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

:

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 (257)


Name (Synonyms) Correlation
drug1980 Mavrilimumab Wiki 0.17
drug4171 vv-ECMO + cytokine adsorption (Cytosorb adsorber) Wiki 0.12
drug4172 vv-ECMO only (no cytokine adsorption) Wiki 0.12
Name (Synonyms) Correlation
drug1438 HFNC Wiki 0.12
drug3408 Telmisartan Wiki 0.10
drug2878 Respiratory mechanics measurement Wiki 0.09
drug245 Angiotensin 1-7 Wiki 0.09
drug2851 Relaxation Wiki 0.09
drug1575 Hyperbaric oxygen therapy Wiki 0.09
drug358 Awake prone positioning Wiki 0.09
drug1525 Hydroxychloroquine + azithromycin + / - tocilizumab Wiki 0.09
drug2086 Monitoring for aggravation Wiki 0.09
drug3734 XCEL-UMC-BETA Wiki 0.09
drug1953 Machine learning model Wiki 0.09
drug3093 Serologic testing Wiki 0.09
drug3155 Social Distancing Advertisements Wiki 0.09
drug3240 Standard of care. Wiki 0.09
drug2289 Observation only Wiki 0.09
drug1132 ELMO PROJECT AT COVID-19: STUDY IN HUMANS Wiki 0.09
drug3725 Without haptic stimulation Wiki 0.09
drug2372 PB1046 Wiki 0.09
drug196 AirGo Respiratory Monitor Wiki 0.09
drug2688 Psilocybin Wiki 0.09
drug3877 epidemiological and demographic characteristics Wiki 0.09
drug1621 IgIV Wiki 0.09
drug3161 Sodium Nitrite Wiki 0.09
drug1459 Helmet CPAP Wiki 0.09
drug2143 NaCl Wiki 0.09
drug3536 Treatment with Dexmedetomidine Wiki 0.09
drug2661 Prolonged Exposure (PE) Wiki 0.09
drug1117 ECCO2R Wiki 0.09
drug4176 zinc Wiki 0.09
drug2836 Reconsolidation of Traumatic Memories (RTM) Wiki 0.09
drug198 Airway pressure release ventilation Wiki 0.09
drug2167 Nebulised unfractionated heparin (UFH) Wiki 0.09
drug1969 Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol) Wiki 0.09
drug1936 MRI Wiki 0.09
drug1449 Haptic stimulation Wiki 0.09
drug3748 Zilucoplan® Wiki 0.09
drug787 Choice of Assignment: Enhanced Active Choice Wiki 0.09
drug4046 positive psychological intervention Wiki 0.09
drug3819 bromelain Wiki 0.09
drug4166 ventilatory support with oxygen therapy Wiki 0.09
drug214 Almitrine Wiki 0.09
drug1441 HIT-exercise Wiki 0.09
drug215 Alteplase 100 MG [Activase] Wiki 0.09
drug3608 Usual care positioning with no instructions Wiki 0.09
drug2442 Patient with SAR-CoV-2 infection Wiki 0.09
drug112 ASP2390 Wiki 0.09
drug1009 Decidual Stromal Cells (DSC) Wiki 0.09
drug4062 pulmonary ultrasound Wiki 0.09
drug159 Acceptability questionnaire Wiki 0.09
drug2737 Quercetin Wiki 0.09
drug2667 Prone position Wiki 0.09
drug1739 Isotonic saline Wiki 0.09
drug1503 Hospital anxiety and depression scale Wiki 0.09
drug3120 Sham intervention Wiki 0.09
drug786 Choice of Assignment: Active Choice Wiki 0.09
drug319 Assigned Strategies: Active Choice Wiki 0.09
drug788 Choice of Assignment: Opt-in Wiki 0.09
drug626 COVID visitation restrictions Wiki 0.09
drug2361 Oxygen Hood Wiki 0.09
drug923 Coronary artery calcium score and cardiac computed tomographic angiography Wiki 0.09
drug2363 Oxygen gas Wiki 0.09
drug1878 Low Dose (10 mg) Control Wiki 0.09
drug2261 Normobaric oxygen therapy Wiki 0.09
drug93 APPS Wiki 0.09
drug297 Arm exercise electrocardiographic stress test Wiki 0.09
drug1585 ICU Recovery + Physical Therapy Wiki 0.09
drug814 Closed-loop control of oxygen supplementation by O2matic Wiki 0.09
drug3527 Treadmill electrocardiographic stress test Wiki 0.09
drug2469 Peripheral blood sampling Wiki 0.09
drug1389 Gas exchange measurement Wiki 0.09
drug3025 Saline Placebo Wiki 0.09
drug2295 Observational only Wiki 0.09
drug321 Assigned Strategies: Opt-in Wiki 0.09
drug1671 Inhaled budesonide and formoterol Wiki 0.09
drug1700 Intermittent prone positioning instructions Wiki 0.09
drug751 Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies Wiki 0.09
drug3254 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection Wiki 0.09
drug4119 standard operating procedures Wiki 0.09
drug2552 Placebo of excipient(s) will be administered Wiki 0.09
drug2604 Postural Positioning Wiki 0.09
drug2464 Performing Virtual Actions Wiki 0.09
drug128 AVIGAN 200 mg FT Wiki 0.09
drug3256 Standard therapy recommended by the Ministry of Health of the Russian Federation. Wiki 0.09
drug2887 Retrospective case-control analysis Wiki 0.09
drug2410 PT-Pal Wiki 0.09
drug1080 Dociparastat sodium Wiki 0.09
drug273 Anticoagulation Agents (Edoxaban and/or high dose LMWH) Wiki 0.09
drug2710 Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) Wiki 0.09
drug172 Active control condition Wiki 0.09
drug1623 Iloprost Wiki 0.09
drug3020 STP + COVID-19 Convalescent Plasma (CP) Wiki 0.09
drug1460 Helmet Continuous Positive Airway Pressure (CPAP) Wiki 0.09
drug3941 life questionnaires Wiki 0.09
drug1672 Inhaled nitric oxide (iNO) Wiki 0.09
drug1811 Lactoferrin (Apolactoferrin) Wiki 0.09
drug3227 Standard of Care (SoC) Wiki 0.09
drug2488 Phsyiotherapy Wiki 0.09
drug163 Acetylsalicylic acid Wiki 0.09
drug1250 Experts consensus Wiki 0.09
drug2806 Rapamycin Wiki 0.09
drug260 Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS) Wiki 0.09
drug1667 Inhaled ILOPROST Wiki 0.09
drug3419 Tenecteplase Wiki 0.09
drug1987 Mechanical ventilation with the automated BVM compressor Wiki 0.09
drug682 CPAP treatment Wiki 0.09
drug69 ACE inhibitor, angiotensin receptor blocker Wiki 0.09
drug1016 Defibrotide Injection Wiki 0.09
drug971 DFV890 Wiki 0.09
drug12 0.9%sodium chloride Wiki 0.09
drug1875 Losmapimod oral tablet Wiki 0.09
drug3898 high flow nasal cannula device Wiki 0.09
drug2005 Mefloquine + azithromycin + / - tocilizumab Wiki 0.09
drug292 Aprepitant injectable emulsion Wiki 0.09
drug3237 Standard of care therapies Wiki 0.09
drug1461 Helmet non-invasive ventilation Wiki 0.09
drug2335 Only Standard Treatment Wiki 0.09
drug2935 Ruxolitinib plus simvastatin Wiki 0.09
drug4147 thoracic lung ultrasound Wiki 0.09
drug2841 Regadenoson myocardial perfusion imaging stress test Wiki 0.09
drug3638 Verapamil Wiki 0.09
drug681 CPAP Wiki 0.09
drug3503 Tracheotomy Wiki 0.09
drug1236 Exercise Training Only Wiki 0.09
drug250 Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB) Wiki 0.09
drug2755 Questionnaires, spirometry Wiki 0.09
drug1131 ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY Wiki 0.09
drug1970 Masimo, LidCO Wiki 0.09
drug1439 HFNO Wiki 0.09
drug3895 gammaCore® Sapphire (non-invasive vagus nerve stimulator) Wiki 0.09
drug355 Aviptadil by intravenous infusion + standard of care Wiki 0.09
drug3070 Self-guided exercises Wiki 0.09
drug320 Assigned Strategies: Enhanced Active Choice Wiki 0.09
drug2004 Mefloquine Wiki 0.09
drug940 Covid19 Wiki 0.09
drug1474 High Flow Nasal Oxygen (HFNO) Wiki 0.09
drug356 Awake Prone Positioning Wiki 0.09
drug3289 Sulodexide Wiki 0.09
drug2286 Observation of Virtual Actions (step 4) Wiki 0.09
drug223 Amiodarone Wiki 0.09
drug1346 Fondaparinux Wiki 0.09
drug1561 Hydroxychloroquine sulfate &Azithromycin Wiki 0.09
drug262 Anti-SARS-CoV2 serological controls and serum neutralization Wiki 0.09
drug3671 Vit D Wiki 0.09
drug3253 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation Wiki 0.09
drug3480 Tirofiban Injection Wiki 0.09
drug3958 mechanical ventilation Wiki 0.09
drug3717 Wellness Wiki 0.09
drug1674 Inhaled placebo Wiki 0.09
drug3291 Supine position Wiki 0.09
drug1574 Hyperbaric oxygen Wiki 0.09
drug2529 Placebo PBMT/sMF Wiki 0.09
drug1273 FAVIR 200 MG FT Wiki 0.09
drug1224 Evaluate HACOR score effectivity in this patients Wiki 0.09
drug393 BDB-001 Injection Wiki 0.09
drug2729 Quality of Life Wiki 0.09
drug2134 NK-1R antagonist Wiki 0.09
drug3851 conventional oxygen Wiki 0.09
drug3637 Ventil - a gas flow divider Wiki 0.09
drug3241 Standard oxygen therapy Wiki 0.09
drug926 Corticosteroid injection Wiki 0.09
drug3572 Ultra-Low-dose radiotherapy Wiki 0.09
drug2198 Nitazoxanide and atazanavir/ritonavir Wiki 0.09
drug2358 Oxycodone and Midazolam Wiki 0.09
drug3255 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation Wiki 0.09
drug990 Dapagliflozin 10 MG Wiki 0.09
drug1456 Healthy Weight Program (HW) Wiki 0.09
drug4028 patients receiving nasal high flow Wiki 0.09
drug3641 VibroLUNG Wiki 0.09
drug216 Alteplase 50 MG [Activase] Wiki 0.09
drug3013 SPIN-CHAT Program Wiki 0.09
drug3447 The usual treatment Wiki 0.09
drug4145 thoracic CT-scan Wiki 0.09
drug2359 Oxycodone, Paroxetine, and Quetiapine Wiki 0.09
drug2253 Normal Saline Infusion + standard of care Wiki 0.09
drug3208 Standard Therapy Protocol (STP) Wiki 0.09
drug1476 High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT) Wiki 0.09
drug3524 Transpulmonary pressure measurements Wiki 0.09
drug66 ABX464 Wiki 0.09
drug3021 STP + Standard Plasma (SP) Wiki 0.09
drug2504 Piperacillin/tazobactam Wiki 0.09
drug2285 Observation of Virtual Actions Wiki 0.09
drug1639 Impact Event Score Wiki 0.09
drug1603 ISIS 721744 Wiki 0.09
drug1462 Helmet non-invasive ventilation (NIV) Wiki 0.09
drug532 Body Project (BP) Wiki 0.09
drug171 Active PBMT/sMF Wiki 0.09
drug359 Awake proning Wiki 0.09
drug1237 Exercise and Cognitive Training Wiki 0.09
drug4155 trimethoprim/sulfamethoxazole Wiki 0.09
drug1991 Medical Ozone procedure Wiki 0.09
drug2338 Ophthalmologic exam Wiki 0.09
drug2665 Prone Positioning (PP) Wiki 0.09
drug1889 Low dose Low molecular weight heparin or Placebo Wiki 0.09
drug278 Antroquinonol Wiki 0.09
drug1919 MAS825 Wiki 0.09
drug3772 aerosolized DNase Wiki 0.09
drug2103 Multiple Doses of Anti-SARS-CoV-2 convalescent plasma Wiki 0.09
drug673 COVID-19+ observational Wiki 0.09
drug2505 Placebo Wiki 0.08
drug2251 Normal Saline Wiki 0.08
drug364 Azithromycin Wiki 0.07
drug2572 Placebos Wiki 0.06
drug2776 RLF-100 (aviptadil) Wiki 0.06
drug1895 Low molecular weight heparin Wiki 0.06
drug3749 Zinc Wiki 0.06
drug4054 prone position Wiki 0.06
drug1609 Ibrutinib Wiki 0.06
drug916 Conventional treatment Wiki 0.06
drug3133 Simvastatin Wiki 0.06
drug1033 Dexamethasone injection Wiki 0.06
drug3688 Vonoprazan Wiki 0.06
drug2709 Pulmozyme Wiki 0.06
drug812 Clopidogrel Wiki 0.06
drug2207 Nitrogen gas Wiki 0.06
drug1754 Ivermectin Oral Product Wiki 0.06
drug2621 Practice details Wiki 0.06
drug1520 Hydroxychloroquine Wiki 0.06
drug2210 No Intervention Wiki 0.05
drug3045 Sargramostim Wiki 0.05
drug261 Anti-SARS-CoV2 Serology Wiki 0.05
drug1978 Matching placebo Wiki 0.05
drug2006 Melatonin Wiki 0.05
drug2664 Prone Positioning Wiki 0.05
drug306 Aspirin Wiki 0.05
drug2895 Rifampin Wiki 0.04
drug176 Ad26.COV2.S Wiki 0.04
drug4069 questionnaire Wiki 0.04
drug2360 Oxygen Wiki 0.04
drug1434 HCQ Wiki 0.04
drug3221 Standard of Care Wiki 0.04
drug2327 Online Survey Wiki 0.04
drug632 COVID-19 Convalescent Plasma Wiki 0.04
drug4071 questionnaire assesment Wiki 0.04
drug1296 Favipiravir Wiki 0.04
drug1093 Doxycycline Wiki 0.04
drug776 Chloroquine Wiki 0.03
drug2557 Placebo oral tablet Wiki 0.03
drug1874 Losartan Wiki 0.03
drug229 Anakinra Wiki 0.03
drug3812 blood sample Wiki 0.03
drug3676 Vitamin D Wiki 0.03
drug3212 Standard care Wiki 0.03
drug3485 Tocilizumab Wiki 0.03
drug1030 Dexamethasone Wiki 0.03
drug3603 Usual Care Wiki 0.03
drug881 Control Wiki 0.03
drug1872 Lopinavir/ritonavir Wiki 0.03
drug3674 Vitamin C Wiki 0.02
drug4034 placebo Wiki 0.02
drug908 Convalescent plasma Wiki 0.02
drug2855 Remdesivir Wiki 0.02
drug1745 Ivermectin Wiki 0.02
drug895 Convalescent Plasma Wiki 0.02
drug2741 Questionnaire Wiki 0.02

Correlated MeSH Terms (58)


