo-Controlled Parallel, Phase II Clinical Efficacy Study Evaluating NORS To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Mild COVID-19

This is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection.

NCT04443868
Conditions
  1. SARS-CoV Infection
Interventions
  1. Drug: Nitric Oxide-Releasing Drug
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms.

Measure: To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity

Time: 6 Days

Secondary Outcomes

Description: Measure the proportion of subjects reaching Ct threshold (ie: unmeasurable viral load) between NONI and control

Measure: To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection

Time: 2, 4 and 6 days

Description: Measure the difference in time-to Ct threshold (ie: unmeasurable viral load) between NONI and control.

Measure: To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection

Time: 2, 4 and 6 days

Description: Measure the proportion of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms

Measure: To Measure the efficacy of NONI in prevention of progression of COVID-19

Time: 28 days

Description: Measure the difference in 12-point COVID Symptom PROs score 0-3 (min 0 & max 36) and a QoL score from 0-100 (lower is worse) from baseline between NONI and control arms.

Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19

Time: 6 days

Description: Measure the difference in proportion of subjects experiencing a reduction of ≥ 5 from baseline between NONI and control arms.

Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19

Time: 2, 4, 6, 14 and 28 days

Description: Measure the difference in proportion of subjects with reduction to a score of zero from baseline between NONI and control arms.

Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19

Time: 2, 4, 6, 14 and 28 days

Description: Number of participants lost-to-follow-up,discontinuing study treatment or number of treatments due to intolerance

Measure: To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection

Time: 14 days

Description: Severity and frequency of adverse events, pain, discomfort or discontinuations of treatment.

Measure: To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection

Time: 14 days
113 Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.

NCT04445454
Conditions
  1. Coronavirus Infection
Interventions
  1. Biological: Mesenchymal stromal cells
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To assess the infusional toxicity

Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: To assess the number of Adverse events of special interest : Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events.

Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: Group A (patients not under mechanical ventilation): to determine the pourcentage of patients requiring mechanical ventilation

Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: Group B (patients under mechanical ventilation): to determine the vital status (dead/alive)

Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Secondary Outcomes

Description: To assess the clinical status (on a 7-point WHO ordinal scale)

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the duration of oxygen therapy and/or mechanical ventilation

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the length of stay at the intensive care unit and of hospitalization

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the number of organ failures

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the intensity of the inflammatory response

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the evolution of coagulation parameter

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the presence of Biomarker of lung lesion, repair and scarring

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the v iral load over the 28 days after inclusion and seroconversion to COVID-19 over the 90 days after inclusion

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the pulmonary function

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the number of adverse reactions (ARs), ARs grade > 3, serious adverse events (SAEs), serious ARs (SARs), suspected expected and unexpected SARs (SESARs and SUSARs).

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Other Outcomes

Description: To determine the FACS analysis of regulatory T-cell (Treg) levels and Treg and Tconv sub-populations

Measure: To investigate immune modulation

Time: Day 28

Description: To assess the cytotoxic activity by MLR

Measure: To compare the cytotoxic activity of PBMCs from healthy control and COVID-19 patients (divided in responders / non-responders to MSC therapy) against MSCs in vitro

Time: Day 28
114 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 Infectious Unit
  2. Patient Hospitalized in Intensive Reanimation Unit
  3. 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
115 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 ]
116 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 Emergencie 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
117 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
118 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
119 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.
120 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
121 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
122 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.
123 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
124 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
125 Reducing Asymptomatic Infection With Vitamin D in Coronavirus Disease

This study is intended to address whether oral daily vitamin D supplementation reduces infection with SARS-CoV-2 in healthy young adults. The primary aim of the study is to demonstrate a reduction in 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population following 24 weeks of taking oral vitamin D supplemented at a dose of 1000 I.U. daily, versus matching placebo. The secondary aims of this study are to explore: 1. Any effect on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.

NCT04476680
Conditions
  1. SARS-CoV Infection
  2. Vitamin D Deficiency
  3. Covid19
  4. Acute Respiratory Tract Infection
Interventions
  1. Dietary Supplement: Vitamin D 1000 IU
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Vitamin D Deficiency Asymptomatic Infections
HPO:Low levels of vitamin D Respiratory tract infection

Primary Outcomes

Description: asymptomatic seroconversion for SARS-CoV-2

Measure: Seroconversion

Time: 24 weeks

Description: asymptomatic seroconversion for SARS-CoV-2

Measure: Interim analysis - seropositivity at 12 weeks

Time: 12 weeks

Secondary Outcomes

Description: Sensitivity and specificity of dried blood spot assay compared with venous blood serology

Measure: Dried Blood Spot performance

Time: 24 weeks

Description: Sensitivity and specificity of salivary IgA compared with venous blood serology

Measure: Salivary IgA performance

Time: 24 weeks

Description: The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.

Measure: Prevalence of SARS-CoV-2

Time: 24 weeks

Description: The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time

Measure: Change in seropositivity

Time: 24 weeks

Description: The effect of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity

Measure: Change in seroconversion rate

Time: 24 weeks
126 Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19

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

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

Primary Outcomes

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

Measure: Survival without needs of ventilator utilization at day 14

Time: day 14

Secondary Outcomes

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

Measure: WHO progression scale at day 7 and 14

Time: day 7 and day 14

Description: Overall survival

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

Time: 14, 28, 60 and 90 days

Description: Cumulative incidence of discharge alive

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

Time: 14 and 28 days

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

Measure: Survival without needs of mechanical ventilation at day 1

Time: day 1

Description: Cumulative incidence of oxygen supply independency

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

Time: 14 and 28 days
127 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
128 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
129 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
130 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 Communicable Diseases

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
131 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Severe COVID-19 Patients

The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.

NCT04483973
Conditions
  1. Covid19
  2. Coronavirus
  3. Coronavirus Infection
  4. Corona Virus Infection
Interventions
  1. Drug: Ebselen
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of participants with treatment-related adverse events

Time: 30 days

Secondary Outcomes

Description: Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.

Measure: WHO Ordinal Scale

Time: 30 days

Description: Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)

Measure: Degree of supplemental oxygen

Time: 30 days

Description: Peripheral oxygen saturation measured by pulse oximetry

Measure: Peripheral Oxygen Saturation (SpO2)

Time: 30 days
132 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Moderate COVID-19 Patients

The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.

NCT04484025
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Coronavirus
  4. Coronavirus Infection
Interventions
  1. Drug: Ebselen
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of participants with treatment-related adverse events

Time: 30 days

Secondary Outcomes

Description: Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.

Measure: WHO Ordinal Scale

Time: 30 days

Description: Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)

Measure: Degree of supplemental oxygen

Time: 30 days

Description: Peripheral oxygen saturation measured by pulse oximetry

Measure: Peripheral Oxygen Saturation (SpO2)

Time: 30 days
133 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
134 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
135 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
136 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
137 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
138 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
139 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 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
140 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
141 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
142 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
143 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
144 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
145 MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients

While many people with COVID-19 suffer from respiratory disease, there is growing evidence that the virus also affects other organs. The purpose of this study is to better understand the effects of COVID-19 on the lungs and other organs. The study investigators have developed new techniques in Magnetic Resonance Imaging (MRI) to scan the lungs, heart, brain and liver. The study investigators hope to learn more about how the virus causes inflammation in these organs and how this inflammation changes over time as people recover from COVID-19 illness. The study aims to enroll 228 people in Alberta. Participants will undergo one or more MRI scans and have blood testing at one or more time points to assess for inflammation, kidney function, liver function and possible heart injury. Participants will also undergo testing to assess sense of smell, cognition (thinking and memory), spirometry (breathing test for lung function) and and exercise tolerance (walk test). The study investigators hope this study will help us learn more about the long-term risks of COVID-19 disease.

NCT04525404
Conditions
  1. Covid19
  2. Coronavirus Infection
  3. SARS-CoV Infection
Interventions
  1. Diagnostic Test: MRI (heart, brain, lungs, liver)
  2. Diagnostic Test: Bloodwork
  3. Other: Cognitive testing
  4. Other: Olfaction testing
  5. Diagnostic Test: Spirometry
  6. Other: Walk Test
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Myocardial T1 is a surrogate marker of myocardial edema and the most sensitive MRI measure of acute myocarditis. We will show that myocardial T1 at baseline is significantly higher than myocardial T1 at 12 weeks follow-up. At 12 weeks, we will also compare native myocardial T1 in patients with baseline elevated troponin to those with baseline normal troponin as well as healthy controls

Measure: Native myocardial T1 relaxation time

Time: 12 weeks post COVID-19 diagnosis

Secondary Outcomes

Description: Similar within group and between group comparisons of MRI derived lung water content, liver water content, and the presence of brain inflammation on FLAIR imaging

Measure: FLAIR imaging

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week cognitive testing (NIH toolbox score) to the corresponding findings on MRI of brain, heart and lung at baseline

Measure: Compare 12-week cognitive testing to the corresponding findings on MRI of brain, heart and lung at baseline

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week spirometry (FEV1, FVC and FEV1:FVC) to the corresponding findings on MRI of brain, heart and lung at baseline

Measure: Compare 12-week spirometry to the corresponding findings on MRI of brain, heart and lung at baseline

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week walk test results (distance and time) to the corresponding findings on MRI of brain, heart and lung at baseline

Measure: Compare 12-week walk test results to the corresponding findings on MRI of brain, heart and lung at baseline

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI

Measure: Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI

Time: 12 weeks post COVID-19 diagnosis

Description: Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic

Measure: Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic

Time: 12-24 weeks post COVID-19 diagnosis
146 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)
147 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 Virus
  3. COVID-19
  4. 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
148 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);
149 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.
150 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
151 Evaluation of SARS-CoV-2 Sample Acquisition Efficiency and PPE Usage With and Without the Hexapod Personal Protective Booth

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

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

Primary Outcomes

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

Measure: Change in Testing Throughput After Hexapod Implementation

Time: Up to 22 weeks

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

Measure: Change in Isolation Gowns Utilized After Hexapod Utilization

Time: Up to 22 weeks

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

Measure: Change in Cost per Test After Hexapod Implementation

Time: Up to 22 weeks

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

Measure: Return on Investment

Time: Up to 22 weeks

Secondary Outcomes

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

Measure: Change in Testing Personnel Cost Per Test

Time: Up to 22 weeks

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

Measure: Change in Cost of Isolation Gowns Utilized

Time: Up to 22 weeks

Other Outcomes

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

Measure: Cost of Additional Consumable Supplies Utilized

Time: Up to 22 weeks
152 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
153 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
154 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
155 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
156 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
157 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
158 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
159 Minnesota COVID-19 Testing Project

The goal of this project is to help the state of Minnesota understand why individuals are not getting tested and potentially identify trusted individuals or organizations that could be used in follow-up work to send messages. Investigators focus on the first two issues of unit and item nonresponse, which is not random across the population and thus could lead to nonresponse bias. To do so, investigators are deploying flyers through 10 Twin City area food shelves and potentially through public housing units with information on how to answer an online questionnaire.

NCT04568889
Conditions
  1. Covid19
  2. Infectious Disease
Interventions
  1. Behavioral: A $10 Survey Incentive
  2. Behavioral: A $20 Survey Incentive
  3. Behavioral: Emphasis of Government Involvement
  4. Behavioral: Emphasis of Academic Researchers Involvement
  5. Behavioral: Cost-Benefit Frame
  6. Behavioral: Duty Frame
  7. Behavioral: Racial/Ethnic Frame
  8. Behavioral: No Messaging
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Number of participants who received a flyer that mentions a $20 incentive and completed the survey

Measure: Effect of monetary incentives in increasing unit response 1

Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.

Description: Number of participants who received a flyer that mentions a $10 incentive and completed the survey.

Measure: Effect of monetary incentives in increasing unit response 2

Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.

Description: Number of participants who received a flyer that mentions a government frame and completed the survey

Measure: Effect of a government frame in reducing unit response 1

Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.

Description: Number of participants who received a flyer that mentions a research frame and completed the survey.

Measure: Effect of a government frame in reducing unit response 2

Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.

Description: Number of participants who received a flyer that mentions a government frame and $20 incentive and completed the survey

Measure: Interactions between monetary incentives and a government frame 1

Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.

Description: Number of participants who received a flyer that mentions a government frame and $10 incentive and completed the survey

Measure: Interactions between monetary incentives and a government frame 2

Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.

Description: Number of participants who received a flyer that mentions a researcher frame and $20 incentive and completed the survey

Measure: Interactions between monetary incentives and a government frame 3

Time: This outcome will be assessed during the 20-minute Baseline Survey.

Description: Number of participants who received a flyer that mentions a researcher frame and $10 incentive and completed the survey

Measure: Interactions between monetary incentives and a government frame 4

Time: This outcome will be assessed during the 20-minute Baseline Survey.

Description: Demographic characteristics (e.g. sex, education level, income level, race/ethnicity) of participants who are assigned to each treatment arm and completed the survey.

Measure: Demographic characteristics of participants assigned into each treatment arm

Time: This outcome will be assessed during the 20-minute Baseline Survey.

Description: Number of survey participants who are randomly assigned to receive each messaging frame that: a) emphasizes the public health benefits of answering the survey questions (cost-benefit frame); b) emphasizes an individual's responsibility to their community (duty frame); c) emphasizes the disproportionate impact of COVID-19 on certain ethnic and racial groups; or d) provides no messaging.

Measure: Effect of various messaging frames in increasing item non-response

Time: This outcome will be assessed during the 20-minute Baseline Survey.
160 Evaluation of a Screening Program for SARS-CoV-2 Infection in the General Population Based on the Use of New Detection Approaches or for Diagnostic Orientation on Saliva (COVID-19)

The investigators hypothesize that detection of SARS-CoV2 on saliva samples will increase the performance of the screening program compared to the reference strategy (RT-PCR on a nasopharyngeal swab).

NCT04578509
Conditions
  1. SARS-CoV-2 Infection
  2. COVID-19
Interventions
  1. Diagnostic Test: Nasopharyngeal swab
  2. Diagnostic Test: Saliva sample
  3. Other: Data collection
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: RT-PCR on nasopharyngeal is considered as gold standard

Measure: Positivity of RT-PCR on nasopharyngeal swab for the SARS-CoV-2 virus

Time: At diagnosis

Secondary Outcomes

Measure: Positivity of RT-PCR on saliva sample for the SARS-CoV-2 virus

Time: At diagnosis

Measure: Positivity of new detection approach on saliva sample for the SARS-CoV-2 virus

Time: At diagnosis

Measure: Positivity of antigenic test on nasopharyngeal swab for the SARS-CoV-2 virus

Time: At diagnosis

Description: Number of samples tested in a day for each test

Measure: Practicability to samples

Time: At diagnosis

Description: Quantity of premises required for each test

Measure: Practicability to premises

Time: At diagnosis

Description: Feasibly Reading and interpretation For each test

Measure: Practicability to interpretation

Time: At diagnosis

Description: Render times for each test

Measure: Practicability to render time

Time: At diagnosis

Description: Research of IgG by ELISA and RDT

Measure: IgG Antibody detection in saliva

Time: At diagnosis

Description: Research of IgM by ELISA and RDT

Measure: IgM Antibody detection in saliva

Time: At diagnosis

Description: Research of IgA by ELISA and RDT

Measure: IgA Antibody detection in saliva

Time: At diagnosis

Description: Evaluation by questionnaire of the patient tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions are about pain, discomfort, speed of performance)

Measure: Patient tolerance of the salivary self-sampling

Time: At diagnosis

Description: Evaluation by questionnaire of the operator tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions is about pain, discomfort, speed of performance)

Measure: Operator tolerance of the salivary self-sampling

Time: At diagnosis

Description: Including sampling, transport, technique (consumables, reagents, machine), human resources

Measure: Cost of each approach

Time: At diagnosis
161 Prevalence and Outcome of SARS-CoV-2 Infection in Solid Organ and Hematopoietic Cell Transplant Recipients: The COVITRA Study

This project will provide novel data using a large cohort of more than 3000 transplanted patients. Risk and protective factors for SARS-CoV-2 infection and COVID-19 disease severity will be identified. The proportion of patients who develop antibodies after infection will be revealed. In this way the presence of these antibodies can be evaluated as a test for prior infection. Our study additionally will demonstrate how long these antibodies remain present and whether they are protective against a new infection.

NCT04579471
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Transplantation Infection
Interventions
  1. Diagnostic Test: SARS-CoV-2 IgG
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Prevalence and risk-factors for SARS-CoV-2 infection

Measure: Prevalence and risk-factors for SARS-CoV-2 infection

Time: inclusion during 4 months

Description: Prevalence and risk-factors for COVID-19

Measure: Prevalence and risk-factors for COVID-19

Time: inclusion during 4 months

Secondary Outcomes

Description: Durability of IgG positivity/immunity

Measure: Durability of IgG positivity

Time: 12 months
162 Phase 3 Randomised Controlled Trial of Vitamin D Supplementation to Reduce Risk and Severity of COVID-19 and Other Acute Respiratory Infections in the UK Population

CORONAVIT is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin D status results in reduced risk and/or severity of COVID-19 and other acute respiratory infections.

NCT04579640
Conditions
  1. Covid19
  2. Acute Respiratory Tract Infection
Interventions
  1. Dietary Supplement: Vitamin D
MeSH:Infection Communicable Diseases Respiratory Tract Infections
HPO:Respiratory tract infection

Primary Outcomes

Measure: Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause.

Time: Over 6 months

Secondary Outcomes

Description: Secondary efficacy outcome

Measure: Proportion of participants seroconverting to SARS-CoV-2 (i.e. with test results for antibodies to SARS-CoV-2 transitioning from negative at baseline to positive at follow-up)

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants developing antigen test-positive COVID-19

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants developing 'probable COVID-19', as adjudged using a validated symptom score

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants developing antigen test-positive influenza

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants reporting symptoms of acute respiratory infection

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants with asthma who experience one or more exacerbations of asthma requiring treatment with oral corticosteroids and/or requiring hospital treatment

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants with COPD who experience one or more exacerbations of COPD requiring treatment with oral corticosteroids and/or antibiotics, and/or requiring hospital treatment

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection who report symptoms of COVID-19 lasting more than 4 weeks after onset

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Mean MRC dyspnoea score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection

Time: 6 months

Description: Secondary efficacy outcome

Measure: Mean FACIT Fatigue Scale score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection

Time: 6 months

Description: Secondary efficacy outcome

Measure: Mean COVID-19 Recovery Questionnaire score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection

Time: 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants who experience COVID-19 requiring hospitalisation

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants hospitalised for COVID-19 requiring ventilatory support

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants who experience influenza requiring hospitalisation

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants dying of any cause during participation in the trial

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants dying of acute respiratory infection during participation in the trial

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants dying of COVID-19 during participation in the trial

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: Proportion of participants dying of influenza during participation in the trial • mean end-study 25(OH)D concentrations (sub-set of participants having end-study tests of vitamin D status)

Time: Over 6 months

Description: Secondary efficacy outcome

Measure: mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status) Mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status)

Time: 6 months

Description: Secondary safety outcome

Measure: Proportion of participants experiencing known hypercalcaemia

Time: Over 6 months

Description: Secondary safety outcome

Measure: Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation

Time: Over 6 months

Description: Secondary safety outcome

Measure: Proportion of participants experiencing a serious adverse event of any cause

Time: Over 6 months
163 Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus

Randomized, double-blind prospective trial to test the efficacy and acceptability of therapeutic, antiseptic mouth rinses to inactivate severe acute respiratory syndrome coronavirus (SARS-CoV-2) in saliva of COVID-19 positive patients aged 18-65 years old. All mouthrinses are commercially available and will be used according to on-label instructions. Patients will be randomized to a mouthrinse and will be asked to give a saliva sample immediately before and after a one minute mouthwash. Saliva samples will be collected from patients at 15 minute intervals thereafter up to an hour (15, 30, 45 and 60 minutes). The samples will be stored and used for real-time reverse transcription polymerase chain reaction (RT-PCR) detection of viral SARS-CoV-2 RNA and viral infectivity assays. Patients will also complete a short-survey on the taste and experience of using the mouthwash. This study involves 480 subject participants and one, 75-90 minute visit.

NCT04584684
Conditions
  1. Covid19
  2. Coronavirus Infection
  3. SARS-CoV-2 Infection
Interventions
  1. Drug: 1.5-2% w/v Hydrogen Peroxide
  2. Drug: 0.12% Chlorhexidine Gluconate
  3. Drug: 21% Ethanol plus essential oils
  4. Drug: 1% w/v Povidone-iodide
  5. Drug: 0.075% Cetylpyridinium Chloride
  6. Other: Saline
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 15 Minutes

Time: Baseline, 15 minutes

Description: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 30 Minutes

Time: Baseline, 30 Minutes

Description: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 45 Minutes

Time: Baseline, 45 Minutes

Description: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 60 Minutes

Time: Baseline, 60 Minutes
164 Mucosal Immunity in Patients Diagnosed With SARS-CoV-2 Infection and Their Household Contacts

In this study nasal fluid (mucosal lining fluid), nose and throat swabs and blood was collected from patients with a confirmed SARS-CoV-2 infection who remained in home isolation, as well as from their household contacts who remained in home quarantine. On the collected nose and throat swabs a coronavirus PCR was performed. Antibodies against SARS-CoV-2 were measured in the mucosal lining fluid and blood samples.

NCT04590352
Conditions
  1. SARS-CoV-2 Infection
Interventions
  1. Procedure: nasopharyngeal and throat swab
  2. Procedure: collection of mucosal lining fluid
  3. Procedure: blood collection via fingerprick
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

Measure: Mucosal antibodies

Time: Day 0

Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

Measure: Mucosal antibodies

Time: Day 3 (index cases)

Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

Measure: Mucosal antibodies

Time: Day 6 (index cases)

Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

Measure: Mucosal antibodies

Time: Day 7 (household contacts)

Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

Measure: Mucosal antibodies

Time: Day 14 (household contacts)

Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

Measure: Mucosal antibodies in all participants

Time: Day 28

Secondary Outcomes

Description: SARS-CoV-2 PCR on nasopharyngeal swab and throat swab

Measure: SARS-CoV-2 infection

Time: day 0

Description: Descriptive analysis of SARS-CoV-2 antibody concentrations in serum at day 28.

Measure: Serum antibodies

Time: day 28

Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

Measure: Functional antibody assays

Time: Day 0

Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

Measure: Functional antibody assays

Time: Day 3 (index cases)

Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

Measure: Functional antibody assays

Time: Day 6 (index cases)

Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

Measure: Functional antibody assays

Time: Day 7 (household contacts)

Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

Measure: Functional antibody assays

Time: Day 14 (household contacts)

Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

Measure: Functional antibody assays

Time: Day 28
165 Safety, Tolerability and Efficacy of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection

This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection

NCT04590547
Conditions
  1. Pneumonitis
  2. SARS-CoV Infection
Interventions
  1. Drug: GLS-1027
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Incidence of serious adverse events relative to treatment group

Time: 56 days

Measure: Incidence of progression to WHO Classification of ≥6 to include intubation with mechanical ventilation, need for ECMO, or death relative to treatment group

Time: 56 days

Secondary Outcomes

Measure: Assess the number of days requiring ICU care relative to treatment group

Time: 56 days

Measure: Assess the number of days of mechanical ventilation relative to treatment group

Time: 56 days
166 Application of Telemedicine to Optimize Teamwork and Infection Control of Critical Patients in Isolation Rooms in the Emergency Department During Novel Coronavirus Disease 2019 Outbreak

Since 2000, various emerging infectious diseases have repeatedly caused serious impact on the health of the global population and the healthcare systems. With the growing international transportation and improving accessibility of the healthcare systems, hospitals have been inevitably the first sentinels dealing with emerging infectious diseases. The biological disasters, such as the Severe Acute Respiratory Syndrome (SARS) in 2003, the Middle East Respiratory Syndrome (MERS) outbreak in South Korean in 2015, and the Coronavirus disease 2019 (COVID-19) outbreak this year, challenged our vulnerable healthcare systems and caused great loss of lives. Regarding the ongoing global epidemics and possible community outbreaks of the COVID-19, the management of biological disasters for an overcrowded emergency department should be planned. In the early 2020, the emergency department used a double-triage and telemedicine method to treat non-critical patient with suspected COVID-19. This application reduced the exposure time of the first responders and reserve adequate interview quality. However, for the critical patients treated in the isolated resuscitation rooms, the unique environment limited the teamwork and communication for the resuscitation team. These factors might led to poorer quality of critical care. The investigators designed a telemedicine-teamwork model, which connected the isolation room, prepare room and nursing station by an video-conferencing system in the emergency department. This model try to break the barriers of space between the rooms and facilitate the teamwork communications between each unit. Besides, by providing a more efficient workflow, this model could lower the total exposure time for all workers in the contaminated area. This study was conducted to evaluate the benefits of the telemedicine-teamwork model and provide a practical, safe and effective alternative to critical care of the patients with suspected highly infectious diseases.