Name (Synonyms) Correlation
D011665 Pulmonary Valve Insufficiency NIH 0.23
D012128 Respiratory Distress Syndrome, Adult NIH 0.18
D000860 Hypoxia NIH 0.17
Name (Synonyms) Correlation
D012127 Respiratory Distress Syndrome, Newborn NIH 0.15
D055371 Acute Lung Injury NIH 0.14
D011014 Pneumonia NIH 0.13
D045169 Severe Acute Respiratory Syndrome NIH 0.12
D007249 Inflammation NIH 0.11
D018352 Coronavirus Infections NIH 0.11
D012594 Scleroderma, Localized NIH 0.09
D012595 Scleroderma, Systemic NIH 0.09
D001851 Bone Diseases, Metabolic NIH 0.09
D006935 Hypercapnia NIH 0.09
D009133 Muscular Atrophy NIH 0.09
D001284 Atrophy NIH 0.09
D010291 Paresis NIH 0.09
D055948 Sarcopenia NIH 0.09
D005128 Eye Diseases NIH 0.09
D055370 Lung Injury NIH 0.08
D006333 Heart Failure NIH 0.08
D013577 Syndrome NIH 0.08
D011024 Pneumonia, Viral NIH 0.07
D013896 Thoracic Diseases NIH 0.06
D000075902 Clinical Deterioration NIH 0.06
D007040 Hypoventilation NIH 0.06
D011654 Pulmonary Edema NIH 0.05
D008269 Macular Edema NIH 0.05
D011111 Polymyalgia Rheumatica NIH 0.05
D013700 Giant Cell Arteritis NIH 0.05
D005356 Fibromyalgia NIH 0.04
D012818 Signs and Symptoms, Respiratory NIH 0.04
D016769 Embolism and Thrombosis NIH 0.04
D003693 Delirium NIH 0.04
D010003 Osteoarthritis, NIH 0.04
D001068 Feeding and Eating Disorders NIH 0.03
D016638 Critical Illness NIH 0.03
D040921 Stress Disorders, Traumatic NIH 0.03
D012141 Respiratory Tract Infections NIH 0.03
D000070642 Brain Injuries, Traumatic NIH 0.03
D007239 Infection NIH 0.03
D013313 Stress Disorders, Post-Traumatic NIH 0.03
D001930 Brain Injuries, NIH 0.03
D006331 Heart Diseases NIH 0.03
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.03
D012598 Scoliosi NIH 0.02
D009103 Multiple Sclerosis NIH 0.02
D008173 Lung Diseases, Obstructive NIH 0.02
D002908 Chronic Disease NIH 0.02
D004617 Embolism NIH 0.02
D003141 Communicable Diseases NIH 0.02
D058186 Acute Kidney Injury NIH 0.02
D008171 Lung Diseases, NIH 0.02
D006973 Hypertension NIH 0.02
D013927 Thrombosis NIH 0.02
D002318 Cardiovascular Diseases NIH 0.02
D004630 Emergencies NIH 0.02
D004194 Disease NIH 0.01
D014777 Virus Diseases NIH 0.01

Correlated HPO Terms (17)


Name (Synonyms) Correlation
HP:0010444 Pulmonary insufficiency HPO 0.23
HP:0012418 Hypoxemia HPO 0.15
HP:0002090 Pneumonia HPO 0.13
Name (Synonyms) Correlation
HP:0000478 Abnormality of the eye HPO 0.09
HP:0012344 Morphea HPO 0.09
HP:0003202 Skeletal muscle atrophy HPO 0.09
HP:0000938 Osteopenia HPO 0.09
HP:0001269 Hemiparesis HPO 0.09
HP:0012416 Hypercapnia HPO 0.09
HP:0002791 Hypoventilation HPO 0.06
HP:0011505 Cystoid macular edema HPO 0.06
HP:0100598 Pulmonary edema HPO 0.06
HP:0001635 Congestive heart failure HPO 0.06
HP:0011947 Respiratory tract infection HPO 0.03
HP:0001907 Thromboembolism HPO 0.02
HP:0001919 Acute kidney injury HPO 0.02
HP:0002088 Abnormal lung morphology HPO 0.02

Clinical Trials

Navigate: Correlations   HPO

There are 132 clinical trials


1 Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis

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

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

Primary Outcomes

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

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

Time: Post-intervention at day 52

Secondary Outcomes

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

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

Time: Post-intervention at day 52.

Description: Measurement of the QT interval through electrocardiogram evaluation.

Measure: Measurement of the QT interval.

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

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

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

Time: Day 52.

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

Measure: Comparison of hematological and biochemical parameters.

Time: Day 52.

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

Measure: Occurrence of adverse events.

Time: Post-intervention at day 52.

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

Measure: Assessment of COVID-19 symptom severity.

Time: Post-intervention at day 52.

Description: Proportion of participants who discontinue study intervention,

Measure: Proportion of participants who discontinue study intervention.

Time: Post-intervention at day 52.

Description: Proportion of participants who required hospital care.

Measure: Proportion of participants who required hospital care.

Time: Post-intervention at day 52.

Description: Proportion of participants who required mechanical ventilation.

Measure: Proportion of participants who required mechanical ventilation.

Time: Post-intervention at day 52.
2 Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)

Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.

NCT04318015
Conditions
  1. COVID-19
  2. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo oral tablet
MeSH:Severe Acute Respiratory Syndrome Corona Coronavirus Infections

Primary Outcomes

Description: Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.

Measure: Symptomatic COVID-19 infection rate

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Secondary Outcomes

Description: Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test.

Measure: Symptomatic non-COVID viral infection rate

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Description: Number of days absent from labor due to COVID-19 symptomatic infection

Measure: Days of labor absenteeism

Time: From date of randomization until study completion 60 days after treatment start

Description: Absenteeism from labor rate due to COVID-19 symptomatic infection

Measure: Rate of labor absenteeism

Time: From date of randomization until study completion 60 days after treatment start

Description: Rate of severe respiratory COVID-19 disease in healthcare personnel

Measure: Rate of severe respiratory COVID-19 disease in healthcare personnel

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
3 A Clinical and Radiological Model to Predict the Prognosis for COVID-19 Patients

To develop and validate a machine-learning model based on clinical, laboratory, and radiological characteristics alone or combination of COVID-19 patients to facilitate risk Assessment before and after symptoms and triage (home, hospitalization inward or ICU).

NCT04337502
Conditions
  1. Coronavirus
  2. Machine Learning
Interventions
  1. Diagnostic Test: Machine learning model
MeSH:Coronavi Coronavirus Infections

Primary Outcomes

Description: AUC, accuracy, sensitivity, and specificity

Measure: Predictive performance

Time: Janunary 1, 2020, to February 13, 2020
4 RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)

Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less impactful, and reduce nightmares, flashbacks, and other features of PTSD. The memory is reviewed in the context of an imaginal movie theater, presenting a fast (~45 sec) black and white movie of the trauma memory, with further adjustment as needed so the patient can comfortably watch it. Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial comparing RTM versus prolonged exposure (PE), the PTSD therapy with the strongest current evidence base. The investigators hypothesize that RTM will be non-inferior to PE in reducing PTSD symptom severity post-treatment and at 1-year follow up; will achieve faster remission, with fewer dropouts; will improve cognitive function; and that epigenetic markers will correlate with treatment response. The investigators will randomize 108 active or retired service members (SMs) with PTSD to ≤10 sessions of RTM or PE, affording power to test our hypotheses while allowing for ≤ 25% dropouts. The investigators will use an intent to treat analysis, and the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, or DSM5 (CAPS-5), conducted by blinded assessors, will be the primary outcome measure. Secondary measures of depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100), will be assessed pre- and post-treatment, and at 2, 6, and 12 months. ANOVA will compare symptom severity over time within and between groups. Blood draws will be obtained pre- and posttreatment to assess predictors of treatment response and epigenetic markers of change. The NIH Toolbox Neurocognitive Assessment, pre- and post-treatment, will assess impact on cognitive function. The investigators will track comorbid TBI, anticipating it will not adversely impact response. More effective therapies for PTSD, with and without TBI, must be developed and evaluated. RTM is safe and promising, but requires testing against evidence-based interventions in well-designed randomized clinical trials (RCTs). The full study can now be conducted via video conferencing due to COVID-19.

NCT03827057
Conditions
  1. Posttraumatic Stress Disorder
  2. Traumatic Brain Injury
Interventions
  1. Behavioral: Reconsolidation of Traumatic Memories (RTM)
  2. Behavioral: Prolonged Exposure (PE)
MeSH:Brain Injuries Brain Injuries, Traumatic Dis Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: the gold standard for PTSD diagnosis, a trained expert administrator scores PTSD symptom severity; range 0-80, higher score represents greater severity

Measure: Clinician Administered PTSD Symptom Scale for DSM5 (CAPS-5)

Time: week 10

Secondary Outcomes

Description: well-validated and widely used 9-item self-report measure of depression symptom severity, range 0-27, higher score represents greater severity

Measure: Change in Patient Health Questionnaire (PHQ-9) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 20-item screen for PTSD, in which each item is rated on a 5-point Likert scale, range 0-80, higher score represents greater severity

Measure: Change in PTSD Checklist for DSM5 (PCL5) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a clinically validated 9-item assessment of sleep quality and sleep disturbances; range 0 to 21, higher score represents greater severity

Measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 22-item self-report measure assessing functional status and post concussive symptoms, range 0-88, higher score represents greater severity

Measure: Change in Neurobehavioral Symptom Inventory (NSI) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 100 item self-report inventory measuring overall quality of life in 8 dimensions; range 100 to 500, higher score represents greater severity

Measure: Change in World Health Organization Quality of Life Inventory (WHOQOL-100) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Other Outcomes

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the single molecule array (SIMOA) technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma tumor necrosis factor-alpha level

Time: week 10, compared to baseline

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the SIMOA technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma interleukin-6 level

Time: week 10, compared to baseline

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the SIMOA technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma interleukin-10 level

Time: week 10, compared to baseline

Description: Normalized Summary Score for a battery of 7 tests to measure various aspects of cognition including memory, executive function, attention span; normed for age, with a score of 50 being average, scores greater than 50 demonstrate greater than average cognitive function, and scores lower than 50 indicating lower than average cognitive function

Measure: Change in NIH Toolbox Cognition Battery (NIH-TB) Neurocognitive Assessment Composite Score

Time: week 10, compared to baseline
5 Prevention of Eating Disorders in At-Risk Female Students: Adaptation and Evaluation of Two Interventions in French-Speaking Switzerland

Eating disorders are psychopathologies with serious repercussions on the somatic, psychological and social level. Currently available treatments are unfortunately for now not fully efficient, therefore researchers have recommended to develop prevention initiatives. Until now, no study has been carried out in Switzerland to evaluate the efficacy of an intervention for the prevention of eating disorders. The goal of the present study is to evaluate two eating disorders prevention intervention that have been largely validated in the US, called the Body Project (BP) and the Healthy Weight Program (HW). Both interventions target body dissatisfaction, which is a well-identified risk factor of eating disorders. They will be compared to a one-month waiting list. Because of the pandemic situation due to the Severe Acute Respiratory Syndrome coronavirus (COVID-19), both interventions will be delivered virtually via a collaborative platform. The sessions will be recorded to carry out a quality control. To compare the BP and HW interventions to a waiting list, a three-arm randomized controlled study will be carried out, including female students from French-speaking Switzerland. Recruitment will include 90 participants. Participants will be randomly assigned to one of the three arms of the study. They will be evaluated before (T0) and after (T1) the interventions or the waiting list. Following the interventions, the participants will have one month of follow-up before a final evaluation (T2). Participants on the waiting list will receive the BP following the one-month waiting period and will then be evaluated (T2). After having signed the consent form, the participant will be randomized to one of the three study arms, with a 1: 1: 1 allocation ratio. Interventions will be given in groups of six participants. Randomization will be blocked to ensure groups of equal size, and that groups of six participants for each arm are regularly formed. The blocks will be of variable size (3, 6, 9) to protect the concealment. The hypotheses are as follows: 1. The two interventions BP and HW will have an effect on body dissatisfaction (primary outcome) as well as on the thin-ideal internalization, dietary restraint, negative affect, and eating disorders psychopathology (secondary outcomes), compared to the waiting list; 2. There will be no differences between the BP and the HW on the primary and secondary outcomes; 3. The effects observed thanks to the interventions will be maintained after one month of follow-up.

NCT04558073
Conditions
  1. Body Dissatisfaction
Interventions
  1. Behavioral: Body Project (BP)
  2. Behavioral: Healthy Weight Program (HW)
MeSH:Feeding and Feeding and Eating Disorders

Primary Outcomes

Description: Mean change in Body Dissatisfaction after interventions in comparison with waiting-list

Measure: Mean Change in Body Dissatisfaction on the Body Shape Questionnaire 8C (score ranging from 8 to 48, with higher scores indicating higher body dissatisfaction) from baseline to post-intervention or post-waiting

Time: one month (Month 1)

Secondary Outcomes

Description: Mean change in thin-ideal internalization after interventions in comparison with waiting-list

Measure: Mean Change in Thin-Ideal Internalization on the Socio-Cultural Attitudes Towards Appearance Questionnaire (score ranging from 1 to 5 with higher scores indicating higher thin-ideal internalization) from baseline to post-intervention or post-waiting

Time: one month (Month 1)

Description: Mean change in Dietary Restraint after interventions in comparison with waiting-list

Measure: Mean Change in Dietary Restraint on the Dutch Eating Behaviour Questionnaire (score ranging from 1 to 5 with higher scores indicating higher dietary restraint) from baseline to post-intervention or post-waiting

Time: one month (Month 1)

Description: Mean change in Anxiety after interventions in comparison with waiting-list

Measure: Mean Change in Anxiety on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher anxiety) from baseline to post-intervention or post-waiting

Time: one month (Month 1)

Description: Mean change in Depression after interventions in comparison with waiting-list

Measure: Mean Change in Depression on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher depression) from baseline to post-intervention or post-waiting

Time: one month (Month 1)

Description: Mean change in Eating Disorders Psychopathology after interventions in comparison with waiting-list

Measure: Mean Change in Eating Disorders Psychopathology on the Eating Disorders Examination-Questionnaire (score ranging from 0 to 6 with higher scores indicating higher eating disorders psychopathology) from baseline to post-intervention or post-waiting

Time: one month (Month 1)

Description: Mean change in Body Dissatisfaction between post-intervention and follow-up

Measure: Mean Change in Body Dissatisfaction on the Body Shape Questionnaire 8C (score ranging from 8 to 48, with higher scores indicating higher body dissatisfaction) from post-intervention to follow-up

Time: one month (Month 2)

Description: Mean change in Thin-Ideal Internalization between post-intervention and follow-up

Measure: Mean Change in Thin-Ideal Internalization on the Socio-Cultural Attitudes Towards Appearance Questionnaire (score ranging from 1 to 5 with higher scores indicating higher thin-ideal internalization) from post-intervention to follow-up

Time: one month (Month 2)

Description: Mean change in Dietary Restraint between post-intervention and follow-up

Measure: Mean Change in Dietary Restraint on the Dutch Eating Behaviour Questionnaire (score ranging from 1 to 5 with higher scores indicating higher dietary restraint) from post-intervention to follow-up

Time: one month (Month 2)