NCT04591873
Conditions
  1. Critical Illness
  2. Infections, Respiratory
  3. Emergency Service, Hospital
  4. Telemedicine
Interventions
  1. Other: telemedicine
  2. Other: traditional communication tools
MeSH:Infection Communicable Diseases Respiratory Tract Infections Emergencies Critical Illness
HPO:Respiratory tract infection

Primary Outcomes

Measure: time to complete intubation

Time: immediately after intervention

Secondary Outcomes

Description: Team Emergency Assessment Measure, minimal score is 0 and the maximal score is 4. Higher score means a better outcome.

Measure: teamwork score

Time: immediately after intervention

Measure: exposure time in isolation rooms

Time: immediately after intervention
167 A Two-arm Randomized Double-blind Study With COVID19-0001-USR Administered Via Nebulization to Patients With Mild and/or Moderate Severe Acute Respiratory Syndrome (SARS-COV-2) Infection to Decrease Viral Load

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

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

Primary Outcomes

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

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

Time: Treatment Period of 7 days
168 Vitamin D3 Supplementation to Prevent Respiratory Tract Infections in Hospital Workers: a Pragmatic Study

The Cooper vitamin D3 study is a randomized study investigating whether daily vitamin D3 supplementation can prevent respiratory tract infections in hospital workers.

NCT04596657
Conditions
  1. Respiratory Tract Infections
  2. Covid19
  3. Flu Like Illness
Interventions
  1. Dietary Supplement: Vitamin D supplementation
MeSH:Infection Communicable Diseases Respiratory Tract Infections
HPO:Respiratory tract infection

Primary Outcomes

Description: Incidence of acute respiratory tract infection

Measure: Respiratory tract infection

Time: 9 months
169 A Randomized Control Trial to Change Nurse Leadership in Maintaining Minimum Service Delivery Standards for Hospital Infection Control in the Era of COVID-19

The aim is to deliver an intervention to promote nurse leadership and decision-making in the hospital setting, by providing them with training for maintaining minimum service delivery standards for hospital infection control with respect to COVID-19; but also other infectious disease burden management.

NCT04603079
Conditions
  1. Nurse's Role
  2. Infection
Interventions
  1. Behavioral: Intervention for COVID-19 preventive protocols
MeSH:Infection Communicable Diseases Cross Infection

Primary Outcomes

Description: It will consist of 44 questions for core competencies of infection control and prevention, including 10 constructs of: (1) Identification of infectious disease processes, (2) Surveillance and epidemiologic investigations, (3) Preventing/controlling the transmission of infectious agents, (4) Employee/occupational health, (5) Management and communication planning, (6) Quality/performance improvement and patient safety, and (7) Education and research education, (8) Confidence with training and awareness for identification and implementation for COVID-19 prevention and control strategies, (9) confidence in training and awareness, and (10) satisfaction with workplace support. It is a five-point Likert-type scale (strongly agree - agree - neutral - disagree - strongly disagree). The highest value of the scale is 6 and the lowest value is 1; with 6 points showing strong agreement with the item statement (E.g. Q1. Can you differentiate between other infections and COVID-19).

Measure: Core competencies in nurses for infection control and prevention (Min and Sil 2014)

Time: 3 months
170 Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan on Outcomes of Coronavirus Infection?

SARS-CoV-2 is a member of a class of viruses: angiotensin converting enzyme 2 (ACE2)-binding viruses that we call "ABVs". The World Health Organization (WHO) and others are performing randomized controlled trials (RCTs) of vaccines and novel antivirals to address SARS-CoV-2 directly. However, the critical illness complications of COVID-19 are caused in part by SARS-CoV-2's binding and inhibiting ACE2 and the consequent host response. ACE 2 is the receptor for H1N1, H5N1, and SARS-CoV-2. After binding ACE2, SARS-CoV-2 is endocytosed, and surface ACE2 is down-regulated, increasing angiotensin II (ATII a potent vasoconstrictor) in COVID-19. The original ARB, losartan, limits lung injury in murine influenza H7N9 and decreases viral titre and RNA. We have a unique opportunity to complement vaccine and anti-viral RCTs with an RCT modulating the host response using an angiotensin II type 1 receptor blocker (ARB, losartan) to decrease the mortality of hospitalized COVID-19 patient.

NCT04606563
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Drug: Losartan
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Mortality

Time: 28 days

Secondary Outcomes

Measure: Hospital Mortality

Time: up to 6 months

Description: Location within hospital (ICU or wards)

Measure: ICU Admission

Time: up to 6 months

Measure: days alive and free of vasopressors, ventilation, and renal replacement therapy

Time: up to 14 days

Description: Sequential Organ Failure Assessment (SOFA) score

Measure: SOFA score

Time: 28 days

Description: Use of inotropic agents and increase(s) of of troponin and/or NT-proBNP from admission level

Measure: Acute cardiac injury

Time: 6 months

Description: Severe adverse effects of ARBs and mortality

Measure: Severe adverse events

Time: 6 months

Measure: Mortality

Time: at 1, 3 and 6 months
171 Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)

This study will use a digital platform to longitudinally track comprehensive information including patient self-report as well as data that describe the process and outcome of care in the electronic medical record (EMR) of a large representative sample of patients under investigation for SARSCOV2. The objective is to generate knowledge rapidly using digital tools and collaborative sciences to produce real-time data, analysis, and reporting compared to more traditional approaches. An additional goal is to promote an open science approach whereby scientists, with proper approvals and in line with the permissions granted by the participants, have the opportunity to work with data in ways that protects individual privacy but promotes rapid dissemination and implementation of knowledge.

NCT04610515
Conditions
  1. Covid19
  2. ME/CFS
  3. SARS COV2
  4. Novel Coronavirus Infection
  5. Neurocognitive Disorders
  6. Cardiovascular Diseases
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Cardiovascular Diseases Neurocognitive Disorders
HPO:Abnormality of the cardiovascular system

Primary Outcomes

Description: determine the risk of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in those with symptoms of SARSCOV2 infection with vs. without a positive confirmatory test.

Measure: Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

Time: 18 months post enrollment

Secondary Outcomes

Description: Count of ambulatory care and/or ED visits post enrollment as obtained from the EMR

Measure: Ambulatory care and/or ED visits post enrollment

Time: 18 months post enrollment

Description: Count of hospitalizations post enrollment as obtained from the EMR

Measure: Hospitalizations post enrollment

Time: 18 months post enrollment

Description: death during hospital admission as determined by data from the EMR

Measure: Death during hospital admission

Time: 18 months post enrollment

Description: Hospital-free survival as determined by data from the EMR

Measure: Hospital-free survival

Time: 18 months post enrollment

Description: ICU-free survival as determined by data from the EMR

Measure: ICU-free survival

Time: 18 months post enrollment
172 Phase III, Random-Open, Clinical Trials on the Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

The benefit of the research is to provide information regarding the efficacy and safety of Favipiravir plus the Standard of Care (SoC) for mild-moderate COVID-19 patients to be a reference for policy recommendations regarding the use of Favipiravir as an antiviral drug for the treatment of Covid-19.

NCT04613271
Conditions
  1. Infectious Disease
  2. SARS-CoV Infection
  3. Covid19
Interventions
  1. Drug: Favipiravir
  2. Drug: Azithromycin
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical improvement measured by no sign & symptom and RTPCR negative from baseline to Day 3

Measure: Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative

Time: until 3 days

Secondary Outcomes

Description: Duration of hospitalization is defined as the number of days in the hospital until Day 19, and descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum) are given for each administration group.

Measure: Duration of hospitalization

Time: until 19 days
173 A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and SARS-CoV-2 Infection

Prospective, observational, exploratory study exploring the relationship between passively-collected data from wearable activity devices and SARS-CoV-2 infection

NCT04623138
Conditions
  1. Covid19
  2. SARS-CoV Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To develop a database of physiological and behavioral data via wearable devices and self-reported questionnaires (e.g.,symptoms) combined with laboratory confirmation of SARS- CoV-2 infection.

Measure: Development of database containing physiological, behavioral data in combination with SARS-CoV-2 infection

Time: Through study completion, an average of 7 months

Description: Physiological and behavioral data from wearable devices (Garmin vivosmart 4, Empatica E4) , patient self-reported data questionnaires (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and laboratory diagnostic confirmation of SARS-CoV-2 infection.

Measure: Correlation between SARS-CoV-2 infection and collected wearable data and self-reported data

Time: Through study completion, an average of 7 months

Description: Physiological and behavioral data from wearable devices (Garmin vivosmart 4, Empatica E4) , patient self-reported data questionnaires (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and laboratory diagnostic confirmation of SARS-CoV-2 infection.

Measure: Development of analytical models for real-time COVID-19 surveillance at the individual and population levels

Time: Through study completion, an average of 7 months

Secondary Outcomes

Description: Model performance and accuracy characteristics of the analytical models on hold out data sets

Measure: Performance of the analytical models for real-time COVID-19 surveillance at the individual and population levels.

Time: Through study completion, an average of 7 months
174 COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)

This study is to establish an accurate, robust and easily scalable COVID-19 viral nucleic acid analysis platform from, but not limited to, saliva to help enable and support contact tracing in the canton of Baselland/ Switzerland. To achieve this, crude ribonucleotide acid (RNA) extraction from saliva is validated in combination with next-generation sequencing (NGS) diagnostics and loop mediated amplification (LAMP) assays as well as point of care test (POCT) for rapid detection of viral antigens on patients' samples.

NCT04625257
Conditions
  1. Coronavirus Infectious Disease 2019 (COVID-19)
Interventions
  1. Other: Saliva based assay: crude RNA extraction
  2. Other: Validation of the NGS method
  3. Other: Validation of the LAMP assays
  4. Other: Validation of the POCT Antigen tests
MeSH:Communicable Diseases Infection Coronavirus Infections

Primary Outcomes

Description: For all qualitative method validation, the qualitative and quantitative result of the Foederatio Analyticorum Medicinalium Helveticorum (FAMH) performed RT-PCR (patient does / does not have SARS-Cov-2 and if yes, how many "ct" values for detection) is considered as the gold standard against which the crude extraction in combination with the LAMP or the NGS method using univariate measures is compared.

Measure: qualitative method validation of the crude extraction in combination with the LAMP or the NGS (count values for detection)

Time: single point assessment at baseline
175 The Clinical Trial of Application of Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection

Currently, SARS-CoV-2 the novel member of the corona virus family, affecting the world leading to COVID-19 disease. It can result life-threatening condition by developing severe acute respiratory distress syndrome (ARDS). Based on previous evidence a group of patients with severe COVID-19 develop a cytokine storm syndrome which leads to hyper-inflammation lung tissue damage. Supportive care is the current management of COVID-19 is and management of ARDS as a main cause of mortality has been remained challenging. Therefore, an urgent effective treatment of COVID-19 regarding hyper-inflammation mechanism is required. Currently, development of novel anti-viral agents and vaccines are the main issues. However, it needs long time, from months to years, until suitable new medications and vaccines have been developed. An immune-modulatory tetra deca peptide (14-mer peptide) named Human Ezrin Peptide 1 (HEP-1) (trade name Gepon) was introduced by the group of Ataullakhanov in Russia. Regarding its proved anti-viral and anti-inflammatory effect, Russian authorities approved Gepon for treatment of ulcerative colitis treatment and Hepatitis -C. In this regard, it seems that Hep-1 is a very safe immune-modulatory agent which can be effective in the management of COVID-19 infection without any adverse effect for the patient.

NCT04627233
Conditions
  1. Covid19
  2. Treatment
  3. Corona Virus Infection
Interventions
  1. Drug: Human Ezrin Peptide 1 (HEP1)
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Time to clinical improvement of disease symptoms

Time: 7 days

Measure: Duration of Hospitalization

Time: 28 days

Measure: Duration of artificial ventilation

Time: 28 days

Secondary Outcomes

Description: Range 0-40

Measure: CT Severity score

Time: 28 days

Measure: CBC

Time: 28 days

Measure: IL-1

Time: 28 days

Measure: IL-6

Time: 28 days

Measure: TNF

Time: 28 days

Measure: CRP

Time: 28 days
176 Prevalence and Risk Factors of COVID-19 Infection in the Upper Silesian Agglomeration Population in 2020

Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at: 1. analysis of available data on incidence and mortality due to COVID-19 and 2. estimation of the occurrence of viral infection SARS-CoV-2 as revealed by the results of serological test (ELISA: IgM, IgG), with assessment of risk factors. The project's objectives are: to assess incidence and mortality due COVID-19 according to sex, age and coexisting diseases; to determine the level of potential "underdiagnosis" of the magnitude of COVID-19 mortality using vital statistics data for Upper-Silesian Conurbation; to assess the prevalence of SARS-CoV-2 based on the level of seropositivity in Upper-Silesian Conurbation; to identify host-related and environmental risk factors if the infection. Analysis of existing data will include monthly records on incidence and mortality over the period 01.01.2020-31.12.2020 and comparison of the findings with the monthly records of 2018 and 2019, for the same population. Cross-sectional epidemiological study will be located in three towne (Katowice, Sosnowiec, Gliwice). In each town a representative age-stratified sample of 2000 subjects will undergo questionnaire assessment and serological examination performed by serological test. The project corresponds with analogous population-based studies on COVID-19 in a number of countries and responds to the WHO recommendation in that field.

NCT04627623
Conditions
  1. Covid19
  2. Respirato
  3. Respiratory Tract Infections
  4. Severe Acute Respiratory Syndrome
  5. Corona Virus Infection
  6. RNA Virus Infections
  7. Virus Disease
  8. Respiratory Tract Disease
Interventions
  1. Diagnostic Test: IgM and IgG antibodies assay
MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Severe Acute Respiratory Syndrome Coronavirus Infections RNA Virus Infections Respiratory Tract Diseases
HPO:Respiratory tract infection

Primary Outcomes

Description: Estimation of real prevalence of elevated IgM and IgG COVID antibodies in general population will allow to estimate real number of current and past COVID infection in the population.

Measure: Estimation of prevalence of specific anti-SARS-CoV-2 IgM and IgG antibodies in general population.

Time: 8 months

Secondary Outcomes

Description: Prevalence of asymptomatic cases into seropositive population

Measure: Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies

Time: 8 months
177 Randomized Phase IIA Clinical Trial to Compare the Efficacy of Ivermectin Versus Placebo to Obtain Negative PCR Results in Patients With Early Phase COVID-19

SAINT-PERU is a triple-blind, randomized controlled trial with two parallel groups to compare the efficacy of ivermectin versus placebo to obtain negative PCR results in patients with early phase COVID-19. The trial is currently planned at a single center in Lima.

NCT04635943
Conditions
  1. Covid19
  2. Coronavirus Infection
  3. SARS-CoV Infection
Interventions
  1. Drug: Ivermectin
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment

Measure: Proportion of patients with a positive SARS-CoV-2 PCR.

Time: 7 days post-treatment

Secondary Outcomes

Description: Change from baseline quantitative and semi-quantitative PCR in nasopharyngeal swab

Measure: Mean viral load

Time: Baseline and on days 4, 7, 14 and 21

Description: Proportion of patients with fever and cough at days 4, 7, 14 and 21 as well as proportion of patients progressing to severe disease or death during the trial

Measure: Fever and cough progression

Time: Up to and including day 21

Description: Proportion of participants with positive IgG at day 21

Measure: Seroconversion at day 21

Time: Up to and including day 21

Description: Proportion of drug-related adverse events

Measure: Proportion of drug-related adverse events

Time: 7 days post treatment

Measure: Levels of IgG, IgM and IgA

Time: Up to and including day 21

Description: Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry

Measure: Frequency of innate immune cells

Time: Up to and including day 7

Description: Frequency of CD4+ T and CD8+ T cells (% over total CD4+T and CD8+ T) expressing any functional marker upon in vitro stimulation of PBMC with SARS-CoV-2 peptides, measured by flow cytometry

Measure: Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T cells

Time: Up to and including day 7

Description: Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher)

Measure: Results from cytokine Human Magnetic 30-Plex Panel

Time: Up to and including day 21

Description: Proportion and parasitic load of intestinal helminths by quantitative Kato-katz and Baerman method

Measure: Presence of intestinal helminths

Time: Baseline and on day 14.
178 Burden of SARS-CoV-2 Infection in Populations With High or Low Risk of Infection

Introduction. Some issues remain to be elucidated about SARS-CoV-2 infection to plan prevention interventions based on scientific evidence, such as the actual prevalence of infection including subclinical and seroconverted cases, the reasons for the different spread and severity of the infection in different subjects and geographical areas as well as the impact of the COVID-19 crisis on the health of healthcare professionals and in the general population. The aims of this project are: (i) to estimate and compare the real prevalence of the SARS-CoV-2 infection and seroconversion in two populations at high or low risk of infection,in Lombardia region and Molise region, respectively; focusing on subgroups at higher risk such as healthcare workers (HCWs); (ii) to estimate the incidence of burnout and post-traumatic stress disorder in HCWs; (iii) to identify factors associated with SARS-CoV-2 infection positivity and to follow up its mid-term effects on health. Methods. Participants will be randomly selected from the general population of both territories and from the HCWs list of the two healthcare facilities involved. SARS-CoV-2 IgG and IgM blood levels will be measured and anamnestic data will be collected through computerized tools. Prevalence of currently or previously infected subjects and their disease status and severity will be estimated and the association with potential risk factors will be analyzed through multivariable regression analyses. Expected results. The study will identify the burden of the infection in the general and HCWs populations. It will also identify the determinants of differences in the spread and severity of the infection, to hypothesize new preventive or therapeutic interventions. This study will provide a basis for monitoring the progress of the infection and its medium-term health consequences, Finally it will allow planning future studies, through analyses in biological samples which will be collected in dedicated biobanks.

NCT04636203
Conditions
  1. SARS-CoV-2 Infection
  2. Covid19
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: To estimate and compare the real prevalence of the SARS-CoV-2 infection and seroconversion in two populations at high or low risk of infection. The knowledge of the real prevalence of currently or previously infected subjects, then the actual immunization in the general population and in HCWs, will allow to estimate the real impact of the condition and to better predict the time-course of potential new outbreaks, considering the estimated impact of the herd immunity in slowing it down

Measure: SARS-CoV-2 infection

Time: From December 15 2020 to June 15 2021

Description: To estimate the incidence of burnout and post-traumatic stress disorder in HCWs. To understand the impact of COVID-19 crisis on their health, also by quantifying their stress levels, and to set the priorities for intervention in this population subgroup (HCWs)

Measure: Burnout and post-traumatic stress disorder in HCWs

Time: From December 15 2020 to June 15 2021

Description: To identify different characteristics of the subjects who have / have had the infection or the positives who have developed more serious forms will allow better understanding of the transmission pathways or the mechanism underlying the pathogenesis of the viral infection and of its manifestations, facilitating the development of new preventive or therapeutic interventions

Measure: SARS-CoV-2 infection positivity factors/determinants

Time: From December 15 2020 to December 15 2021

Secondary Outcomes

Description: It is not yet known whether the immunization acquired after the infection is effective in preventing the development of the infection following a subsequent contact with the virus. This would allow to better plan the prevention interventions on the population and also to give suggestions for the research of the specific vaccine

Measure: Population cohort of immunized subjects

Time: From December 15 2020 to June 15 2022

Description: The biobank set up will be useful for future studies on biomarkers, which can therefore be analyzed once new hypotheses and resources are available.

Measure: Biobank biospecimen collection

Time: From December 15 2020 to June 15 2022
179 Expanded Access Study of Phage Treatment in Covid-19 Patients on Anti-Microbials for Pneumonia or Bacteremia/Septicemia Due to A. Baumannii, P. Aeruginosa or S. Aureus

Bacteriophage treatment in Covid-19 patients being treated with Anti-Microbials for Pneumonia or Bacteremia/Septicemia.

NCT04636554
Conditions
  1. Covid19
  2. Bacteremia
  3. Septicemia
  4. Acinetobacter Baumannii Infection
  5. Pseudomonas Aeruginosa Infection
  6. Staph Aureus Infection
Interventions
  1. Other: Phage Therapy
MeSH:Infection Communicable Diseases Bacteremia Pseudomonas Infections Sepsis Toxemia Pneumonia
HPO:Pneumonia Sepsis

180 Efficacy of Anakinra in the Management of Patients With COVID-19 Infection in Qatar: A Randomized Clinical Trial

Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.

NCT04643678
Conditions
  1. Covid19
  2. Pneumonia
  3. Cytokine Release Syndrome
  4. Corona Virus Infection
  5. Viral Infection
Interventions
  1. Drug: Anakinra
  2. Other: Standard of Care
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Defined as WHO Clinical Progression score of <6 [patient alive, not requiring invasive, non-invasive, or high flow oxygen therapy, vasopressors, dialysis or Extracorporeal membrane oxygenation (ECMO)].

Measure: Treatment Success at day 14

Time: Day 14

Secondary Outcomes

Description: Change in WHO Clinical Progression Score between day 1 and day 7 [WHO Clinical Progression score: 0 (Uninfected) - 10 (Dead)]

Measure: Change in WHO Clinical Progression Score

Time: Day 7

Description: Time to ICU admission up to 28 days

Measure: Time to ICU admission

Time: Day 28

Description: Incidence of adverse events up to 28 days

Measure: Incidence of Adverse Events

Time: Day 28

Description: Length of hospital stay up to 28 days

Measure: Length of hospital stay

Time: Day 28

Description: All-cause mortality rate at hospital discharge or at 28 days, whichever is first

Measure: All-cause Mortality

Time: Day 28
181 A Multi-centre, Randomised, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in Poland

Countries that have not carried out universal mass vaccination against tuberculosis (BCG) have been shown to have higher incidence and death rates due to COVID-19 than countries with mass, long-term BCG immunization programmes. The aim of the study is to answer the following questions: 1. Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of symptoms)? 2. Will the course of COVID-19 be milder among subjects with a negative TB skin test (PPD RT 23 SSI) after an additional dose of BCG than in case of non-vaccinated subjects? 3. Do people with a positive TB skin test have a milder course of COVID-19 infection than people with a negative test result? A multicenter, randomized, partially blinded, placebo-controlled study will be conducted in Rzeszow/Krakow/ Katowice/Warsaw on a group of 1000 volunteers, health care workers according to the following schedule: V 0-1: inclusion/informed consent/interview; V2: administration of TB skin test/anti-SARS-CoV-2 IgG test/serum banking*; V3: TB skin test (TST) interpretation and subjects' division into three groups: (I) positive TST - observation; (II) negative TST- BCG-10 vaccination; (III) negative TST - placebo. Division into groups II and III based on randomisation; V4: serum banking*. Parallel beginning from V3, weekly telephone monitoring participants' health status; In case of COVID-19 symptoms a nasopharyngeal swab to confirm SARS-CoV-2 infection + serum banking*. V5: 3 months after vaccination at the end of the study: history/anti-SARS-CoV-2 IgG test, serum banking*. Statistical analysis - comparison of the course of COVID-19 in groups: (I) with positive TST + observation, (II) with negative TST + BCG, (III) with negative TST + placebo - should demonstrate whether mass BCG vaccination has an impact on the incidence and course of COVID-19. * to measure the level of cytokines involved in cell-mediated immunity process

NCT04648800
Conditions
  1. Covid19
  2. BCG Vaccination Reaction
  3. SARS-CoV Infection
Interventions
  1. Drug: BCG-10 vaccine
  2. Drug: 0.9% saline
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: shock - when catecholamines are required despite initial fluid resuscitation severe respiratory failure - the need for non-invasive or invasive ventilation severe renal failure - the need for renal replacement therapy (for undialysed individuals, i.e. with end-stage renal failure (ESRD)

Measure: death and life- or health-threatening condition (cardiac arrest with effective resuscitation, shock, severe respiratory failure, severe renal failure, stroke/transient cerebral ischaemia)

Time: throughout the period of 18 months from inclusion

Secondary Outcomes

Description: Present symptoms (determined in the Telephone Contact Card) appear to indicate a possible SARS-CovV-2 infection

Measure: Onset of clinical symptoms of COVID-19

Time: 12 weeks from the date of the third visit - V3

Description: based on anti SARS-CoV-2 IgG serological tests

Measure: asymptomatic SARS-CovV-2 infection

Time: 12 weeks from the date of the third visit - V3

Description: the need for hospitalisation and its duration

Measure: Hospitalisation

Time: 12 weeks from the date of the third visit - V3

Description: the need for hospitalisation in the ICU and its duration

Measure: ICU Hospitalisation

Time: 12 weeks from the date of the third visit - V3

Description: requiring passive oxygen therapy to eliminate the symptom or maintain saturation >92%

Measure: Dyspnoea

Time: 12 weeks from the date of the third visit - V3
182 Surfactant Protein Genetic Variants in COVID-19 Infection

Surfactant protein plays important role in innate immunity against respiratory viral infections. However, investigators have shown that the surfactant protein polymorphisms are associated with severity of various pulmonary diseases such as respiratory syncytial virus (RSV), tuberculosis, pediatric acute lung injury. COVID-19 virus gains entry through the respiratory system and responsible for death due to acute respiratory failure. There is a considerable heterogeneity in presentation of COVID-19 infection from asymptomatic patients to severe infection requiring intensive care and some may die. Considering reports of COVID-19 related deaths/severe disease in the same family, it is possible that genetics play an important role in severity of COVID-19 infection. Investigators propose to study the association of surfactant proteins in COVID-19 patients. Key Objectives: a) Characterize genetic markers within the surfactant protein genes in COVID-19 positive patients, b) To determine if there is a correlation between certain genetic markers and the severity of COVID-19 infection which may be used as a prognostic marker, c) To correlate genetic markers with immune studies.