Description: Mean change in Anxiety between post-intervention and follow-up

Measure: Mean Change in Anxiety on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher anxiety) from post-intervention to follow-up

Time: one month (Month 2)

Description: Mean change in Depression between post-intervention and follow-up

Measure: Mean Change in Depression on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher depression) from post-intervention to follow-up

Time: one month (Month 2)

Description: Mean change in Eating Disorders Psychopathology between post-intervention and follow-up

Measure: Mean Change in Eating Disorders Psychopathology on the Eating Disorders Examination-Questionnaire (score ranging from 0 to 6 with higher scores indicating higher eating disorders psychopathology) from post-intervention to follow-up

Time: one month (Month 2)

Other Outcomes

Description: Mean of satisfaction with BP and HW assessed with four Likert scales after interventions

Measure: Mean of four 5-point Likert scales assessing program usefullness, help, understandability, usefulness of exercises (score from 1 to 5 with 5 indicating higher satisfaction) after interventions

Time: Month 1 or Month 2
6 Impact of COVID-19 on the Benefit of Cardiac Rehabilitation

The COVID-19 attack is polymorphic with otorhinolaryngological, pneumological, cardiac, digestive, neurological, muscular attacks with a higher mortality in subjects with comorbidity [> 70 years old, cardiovascular history in particular Arterial hypertension (hypertension ), heart disease…]. This polymorphism is linked to vasculitis and the immune response. Patients with cardiovascular disease are particularly at risk of decompensating, particularly due to the increased metabolism induced by viral infection and reduced cardiovascular capacities. On the cardiovascular level, two sides can be considered. On the one hand, cardiovascular disease (hypertension, coronary artery disease) is a comorbid factor. On the other hand, the myocardial damage reflected by the increase in troponin or an alteration of the ejection fraction is a very clear risk factor for death or severe form. Cardiovascular involvement is particularly high in hospitalized and deceased patients. The odds ratio calculated in a meta-analysis of severe forms of covid-19 with hypertension is 3 [1.9; 3.1], for cardiovascular pathologies of 2.93 [1.73; 4.96]. Recommendations were made for pulmonary rehabilitation but not for cardiovascular rehabilitation. Cardiac rehabilitation is indicated in most cardiovascular pathologies (after acute coronary syndrome, after coronary angioplasty, in heart failure, after coronary or valve heart surgery, etc.). It consists of a multidisciplinary approach combining therapeutic pharmacological adjustment, physical activity, therapeutic education in order to improve physical capacities for exertion and reduce morbidity and mortality. The physical exercises can be endurance or resistance type. Capacity gain at the end of rehabilitation is measured by visual scales, quality of life questionnaires, and a stress test at the start and end of rehabilitation. Most often, rehabilitation centers only do the stress test and estimate through questioning for subjective improvement. The hypothesis is that patients who contracted COVID-19 would have lower cardiac capacities after recovery from the infection than patients without COVID-19 or that their capacity for recovery would be less. There could be a difference in recovery after cardiac rehabilitation between the two populations regardless of whether the cardiac damage requiring rehabilitation was triggered by COVID-19 or was pre-existing.

NCT04513964
Conditions
  1. Heart Failure
  2. Covid19
MeSH:Hea Heart Failure
HPO:Congestive heart failure Left ventricular dysfunction Right ventricular failure

Primary Outcomes

Description: This outcome corresponds to the difference between the average gain in exercise capacity after cardiac rehabilitation between the two groups of patients Control and COVID-19.

Measure: Impact of COVID-19 on exercise capacity gain after cardiovascular rehabilitation

Time: Month 3
7 Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an ICU Admission for Covid-19 (OPTImAL) - a Single Center Prospective Study

Introduction: Survivors of acute respiratory failure develop persistent muscle weakness and deficits in cardiopulmonary endurance combining to limit physical functioning. Early data from the Covid-19 pandemic suggest a high incidence of critically ill patients admitted to intensive care units (ICU) will require mechanical ventilation for acute respiratory failure. Covid-19 patients surviving an admission to the ICU are expected to suffer from physical and cognitive impairments that will limit quality of life and return to pre-hospital level of functioning. In this present study, the investigators will evaluate the safety and feasibility of providing a novel clinical pathway combining ICU after-care at an ICU Recovery clinic with physical therapy interventions. Methods and Analysis: In this single-center, prospective (pre, post cohort) trial in patients surviving ICU admission for Covid-19. The investigators hypothesize that this novel combination is a) safe and feasible to provide for patients surviving Covid-19; b) improve physical function and exercise capacity measured by performance on 6-minute walk test and Short Performance Physical battery; and c) reduce incidence of anxiety, depression and post-traumatic stress assessed with Hospital Anxiety and Depression Scale and the Impact of Events Scale-revised. Safety will be assessed by pooled adverse events and reason for early termination of interventions. Feasibility will be assessed by rate of adherence and attrition. Repeated measures ANOVA will be utilized to assess change in outcomes from at first ICU Recovery Clinic follow-up (2-weeks) and 3- and 6-months post hospital discharge. Ethics and Dissemination: The trial has received ethics approval at the University of Kentucky and enrollment has begun. The results of this trial will support the feasibility of providing ICU follow-up and physical therapy interventions for patients surviving critical illness for Covid-19 and may begin to support effectiveness of such interventions. Investigators plan to disseminate trial results in peer-reviewed journals, as well as presentation at physical therapy and critical care national and international conferences.

NCT04412330
Conditions
  1. Covid-19
  2. Critical Illness
  3. Post Intensive Care Unit Syndrome
  4. Muscle Weakness
Interventions
  1. Other: ICU Recovery + Physical Therapy
MeSH:Muscle Weakness Critical Illness

Primary Outcomes

Description: Incidence of adverse events, quantified by pain or discomfort that causes termination of interventions; a fall (with or without injury) during interventions or directly related to interventions such as fall due to fatigue; and physiologic event/abnormality that warrants termination of interventions or medical follow-up including bradycardia, tachycardia, and emergent hypertension

Measure: Adverse events (safety)

Time: through study completion, an average of 3-months

Secondary Outcomes

Description: Feasibility will be assessed by the consent rate (number of patients agreed to participate/number of patients approached for consent) and adherence attendance measured by the percentage of sessions patient participated divided total number of scheduled appointments. Adherence will also be prospectively assessed by total duration of exercise, dosage and intensity of exercises as described above. Attrition will be quantified by number of patients lost to follow-up.

Measure: Feasibility (success of consent process, adherence, and attrition)

Time: through study completion, an average of 3-months

Description: Distance walked on six-minute walk test performed in line with the ATS/ERS Guidelines as measure of exercise capacity

Measure: Six minute walk test

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Short Performance Physical Battery (SPPB) is a performance-based physical function test with components of balance, repetitive five times sit-to-stand for time, and 4-meter habitual gait speed. Higher scores on SPPB indicate better physical function.

Measure: Short Performance Physical Battery

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Health-related quality of life (HRQoL) will be measured by self-report questionnaire, the Five Dimension Euro-Quality of Life (EQ-5D) that includes a visual analog scale with rating for overall HRQoL (0-100)

Measure: Quality of life (EQ-5DL)

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Cognitive function will be assessed by the Montreal Cognitive Assessment (MOCA) with <23/30 distinguishing mild cognitive impairment. If the patient participating in telemedicine through Zoom then the MOCA-Blind version will be completed.

Measure: Cognitive function

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS), a fourteen-item scale with subset scores of >8/21 indicating anxiety or depression

Measure: Anxiety and Depression

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Distress and Post-traumatic stress disorder (PTSD) will be assessed through the Impact of Events Scale-Revised (IES-R), a 22-item self-report measure, with scores >35/88 recommending provisional diagnosis of PTSD

Measure: PTSD and distress

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: For patients previously employed, the return to work will be assessed using the self-report survey instrument designed for ICU follow-up

Measure: Return to work

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Readmission rate and morality with be assessed

Measure: Secondary complication

Time: Assessed 3 and 6-months post hospital discharge
8 Effects of Three Months of COVID-19 Lockdown Induced Deconditioning After 13 Months of High Intensity Exercise Training in Early Postmenopausal Women

While "conditioning" by exercise training has been widely evaluated, the available literature on "passive deconditioning" (i.e. forced deconditioning) is predominately limited to studies with or with almost complete mechanical and/or metabolic immobilization/sedation of the respective functional system (e.g. paralysis, bedriddenness). Vice versa, the effects of moderately long interruptions of dedicated types of exercise while maintaining everyday activity are rarely addressed. However, this topic is of high relevance, e.g. considering that breaks of health-related exercise programs due to increased family/occupational stress, vacation or temporary orthopedic limitation are rather frequent in everyday life. In the present project we aimed to determine the effects of 3 months of physical deconditioning due to COVID-19 induced lockdown after 13 month of high intensity endurance and resistance exercise in early postmenopausal women on parameters related to health and physical fitness.

NCT04420806
Conditions
  1. Exercise
  2. Detraining
  3. Muscle Weakness
  4. Muscle Atrophy
Interventions
  1. Other: HIT-exercise
  2. Other: Sham intervention
MeSH:Muscle Weakness Muscular Atrophy Atrophy
HPO:Skeletal muscle atrophy

Primary Outcomes

Description: Body composition as determined by Dual-Energy x-Ray Absorptiometry

Measure: Body composition

Time: From intervention end to 3 months FU

Secondary Outcomes

Description: Hip-/Leg extension strength as determined by an isokinetic leg press

Measure: Hip-/Leg extension strength

Time: From intervention end to 3 months FU

Description: cardio-metabolic risk factors summarized in the Metabolic Syndrome Z-Score according to the definition of the International Diabetes Federation

Measure: Metabolic Syndrome

Time: From intervention end to 3 months FU

Description: BMD at the lumbar spine and total hip as determined by Dual Energy x-Ray Absorptiometry

Measure: Bone Mineral Density (BMD)

Time: From intervention end to 3 months FU

Description: Menopausal symptoms as determined by the "Menopausal Rating Scale" (MRS) with a scale from 0 (no complaints) to 4 (very serious complaints).

Measure: Menopausal symptoms

Time: From intervention end to 3 months FU

Description: Back and joint pain as determined by a standardized pain questionnaire with a scale from 0 (never) to 7 (permanent) for pain frequency or 0 (no pain) to 7 (extremely) for pain severity.

Measure: Back and joint pain

Time: From intervention end to 3 months FU
9 VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness

After a hospitalization in Intensive Care Unit (ICU), approximately 50% of patients usually have a ICU-Weakness, i.e. nerves and muscles injury secondary to immobilization and to treatments which had to be used. This disease is expected to be similar or even higher in patients suffering from COVID-19 and hospitalized in ICU due to the average length of hospitalization of several weeks in this population. This condition will delay the return-to-walk of these patients, their discharge from hospitalization and may deteriorate their autonomy in daily life activities. Virtual Reality (VR) environments are already used and have proven their worth for the assessment and rehabilitation of patients with neurological diseases. It therefore seems appropriate to offer the use of virtual environments for this type of population. VR represents a unique opportunity for the rehabilitation care of these patients, and in particular those who have been reached by COVID-19, due to the possible mismatch between the amount of motor rehabilitation to be provided and the fatigability and breathlessness at the slightest effort which seem particularly intense in this population. The main objective of our project is to improve and to accelerate gait recovery in patients hospitalized in Physical and Rehabilitation Medicine after discharge from Resuscitation or Continuous Care Unit and in patients hospitalized in ICU and presenting ICU-weakness secondary to resuscitation, notably due to COVID-19 infection, thanks to the use of Virtual Reality tools. The VR tool will consist of virtual environments presented using a Virtual Reality headset where an avatar (double) of the patient hospitalized in Physical and Rehabilitation Medicine or in ICU will be represented, who will perform different motor tasks involving their lower limbs (ex: walking, or kicking a ball) in several different virtual environments (settings). The patient will be asked to observe actions, then to imagine carrying out their actions which will be performed by the avatar in the virtual environment, then they will be able to control the actions of the avatar using their legs thanks to sensors, then feel walking sensations through the use of haptic devices.

NCT04441164
Conditions
  1. Weakness of the Lower Limbs
Interventions
  1. Other: Observation of Virtual Actions
  2. Other: Relaxation
  3. Other: Acceptability questionnaire
  4. Other: Observation of Virtual Actions (step 4)
  5. Other: Performing Virtual Actions
  6. Other: Haptic stimulation
  7. Other: Without haptic stimulation
MeSH:Muscle Weakness Paresis
HPO:Hemiparesis

Primary Outcomes

Description: Number of meters taken during the 6-minute test the day after the last session.

Measure: 6-minute test

Time: Day 10

Secondary Outcomes

Description: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: 10-meter test (time in seconds)

Measure: Time for 10-meter test

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: 6-minute walk test (need for breaks, scale de Borg, existence of desaturation)

Measure: 6-minute walk test

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: recovery time for walking over 10 meters without human or technical assistance

Measure: Recovery time

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: normal or deficient posture balance in sitting and standing

Measure: Normal or deficient posture balance in sitting and standing

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: Berg Balance Scale. Berg's balance scale includes 14 tests that assess static balance and dynamic balance. Each test is rated from 0 (needs help) to 4 (can do on him/her own). Total score is on 56 points.

Measure: Berg Balance Scale

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: Timed Up and Go test (time in seconds)

Measure: Timed Up and Go test

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: test of the 10 chair lifts (duration in seconds, existence of a desaturation, Borg scale)

Measure: Duration for the test of the 10 chair lifts

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Strength assessment before the start of the first session, the day after the last session and within 1 month of inclusion: MRC testing of the lower limbs. The Medical Research Council's scale (MRC scale) is an assessment of muscle power, rated form 0 (no contraction) to 5 (normal power).

Measure: MRC scale

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Assessment of autonomy before the start of the first session, the day after the last session and within 1 month of inclusion: Functional Independence Measure. The Functional Independence Measure (FIM) is an 18-item instrument measuring a person's level of disability in terms of burden of care. Each item is rated from 1 (requiring total assistance) to 7 (completely independent). Three independent FIM scores can be generated by summing item scores: a total score (FIM total: 18 items), a motor score (FIM motor: eating, grooming, bathing, dressing - upper body, dressing - lower body, toileting, bladder management, bowel management, and transfers bed/chair/wheelchair, toilet, tub/shower, walk, stairs), and a cognitive score (FIM cognitive: auditory comprehension, verbal expression, social interaction, problem solving, and memory). Multiple studies support the reliability and validity of FIM scales in the older population.