NCT04650191
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: Identification of genetic variants
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Correlation of surfactant protein genetic variants with severity of COVID-19 infection

Time: 12 months
183 COMBO Trial: Camostat With Bicalutamide for COVID-19

This will be a randomized, open-label study to determine if camostat or camostat+ bicalutamide decreases the proportion of people with COVID-19 who require hospitalization, compared to historical controls. Patients with symptomatic COVID-19, diagnosed as outpatients, will be randomized 1:1:1, stratified by gender, to treatment with standard of care alone (Arm 1) or with camostat (Arm 2) or with camostat and bicalutamide (Arm 3).

NCT04652765
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Coronavirus Infection
Interventions
  1. Drug: Camostat Mesilate
  2. Drug: Bicalutamide 150 mg
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28

Measure: Number of participants requiring hospitalization

Time: up to 28 days

Secondary Outcomes

Measure: Number of participants experiencing symptoms

Time: up to 21 days

Description: Number of adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)

Measure: Number of drug-related adverse events

Time: up to 60 days

Description: Number of serious adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)

Measure: Number of drug-related serious adverse events

Time: up to 60 days

Description: Number of participants deceased.

Measure: All-cause mortality

Time: up to 60 days

Other Outcomes

Description: Number of calendar days in the hospital

Measure: Duration of hospitalization

Time: up to 60 days

Measure: Number of participants requiring upgrade to intermediate care unit (IMC)

Time: up to 60 days

Description: Number of calendar days in IMC unit

Measure: Duration of IMC stay

Time: up to 60 days

Measure: Number of participants requiring upgrade to intensive care unit (ICU)

Time: up to 60 days

Description: Number of calendar days in ICU

Measure: Duration of ICU stay

Time: up to 60 days

Measure: Number of participants requiring mechanical ventilation

Time: up to 60 days

Description: Number of calendar days requiring mechanical ventilation

Measure: Duration on mechanical ventilation

Time: up to 60 days
184 SARS-Cov2 (COVID-19) Infection and Reinfection Through the Analysis of a RT-PCR Results Database

The SARS-Cov2 pandemic remains associated with many concerns. One of the them is the real frequency of likely re-infection and subsequently the level of protection conferred by the acquired immunity following primary-infection. We propose to analyze a large set of laboratory data produced since the early beginning of the SARS-Cov2 spread in the French population to identify recurrent infection events and, more generally, gain insight about infection kinetics.

NCT04653844
Conditions
  1. Covid-19
  2. SARS-CoV Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: SARS-CoV-2 reinfection rate

Measure: SARS-CoV-2 reinfection rate

Time: 1 day
185 The Dynamics of the Immune Response to Infection by SARS Coronavirus 2

To evaluate host-immune biomarkers including TRAIL, IP-10, CRP and their computational integration for predicting COVID-19 and disease severity in patients with PCR-confirmed COVID-19.

NCT04655521
Conditions
  1. COVID-19
  2. SARS-CoV-2
  3. Viral Infection
MeSH:Infection Communicable Diseases Virus Diseases

Primary Outcomes

Description: Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, as compared to control subjects.

Measure: Differential expression of biomarkers between COVID-19 and controls

Time: up to 90 days

Description: Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, who require more extensive medical intervention (i.e., exhibit severe symptoms), i.e. severe infection vs. non-severe infection

Measure: Differential expression of biomarkers between severe and non-severe COVID-19

Time: up to 90 days

Description: Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration for predicting disease severity in patients with COVID-19, where measures of severity include ICU admission, respiratory failure, mechanical ventilation, septic shock, non-respiratory organ failure, and mortality.

Measure: Correlation of biomarkers with disease severity

Time: up to 90 days

Secondary Outcomes

Description: Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without specific therapy.

Measure: Biomarkers depending on therapy

Time: up to 90 days

Description: Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without bacterial co-infection.

Measure: Biomarkers depending on bacterial co-infection

Time: up to 90 days

Description: Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration with infectiousness, i.e. e.g. viral load.

Measure: Correlation of biomarkers with viral load

Time: up to 90 days
186 Seroprevalence Study of CoV-2-SARS (COVID-19) Infection in Patients With Chronic Inflammatory Rheumatic Diseases

The prevalence of SARS-CoV-2 infection in chronic inflammatory rheumatic diseases has not yet been widely reported, and has been evaluated only in symptomatic patient samples. The proportion of asymptomatic or mildly symptomatic patients is unknown, in patients who share common symptoms with CoV-2-SARS infection. Our objective is to describe the prevalence of seroconversion to CoV-2-SARS by consecutive screening in routine care of patients with chronic inflammatory rheumatism with serological testing

NCT04655612
Conditions
  1. COVID-19
  2. SARS-CoV Infection
  3. Rheumatoid Arthritis
  4. Spondyloarthritis
  5. Ankylosing Spondylitis
  6. Psoriatic Arthritis
MeSH:Infection Communicable Diseases Spondylitis Coronavirus Infections Severe Acute Respiratory Syndrome Arthritis Arthritis, Rheumatoid Arthritis, Psoriatic Spondylitis, Ankylosing Rheumatic Diseases Spondylarthritis Collagen Diseases
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis

Primary Outcomes

Description: Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis

Measure: Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis

Time: 1 day

Secondary Outcomes

Description: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.

Measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.

Time: 1 day

Description: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease

Measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease

Time: 1 day

Description: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics

Measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics

Time: 1 day
187 Hospitalization or Outpatient ManagEment of Patients With Suspected or Confirmed SRAS-CoV-2 Infection: the Revised HOME-CoV Score Study.

In the context of COVID-19 pandemic, identifying low-risk patients who can be safely treated at home and high-risk patients requiring hospitalization or even intensive care is crucial for Emergency Departments. Thanks to a consensus of experts using the Delphi method, we previously defined the HOME-CoV rule. The HOME-CoV rule consists of 8 items precluding home treatment for patients consulting in the Emergency Department (ED) with confirmed or highly suspected mild to moderate COVID-19. It has been validated in a prospective study, patients with a negative rule having a very-low rate of invasive ventilation or death within the 7 days following ED presentation (HOME-CoV study, NCT: 02811237). Using logistic regression, we revised the HOME-CoV rule in order to define a score allowing. The revised HOME-CoV score comprises 7 criteria and, retrospectively assessed in the database of the HOME-CoV study, it exhibits promising performances. A revised HOME-CoV score < 2 had a sensitivity of 0.93 (0.84 to 0.98), a specificity of 0.60 (0.58 to 0.61) and negative predictive value of 1.00 (0.99 to 1.00); and a score > 4 had a sensitivity of 0.41 (0.28 to 0.54), a specificity of 0.93 (0.92 to 0.94) and a positive predictive value of 0.11 (0.07 to 0.16). The present study aims to prospectively validate the revised HOME-CoV score, firstly, in identifying a subgroup of COVID-19 patients with a low risk of evolution to severe COVID-19 and who could be safely treated at home. For this purpose, we will perform an interventional multicentric prospective pragmatic cohort study with implementation of the revised HOME-CoV score to triage COVID-19 patients.

NCT04657471
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: revised HOME-CoV score
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The rate of patients with evolution to severe COVID-19 within 7 days after inclusion among patients with a revised HOME-CoV score <2. Severe COVID-19 is defined as a WHO-OSCI≥5, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7), or all-cause death (8). The revised HOME-CoV score strategy will be considered as safe if the rate of patients who experienced a WHO-OSCI≥5, will be ≤0.5% with an upper limit of the 95% confidence interval ≤1%.

Measure: The safety of the revised HOME-CoV score strategy for home treatment

Time: 7 days

Secondary Outcomes

Description: The rate of patients treated at home,i.e., discharged home within 24 hours following inclusion.

Measure: The efficacy of the revised HOME-CoV score strategy for home treatment

Time: 24 hours

Description: the rate of patients treated at home, i.e., discharged home within 24 hours following inclusion, among patients with a revised HOME-CoV score <2

Measure: The applicability of the revised HOME-CoV score strategy for home treatment

Time: 24 hours

Description: The rate of patients with a revised HOME-CoV score < 2 and treated at home who were not subsequently hospitalized within the 7 days following inclusion.

Measure: The reliability of the revised HOME-CoV score strategy for home treatment

Time: 7 days

Description: The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs. 7 days

Measure: The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥5.

Time: 7 days

Description: The rate of patients with a WHO-OSCI≥6 within the 7 days following inclusion, i.e., intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.

Measure: The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥6

Time: 7 days

Description: The rate of patients who dead within the 7 days following inclusion The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.

Measure: The predictive performances of the revised HOME-CoV score of evolution towards a fatal COVID-19

Time: 7 days

Description: The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.

Measure: Subgroup analysis in patients with confirmed COVID-19 (positive SARS-CoV2 RT-PCR) of the predictive performances of the revised HOME-CoV score

Time: 7 days

Description: The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC)

Measure: The predictive performances of the revised HOME-CoV score as compared to those of other prognostic scores for COVID-19

Time: 7 days

Description: The rate of symptomatic and objectively confirmed deep venous thromboembolism or pulmonary embolism, and of unexplained sudden death occurring within the 7 days following ED admission.

Measure: Venous thrombo-embolism in COVID-19 patients (ancillary study)

Time: 7 days
188 A Placebo-controlled, Multicenter, Double-blind, Randomized, Parallel-group Comparative Study in SARS-CoV-2 Infection (COVID-19)

To assess the efficacy and safety of FOY-305 in patients with SARS-CoV-2 infection (COVID-19) in a placebo-controlled, multicenter, double-blind, randomized, parallel-group comparative study.

NCT04657497
Conditions
  1. SARS-CoV-2 Infection (COVID-19)
Interventions
  1. Drug: FOY-305
  2. Drug: Placebo
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Time to SARS-CoV-2 negative test as assessed by the local laboratory

Measure: Time to SARS-CoV-2 negative test

Time: Up to 14 days

Secondary Outcomes

Description: Time to SARS-CoV-2 negative test as assessed by the central laboratory

Measure: Time to SARS-CoV-2 negative test

Time: Up to 14 days

Description: Proportion of subjects who test negative for SARS-CoV-2 (as assessed by the local and central laboratories)

Measure: Proportion of subjects who test negative for SARS-CoV-2

Time: Up to 14 days

Description: Ordinal scale for severity. The minimum score is 0: No clinical or virological evidence of infection, representing the better outcome, and the maximum value is 8: Death, representing the worse outcome.

Measure: Ordinal scale for severity

Time: Up to 14 days

Description: Proportion of subjects on mechanical ventilator

Measure: Proportion of subjects on mechanical ventilator

Time: Up to 14 days

Description: Proportion of subjects alive or death

Measure: Survival status (alive/death)

Time: Up to 14 days
189 Evaluation of a SARS-CoV-2 Infectious Risk Management Protocol on the Transmission of Nosocomial COVID in Intensive Care Unit"

The current global pandemic at COVID-19 is a major public health issue. Transmission of the virus is primarily through direct and close person-to-person contact. The protection of health care personnel and the limitation of transmission of nosocomial COVID is paramount. Protective measures have already shown their effectiveness in limiting the spread of the virus: the use of masks, the wearing of protective gowns, the wearing of protective eyewear, social and physical distancing. A recent U.S. study (Rhee et al. JAMA 2020) reported a very low incidence of 1.7% of nosocomial COVID, but this was achieved with the application of rigorous infection risk management protocols. In addition to the widespread use of masks and protective measures, dedicated COVID units had been created, with air treatment. The implementation of these dedicated units requires the mobilization of considerable human and material resources, which is not feasible in all hospitals over the long term. In view of the second wave of the epidemic in France, with the rising numbers of new cases of COVDI-19 admitted to intensive care units since the end of the summer 2020, it is essential to organize the intensive care units to ensure the protection of personnel and limit the risk of nosocomial COVID-19, while continuing to care for non-COVID patients. In Intensive Care unit (ICU) at the Nantes University Hospital, a strict protocol for the management of suspected or confirmed COVID patients has been in place since early september 2020. The objective of this study is to evaluate the effectiveness of this protocol for managing the infectious risk of SARS-COV-2 on the incidence of nosocomial COVID in patients admitted in ICU. The secondary objectives are to evaluate the incidence of nosocomial-associated COVIDs contracted by caregivers, and the incidence of asymptomatic positive SARS-CoV-2 cases in ICU.