Measure: Functional Independence Measure

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Acceptability (a priori, patients and caregivers for stage 2) questionnaires

Measure: Acceptability

Time: Day 1 (step 2)

Description: Acceptance (patients for stages 1, 3, 4 and 5) questionnaires

Measure: Acceptance

Time: Day 1 (step 2)

Description: Fatigue assessment (visual analog scale) (steps 1, 3, 4, 5)

Measure: Fatigue

Time: End of each session, at days 1 to 9

Description: Collections of possible undesirable effects by open question at the end of each session with the Virtual Reality tool (steps 1, 3, 4, 5)

Measure: Undesirable effects

Time: End of each session, at days 1 to 9

Description: Assessment of confidence in the future using a questionnaire (steps 1, 3, 4, 5) before the start of the first session, the day after the last session and 1 month from inclusion

Measure: Confidence in the future

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
10 Effects of an Optimized 13-month Physical Exercise on (Early)-Postmenopausal Risk Factors in Women With Osteopenia and Osteoporosis (Actlife)

Menopause usually have a serious impact on a woman's life, associated with negative consequences for health and quality of life. Early preventive assessments are very difficult to implement due to the complex hormone-deficiency-induced effects on a large variety of organs and systems with estrogen receptors. In fact, only a few types of interventions have the potential to comprehensively improve the various risk factors and complaints of the menopausal transition. In detail, however, not every form of exercise training or every training protocol is effective for exerting positive effects on selected risk factors. In particular, the training concept for addressing musculoskeletal or cardio-metabolic risk factors differ fundamentally. In several studies, we confirmed the effect of different complex training programs on risk factors of different postmenopausal female cohorts with special consideration of osteoporotic aspects. The training programs applied in this context were characterized by the consistent implementation of recognized training principles and an in general exercise intensity-oriented approach. Recent studies confirmed the effectiveness of this proceeding for women with relevant postmenopausal risk factors including low bone strength. However, the crucial issue of the most effective, feasible and easily customizable training protocol for addressing postmenopausal risk factors remains to be answered, taking into account that the majority of exercise programs were realized in an ambulatory group setting. The aim of the study will be to evaluate the effects of an optimized physical training on risk factors and complaints of (early) postmenopausal women with special consideration of the osseous fracture risk. Note (05.06.2020): Of importance, the intervention has to be cancelled due to COVID-19 lockdown in March 2020 after 13 months of intervention.

NCT03959995
Conditions
  1. Osteopenia, Osteoporosis
Interventions
  1. Other: High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT)
  2. Other: Wellness
MeSH:Osteoporosis Bone Diseases, Metabolic
HPO:Osteopenia

Primary Outcomes

Description: Bone Mineral Density (BMD) at the lumbar spine region of interest as determined by Dual Energy x-Ray Absorptiometry (DXA)

Measure: BMD Lumbar Spine

Time: from baseline to 13 month follow-up

Secondary Outcomes

Description: Bone Mineral Density at the total hip region of interest as determined by DXA

Measure: BMD total Hip

Time: from baseline to 13 month follow-up

Description: Muscle density at the para-vertebral region as determined by Magnetic Resonance Imaging (MRI)

Measure: Para-vertebral muscle density

Time: from baseline to 13 month follow-up

Description: Muscle density at the mid-thigh region as determined by MRI

Measure: Mid-thigh muscle density

Time: from baseline to 13 month follow-up

Description: Metabolic Syndrome Z-Score according to the Internationale Diabetes Federation (IDF)

Measure: Metabolic Syndrome

Time: from baseline to 13 month follow-up

Description: Visceral body fat as determined by Magnetic Resonance Imaging (MRI)

Measure: Visceral body fat

Time: from baseline to 13 month follow-up

Description: Total body fat as determined by whole body DXA

Measure: Total body fat

Time: from baseline to 13 month follow-up

Description: Total Lean Body Mass as determined by whole body DXA

Measure: Total Lean Body Mass

Time: from baseline to 13 month follow-up

Description: Menopausal complaints as determined by the Menopause Rating Scale (German version. Questionnaire with 11 items; scale from 0 (no complaints/problems) to 4 (very severe complaints/problem)

Measure: Menopausal complaints

Time: from baseline to 13 month follow-up

Description: Maximum isokinetic leg extensor strength as determined by an isokinetic leg press

Measure: Maximum leg strength

Time: from baseline to 13 month follow-up

Description: Total fat rate as determined by Bio Impedance technique (BIA)

Measure: Total fat rate

Time: from baseline to 13 month follow-up

Description: Fat free mass as determined by BIA

Measure: Fat free mass

Time: from baseline to 13 month follow-up
11 Psychological Impact of Quarantine in Osteoporosis Patient During COVID-19 Outbreak

In the context of quarantine with COVID-19, we wish to study the experience and psychological impact in adult patients living with osteoporosis.

NCT04351633
Conditions
  1. Sars-CoV2
  2. Osteoporosis
Interventions
  1. Other: questionnaire assesment
MeSH:Osteoporosis

Primary Outcomes

Measure: percentage of patient with feeling of disabilities

Time: maximum 1 week from baseline on
12 Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise in Older Men With Osteosarcopenia A Randomized Controlled Trial

Osteosarcopenia designates the simultaneous presence of sarcopenia and osteopenia; both chronic conditions of advanced age. Dynamic-resistance exercise (DRT) might be the most powerful agent to fight osteosarcopenia. Indeed, in the present FrOST study, we clearly determine the positive effect of slightly adapted 18 month high-intensity (HIT)-DRT on bone mineral density (BMD), sarcopenia and other health related parameters in osteosarcopenic men. However, after a short training break, COVID-19 induced lock down prevented a re-start of the HIT resistance exercise training in the FrOST cohort. The aim of the present observational study is thus to determine the effects of 6 months of deconditioning on health related parameters under special regard of osteosarcopenia in this cohort of older men with osteosarcopenia.

NCT04444661
Conditions
  1. Osteoporosis
  2. Sarcopenia
MeSH:Osteoporosis Sarcopenia

Primary Outcomes

Description: Skeletal muscle mass index (appendicular skeletal muscle mass / body height; kg/m2) as determined by Dual Energy x-Ray Absorptiometry

Measure: SMI

Time: Change from Baseline to 26 weeks

Secondary Outcomes

Description: Bone Mineral Density at the Lumbar Spine as determined by Dual Energy x-Ray Absorptiometry

Measure: BMD-LS

Time: Change from Baseline to 26 weeks

Description: Bone Mineral Density at the total hip as determined by Dual Energy x-Ray Absorptiometry

Measure: BMD-hip

Time: Change from Baseline to 26 weeks

Description: Z-Score of parameters constituting the metabolic syndrome (i.e. SMI, hand-grip strength, gait velocity)

Measure: Sarcopenia-Z-Score

Time: Change from Baseline to 26 weeks

Description: Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging

Measure: Fat infiltration thigh muscles

Time: Change from Baseline to 26 weeks

Description: Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging

Measure: Fat infiltration para-vertebral muscles

Time: Change from Baseline to 26 weeks

Description: Maximum hip-/leg extensor strength as determined by an isokinetic leg press

Measure: Maximum hip-/leg extensor strength

Time: Change from Baseline to 26 weeks

Description: Metabolic Syndrome Z-Score based on the definition of the International Diabetes Federation including waist circumference, resting glucose, HDL-cholesterol, triglyzerides, mean arterial blood pressure)

Measure: Metabolic Syndrome Z-Score

Time: Change from Baseline to 26 weeks

Description: Late-Life Function and Disability Index of McAuley et al.

Measure: Self rated physical performance

Time: Change from Baseline to 26 weeks
13 Combined Cognitive and Exercise Training for Older Adults: Feasibility & Effectiveness

The overarching aim of this project is to implement and evaluate a proven cognitive training regimen in combination with a community exercise program among older adults who attend wellness exercise programs at the YMCA. To support this aim, the investigators have developed a collaboration with the YMCA of Kitchener-Waterloo, which offer exercise programs targeted to older adults. The specific objectives are: (1) to evaluate the feasibility of a combined exercise and cognitive training in a community-setting among older adults; and (2) to conduct a preliminary evaluation and comparison of changes in cognitive function, physical function, well-being and self-efficacy with 12-weeks of combined exercise and cognitive training versus exercise alone. The hypothesis for each objective are as follows: (1) It is anticipated that this program will be feasible to implement and will be well accepted by the participants and exercise providers. (2) The investigators may not have the power to find statistically significant differences between the control and experimental groups for physical and cognitive function. However, the investigators expect to observe positive changes between the pre- and post-assessments, suggesting improved cognitive function and mobility as a result of the 12-week program.

NCT04515758
Conditions
  1. Osteo Arthritis
  2. Osteoporosis
  3. Joint Replacement
  4. Fibromyalgia
  5. High Blood Pressure
  6. Stable Heart Conditions
  7. Chronic Obstructive Pulmonary Disease
  8. Diabetes
  9. Obesity
Interventions
  1. Other: Exercise and Cognitive Training
  2. Other: Exercise Training Only
MeSH:Osteoporosis Fibromyalgia Osteoarthritis Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Hypertension
HPO:Chronic pulmonary obstruction Hypertension Osteoarthritis Pulmonary obstruction

Primary Outcomes

Description: Total number of people enrolled divided by the total number of people invited to participate (multiplied by 100 to calculate a percentage)

Measure: Recruitment Rate

Time: Pre-program (baseline)

Description: Percentage of people who completed the full program and all assessments

Measure: Completion Rate

Time: Through study completion, 12 weeks

Description: Percentage of people who attended program sessions (exercise and cognitive training components)

Measure: Attendance

Time: Throughout entire intervention (12 weeks, 2 sessions/week per group)

Description: Participant and instructors rating of program components and overall program (via hand-written questionnaire). Participants and instructors must rate their level of agreement (1 = strongly disagree, 2 = disagree, 3 = no opinion, 4 = agree, 5 = strongly agree) with various statements. The higher the rating, the greater the satisfaction. They also must rate if the difficulty of the program was optimal, somewhat easy or hard, or too easy or hard. They must also specify how much money they would be willing to spend on the program. They are also given an opportunity to record optional additional comments/recommendation.

Measure: Change in Participant and Instructor Rating of experience, satisfaction, and feasibility of program

Time: Mid-point (6 weeks) and post-program (12 weeks)

Description: Financial cost of running program (equipment purchased for study - cognitive training tablet and stands - and YMCA staff pay) as reported by researcher and YMCA staff

Measure: Cost of program

Time: Post-program (12 weeks)

Description: Self-reported biological sex (at birth) using basic demographics questionnaire

Measure: Sex

Time: Pre-program (baseline)

Description: One-on-one interview with researcher, answering broad questions about their experience in the program and study

Measure: Participant and Instructor perceived program experience and satisfaction

Time: Post-program (at 12 weeks)

Description: Experience of participants and instructors will also be observed by the researcher (observational notes will be taken by the researcher during each class). No names of participants and instructors will be recorded.

Measure: Participant and Instructor observer-perceived program experience and satisfaction

Time: Throughout entire intervention (12 weeks, 2 sessions/week per group)

Description: Self-reported years of formal education and training (training years for instructors only) using basic demographics questionnaire

Measure: Education

Time: Pre-program (baseline)

Description: Self-reported previous and current occupations using basic demographics questionnaire

Measure: Occupation

Time: Pre-program (baseline)

Description: Self-reported previous and current medical conditions using basic demographics questionnaire

Measure: Medical Condition

Time: Pre-program (baseline)

Description: Self-reported previous and current medications using basic demographics questionnaire

Measure: Medications

Time: Pre-program (baseline)

Description: Using the Montreal Cognitive Assessments (brief clinical tool) to assess visual/spatial abilities, working memory, executive functioning, language, abstraction, and orientation). Will be used to describe participants' baseline cognitive status (a score out of 30 is measured).

Measure: Montreal Cognitive Assessment (global cognitive function)

Time: Pre-program (baseline)

Description: Using the International Physical Activities Questionnaire (IPAQ) to assess physical activity level based on self-reported frequency and duration of job-related, house work-related, transportation-related, and leisure-related physical activities done in the past week. METS-minutes/week will be calculated and reported (i.e. take the number of minutes doing an activity in the past week and multiply by the appropriate metabolic equivalent, which will vary based on the intensity of the physical activity).

Measure: Physical Activity Level

Time: Pre-program (baseline)

Description: Using a cognitive activity scale (score of 0-4 per activity) that requires participants to self-report how often they typically engage in a variety of mentally stimulating activities (i.e. playing card games, reading, cooking, etc.) The more frequently they engage in the activity, the higher the score.

Measure: Participant cognitive activity

Time: Pre-program (baseline)

Description: Using a scale (score of 0-3 per group) that requires participants to self-report how often they typically interact (face-to-face or virtually) with different groups of people (i.e. their spouse, family, friends, co-workers, etc.). The more frequently they interact with the group, the higher the score.

Measure: Participant social activity

Time: Pre-program (baseline)

Description: Self-reported years of age using basic demographics questionnaire

Measure: Participant and Instructor Age

Time: Pre-program (baseline)

Secondary Outcomes

Description: STROOP task which assesses the length of time (seconds) it takes for a participant to correctly name a coloured square (test 1), read the name of a colour (test 2), and say the name of the colour that a word is printed in (test 3). Number of corrected and uncorrected errors are also recorded.

Measure: Change in Stroop Task Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Trails Making Test Part A and B. Part A assesses visual search (participants must connect numbered circles in ascending numerical order (1-2-3-etc). Part B assesses working memory and task-switching (participants must connect circles in ascending numerical and alphabetical order (1-A-2-B- etc.). Time to complete the tests (second) and errors (number) made during the tests are recorded.

Measure: Change in Trail Making Task Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Resting (seated) heart rate (beats per minute) using an automatic blood pressure cuff

Measure: Change in Resting Heart Rate

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Resting (seated) blood pressure (millimeters of mercury) using an automatic blood pressure cuff

Measure: Change in Resting Systolic and Diastolic Blood Pressure

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Using hand dynamometer (assessing grip strength in lbs) for right and left hand (two trials per hand)

Measure: Change in Grip Strength

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Weight (using automatic scale to measure in lbs, converted to kg) and height (measured in feet and inches, converted to meters) measured and combined to provide BMI (kg/m^2)

Measure: Change in Body Mass Index (BMI)

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Divide waist circumference (cm) by hip circumference (cm) to get ratio calculation

Measure: Change in Hip-to-Waist Circumference Ratio

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Agility and functional balance will be assessed using the Timed Up-and-Go (participants stand up from a chair, walk 6 meters, turn around an object, walk back to chair, and sit down). Time to complete test is measured (seconds) and assessor's observational notes of performance are taken.

Measure: Change in Timed Up-and-Go Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Agility and functional balance will be assessed using the Four Square Step Test (participants must step over lines that are set up in a cross formation, creating 4 quadrants. They must step forward, backward, and side to side in a specific pattern (i.e. from quadrant 1 to quadrant 2, to quadrant 3, to quadrant 4). Time to complete test is recorded in seconds.

Measure: Change in Four Square Step Test Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Lower body strength will be assessed using the 5 Time Sit-to-Stand (participants must complete 5 sit-to-stands from a chair as fast as they can). Time to complete all 5 is recorded in seconds.

Measure: Change in Sit-to-Stand Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Functional fitness will be assessed using the 6 minute walk (participants walk along indoor track for 6 minutes). The number of laps achieved in 6 minutes is recorded. Assessor's observational notes of walking performance is also recorded.

Measure: Change in 6-minute walk test Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Well-being will be self-reported using the "Vitality-Plus Scale" (self-reported general health questionnaire - rating of sleep quality, appetite, general energy level, etc.). Participants rate their degree of health on a scale from 1 - 5 (the higher the rating, the better their perceived overall well-being).

Measure: Change in Overall Well-being

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Bandura Scale (named after the researcher who developed it) - self-reported rating of confidence (0 - 100%) to continue exercising routinely in various hypothetical situations (i.e. if one is sick, if the weather is poor, etc). The greater the confidence, the higher the score

Measure: Change in Exercise-related Self-Efficacy

Time: Pre-program (baseline) and post-program (12 weeks)
14 A Multi-center, Open-label, Randomized Parallel Controlled Evaluation on the Efficacy and Safety of BDB-001 Injection in the Treatment of Progressive Severe COVID-19 in Phase II/III

This multi-center, open, randomized study will evaluate the efficacy and safety of BDB-001 injection in severe COVID-19 with severe pneumonia, or acute lung injury/acute respiratory distress syndrome. Patients will be randomized to two treatment arms (Arm A: Conventional treatment + BDB-001; Arm B: Conventional treatment alone).

NCT04449588
Conditions
  1. COVID-19 Pneumonia
Interventions
  1. Drug: BDB-001 Injection
  2. Other: Conventional treatment
MeSH:Pn Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline

Time: Baseline to Day 28

Measure: 28-day all-cause mortality rate

Time: Baseline to Day 28

Secondary Outcomes

Measure: Percentage of subjects achieving recovery in SpO2

Time: Baseline to Day 28

Measure: Mean change of PaO2/FiO2

Time: Baseline to Day 28

Measure: Mechanical ventilation time

Time: Baseline to Day 28

Measure: Time of oxygen therapy

Time: Baseline to Day 28

Measure: Lymphocyte count

Time: Baseline to Day 28

Measure: Change in inflammation indicators (CRP or IL-6) from baseline

Time: Baseline to Day 28

Measure: Improvement in body temperature

Time: Baseline to Day 28

Measure: Mean change from baseline in the clinical improvement based on ordinal scale recommended by the WHO R&D Blueprint during treatment period

Time: Baseline to Day 28

Measure: Improvement at Day3, 7, 11 & Day14 based on ordinal scale recommended by the WHO R&D Blueprint during treatment period

Time: Baseline, Day 3, Day 7, Day 11, Day 14

Measure: Time to get categories 1 to 4 in the 8-points ordinal scale

Time: Baseline to Day 28

Measure: Time to attain an improvement of 1 point on the ordinal scale

Time: Baseline to Day 28
15 Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers

The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients. In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose < 1 Gy. The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.

NCT04394182
Conditions
  1. Pneumonia, Viral
  2. Cytokine Storm
Interventions
  1. Radiation: Ultra-Low-dose radiotherapy
  2. Device: ventilatory support with oxygen therapy
  3. Drug: Lopinavir/ritonavir
  4. Drug: Hydroxychloroquine
  5. Drug: Azithromycin
  6. Drug: Piperacillin/tazobactam
  7. Drug: Low molecular weight heparin
  8. Drug: Corticosteroid injection
  9. Drug: Tocilizumab
MeSH:Pneumonia, Viral Pne Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 2

Time: At 2 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2

Time: At 2 days after RT

Secondary Outcomes

Description: Pa02 / Fi02 > 300 mmHg

Measure: Blood Gas Analysis at Day 2

Time: At 2 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 2

Time: At 2 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 5

Time: At 5 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5

Time: At 5 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 5

Time: At 5 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 7

Time: At 7 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7

Time: At 7 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 7

Time: At 7 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment . It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point. NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)

Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7

Time: At 7 days after RT

Description: Recovery time after RT administration until hospital discharge or death (<48h; 2-7 days; >7 days; clinical worsening or death)

Measure: Recovery time

Time: From RT administration until hospital discharge or death

Description: COVID-19 negativization test

Measure: COVID-19 status

Time: At 7 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment . It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point. NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)

Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1

Time: At 1 month after RT

Description: Toxicity was assessed and rated according to the NIH Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and RTOG scales.

Measure: Acute Toxicity

Time: 1-3 months after RT
16 A Prospective, Double-blind, Randomized, Parallel, Placebo-controlled Pilot Clinical Trial for the Evaluation of the Efficacy and Safety of Two Doses of WJ-MSC in Patients With Acute Respiratory Distress Syndrome Secondary to Infection by COVID-19

Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.

NCT04390139
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Adult Respiratory Distress Syndrome
Interventions
  1. Drug: XCEL-UMC-BETA
  2. Other: Placebo
MeSH:Respiratory Distress Syndrome, Newborn Respi Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Number of patients who died, by treatment group

Measure: All-cause mortality at day 28

Time: Day 28

Secondary Outcomes

Description: Number of patients with treatment-emergent adverse events, by treatment group

Measure: Safety of WJ-MSC

Time: Day 28

Description: Number of patients who, after the start of treatment, required rescue medication, by treatment group

Measure: Need for treatment with rescue medication

Time: Day 28

Description: Number of days that the patient requires invasive mechanical ventilation from the start of treatment to day +28, by treatment group

Measure: Need and duration of mechanical ventilation

Time: Day 28

Description: Days after treatment in which the patient remains alive and free of invasive mechanical ventilation, per treatment group.

Measure: Ventilator free days

Time: Day 28

Description: Variation of the oxygenation index (PaO2 / FiO2) with respect to the baseline value, by treatment group.

Measure: Evolution of PaO2 / FiO2 ratio

Time: Day 28

Description: Variation of the score of the Sequential Organ Failure Assessment (SOFA) Index with respect to the baseline value, by treatment group.

Measure: Evolution of the SOFA index

Time: Day 28

Description: Variation of Acute Physiology and Chronic Health disease Classification System II (APACHE II) score, by treatment group.

Measure: Evolution of the APACHE II score

Time: Day 28

Description: Days of stay in the ICU from the day of admission until discharge to day 28, or date of death if earlier, by treatment group.

Measure: Duration of hospitalization

Time: Day 28

Description: Variation in the count and percentage of leukocytes and neutrophils, by treatment group.

Measure: Evolution of markers of immune response (leucocyte count, neutrophils)

Time: Day 28

Description: Feasibility will be evaluated by the time elapsed from the request of the treatment by the hospital center until the delivery date

Measure: Feasibility of WJ-MSC administration

Time: Day 28

Description: Feasibility will be evaluated by the number of patients treated within 2 days of the request for treatment.

Measure: Feasibility of WJ-MSC administration

Time: Day 28

Description: Variation in the values of the biomarker, by treatment group.

Measure: Evolution of disease biomarker: polymerase chain reaction (RT-PCR)

Time: Day 28

Description: Variation in the values of the biomarker, by treatment group.

Measure: Evolution of disease biomarker: lactate dehydrogenase (LDH)

Time: Day 28

Description: Variation in the values of the biomarker, by treatment group.

Measure: Evolution of disease biomarker: D-dimer

Time: Day 28

Description: Variation in the values of the biomarker, by treatment group.

Measure: Evolution of disease biomarker: Ferritin

Time: Day 28

Other Outcomes

Description: Blood sample analysis

Measure: Analysis of subpopulations of lymphocytes and immunoglobulins

Time: Day 28

Description: In vitro response will be assessed using commercial viral antigens (Miltenyi Biotech)

Measure: Evaluation of the in vitro response of the receptor lymphocytes

Time: Day 28

Description: Reactivity will be assessed using ELISPOT

Measure: Study of reactivity against SARS-CoV-2 peptides

Time: Day 28

Description: Blood sample analysis

Measure: Immunophenotypic study of memory cells in response to SARS-CoV-2 peptides

Time: Day 28

Description: Blood sample analysis for the patient's genomic sequencing

Measure: Genetic variability of patient's genotype in response to treatment

Time: Day 28

Description: Genomic sequencing of the SARS-CoV-2 in a nasopharyngeal sample

Measure: Genetic variability of the SARS-CoV-2 genotype in response to treatment

Time: Day 28
17 Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory Therapy in Patients Diagnosed With COVID-19 Disease

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

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

Primary Outcomes

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

Measure: Survival rate.

Time: up to 8 weeks.

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

Measure: Rate of disease remission.

Time: up to 4 weeks.

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

Measure: The number of patients with PCR negative results.

Time: up to 4 weeks.

Secondary Outcomes

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

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

Time: up to 4 weeks.

Description: Recording the changes in blood pressure mmHg.

Measure: Mean change in blood pressure.

Time: up to 4 weeks.

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

Measure: Mean change in heart beats.

Time: up to 4 weeks.

Description: Recording the changes in body temperature in Celsius.

Measure: Mean change in body temperature.

Time: up to 4 weeks.

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

Measure: Mean change in body respiratory rate.

Time: up to 4 weeks.

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

Measure: Mean change in oxygen saturation.

Time: up to 4 weeks.

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

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

Time: up to 4 weeks.

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

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

Time: up to 4 weeks.

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

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

Time: up to 4 weeks.

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

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

Time: up to 4 weeks.

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

Measure: Mean change in D-dimer.

Time: up to 4 weeks.

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

Measure: Mean change in ferritin.

Time: up to 4 weeks.

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

Measure: Mean change in liver Albumin.

Time: up to 4 weeks.

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

Measure: Mean change in total and direct Bilirubin.

Time: up to 4 weeks.

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

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

Time: up to 4 weeks.

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

Measure: Mean change in aspartate aminotransferase (AST).

Time: up to 4 weeks.

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

Measure: Mean change in Alanine Aminotransferase (ALT).

Time: up to 4 weeks.

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

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

Time: up to 4 weeks.

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

Measure: Mean change in Serum Creatinine.

Time: up to 4 weeks.

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

Measure: Mean change in Serum Creatinine clearance.

Time: up to 4 weeks.

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

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

Time: up to 4 weeks.

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

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

Time: up to 4 weeks.

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

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

Time: up to 4 weeks.

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

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

Time: up to 4 weeks.

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

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

Time: up to 4 weeks.

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

Measure: Mean changes in immunoglobulin G (IgG).

Time: up to 4 weeks.

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

Measure: Mean changes in immunoglobulin M (IgM).

Time: up to 4 weeks.

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

Measure: The mean change in PCR viral load.

Time: up to 4 weeks.

Description: Recording the changes in lung CT.

Measure: Mean change in lung CT manifestation.

Time: up to 4 weeks.

Description: Recording any unexpected Adverse Events of the intervention.

Measure: Nature and severity of Adverse Events.

Time: up to 4 weeks.

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

Measure: Time for lung recovery.

Time: up to 8 weeks.

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

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

Time: up to 4 weeks.
18 Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure

This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Approximately 14,000 records will be accessed for this study from a database of mechanically ventilated patients established for quality improvement purposes. The investigators hypothesize that implementation of a standardized computerized lung protective ventilation protocol across all Intermountain Healthcare hospitals will be feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve outcomes. The objectives of this study are to: - Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in patients with acute respiratory failure requiring mechanical ventilation - Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in the sub-group of patients with the acute respiratory distress syndrome (ARDS) - Measure compliance with the implementation of a computerized lung protective ventilation protocol at 12 Intermountain Healthcare hospitals

NCT03225807
Conditions
  1. Acute Respiratory Distress Syndrome
  2. ARDS
  3. Respiratory Distress Syndrome, Acute
  4. Respiratory Insufficiency
  5. Respiratory Distress Syndrome
  6. Shock Lung
  7. Severe Acute Respiratory Syndrome
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Pulmonary Valve Insufficiency Syndrome
HPO:Pulmonary insufficiency

Primary Outcomes

Measure: Ventilator free days to day 28

Time: 28 days

Secondary Outcomes

Measure: 30 day mortality

Time: 30 days

Measure: 90 day mortality

Time: 90 days

Measure: Hospital discharge disposition

Time: 30 days

Measure: Hospital mortality

Time: 1 week

Measure: Time to first ICU activity

Time: 24 hours
19 ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA)

This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.

NCT04193878
Conditions
  1. Pneumonia
  2. Hypoxemia
  3. Acute Respiratory Failure
Interventions
  1. Drug: Inhaled budesonide and formoterol
  2. Drug: Inhaled placebo
MeSH:Pneumonia Respiratory Insufficiency Hypoxia
HPO:Hypoxemia Pneumonia

Primary Outcomes

Description: High flow nasal cannula (HFNC) and/or Noninvasive ventilation (NIV) use for greater than 36 hours OR Invasive mechanical ventilation for greater than 36 hours OR Death in a patient placed on respiratory support (HFNC, NIV, ventilator) who dies before 36 hours

Measure: Acute respiratory failure (ARF)

Time: within 7 days of randomization

Secondary Outcomes

Measure: Hospital length of stay

Time: within 60 days of randomization

Measure: Duration of need for supplemental oxygen

Time: within 60 days of randomization

Measure: Proportion of patients intubated for respiratory failure

Time: Within 7 days of randomization
20 Acute Respiratory Failure and Continuous Positive Airway Pressure Therapy in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: a Real Life Evaluation

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

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

Primary Outcomes

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

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

Time: 1-6 months

Secondary Outcomes

Description: How many patients died during the hospitalization

Measure: in-hospital mortality

Time: 1 month

Description: How many patients died 30 days after the discharge

Measure: 30 days mortality

Time: 1 month

Description: How many patients died 6 months after the discharge

Measure: 6 months mortality

Time: 6 months

Description: How many patients were intubated during the hospitalization

Measure: Intubation rate

Time: 7 days

Description: How many days/hours from admittance to intubation

Measure: Time to Intubation

Time: 7 days

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

Measure: Time to ventilation

Time: 7 days

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

Measure: Non invasive to Invasive time

Time: 7 days

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

Measure: Recovery rate

Time: 1 month

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

Measure: Recurrence rate

Time: 1 month

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

Measure: Risk factor for COVID19

Time: retrospective

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

Measure: Blood tests and outcome

Time: 1 month

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

Measure: Antiviral therapy

Time: 1 month

Description: Assessment of bacterial, fungal or other coinfections rate

Measure: Coinfections

Time: 1 month

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

Measure: Radiological findings

Time: 1 month

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

Measure: Ultrasound findings

Time: 1 month

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

Measure: Myocardial injury

Time: 1 month

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

Measure: Medical management

Time: 1 month
21 Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation

Opioids can decrease breathing and co-administration of benzodiazepines with opioids can further decrease breathing. It is unknown whether certain other drugs also decrease breathing when co-administered with opioids. The objective of this study is to determine whether certain drugs combined with an opioid decrease breathing compared to breathing with an opioid alone. In order to assess this, this study will utilize the Read Rebreathing method, where study participants breathe increased levels of oxygen and carbon dioxide. The increased levels of carbon dioxide cause the study participants to increase breathing. This increased breathing response can be decreased by opioids and benzodiazepines, and potentially other drugs. Using this procedure, low doses of opioids or benzodiazepines can be administered that have minimal-to-no effects on breathing when study participants are going about normal activities breathing room air, however breathing increases less than expected as carbon dioxide levels are increased. This study will also obtain quantitative pupillometry measurements before and after each rebreathing assessment to allow for comparisons of pupillary changes to ventilatory changes when subjects receive different drugs and drug combinations. This study includes three parts: A Lead-In Reproducibility Phase and two main parts (Part 1 and Part 2). The Lead-In Reproducibility Phase will measure the variability between study participants and between repeated uses of the method in the same study participant within a day and between days. Part 1 will study an opioid alone, benzodiazepine alone, and their combination to show the methodology will detect changes in breathing at low doses of the drugs that are known to affect breathing. Part 2 will assess whether two drugs, selected due to their effects on breathing in a nonclinical model, decrease the breathing response when combined with an opioid compared to when an opioid is administered alone.