NCT04659356
Conditions
  1. Coronavirus Infectious Disease (COVID-19)
  2. Nosocomial Infection
  3. Nosocomial COVID-19
Interventions
  1. Other: Patients admitted in Intensive Care Units
MeSH:Infection Communicable Diseases Cross Infection Coronavirus Infections

Primary Outcomes

Description: Occurence of a nosocomial COVID-19 that is certain or probable. Community-acquired certain and probable COVIDs will be excluded from the main analysis. The incidence rate of nosocomial COVID will be expressed in patient-days: Ratio of the number of patients with nosocomial COVID to the sum of exposure times, i.e. : for patients without nosocomial COVID: duration of hospitalization in ICU for patients presenting with nosocomial COVID: delay between the date of the start of hospitalization in ICU and the occurrence of nosocomial COVID.

Measure: Incidence of nosocomial COVID-19

Time: up to 6 months

Secondary Outcomes

Description: Prevalence of community-acquired COVID that is certain and Prevalence of community-acquired COVID that is probable. Prevalence of nosocomial and community-acquired COVID in healthcare workers. Prevalence will be defined as the ratio of the number of caregivers developing a COVID to the number of caregivers working in ICU during the inclusion period. Prevalence of patients with SARS-CoV-2 positive samples but asymptomatic in ICU. Risk factors to development a nosocomial COVID (certain and probable).

Measure: Occurrence of a nosocomial COVID-19 that is certain and Occurrence of a nosocomial COVID-19 that is probable.

Time: up to 12 months

Description: ICU nosocomial infections rates (ventilator associated acquired pneumonia) Highly resistant bacteria colonization and infection acquired in ICU

Measure: evaluate the occurence

Time: up to 12 months
190 Prospective Studies in School-aged Children and Adolescents With COVID-19 Treated at HCFMUSP

This is a protocol aimed at children and adolescents contaminated with COVID, treated at the Hospital das Clínicas, University of Sao Paulo, Brazil (HCFMUSP), in the recovery phase. The study aims to evaluate the spectrum of pathogenic lesions of the virus not only in the respiratory system, but digestive, immunological, neurological and others. Clinical, evolutionary, laboratory and functional parameters will be used.

NCT04659486
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. SARS (Severe Acute Respiratory Syndrome)
  4. SARS-CoV Infection
Interventions
  1. Behavioral: Home-based exercise training
MeSH:Infection Communicable Diseases Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: The instrument was translated and validated for the Brazilian population

Measure: Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)

Time: Change from Baseline at 3 months

Description: The instrument was translated and validated for the Brazilian population

Measure: Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)

Time: Change from Baseline at 6 months

Secondary Outcomes

Description: Aims to investigate the mechanisms that lead to dyspnea and, consequently, intolerance to physical effort

Measure: Flow-volume loop assessed by spirometry

Time: Baseline, 3 months, 6 months

Description: It will also be assessed for school-age children (7-10 years old) and adolescents (11-18 years old) and by their primary caregiver

Measure: Health-related quality of life assessed by the Pediatric Outcomes Data Collection Instrument

Time: Baseline, 3 months, 6 months, 12 months

Measure: Complete blood count (hemoglobin, leukocyte, lymphocyte and platelet count)

Time: Baseline, 3 months, 6 months, 12 months

Measure: Inflammatory markers (C-reactive protein, fibrinogen, D-dimer and ferritin);

Time: Baseline, 3 months, 6 months,12 months

Measure: Lactate dehydrogenase

Time: Baseline, 3 months, 6 months, 12 months

Measure: Aspartate and alanine aminotransferase

Time: Baseline, 3 months, 6 months, 12 months

Measure: Serum urea and creatinine

Time: Baseline, 3 months, 6 months, 12 months

Measure: Triglycerides

Time: Baseline, 3 months, 6 months, 12 months

Measure: Creatinine phosphokinase (CK)

Time: Baseline, 3 months, 6 months, 12 months

Measure: Amilase

Time: Baseline, 3 months, 6 months, 12 months

Measure: Lipase

Time: Baseline, 3 months, 6 months, 12 months

Measure: Troponin T

Time: Baseline, 3 months, 6 months, 12 months

Measure: Pro-BNP

Time: Baseline, 3 months, 6 months, 12 months

Description: Patchy ground-glass opacities, crazy-paving pattern, and localization and pattern of large, confluent or small nodular lesions will be assessed

Measure: Lung abnormalities will be assessed by pulmonary computed tomography

Time: Baseline, 3 months, 6 months, 12 months

Description: Conventional transthoracic echocardiogram with color Doppler to assess systolic and diastolic function

Measure: Systolic and diastolic function will be assessed by echocardiogram

Time: Baseline, 3 months, 6 months, 12 months

Description: Conventional transthoracic echocardiogram with color Doppler to search for valve dysfunction

Measure: Valve dysfunction will be assessed by echocardiogram

Time: Baseline, 3 months, 6 months, 12 months

Description: Conventional transthoracic echocardiogram with color Doppler to search for pericardial effusion

Measure: Pericardial effusion will be assessed by echocardiogram

Time: Baseline, 3 months, 6 months, 12 months

Description: Conventional transthoracic echocardiogram with color Doppler to search for aspects of the coronary arteries

Measure: Coronary arteries will be assessed by echocardiogram

Time: Baseline, 3 months, 6 months, 12 months

Description: Echocardiogram with two-dimensional speckle-tracking technique to identify subclinical changes suggestive of ischemia or myocarditis

Measure: Ischemia will be assessed by echocardiogram

Time: Baseline, 3 months, 6 months, 12 months

Description: Baseline levels of cytokines IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-y, and IL-17A in serum samples will be tested by flow cytometry using the CBA technique (Cytometric bead array, BD Biosciences)

Measure: Immunocompetence, including thymic function

Time: Baseline, 3 months, 6 months, 12 months

Measure: Leukogram will be assessed by leukocyte and lymphocyte counts

Time: Baseline, 3 months, 6 months,, 12 months

Description: T cell lineages: CD3CD4, CD3CD8, naive cells (CD45RA+), memory cells (CD45RA-), effector cells (CD38+HLADR+)

Measure: Immunophenotyping of lymphocytes T cell lineages will be evaluated by flow cytometry

Time: Baseline, 3 months, 6 months, 12 months

Description: B cell lineages: CD19, naive cells (CD27-), memory cells (CD27+), plasmablasts (CD27+CD38+CD138-), (plasmocytes CD27+CD38+CD138+)

Measure: Immunophenotyping of lymphocytes B cell lineages will be evaluated by flow cytometry

Time: Baseline, 3 months, 6 months, 12 months

Description: NK cells: (CD3-CD16+CD56+), degranulated: CD107a+

Measure: Immunophenotyping of lymphocytes NK cells will be evaluated by flow cytometry

Time: Baseline, 3 months, 6 months, 12 months

Measure: Serum levels of anti-Streptococcus pneumoniae IgG antibodies

Time: Baseline, 3 months, 6 months, 12 months

Description: The antipneumococcal antibody titer against 6 polysaccharides (serotypes 1, 5, 6B, 9V, 14, and 18C) will be analyzed by ELISA. The seroconversion criteria is IgG values > 1.3 mg/mL for each polysaccharide assessed

Measure: Anti-pneumococcal vaccine response will be assessed by ELISA

Time: Baseline, 3 months, 6 months, 12 months

Description: TRECs evaluate the peripheral function of the thymus from cells that have recently been released, using the RT-PCR technique

Measure: Evaluation of the thymus by the determination of TRECs (Thymic recent emigrant cells or T-cell receptor excision circles)

Time: Baseline, 3 months, 6 months, 12 months

Description: (anti-thyroperoxidase antibodies, anti-thyroglobulin)

Measure: Changes in frequency of the autoantibodies of the thyroid gland

Time: Baseline, 3 months, 6 months, 12 months

Measure: Changes in frequency of the anti-GAD antibody will be assessed using immunoprecipitation

Time: Baseline, 3 months, 6 months, 12 months

Measure: Changes in frequency of the anti-islet antibody of Langerhans will be assessed using indirect fluorescence

Time: Baseline, 3 months, 6 months, 12 months

Measure: Changes in frequency of the anti-insulin antibody will be assessed by radioimmunoassay

Time: Baseline, 3 months, 6 months, 12 months

Measure: Diagnosis of thyroid dysfunction will be assessed by thyroid profile (TSH, free T4 and T3)

Time: Baseline, 3 months, 6 months, 12 months

Measure: Diagnosis of type 1 diabetes mellitus will be assessed by the metabolic profile (fasting glucose, glycated hemoglobin and C peptide)

Time: Baseline, 3 months, 6 months,, 12 months

Measure: Linear growth will be assessed by using a standardized stadiometer, calculating standard deviation, growth curves, and growth speed

Time: Baseline, 3 months, 6 months, 12 months

Measure: Development of puberty will be assessed according to the criteria of Tanner and Marshall in adolescents in the prepubertal age group

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone age will be assessed using non-dominant hand and wrist radiography

Time: Baseline, 12 months

Measure: Bone mineral density will be assessed by Bone densitometry (DXA) in the region of the lumbar spine

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone mineral content will be assessed by Bone densitometry (DXA) in the region of the lumbar spine

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone mineral density will be assessed by Bone densitometry (DXA) in the proximal femur

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone mineral content will be assessed by Bone densitometry (DXA) in the proximal femur

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone mineral density will be assessed by Bone densitometry (DXA) in the whole body

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone mineral content will be assessed by Bone densitometry (DXA) in the whole body

Time: Baseline, 3 months, 6 months, 12 months

Measure: Body composition (visceral adipose tissue) will be assessed by Bone densitometry

Time: Baseline, 3 months, 6 months, 12 months

Measure: Body composition (lean mass) will be assessed by Bone densitometry

Time: Baseline, 3 months, 6 months, 12 months

Measure: Body composition (fat mass) will be assessed by Bone densitometry

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone biochemical and bone remodeling markers (calcium, phosphorus, 25OH alkaline phosphatase vitamin D, PTH, CTX, P1NP)

Time: Baseline, 3 months, 6 months, 12 months

Measure: Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk used during the "timed up and go" test

Time: Baseline, 3 months, 6 months, 12 months

Measure: Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 6-minute walk test

Time: Baseline, 3 months, 6 months, 12 months

Measure: Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 10 meter gait test

Time: Baseline, 3 months, 6 months, 12 months

Measure: Pediatric gait assessment will be assessed by musculoskeletal ultrasound

Time: Baseline, 3 months, 6 months, 12 months

Description: According to the gene sequence studied, the analysis will be performed using the Sanger sequencing technique with capillary electrophoresis in a 3130 automatic sequencer (Applied Biosystems). The genetic polymorphisms of the ABO system gene (rs505922), two polymorphisms of the OPRM1 gene (rs1799971 and rs1799972) and a polymorphism of the BDNF gene (rs6265) will be investigated, with possible contributions to the risk of impaired gait.

Measure: Genetic Polymorphism Analysis will be assessed by salting out methodology followed by q-PCR (Real-time PCR) using the TaqMan assay using Step One Plus equipment

Time: Baseline, 3 months, 6 months, 12 months

Description: This is an 18-item parent questionnaire for children and adolescents (18 years and younger). This rating scale includes positive "weaknesses" and negative "strengths" scoring, assessing symptoms of Attention-Deficit/Hyperactivity Disorder. Parents are asked to compare their child's behavior in a variety of settings over the past month to other children on a 7-point: 3-Far below, 2-Below, 1-Slightly below, 0-Average, -1-Slightly average, -2-Above, -3-Far above. Higher scores indicate greater symptomology

Measure: Mental health will be assessed by the "Strengths and Weaknesses of Attention-deficit/hyperactivity disorder (ADHD) symptoms and Normal behaviors"

Time: Baseline, 3 months, 6 months, 12 months

Description: The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire, and includes 25 items on psychological attribute: emotional symptoms (5 items), conduct problems (5 items) hyperactivity/inattention (5 items), peer relationship problems (5 items), prosocial behaviour (5 items). Higher scores indicate greater difficulties

Measure: Mental health will be assessed by the "Strengths and Difficulties Questionnaire"

Time: Baseline, 3 months, 6 months, 12 months

Description: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress (7 items each subscale). Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much). Sum scores for the total DASS-total scale range between 0 and 120. Scores ≥60 (for DASS-total) and ≥21 (for the depression subscale) are labeled as "high" or "severe".