NCT04310579
Conditions
  1. Hypercapnia
  2. Ventilatory Depression
Interventions
  1. Drug: Oxycodone and Midazolam
  2. Drug: Oxycodone, Paroxetine, and Quetiapine
MeSH:Respiratory Insufficiency Hypercapnia
HPO:Hypercapnia

Primary Outcomes

Description: Data will be analyzed using nonlinear regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2) data and used to estimate VE55.

Measure: Part 1 - Comparison of the minute ventilation at the 55 mm Hg end tidal carbon dioxide (CO2) point (VE55) of midazolam combined with oxycodone vs. oxycodone alone.

Time: Part 1: 2 hour timepoint on Day 1

Description: Data will be analyzed using nonlinear regression of the minute ventilation versus PETCO2 data and used to estimate VE55.

Measure: Part 2 - Comparison of the minute ventilation at the 55 mm Hg end tidal CO2 point (VE55) of paroxetine or quetiapine combined with oxycodone vs. oxycodone alone on Day 1.

Time: Part 2: 5 hour timepoint on Day 1

Description: Data will be analyzed using nonlinear regression of the minute ventilation versus PETCO2 data and used to estimate VE55.

Measure: Part 2 - Comparison of the minute ventilation at the 55 mm Hg end tidal CO2 point (VE55) of paroxetine or quetiapine combined with oxycodone vs. oxycodone alone on Day 5.

Time: Part 2: 5 hour timepoint on Day 5

Secondary Outcomes

Description: Data will be analyzed using nonlinear regression of the minute ventilation versus PETCO2 data and used to estimate VE55.

Measure: Part 1 - VE55 of oxycodone or midazolam alone compared to placebo

Time: Part 1: 2 hour timepoint on Day 1

Description: Data will be analyzed using nonlinear regression of the minute ventilation versus PETCO2 data and used to estimate VE55.

Measure: Part 2 - VE55 of paroxetine or quetiapine alone compared to placebo

Time: Part 2: 5 hour timepoint on Day 4

Description: Cmax will be summarized using descriptive statistics

Measure: Part 1 - Maximum observed plasma concentration (Cmax) of oxycodone alone vs. in combination with midazolam

Time: Part 1: Day 1 at 0, 1, 2, 3, 4, 6, 8, 12, 24 hour

Description: Cmax will be summarized using descriptive statistics

Measure: Part 2 - Cmax of oxycodone alone vs. in combination with paroxetine or quetiapine on Day 1

Time: Part 2: Day 1 at 3, 4, 5, 6, 9, 12, 24 hour

Description: Cmax will be summarized using descriptive statistics

Measure: Part 2 - Cmax of oxycodone alone vs. in combination with paroxetine or quetiapine on Day 5

Time: Part 2: Day 5 at 3, 4, 5, 6, 9, 12, 24 hour

Description: AUC will be summarized using descriptive statistics

Measure: Part 1 - Area under the plasma concentration-time curve (AUC) of oxycodone alone vs. in combination with midazolam

Time: Part 1: Day 1

Description: AUC will be summarized using descriptive statistics

Measure: Part 2 - AUC of oxycodone alone vs. in combination with paroxetine or quetiapine on Day 1

Time: Part 2: Day 1

Description: AUC will be summarized using descriptive statistics

Measure: Part 2 - AUC of oxycodone alone vs. in combination with paroxetine or quetiapine on Day 5

Time: Part 2: Day 5
22 Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure

Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation. Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with Aviptadil, a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care vs. placebo + maximal intensive care. Patients will be randomized to intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.

NCT04311697
Conditions
  1. Critical COVID-19 With Respiratory Failure
  2. Acute Respiratory Distress Syndrome (ARDS)
  3. Corona Virus Infection
  4. Acute Lung Injury
Interventions
  1. Drug: Aviptadil by intravenous infusion + standard of care
  2. Drug: Normal Saline Infusion + standard of care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Lung Injury

Primary Outcomes

Description: Mortality

Measure: Mortality

Time: 5 Days with followup through 30 days

Description: Index of Respiratory Distress

Measure: PaO2:FiO2 ratio

Time: 5 Days with followup through the end of telemetry monitoring

Secondary Outcomes

Description: TNF alpha levels as measured in hospital laboratory

Measure: TNF alpha

Time: 5 Days

Description: Multi-system organ failure free days

Measure: Multi-system organ failure free days

Time: 5 days with followup through 30 days

Description: Days free of Respiratory Failure

Measure: Days free of Respiratory Failure

Time: 14 days
23 Predictors of Respiratory Failure Requiring ICU Admission Among Hospitalized Patients With SARS-Cov-2 Infection

The emergence of SARS-CoV-2 is currently engaging and consuming most of resources of efficient healthcare systems in Europe, and several hospitals are currently experiencing a shortage of ICU beds for critically-ill patients with SARS-CoV-2 pneumonia. A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need ICU admission and/or those who may benefit from a prompt antiviral therapy

NCT04316949
Conditions
  1. SARS-CoV-2 Pneumonia
MeSH:Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: Composite of ICU admission or SpO2<92% with 100% FiO2 of oxygen treatment (reservoir mask or CPAP or NIV), respiratory rate >30 bpm, respiratory distress

Measure: Respiratory failure

Time: 14 days

Secondary Outcomes

Description: Incidence of bacterial superinfection among ventilated patients with SARS-CoV-2 pneumonia

Measure: Occurence of bacterial superinfection

Time: 14 days
24 EC-COVID-PCS - Early CPAP in COVID Patients With Respiratory Failure. A Prospective Cohort Study.

This cohort study aims at prospectively collecting detailed clinical information on patients positive to or suspected of COVID-19 visiting Italian emergency departments (EDs). The objectives of the study are: 1. To monitor and describe the COVID-19 patients visiting Italian EDs. 2. To assess the prognostic impact of demographics, clinical characteristics, risk factors and pre-existing diseases. 3. To develop a predictive model, providing estimates of the prognosis using multiple relevant factors. 4. To construct a detailed database to enable comparative effectiveness research (CER), with the goal of generating hypothesis of efficacy and effectiveness of treatments, therapies and interventions, in the management and treatment of COVID-19 patients.

NCT04323878
Conditions
  1. Early CPAP Ventilation in COVID-19 Patients
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: The study outcomes will be death or need of intubation within 7 days since ED arrival.

Measure: Death or need of intubation

Time: 7 days since ED arrival

Secondary Outcomes

Description: 30-day mortality

Measure: 30-day mortality

Time: 30 days since ED arrival
25 Cytokine Adsorption in Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation

In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. Our primary goal is to investigate the efficacy of treatment with a CytoSorb® adsorber in patients with severe COVID-19 disease requiring venous ECMO over 72 hours after initiation of ECMO. The primary endpoint is the reduction of plasma interleukin-6 levels 72 hours after initiation of ECMO support. As secondary endpoints we investigate 30-day survival, vasopressor and volume requirements, lactate in terms of lactate and platelet function. As safety variables, we further investigate the levels of the applied antibiotics (usually ampicillin and sulbactam).

NCT04324528
Conditions
  1. Coronavirus
  2. COVID-19
  3. SARS-CoV Infection
  4. Respiratory Failure
  5. Cytokine Storm
Interventions
  1. Device: vv-ECMO + cytokine adsorption (Cytosorb adsorber)
  2. Device: vv-ECMO only (no cytokine adsorption)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)

Measure: interleukin-6 (IL-6) level after 72 hours

Time: 72 hours

Secondary Outcomes

Description: survival after 30 days

Measure: 30-day-survival

Time: 72 hours

Description: needed dosage of norepinephrine and other vasopressors

Measure: vasopressor dosage

Time: 72 hours

Description: fluid balance levels during cytokine adsorption

Measure: fluid balance

Time: 72 hours

Description: serum-lactate levels during cytokine adsorption

Measure: lactate

Time: 72 hours
26 EC-COVID-RCT. Early CPAP in COVID Patients With Respiratory Failure. A Randomized Clinical Trial

The study aims at clarifying whether early treatment with continuous positive airway pressure (CPAP) ventilation is able to reduce the need for intubation or death in patients visiting an emergency department (ED) with known or suspected COVID-19 infection and insufficiency respiratory.

NCT04326075
Conditions
  1. CPAP Ventilation
  2. COVID-19
  3. Emergency Departments
Interventions
  1. Device: CPAP treatment
MeSH:Respiratory Insufficiency Emergencies

Primary Outcomes

Description: The study outcomes will be death or need of intubation within 7 days since ED arrival.

Measure: Death or need of intubation

Time: 7 days since ED arrival

Secondary Outcomes

Description: 30-day mortality

Measure: 30-day mortality

Time: 30 days since ED arrival
27 A Prospective, Randomized, Open-label, Interventional Study to Investigate the Efficacy of Sargramostim (Leukine®) in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 (Corona Virus Disease) Patients With Acute Hypoxic Respiratory Failure.

Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure.

NCT04326920
Conditions
  1. COVID-19
Interventions
  1. Drug: Sargramostim
  2. Other: Control
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: by mean change in PaO2/FiO2 (PaO2=Partial pressure of oxygen; FiO2= Fraction of inspired oxygen)

Measure: Improvement in oxygenation at a dose of 250 mcg daily during 5 days improves oxygenation in COVID-19 patients with acute hypoxic respiratory failure

Time: at end of 5 day treatment period

Secondary Outcomes

Measure: Incidence of AE (Adverse Event)

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Incidence of SAEs (Serious Adverse Event)

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Clinical Status using 6-point ordinal scale

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Clinical Status using Clincal sign score

Time: at end of 5 day treatment period, 10 day period,10-20 weeks

Measure: Clinical Status using SOFA score (Sequential Organ Failure Assessment score),

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Clinical Status using NEWS2 score (National Early Warning Score)

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Description: demonstrated by bacterial or fungal culture

Measure: incidence of severe or life-threatening bacterial, invasive fungal or opportunistic infection

Time: during hospital admission (up to 28 days)

Measure: number of patients requiring initiation of mechanical ventilation

Time: during hospital admission (up to 28 days)

Measure: Number of deaths due to any cause at 4 weeks

Time: 4 weeks post inclusion

Measure: Number of deaths due to any cause at 20 weeks

Time: 20 weeks post inclusion

Description: defined by HS (Hemophagocytic Syndrome) score

Measure: number of patients developing features of secondary haemophagocytic lymphohistiocytosis

Time: at enrolment, end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: long term Clinical status defined by 6-point ordinal scale

Time: 10-20 week

Measure: long term Clinical status defined by chest X-ray

Time: 10-20 weeks

Measure: long term Clinical status defined lung function

Time: 10-12 weeks
28 A Randomized, Controlled, Open Label, Multicentre Clinical Trial to Explore Safety and Efficacy of Hyperbaric Oxygen for Preventing ICU Admission, Morbidity and Mortality in Adult Patients With COVID-19

COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure. We explore a treatment administered in a randomized clinical trial that could prevent ICU admission and reduce mortality. The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the inflammatory response.

NCT04327505
Conditions
  1. SARS (Severe Acute Respiratory Syndrome)
  2. Cytokine Storm
  3. ARDS, Human
  4. COVID-19
  5. Sars-CoV2
  6. Acute Respiratory Failure
Interventions
  1. Drug: Hyperbaric oxygen
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Insufficiency Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: The proportion of subjects admitted to ICU from day 1 to day 30, based on at least one of the following criteria: i) Rapid progression over hours ii) Lack of improvement on high flow oxygen >40L/min or non invasive ventilation with fraction of inspired oxygen (FiO2) > 0.6 iii) Evolving Hypercapnia or increased work of breathing not responding to increased oxygen despite maximum standard of care available outside ICU iv) Hemodynamic instability or multi organ failure with maximum standard of care available outside ICU

Measure: ICU admission

Time: Through study completion 30 days

Secondary Outcomes

Description: Proportion of subjects with 30-day mortality, all cause Mortality, from day 1 to day 30.

Measure: 30-day mortality

Time: Through study completion 30 days

Description: Time-to-Intubation, i.e. cumulative days free of invasive mechanical ventilation, from day 1 to day 30

Measure: Time-to-intubation

Time: Through study completion 30 days

Description: Time-to-ICU, i.e. cumulative ICU free days, derived as the number of days from day 1 to ICU, where all ICU free subjects are censored at day 30.

Measure: Time-to-ICU

Time: Through study completion 30 days

Description: Mean change in inflammatory response from day 1 to day 30. White cell count + differentiation Procalcitonin C-Reactive protein Cytokines (IL-6) (if available at local laboratory) Ferritin D-Dimer LDH

Measure: Inflammatory response

Time: Through study completion 30 days

Description: Overall survival (Kaplan-Meier)

Measure: Overall survival

Time: Through study completion 30 days

Other Outcomes

Description: Hospital mortality of any cause, proportion of subjects, from day 1 to day 30.

Measure: Hospital mortality

Time: Through study completion 30 days

Description: Proportion of subjects with ICU mortality, Mortality of any cause in ICU, from day 1 to day 30.

Measure: ICU mortality

Time: From ICU admission to study completion 30 days

Description: Time-to-stop of intubation/invasive mechanical ventilation, from ICU admission to day 30.

Measure: Time in Invasive Ventilation

Time: From ICU admission to study completion 30 days

Description: Mean daily NEWS from day 1 to day 30.

Measure: NEWS

Time: Through study completion 30 days

Description: Mean change in PaO2/FiO2 (PFI), from day 1 to day 2, … to day 30.

Measure: PaO2/FiO2 (PFI)

Time: Through study completion 30 days

Description: Proportion of HBO treatments given vs planned. Proportion of subjects with HBO treatment administered within 24h after enrolment.

Measure: HBO Compliance

Time: Day 1 to day 7

Description: Time-to-discharge from hospital

Measure: Hospital discharge

Time: Through study completion 30 days

Description: Mean oxygen dose per day including HBO and cumulative pulmonary oxygen toxicity expressed as Units of oxygen pulmonary toxicity dose (UPTD) and Cumulative pulmonary toxicity dose (CPTD) from day 1 to day 30.

Measure: Oxygen dose

Time: Through study completion 30 days

Description: Median number of HBO treatments and dose of HBO given, from day 1 to day 7

Measure: HBO dose

Time: Day 1 to day 7

Description: Change in expression of Micro RNA in plasma from day 1 to day 30

Measure: Micro RNA

Time: Through study completion 30 days

Description: Change in gene expression and Micro RNA interactions in Peripheral Blood Mononuclear Cells (PBMC) (20 Subjects) from day 1 to day 30

Measure: Hypoxic response

Time: Through study completion 30 days

Description: Immunological response (20 subjects) from day 1 to day 30 in the following. Cytokines extended including (IL-1β, IL-2, IL-6, IL33 and TNFα) Lymphocyte profile Flowcytometry with identification of monocyte/lymphocyte subsets including but not limited to CD3+/CD4+/CD8+ and CD4+/CD8+ ratio FITMaN panel/Flow cytometry, Interleukins (IL-1β, IL-2, IL-6, IL33 and TNFα), T-reg cells (CD3+/CD4+/CD25+/CD127+) Monocyte proliferation markers, Ex vivo monocyte function

Measure: Immunological response

Time: Through study completion 30 days

Description: Mean change in routine biomarkers for organ dysfunction, from day 1to day 30.