Measure: Mental health will be assessed by the "Depression, Anxiety and Stress Scale"

Time: Baseline, 3 months, 6 months, 12 months

Description: ActivPAL will be used for 7 days for at least 10 hours/day

Measure: Physical activity levels assessed by ActivPAL

Time: Baseline, 3 months, 6 months, 12 months

Description: 24-hour recalls will be assessed on three non-consecutive days (two weekdays, and one weekend). Online Dietbox will be used.

Measure: Food consumption levels assessed by food records

Time: Baseline, 3 months, 6 months, 12 months

Description: Baseline blood flow measurements will be assessed in the brachial artery

Measure: Blood flow will be assessed using a Doppler Ultrasound

Time: Baseline, 3 months, 6 months, 12 months

Description: Flow-mediated vasodilation (VMF) will be assessed in the brachial artery

Measure: Endothelial function will be assessed using a Doppler Ultrasound

Time: Baseline, 3 months, 6 months, 12 months
191 Wide Scale Monitoring for Acute Respiratory Infection Using a Mobile-Based Study Platform

This is a prospective observational study using a mobile study platform (app) that is designed for use on Android phones. Study participants will provide baseline demographic and medical information and report symptoms of respiratory infection on a weekly basis using the app. Participants will also report use of prevention techniques on the weekly survey. Mobility data will be collected passively using the sensors on the participant's smartphone, if the participant has granted the proper device permissions. The overall goals of the study are to track spread of coronavirus-like illness (CLI), influenza-like illness (ILI) and non-specific respiratory illness (NSRI) on a near-real time basis and identify specific behaviors associated with an increased or decreased risk of developing these conditions.

NCT04663776
Conditions
  1. Covid19
  2. Influenza
  3. Respiratory Tract Infections
  4. Acute Respiratory Tract Infection
  5. Acute Respiratory Distress Syndrome
MeSH:Infection Communicable Diseases Respiratory Tract Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury
HPO:Respiratory tract infection

Primary Outcomes

Description: The definition of ILI will be adapted from CDC guidelines as a participant reporting fever in addition to cough or sore throat without any other known cause. All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the final outcome, the total incidence may not add up to exactly 100%.

Measure: Incidence of influenza-like illness (ILI) and COVID-like illness (CLI) in a study participant.

Time: 6-month participation period

Description: CLI will be defined as fever and cough, or shortness of breath, or loss of smell. Incidence will be defined as reporting of the above symptoms in the 7 days prior (and not previously). All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the final outcome, the total incidence may not add up to exactly 100%.

Measure: Incidence of COVID-like illness (CLI) in a study participant.

Time: 6-month participation period

Secondary Outcomes

Description: Patterns of mobility (e.g. time away from home, use of public transportation), and reported use of prevention strategies such as wearing a mask and social distancing in participants who do, or don't, develop CIL and/or ILI will be compared. All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the final outcome, the total prevalence may not add up to exactly 100%.

Measure: Disease Prevalence

Time: 1-year study period
192 Predicting Severity and Disease Progression in Influenza-like Illness

Respiratory infections such as colds, flu and pneumonia affect millions of people around the world every year. Most cases are mild, but some people become very unwell. Influenza ('flu') is one of the most common causes of lung infection. Seasonal flu affects between 10% and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. In addition, both influenza and coronaviruses have caused pandemics in recent years, leading to severe disease in many people. Although flu vaccines are available, these need to change every year to overcome rapid changes in the virus and are not completely protective. This study aims to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection. The aim is to recruit 100 patients admitted to hospital due to a respiratory infection. It is voluntary to take part and participants can choose to withdraw at any time. The study will involve some blood and nose samples. This will be done on Day 0, Day 2 and Discharge from hospital, and an out-patient follow-up visit on Day 28. The data will be used to develop novel diagnostic tools to assist in rational treatment decisions that will benefit both individual patients and resource allocation. It will also establish research preparedness for upcoming pandemics.

NCT04664075
Conditions
  1. Influenza
  2. SARS (Severe Acute Respiratory Syndrome)
  3. Respiratory Viral Infection
  4. Respiratory Tract Infections
  5. Infection, Bacterial
  6. Infection Viral
  7. Covid19
  8. RNA Virus Infections
Interventions
  1. Biological: Respiratory infections
MeSH:Infection Communicable Diseases Respiratory Tract Infections Bacterial Infections Influenza, Human Virus Diseases Severe Acute Respiratory Syndrome Coronavi Coronavirus Infections RNA Virus Infections Disease Progression
HPO:Respiratory tract infection

Primary Outcomes

Description: The identity of pathological organisms associated with influenza-like illness (including respiratory viruses and bacteria) will be obtained from the patient's medical record

Measure: Describe the aetiology of influenza-like illness in hospitalised adults

Time: Day 0 to Day 28

Description: The following data will be collected from the patient's medical record. At enrolment, data will consist of: past medical history, clinical signs and symptoms relating to this admission, vital signs (pulse rate, blood pressure, temperature, oxygen saturation), demographics, drug history, laboratory results including diagnostic microbiological tests and interventions. Data collection on Day 28 will consist of clinical diagnosis at discharge, any febrile illness in the 7 days preceding the visit, mortality and complications between Day 0 and 28.

Measure: Describe the clinical outcomes of influenza-like illness in hospitalised adults

Time: Day 0 to Day 28

Secondary Outcomes

Description: Cytokine levels (in pg/mL) will be measured in plasma and nasal lining fluid samples by MesoScale Discovery

Measure: Identify changes in cytokine levels during influenza-like illness in hospitalised adults

Time: Day 0 to Day 28
193 A Prospective Study of Patients With B-Cell Hematologic Malignancies on Ibrutinib Therapy Who Are Infected With Coronavirus Disease 2019 (COVID-19)

This phase II trial studies the effects of ibrutinib in treating patients with B-cell malignancies who are infected with COVID-19. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ibrutinib is a first in class Bruton tyrosine kinase inhibitor (BTKi), for the treatment of B-cell malignancies. This study is being done to determine if taking ibrutinib after contracting COVID-19 will make symptoms better or worse.

NCT04665115
Conditions
  1. Asymptomatic COVID-19 Infection Laboratory-Confirmed
  2. B-Cell Neoplasm
  3. Chronic Lymphocytic Leukemia
  4. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  5. Mantle Cell Lymphoma
  6. Marginal Zone Lymphoma
  7. Small Lymphocytic Lymphoma
  8. Symptomatic COVID-19 Infection Laboratory-Confirmed
  9. Waldenstrom Macroglobulinemia
Interventions
  1. Drug: Ibrutinib
  2. Other: Quality-of-Life Assessment
MeSH:Infection Communicable Diseases Laboratory Infection Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Waldenstrom Macroglobulinemia
HPO:Chronic lymphatic leukemia Leukemia Lymphoid leukemia Lymphoma Monoclonal immunoglobulin M proteinemia

Primary Outcomes

Description: Will calculate the proportion of patients who were outpatient at the time of study entry, and evaluate whether or not patients in this cohort required hospitalization associated with their coronavirus disease 2019 (COVID-19) infection.

Measure: Proportion of patients who require hospitalization for their COVID-19 disease or die (Cohort 1)

Time: Up to 28 days after study registration

Measure: Proportion of patients who require mechanical ventilation and/or die (Cohort 2)

Time: Up to 28 days after study entry

Secondary Outcomes

Description: Will characterize and calculate the proportion of patients who develop a "flare phenomenon" if ibrutinib is stopped. Will calculate corresponding 95% exact binomial confidence intervals for these outcomes. These will be graphically and quantitatively compared, where chi-square or Mantel-Haenszel-Cochran tests will be used to compare the numbers of patients who have the incident event of interest between treatment arms or other groups of interest.

Measure: Rate of "flare phenomena" (Cohort I)

Time: Up to 84 days

Description: We will evaluate and characterize baseline status and changes in 8 primary COVID-19 related symptoms in these outpatient subjects: fever, loss of smell, cough, shortness of breath, fatigue, aching muscles, diarrhea, and decreased appetite. These will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Resolution of symptoms will be defined as no fever, no loss of smell, and severity or frequency of the remaining six symptoms rated as 0 (none/never) or 1 (mild/rarely) on the PRO-CTCAE.

Measure: Patient-reported health and symptom status (Cohort I)

Time: Up to 84 days

Description: We will characterize and summarize overall and by B-cell histologic diagnosis whether or not patients suspend their ibrutinib therapy while in an outpatient setting during the first 28 days on study, and patterns of resumption of ibrutinib. Specifically, we will evaluate this outcome by assessing the number of days patients received ibrutinib in the first 28 days after enrollment on this trial.

Measure: Patterns on ibrutinib therapy during COVID-19 infection (Cohort I)

Time: Up to 84 days

Measure: Reasons for hospitalization (Cohort I)

Time: Up to 84 days

Measure: Mortality (Cohort II)

Time: Up to 84 days

Measure: Time to hospital discharge (Cohort II)

Time: Up to 84 days

Description: Will characterize and summarize the need for and duration of oxygen supplementation.

Measure: Intubation and oxygen supplementation (Cohort II)

Time: Up to 84 days

Measure: Incidence of "flare phenomena" (Cohort II)

Time: Up to 84 days

Description: The proportions of patients who are documented as having viral clearance at the various time points will be summarized at each time point within each treatment arm. These proportions will be evaluated within as well as across the cohorts. Within each cohort, we will compare these rates at each of the time points using chi-square or Mantel-Haenszel-Cochran tests to assess differences between treatment arms or groups. Further, logistic regression models will be used to assess incidence of viral clearance and how treatment arm and other demographic and clinical factors affect the ability of patients to achieve viral clearance.

Measure: Viral clearance

Time: On days 15, 28, 42, and 56 after registration

Description: The proportion of patients who are able to develop COVID-19 antibodies by days 15 and 28, defined as the number of patients who have a threshold level of detectable COVID-19 antibodies divided by the total number of patients in the specific cohort/arm.

Measure: Development of COVID-19 antibodies

Time: Up to 28 days

Measure: Coagulopathy and thrombosis measures

Time: Up to 28 days

Description: Will evaluate the baseline as well as change in plasma cytokines between treatment arms: IL-1beta, IL-1Ralpha, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL- IL-9, IL-10, IFNgamma, IP10, TNFalpha in longitudinal samples.

Measure: Cytokine measures

Time: Up to 84 days

Description: Will evaluate the baseline as well as change in several immune cell subsets, including CD3 T cells, CD4 T-helper cells (and their subsets), CD8 T-suppressor cells (and their subsets), NK cells, B cells, and monocytes.

Measure: Immune subset measures

Time: Up to 84 days
194 Expert Statements on Infection Control in Intensive Care Unit for Severe Acute Respiratory Syndrome Coronavirus 2

The investigators aim to develop expert consensus statements on infection control management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in intensive care units (ICU).

NCT04665960
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. SARS Pneumonia
  4. Coronavirus Infection
  5. Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Survey questionnaire with seven point Likert scale (1-3 means disagreement and 5-7 means agreement) and multiple choice statements

Measure: Consensus using participating experts opinions.

Time: 30 days
195 A Phase 2 Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety, Reactogenicity, and Immunogenicity of the SARS CoV-2 Vaccine ARCT-021 in Healthy Adult Participants

This is a Phase 2, randomized, placebo-controlled, and observer-blind study in healthy adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: As 2 doses (at two different dose levels), separated by 28 days or as 1 dose In adults 18 years of age and older

NCT04668339
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Corona Virus Infection
Interventions
  1. Biological: ARCT-021 single dose priming
  2. Biological: ARCT-021 two lower dose priming
  3. Biological: ARCT-021 two higher dose priming
  4. Biological: Placebo (two doses), priming
  5. Biological: Randomized booster
  6. Biological: Placebo booster
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Adverse events reported daily in a diary that reflect common symptoms or findings at the injection site following vaccination

Measure: Percentages of participants reporting solicited local adverse events

Time: for 7 days following each dose administration

Description: Adverse events reported daily in a diary that reflect generalized symptoms following vaccination

Measure: Percentages of participants reporting solicited systemic adverse events

Time: for 7 days following each dose administration

Description: spontaneously reported adverse events

Measure: Percentages of participants reporting adverse events

Time: 28 days following each dose administration

Description: unsolicited adverse events that meet the definition of serious

Measure: Percentages of participants reporting serious adverse events

Time: Day 0 to Day 388

Description: unsolicited adverse events that lead to healthcare provider visit

Measure: Percentages of participants reporting medically attended adverse events

Time: Day 0 to Day 388

Description: unsolicited adverse events associated with new diagnosis of chronic disease

Measure: Percentages of participants reporting new onset of chronic disease

Time: Day 0 to Day 388

Description: chemistry and hematology

Measure: Percentages of participants with abnormal chemistry and hematology values

Time: Day 0 to Day 215

Description: neutralizing antibody response

Measure: SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs

Time: Day 0 to Day 388

Description: neutralizing antibody response

Measure: Changes in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point, expressed as GMFRs

Time: Through Day 388

Description: neutralizing antibody response

Measure: Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 serum neutralizing antibody levels

Time: Through Day 388

Secondary Outcomes

Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses

Measure: SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels, expressed as GMCs

Time: Day 0 to Day 388

Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses

Measure: Changes in SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs

Time: Through Day 388

Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses

Measure: Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels

Time: Through Day 388
196 A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-919 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)

The purpose of this study is to evaluate the safety and immunogenicity of 2 doses of TAK-919 by intramuscular (IM) injection in healthy Japanese male and female adults.

NCT04677660
Conditions
  1. Prevention of Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
Interventions
  1. Biological: TAK-919
  2. Biological: Placebo
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered an investigational medicinal product (IMP); it does not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs are defined as injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.

Measure: Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following Each Vaccination

Time: Up to Day 7 after each vaccination

Description: Solicited systemic AEs are defined as headache, fatigue, myalgia, arthralgia, nausea/vomiting, chills, and fever.

Measure: Percentage of Participants with Solicited Systemic AEs for 7 Days Following Each Vaccination

Time: Up to Day 7 after each vaccination

Description: Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.

Measure: Percentage of Participants with Unsolicited AEs for 28 Days After Each Vaccination

Time: Up to Day 28 after each vaccination

Description: An SAE is defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event.

Measure: Percentage of Participants with Serious AE (SAE) until Day 57

Time: Up to Day 57

Measure: Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 57

Time: Up to Day 57

Measure: Percentage of Participants with Any AE Leading to Discontinuation of Vaccination

Time: Up to Day 57 (up to discontinuation of vaccination)

Measure: Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 57

Time: Up to Day 57

Measure: Percentage of Participants with SARS-CoV-2 Infection until Day 57

Time: Up to Day 57

Description: GMT of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

Measure: Geometric Mean Titers (GMT) of Serum binding antibody (bAb) Against SARS-CoV-2 on Day 57

Time: Day 57

Description: GMFR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

Measure: Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57

Time: Day 57

Description: SCR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein. SCR is defined at percentage of participants with a change from below the limit of detection (LOD) to equal to or above LOD, OR, >= 4-fold rises from baseline.

Measure: Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57

Time: Day 57

Secondary Outcomes

Measure: Percentage of Participants with SAE throughout the Trial

Time: Up to Day 394

Measure: Percentage of Participants with MAAEs throughout the Trial

Time: Up to Day 394

Measure: Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial from the Day of Vaccination throughout the Trial

Time: Up to Day 394

Measure: Percentage of Participants with SARS-CoV-2 Infection throughout the Trial

Time: Up to Day 394

Description: GMT of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

Measure: GMT of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394

Time: Day 29, Day 43, Day 209 and Day 394

Description: GMFR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

Measure: GMFR of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394

Time: Day 29, Day 43, Day 209 and Day 394

Description: SCR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein. SCR is defined at percentage of participants with a change from below the LOD to equal to or above LOD, OR, >= 4-fold rises from baseline.

Measure: SCR of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394

Time: Day 29, Day 43, Day 209 and Day 394

Description: GMT of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus.

Measure: GMT of serum neutralizing antibody (nAb) against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394

Time: Day 29, Day 43, Day 57, Day 209, and Day 394

Description: GMFR of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus.

Measure: GMFR of serum nAb against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394

Time: Day 29, Day 43, Day 57, Day 209, and Day 394

Description: SCR of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus. SCR is defined at percentage of subjects with a change from below the lower limit of quantification (LLOQ) to equal to or above LLOQ, OR, >= 4-fold rises from baseline.

Measure: SCR of serum nAb against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394

Time: Day 29, Day 43, Day 57, Day 209, and Day 394
197 European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC): Paediatric Protocol

Across Europe and worldwide, there are many studies following groups (cohorts) of children living with human immunodeficiency virus (HIV) and other infections over time, to monitor their long-term health. Some of these infections are rare: for example, few children in Western Europe are living with HIV, so the studies often have fairly small numbers of participants. This can make it difficult to answer research questions in these cohorts and means that doctors and researchers working with these patients in different countries need to work together. This is particularly important as children are not often included in clinical trials of treatments and other interventions. The European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) is an international network of researchers working together in this way. Researchers in the network represent cohort studies of pregnant women and children with, or at risk of, infections from across Europe and Thailand. The research focuses on infections in pregnant women and children, particularly HIV, hepatitis B and C virus, and tuberculosis, and, from 2020, novel coronavirus (COVID-19). By combining data from many cohorts, the researchers aim to answer questions that could not be answered by one study individually (for example, because a large number of pregnant women or children are needed to answer the question). This protocol focuses on the paediatric component of EPPICC's research, which focuses on the treatment of children at risk of and living with infections. For example, what medicines are used most often and how do they affect children's health? EPPICC is an observational study, which means that children do not receive any extra treatment as part of the study. Instead, children are "observed" during their routine medical care. Each cohort keeps records of the children's health collected at routine clinic visits, including information such as date of birth and sex, results of diagnostic tests, treatments received, and any illnesses or other events that the children have had. The EPPICC study combines and analyses data from all of the cohorts that take part, to answer questions about the risks and benefits of different diagnosis or treatment strategies, the long-term effects of infection and treatment during childhood and young adulthood, and regional variations (e.g. between Western and Eastern Europe) in the risk and management of infections. All of the data collected through the EPPICC Paediatric Protocol are stored securely at the Medical Research Council Clinical Trials Unit (MRC CTU) at UCL. Data collection and storage are governed by the General Data Protection Regulation. A Steering Committee guides the research to make sure it is relevant and of high quality. Public and patient involvement (PPI) may be provided by individual cohorts' own groups, as well as by the interlinked Penta organisation, which is a network of paediatricians and researchers working in infections in Europe and globally. The PPI groups help with release of the results of the research. The results are also published on the Penta Foundation's public website (https://penta-id.org/), and presented at conferences and published in Open Access scientific journals.

NCT04677842
Conditions
  1. HIV Infections
  2. Tuberculosis Infection
  3. Hepatitis C
  4. Covid19
Interventions
  1. Drug: ART Therapy
MeSH:Infection Communicable Diseases Tuberculosis Latent Tuberculosis Hepatitis C Hepatitis
HPO:Hepatitis

Primary Outcomes

Measure: CD4 count in adulthood of young people with HIV assessed using routine clinical data

Time: through study completion, an average of 5 year

Measure: 2. Viral suppression in adulthood of young people with HIV assessed using routine clinical data

Time: through study completion, an average of 5 year

Measure: Viral suppression defined as <50 copies, <400 copies and 1000 copies/mL) upto 144 weeks.

Time: up to 144 weeks

Measure: CD4 change from drug start up to 144 weeks

Time: up to 144 weeks

Measure: Cumulative incidence of virological failure (>1000 copies/mL)

Time: through study completion, an average of 5 years

Measure: From start of novel drug of interest through to earliest date of the following: death, loss to follow-up, discontinuation of drug or last visit

Time: From date of novel drug initiation until earliest date of death, loss to follow-up, discontinuation of drug or last visit assessed up to 36 months
198 Reconvalescent Plasma / Camostat Mesylate Early in Sars-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals

This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.

NCT04681430
Conditions
  1. Corona Virus Infection
  2. SARS-CoV-2 Infe
  3. SARS-CoV-2 Infection
  4. SARS-CoV-2 PCR Test Positive
  5. SARS-CoV-2 Acute Respiratory Disease
Interventions
  1. Biological: Convalescent plasma
  2. Drug: Camostat Mesilate
  3. Drug: Placebo for Camostat Mesilate
  4. Other: Standard of Care (SoC)
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: The primary endpoint of the study is the number of individuals whose clinical status is on the COVID-19 modified WHO ordinal scale ≥ 4b up to and including day 28

Measure: WHO ordinal Covid-19 scale up to day 28

Time: up to and including day 28

Secondary Outcomes

Description: Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 4b-8

Measure: Cumulative number WHO categories 4b-8

Time: day 8, day 14, day 56 and day 90

Description: Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 3-4a

Measure: Cumulative number WHO categories 3-4a

Time: day 8, day 14, day 28, day 56 and day 90

Description: Cumulative number of participants not hospitalized at day 90

Measure: Not hospitalized

Time: at day 90

Description: All-cause mortality at day 90

Measure: All-cause mortality

Time: at day 90

Description: Number of patient with SARS-CoV-2 reinfection up to day 90

Measure: Reinfection

Time: up to day 90

Description: Number of patient with secondary sclerosis cholangitis at day 90

Measure: Secondary sclerosing cholangitis (SSC)

Time: at day 90

Description: Number of patient with COVID-19 associated chronic pulmonary disease

Measure: chronic pulmonary disease as sequelae from COVID-19

Time: at day 90

Description: The proportion of patients with remdesivir therapy

Measure: patients with remdesivir treatment

Time: up to day 90

Description: The clinical status on the WHO COVID-19 ordinal scale of at the start of remdesivir treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death

Measure: COVID-19 WHO status of patients at start of remdesivir treatment

Time: up to day 90

Description: The proportion of patients on dexamethasone therapy

Measure: patients with dexamethasone treatment

Time: up to day 90

Description: The clinical status on the WHO COVID-19 ordinal scale of at the start of dexamethasone treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death

Measure: COVID-19 WHO status of patients at start of dexamethasone treatment

Time: up to day 90

Description: Time to resolution of COVID-19 related symptoms (e.g. fever)

Measure: resolution of COVID-19 symptoms

Time: until day of resolution up to day 90

Description: Time to first negative SARS-CoV-2-PCR (polymerase chain reaction)

Measure: negative SARS-CoV-2-PCR test

Time: until day of first negative test up to day 90

Description: Duration of oxygen therapy (in days)

Measure: Oxygen therapy

Time: number of days with oxygen therapy up to day 90

Description: Frequency of occurrence of COVID-19 pneumonia

Measure: COVID-19 pneumonia

Time: up to day 90

Description: Percentage of participants in each group with need for mechanical ventilation

Measure: Percentage of participants requiring mechanical ventilation

Time: up to day 90

Description: Number of ventilation days per participant up to day 90

Measure: Number of ventilation days per participant up to day 90

Time: up to day 90

Description: Duration of hospital stay (in days), duration in intensive care/intermediate care (IMC) (in days)

Measure: hospital stay and intensive care

Time: up to day 90

Description: All-cause mortality at day 28

Measure: Mortality

Time: at day 28

Description: Cumulative incidence of Serious Adverse Events (SAE) per group within 90 days follow up

Measure: SAEs

Time: up to day 90

Description: Cumulative incidence of grade 3/4 Adverse Events (AE) per group

Measure: Grade 3/4 AEs

Time: up to day 90

Description: SARS-CoV-2 antibody concentrations (IgA in g/l) in serum on day 8, day 14, day 90

Measure: SARS-CoV-2 antibody IgA concentrations

Time: on day 8, day 14, day 90

Description: SARS-CoV-2 antibody concentrations (IgG in g/l) in serum on day 8, day 14, day 90

Measure: SARS-CoV-2 antibody IgG concentrations

Time: on day 8, day 14, day 90

Description: SARS-CoV-2 neutralizing antibody titers in serum on day 8, day 14, day 90

Measure: SARS-CoV-2 neutralizing antibody titers

Time: on day 8, day 14, day 90

Description: Number of screening failures due to the lack of a suitable plasma preparation

Measure: Plasma treatment screening failures

Time: up to day 8 (End of treatment)
199 Randomized Controlled Clinical Study (RCT) Phase 3 of the Safety and Efficacy of Hypochlorous Acid in the Prophylaxis of Healthcare Personnel at High Risk of Infection by SARS-CoV2 (COVID19) Versus Placebo

The pandemic caused by SARS-CoV-2 is a global emergency present in 6 continents including 66 countries, incurring a shortage of effective and safe therapeutic alternatives that can contribute to reducing the risk of contamination, as well as helping to reduce the viral load of the positive patient. This requires a coordinated, effective and immediate action on the part of governments, companies, academic entities and even at the individual level. In the search for new therapeutic and prevention alternatives, the application of hypochlorous acid (HClO) to the nasal mucosa is proposed, a broad-spectrum and fast-acting antimicrobial solution, whose safety has been proven in preclinical trials. The efficacy of HClO has been tested against enveloped and non-enveloped viruses, reducing virus particles without affecting human cells. This solution could contribute to reducing the viral load and the risk of contamination of patients and professionals. This could have an impact on controlling the COVID-19 pandemic.

NCT04684550