Measure: Multi organ dysfunction

Time: Through study completion 30 days

Description: Viral load, review of records from day 1 to day 30.

Measure: Viral load

Time: Through study completion 30 days

Description: Number of secondary infections, review of records, number of events and patients from day 1 to day 30.

Measure: Secondary infections

Time: Through study completion 30 days

Description: Diagnosed PE needing treatment, review of records, number of events and patients from day 1 to day 30.

Measure: Pulmonary embolism

Time: Through study completion 30 days

Description: Changes on Pulmonary CT, review of records from day 1 to day 30.

Measure: Pulmonary CT

Time: Through study completion 30 days

Description: Changes on Chest X-ray, review of records from day 1 to day 30.

Measure: Chest X-ray

Time: Through study completion 30 days

Description: Changes in Lung ultrasound, review of records from day 1 to day 30.

Measure: Lung ultrasound

Time: Through study completion 30 days
29 Angiotensin-(1,7) Treatment in COVID-19: the ATCO Trial

Background: A novel Coronavirus (SARS-CoV-2) described in late 2019 in Wuhan, China, has led to a pandemic and to a specific coronavirus-related disease (COVID-19), which is mainly characterized by a respiratory involvement. While researching for a vaccine has been started, effective therapeutic solutions are urgently needed to face this threaten. The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host 's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that is downregulated in COVID-19 patient and it may potentially improve respiratory function in this setting. Methods/Design: The Investigators describe herein the methodology of a randomized, controlled, adaptive Phase II/Phase III trial to test the safety, efficacy and clinical impact of the infusion of angiotensin-(1-7) in COVID-19 patients with respiratory failure requiring mechanical ventilation. A first phase of the study, including a limited number of patients (n=20), will serve to confirm the safety of the study drug, by observing the number of the severe adverse events. In a second phase, the enrollment will continue to investigate the primary endpoint of the study (i.e. number of days where the patient is alive and not on mechanical ventilation up to day 28) to evaluate the efficacy and the clinical impact of this drug. Secondary outcomes will include the hospital length of stay, ICU length of stay, ICU and hospital mortality, time to weaning from mechanical ventilation, reintubation rate, secondary infections, needs for vasopressors, PaO2/FiO2 changes, incidence of deep vein thrombosis, changes in inflammatory markers, angiotensins plasmatic levels and changes in radiological findings. The estimated sample size to demonstrate a reduction in the primary outcome from a median of 14 to 11 days is 56 patients, 60 including a dropout rate of 3% (i.e. 30 per group), but a preplanned recalculation of the study sample size is previewed after the enrollment of 30 patients. Expected outcomes/Discussion: This controlled trial will assess the efficacy, safety and clinical impact of the Angiotensin-(1-7) infusion in a cohort of COVID-19 patients requiring mechanical ventilation. The results of this trial may provide useful information for the management of this disease.

NCT04332666
Conditions
  1. Coronavirus
  2. Respiratory Failure
  3. Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
  4. SARS-CoV-2
Interventions
  1. Drug: Angiotensin 1-7
  2. Drug: Placebos
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: composite outcome of mortality and necessity of mechanical ventilation

Measure: ventilator free days

Time: 28 days

Secondary Outcomes

Description: number of days free from intensive care unit

Measure: ICU free days

Time: trough study completion, on average 40 days

Description: Hospital length of stay

Measure: Hospital length of stay

Time: through study completion, on average 60 days

Description: Time to wean from mechanical ventilation

Measure: Time to wean from mechanical ventilation

Time: through study completion, on average 14 days

Description: PaO2/FiO2 changes during drug administration

Measure: PaO2/FiO2 changes during drug administration

Time: 48 hours

Description: US confirmed deep vein thrombosis

Measure: Deep vein thrombosis incidence

Time: through study completion, on average 30 days

Description: including IL-1, IL-2, IL-6, IL-7, IL-8, IL-10, TNF-alpha, interferon gamma

Measure: Changes in inflammatory markers

Time: at randomization, 48 hours after randomization and 72 hours after randomization

Description: Ang II and Ang-(1-7) plasmatic levels

Measure: RAS effectors levels

Time: at randomization, 48 hours after randomization and 72 hours after randomization

Description: Chest x-ray or CT scan changes

Measure: Radiological findings

Time: through study completion, on average 30 days

Other Outcomes

Description: phase 2b = principal safety outcome; phase 3 = secondary outcome

Measure: Rate of serious adverse events

Time: study drug administration/day 28 or ICU discharge or death
30 Use of Defibrotide to Reduce Progression of Acute Respiratory Failure Rate in Patients With COVID-19 Pneumonia

Phase II, prospective, interventional, single-arm, multicentric, open label trial, with a parallel retrospective collection of data on not treated patients from IRCCS, San Raffaele Scientific Institute included in the institutional observational study. A sample of 50 patients with COVID-19 pneumonia will allow to detect an absolute reduction in the rate of Respiratory-failure at day+14 after treatment of 20%, assuming that the actual rate of failure in the corresponding not treated patients is 70% (alpha=5%, power=90%, two-sided test). The software PASS15 was used for calculations. The study will also include a parallel retrospective group of temporally concomitant patients from IRCCS, San Raffaele Scientific Institute, who did not receive an experimental treatment and who are enrolled in an already IRB approved observational study

NCT04335201
Conditions
  1. Patients With COVID-19 Pneumonia Will Allow to Detect an Absolute Reduction in the Rate of Respiratory-failure
Interventions
  1. Drug: Defibrotide Injection
MeSH:Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: To demonstrate that the treatment with Defibrotide administered intravenously in addition to the best available therapy according to institutional guidelines (protease inhibitors antiviral treatment and hydroxychloroquine (HCQ), and if needed, metilprednisolone is able to reduce the progression of acute respiratory failure, the need of mechanical ventilation, the transfer to the intensive care unit or death, in patients with severe COVID-19 pneumonia. Patients with a baseline PaO2/FiO2 >= 200: progression of respiratory failure is defined by: severe gas transfer deficit (PaO2/FiO2 < 200); persistent respiratory distress while receiving oxygen (persistent marked dyspnea, use of accessory respiratory muscles, paradoxical respiratory movements); transfer to the intensive care unit; death. The rate will be calculated as the proportion of patients who experienced at least one of the events above by day+14 from treatment start.

Measure: to able to reduce the progression of acute respiratory failure

Time: 14 days

Secondary Outcomes

Description: To evaluate the safety of Defibrotide will be analyzed the frequency and incidence of Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Measure: Adverse events

Time: 7 days

Description: evaluate the time of hospitalization that will determine how much and how the administration of defibrotide can resolve the infection

Measure: duration of hospitalization

Time: 14 days

Description: To evaluate the level of PCR, LDH, ferritin, IL-10, IL-6, TNF-alpha, IFN-gamma, PTX3 at day +7 and +14 after start of treatment with Defibrotide. performed per day. Laboratory values performed at day 7 and 14 will be analyzed and compared with each other to understand their progress.

Measure: systemic inflammation

Time: 14 days

Description: To evaluate the overall survival at day+28 after start treatment with Defibrotide

Measure: overall survival

Time: 28 days
31 Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care Due to Coronavirus Disease 2019 (COVID-19)- Randomised Controlled Trial

Trial design: Prospective, multi-centre, randomised, pragmatic, double blind trial Methods: Participants: Adult (>18 years) within 24 hours of admission to intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria: symptoms of febrile disease for ≥1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, incl. long QT syndromes, participation in another outcome-based interventional trial within last 30 days, patients taking Hydrochloroquine for other indication than COVID-19, pregnancy. Interventions: Patients will be randomised in 1:1:1 ratio to receive Hydrochloroquine 800mg orally in two doses followed by 400mg daily in two doses and Azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or Hydrochloroquine+ placebo (HC group) or placebo + placebo (C-group) in addition to best standard of care, which may evolve during the trial period but will not differ between groups. Objective: To test the hypothesis that early administration of combination therapy slows disease progression and improves mechanical-ventilation free survival. Outcomes: Primary outcome: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14. Secondary outcomes: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline. ICU-LOS D28 and D 90 mortality (in hospital) Tertiary (exploratory) outcomes: Viral load at D7 of study enrolment (No of viral RNA copies/ml of blood), proportion of patients alive and rtPCR negative from nasal swab at D14, Difference of FiO2 requirement and respiratory system compliance between day 0 and 7. Randomization: In 1:1:1 ratio and stratified according to study centre and patients age (cut-off 70 years) Blinding (masking): Patients, treating clinicians, outcome assessors and data analyst will be blinded to study treatment allocation. Unblinded study pharmacist or research nurse will prepare investigational products.

NCT04339816
Conditions
  1. COVID-19
  2. Respiratory Failure
Interventions
  1. Drug: Azithromycin
  2. Drug: Hydroxychloroquine
  3. Drug: Placebo
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14.

Measure: Proportion of alive patients free off mechanical ventilation

Time: 14 days after enrolment

Secondary Outcomes

Description: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline.

Measure: Proportion of patients who avoided the need of mechanical ventilation

Time: 14 days

Description: Length of stay in intensive care unit

Measure: ICU LOS

Time: 28 days

Description: Proportion of patients who died by day 28

Measure: Mortality28

Time: 28 days

Description: Proportion of patients who died by day 90

Measure: Mortality90

Time: 90 days
32 NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure

Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure. Propose adaptations to HACOR score based on the "state of art" of COVID-19

NCT04342104
Conditions
  1. Respiratory Failure
  2. Covid-19
Interventions
  1. Other: Monitoring for aggravation
  2. Other: Evaluate HACOR score effectivity in this patients
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Analyze if HACOR score is effective in predicting nonivasive ventilation failure in COVID-19 associated respiratory failure

Measure: HACOR score efficacy

Time: 1 hour after initation of CPAP or NIV

Description: Analyze the role of possible variables to be added to HACOR score in order to improve efficay in COVID-19 patients

Measure: HACOR score addaptation

Time: 1 - 2 weeks
33 UPright Incline Positioning in COVID-19 Patients for Oxygen SATuration Improvement With Hypoxemic Respiratory Failure (UPSAT)

COVID-19 is a respiratory illness caused by SARS-CoV-2 with a range of symptoms from mild, self-limiting respiratory tract infections to severe progressive pneumonia, multiorgan dysfunction and death. A portion of individuals with COVID-19 experience life-threatening hypoxia requiring supplemental oxygen and mechanical ventilation. Management of hypoxia in this population is complicated by contraindication of non-invasive ventilation and limitations in access to mechanical ventilation and critical care staff given the clinical burden of disease. Positional therapy is readily deployable and may ultimately be used to treat COVID-19 related respiratory failure in resources limited settings; and, it has been demonstrated to improve oxygenation and is easy to implement in the clinical setting. The overall goal of this randomized controlled trial is to establish the feasibility of performing a randomized trial using a simple, minimally invasive positional therapy approach to improve hypoxia and reduce progression to mechanical ventilation. The objectives are to examine the effectiveness and feasibility of maintaining an inclined position in patients with confirmed or suspected COVID-19 associated hypoxemic respiratory failure. The investigators hypothesize that (1) oxyhemoglobin saturation will improve with therapy, (2) participants will tolerate and adhere to the intervention, and that (3) participants who adhere to positional therapy will have reduced rates of mechanical ventilation at 72 hours. If successful, this feasibility trial will demonstrate that a simple, readily deployed nocturnal postural maneuver is well tolerated and reverses underlying defects in ventilation and oxygenation due to COVID-19. It will also inform the design of a pivotal Phase III trial with estimates of sample sizes for clinically relevant outcomes.

NCT04344561
Conditions
  1. COVID
  2. Hypoxic Respiratory Failure
Interventions
  1. Other: Postural Positioning
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Number of participants needing mechanical ventilation over total number of participants per arm.

Measure: Incidence of Mechanical Ventilation

Time: 72 hours

Secondary Outcomes

Description: Number of participants with supplemental oxygen requirements.

Measure: Number of participants with supplemental oxygen requirements

Time: 72 hours

Description: Mean oxyhemoglobin saturation (percentage) measured over a 24-hour period.

Measure: Mean oxyhemoglobin saturation

Time: At 24, 48 and 72 hours

Description: Mean oxyhemoglobin saturation (percentage) measured over an 8-hour period (between 10pm and 6am).

Measure: Mean Nocturnal Oxyhemoglobin Saturation

Time: Measured between 10pm and 6am daily, up to 72 hours

Description: Heart Rate (beats per minute) on Routine Vital Sign Assessment.

Measure: Heart Rate

Time: At 10, 24, 48 and 72 hours

Description: Respiratory Rate (cycles per minute) on Routine Vital Sign Assessment.

Measure: Respiratory Rate

Time: At 10, 24, 48 and 72 hours

Description: Percentage of time participants stay in the assigned position will be used to determine adherence.

Measure: Percentage of time in the assigned position

Time: 72 hours

Other Outcomes

Description: Mean oxyhemoglobin saturation (percentage) during final 7 minutes in a position.

Measure: Acute change in oxyhemoglobin saturation

Time: During the final 7 minutes at each position, up to 72 hours
34 Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 pneumonia_COVIDICUS

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival. The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.

NCT04344730
Conditions
  1. Acute Hypoxemic Respiratory Failure
  2. COVID-19
Interventions
  1. Drug: Dexamethasone injection
  2. Drug: placebo
  3. Procedure: conventional oxygen
  4. Procedure: CPAP
  5. Procedure: HFNO
  6. Procedure: mechanical ventilation
MeSH:Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: The time-to-death from all causes within the first 60 days after randomization.

Measure: The time-to-death from all causes

Time: day-60

Description: the time to need for mechanical ventilation (MV), as defined by any of the 3 criteria for intubation within the first 28 days after randomization.

Measure: The time to need for mechanical ventilation (MV)

Time: day-28.

Secondary Outcomes

Description: The cycle threshold for SARS-CoV-2 PCR at baseline, day 7 and day 10 in samples of the same origin (preferably subglottic i.e. bronchoalveolar lavage or tracheal aspiration, otherwise nasopharyngeal swab)

Measure: The viral load in the respiratory tract

Time: day-10

Description: Proportion of patients with at least one episode of any healthcare-associated infection between randomization and D28

Measure: Number of patient with at least one episode of healthcare-associated infections

Time: day-28

Description: To compare the exposition to mechanical ventilation

Measure: Number of days alive without mechanical ventilation

Time: day-28

Description: Changes in SOFA (Sepsis-related Organ Failure Assessment) score. (min = 0 for normal status max = 24 for worse status)

Measure: Measure of SOFA score

Time: day-28

Description: to compare the exposition to renal replacement therapy

Measure: Number of days alive without renal replacement therapy

Time: day-28

Description: To compare the lengths of ICU

Measure: Lengths of ICU-stay

Time: day-60

Description: To compare the lengths of hospital-stay

Measure: Lengths of hospital-stay

Time: day-60

Description: Proportion of patients with severe hypoxemia, which is defined as an oxygen saturation of less than 80% during the same interval during the interval between induction and 2 minutes after tracheal intubation

Measure: Number of patients with severe hypoxemia,

Time: day 60

Description: Proportion of patients with cardiac arrest within 1 hour after intubation

Measure: Number of patients with cardiac arrest within 1 hour after intubation

Time: day 60
35 PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID) - an Observational Study of Invasively Ventilated Patients in the Netherlands

The purpose of this national, multicenter service review is to determine and compare ventilation management in COVID-19 patients in the Netherlands, and to determine whether certain ventilation settings have an independent association with duration of ventilation. In every adult invasively ventilated COVID-19 patient from a participating ICU, granular ventilator settings and parameters will be collected from start of invasive ventilation for up to 72 hours. Follow up is until ICU and hospital discharge, and until day 90. The primary outcome includes main ventilator settings (including tidal volume, airway pressures, oxygen fraction and respiratory rate). Secondary endpoints are ventilator-free days and alive at day 28 (VFD-28); duration of mechanical ventilation; use of prone positioning and recruitment maneuvers; duration of ICU and hospital stay; incidence of kidney injury; and ICU, hospital, 28-day and 90-day mortality.

NCT04346342
Conditions
  1. COVID
  2. Mechanical Ventilation
  3. Acute Respiratory Failure
MeSH:Respiratory Insufficiency

Primary Outcomes

Measure: Ventilation Mode

Time: Day 1 to Day 3 from initiation of mechanical ventilation

Measure: Tidal volume set

Time: Day 1 to Day 3 from initiation of mechanical ventilation

Measure: Expiratory tidal volume

Time: Day 1 to Day 3 from initiation of mechanical ventilation

Measure: Positive end-expiratory pressure

Time: Day 1 to Day 3 from initiation of mechanical ventilation

Measure: Maximum airway pressure or plateau pressure (P plateau) or peak pressure (P peak) (cm H2O);

Time: Day 1 to Day 3 from initiation of mechanical ventilation

Measure: Level of pressure support above positive end-expiratory pressure (PEEP)

Time: Day 1 to Day 3 from initiation of mechanical ventilation

Measure: Inspired fraction of oxygen

Time: Day 1 to Day 3 from initiation of mechanical ventilation

Measure: Set and measured respiratory rate

Time: Day 1 to Day 3 from initiation of mechanical ventilation

Measure: Inspiration to expiration ratio

Time: Day 1 to Day 3 from initiation of mechanical ventilation

Secondary Outcomes

Measure: Number of ventilation-free days and alive at day 28

Time: Until 28 days from initiation of mechanical ventilation

Description: time between start invasive ventilation and successful extubation in survivors

Measure: Duration of ventilation in survivors;

Time: Until 28 days from initiation of mechanical ventilation

Measure: Use of prone positioning

Time: Day 1 to Day 3 from initiation of mechanical ventilation

Measure: Use of recruitment maneuvers

Time: Day 1 to Day 3 from initiation of mechanical ventilation

Measure: Incidence of acute kidney injury

Time: Until 28 days from initiation of mechanical ventilation

Description: Time between admission and discharge ICU or death in ICU

Measure: Duration of ICU stay

Time: Until 28 days from initiation of mechanical ventilation

Description: Time between admission and discharge from hospital or death in hospital

Measure: Duration of hospital stay

Time: Until 28 days from initiation of mechanical ventilation

Description: Any death during ICU stay

Measure: ICU mortality

Time: Until 28 days from initiation of mechanical ventilation

Description: Any death during hospital stay

Measure: Hospital mortality

Time: Until 28 days from initiation of mechanical ventilation

Measure: 28-day mortality

Time: Until 28 days from initiation of mechanical ventilation

Measure: 90-day mortality

Time: Until 90 days from initiation of mechanical ventilation
36 An Open Randomized Study of the Effectiveness of the Drug Dalargin for the Prevention and Treatment of Symptoms of Pulmonary Complications in Patients With Coronavirus Infection (SARS-COVID-19)

The purpose of the study is to evaluate an effectiveness of the drug Dalargin for the prevention and treatment of severe pulmonary complications symptoms associated with severe and critical coronavirus infection cases (SARS COVID19, expanded as Severe acute respiratory syndrome Cоrona Virus Disease 2019 ). Test drug that will be administered to patients are: - Dalargin, solution for inhalation administration, - Dalargin, solution for intravenous and intramuscular administration.

NCT04346693
Conditions
  1. Acute Respiratory Tract Infection
  2. Acute Respiratory Insufficiency
  3. Pneumonia
  4. Septic Shock
  5. Hypoxemia
Interventions
  1. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation.
  2. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection
  3. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation
  4. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation
MeSH:Infection Respiratory Tract Infections Pneumonia Respiratory Insufficiency Pulmonary Valve Insufficiency Hypoxia
HPO:Hypoxemia Pneumonia Pulmonary insufficiency Respiratory tract infection

Primary Outcomes

Description: Estimated by Polymerase chain reaction (PCR)

Measure: The change of viral load in patients with SARS-COVID-19.

Time: Upon patient inclusion in the study, after 96 hours and on the 10day;

Description: Assessed through the entire patient participation in the study

Measure: The frequency of development of Acute Respiratory Distress Syndrome (ADRS)

Time: up to 10 days

Description: The number of days a patient is hospitalized

Measure: Duration of hospitalization

Time: up to 10 days

Description: Early mortality from all causes will be estimated

Measure: The frequency of early mortality

Time: up to 30 days

Description: Late mortality from all causes will be estimated

Measure: The frequency of late mortality

Time: up to 90 days

Description: Clinical status at the time of completion of participation in the study will be estimated based upon the following criteria: Death; Hospitalization is extended, on invasive mechanical ventilation of the lungs with extracorporeal membrane oxygenation; Hospitalization extended, on non-invasive ventilation; Hospitalization is extended, needs additional oxygen; Hospitalization is extended, additional oxygen is not required; Discharged.

Measure: Clinical status at the time of completion of participation in the study

Time: an average of 10 days
37 An Open Randomized Study of the Effectiveness of the Drug Mefloquine, Tablets 250 mg, Produced by FSUE SPC "Farmzashita" of the Federal Medical Biological Agency, FMBA of Russia (Russia) for the Treatment of Patients With COVID19

Study of the effectiveness and safety of the drug Mefloquine, tablets 250 mg, produced by FSUE "SPC" Farmzaschita " FMBA of Russia (Russia), in comparison with the drug Hydroxychloroquine, tablets 200 mg, for the treatment of patients with coronavirus infection, in the "off-label" mode, to make a decision on the possibility of expanding the indications for use.

NCT04347031
Conditions
  1. Pneumonia, Viral
  2. Respiratory Failure
Interventions
  1. Drug: Mefloquine
  2. Drug: Hydroxychloroquine
  3. Combination Product: Mefloquine + azithromycin + / - tocilizumab
  4. Combination Product: Hydroxychloroquine + azithromycin + / - tocilizumab
MeSH:Pneumonia, Viral Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: The number of patients with development of respiratory failure requiring transfer to the ICU.

Measure: 1st primary endpoint for group 1

Time: up to 10 days

Description: The period of clinical recovery.

Measure: 2nd primary endpoint for group 1

Time: up to 10 days

Description: The period of clinical recovery.

Measure: 1st primary endpoint for group 2

Time: up to 10 days

Description: Frequency of fatal outcomes associated with coronavirus infection disease (COVID19)

Measure: 2nd primary endpoint for group 2

Time: through study completion, an average of 3 months

Secondary Outcomes

Description: A change in viral load by conducting PCR assay through different timeframes

Measure: 1st secondary endpoint for group 1

Time: on days 5 and 10

Description: Frequency of clinical cure on day 10 from the start of therapy

Measure: 2nd secondary endpoint for group 1

Time: on day 10

Description: The retention time of the reaction temperature from the start of the treatment.

Measure: 3d secondary endpoint for group 1

Time: up to 10 days

Description: Concentration of C-reactive protein in blood plasma.

Measure: 4th secondary endpoint for group 1

Time: up to 10 days

Description: Respiratory index.

Measure: 5th secondary endpoint for group 1

Time: up to 10 days

Description: Frequency appearance unwanted phenomena and serious unwanted phenomena

Measure: 6th secondary endpoint for group 1

Time: up to 10 days

Description: A change in viral load by conducting PCR assay through different timeframes

Measure: 1st secondary endpoint for group 2

Time: on days 5 and 10

Description: Respiratory index.

Measure: 2nd secondary endpoint for group 2

Time: up to 10 days

Description: The retention time of the reaction temperature from the start of treatment.

Measure: 3d secondary endpoint for group 2

Time: up to 10 days

Description: Concentration of C-reactive protein in blood plasma.

Measure: 4th secondary endpoint for group 2

Time: up to 10 days

Description: Number of patients required transition to alternative therapy schedule

Measure: 5th secondary endpoint for group 2

Time: up to 10 days

Description: Frequency of adverse events and serious adverse events

Measure: 6th secondary endpoint for group 2

Time: up to 10 days
38 Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE

Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. COVID-19 induced) ARDS could improve gas exchange and reduce the need for invasive mechanical ventilation, but has not been studied outside of case series.The investigators will conduct a randomized controlled study of patients with COVID-19 induced respiratory failure to determine if prone positioning reduces the need for mechanical ventilation compared to standard management.

NCT04347941
Conditions
  1. ARDS, Human
  2. Mechanical Ventilation Complication
  3. COVID19
Interventions
  1. Procedure: Prone Positioning
  2. Procedure: Standard of care.
MeSH:Respiratory Insufficiency Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: A measure of effect of awake prone positioning in reducing requirement for invasive mechanical ventilation.

Measure: The effect of prone positioning on requirement for invasive mechanical ventilation in patients with COVID 19 induced respiratory failure.

Time: Up to 28 days post randomisation

Secondary Outcomes

Description: Total time spent in prone and supine position as recorded by nurse

Measure: Length of time tolerating prone positioning

Time: Daily during intervention up to 28 days post randomisation

Description: Measure of change in oxygenation before intervention

Measure: PaO2/FiO2 measured before prone positioning

Time: Immediately before intervention

Description: Measure of change in oxygenation following intervention

Measure: PaO2/FiO2 ratio after 1 hours of prone positioning

Time: During intervention

Description: Measure of change in oxygenation using pulse oximetry before intervention where ABG not available

Measure: SpO2/FiO2 ratio measured before prone positioning

Time: Immediately before intervention

Description: Measure of change in oxygenation before intervention where ABG not available

Measure: SpO2/FiO2 ratio after 1 hours of prone positioning

Time: During Intervention

Description: Escalation of ventilatory support

Measure: Number requiring increase in ventilatory assistance (CPAP+BIPAP+IMV etc)

Time: Up to 28 days post randomisation

Description: Measure of work of breathing in COVID-19 based on Oxygen Delivery Device, Oxygen Saturation and respiratory rate and accessory muscle use with 0-3 Mild, 4-6 Moderate and 7-10 Severe

Measure: Work of breathing assessment (Respiratory distress scale)

Time: Immediately before and during intervention

Description: Substudy examining use of bioimpedance as a surrogate measure of lung edema following prone positioning

Measure: Changes in bioimpedance measures of lung edema in patients in PP

Time: During intervention

Description: Rescue awake prone positioning in control patients in response to hypoxia

Measure: Use of awake prone positioning as a rescue intervention in control patients

Time: Up to 28 days post randomisation
39 Randomized Phase II Clinical Trial of Ruxolitinib Plus Simvastatin in the Prevention and Treatment of Respiratory Failure of COVID-19.Ruxo-Sim-20 Clinical Trial.

COVID-19's mechanism to enter the cell is initiated by its interaction with its cellular receptor, the angiotensin-converting enzyme. As a result of this union, a clathrin-mediated endocytosis process begins. This route is one of the therapeutic targets for which available drugs are being investigated in order to treat COVID-19 infection. This is one of the mechanisms blocked by drugs like ruxolitinib and chloroquine. Various drugs approved for clinical use that block the clathrin-mediated endocytosis pathway have been explored. It has been found that the best in vitro and in vivo results were obtained with statins, which also allowed generating a greater potent adaptive immune response. Therefore, statins and specifically simvastatin make it possible to block the entry process used by COVID-19, block inflammation by various mechanisms and increase the adaptive immune response. All of these processes are desirable in patients infected with COVID-19. Statins have been proposed to have beneficial effects in patients infected with MERS-COV, another coronavirus similar to COVID-19, but there have been no randomized studies supporting the use of statins in patients with COVID-19 infection. In this project we propose the combined use of one of these drugs, ruxolitinib with simvastatin, looking for a synergistic effect in the inhibition of viral entry and in the anti-inflammatory effect.

NCT04348695
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Ruxolitinib plus simvastatin
  2. Other: Standard of Care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 7 from randomization.

Measure: Percentage of patients who develop severe respiratory failure.

Time: 7 days

Secondary Outcomes

Description: Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 14 from randomization.

Measure: Percentage of patients who develop severe respiratory failure.

Time: 14 days

Description: Time from ICU admision to ICU discharge.

Measure: Length of ICU stay.

Time: 28 days

Description: Time from hospital admision to hospital discharge.

Measure: Length of hospital stay

Time: 28 days

Description: Percentage of patients alive at 6 months

Measure: Survival rate at 6 months

Time: 6 months

Description: Percentage of patients alive at 12 months

Measure: Survival rate at 12 months

Time: 12 months

Description: Percentage of patients who died from any cause 28 days after inclusion in the study

Measure: Survival rate at 28 days

Time: 28 days

Description: Percentage of patients with each AE by grade in relation with total number of treated patients

Measure: Percentage of patients with each AE by grade

Time: 28 days

Description: Percentage of patients who discontinued due to AEs in relation with total number of treated patients

Measure: Percentage of patients who discontinued due to AEs

Time: 28 days
40 Early Extubation for Patients With Acute Hypoxemic Respiratory Failure

The objective of the study is to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic.

NCT04349332
Conditions
  1. Mechanical Ventilation
  2. Corona Virus Infection
Interventions
  1. Device: Helmet non-invasive ventilation (NIV)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: duration of mechanical ventilation via endotracheal tube

Measure: ventilator days

Time: up to 4 weeks

Secondary Outcomes

Description: number of days admitted to the ICU

Measure: Intensive care unit (ICU) length of stay

Time: up to 6 weeks

Description: number of patients requiring endotracheal intubation after extubation

Measure: need for re-intubation

Time: up to 6 weeks

Other Outcomes

Description: number of days spent in hospital during enrollment hospitalization

Measure: hospital length of stay

Time: up to 6 weeks

Description: death from any cause during hospitalization time of enrollment

Measure: hospital mortality

Time: up to 6 weeks

Description: death from any cause 90 day, 1year

Measure: long term mortality

Time: up to 1 year

Description: including ventilator associated pneumonia, GI hemorrhage, DVT/PE, sacral decubitus ulcer, delirium, ICU acquired weakness

Measure: ICU related complications

Time: up to 6 weeks

Description: measure the location (home, rehabilitation center, nursing home)

Measure: discharge location

Time: up to 90 days

Description: days alive and institution free

Measure: health care utilization

Time: up to 6 weeks

Description: ultrasound measurement at end expiration: enrollment, pre extubation, post extubation

Measure: diaphragm ultrasound thickness

Time: up to 6 weeks

Description: ultrasound measurement at end expiration and inspiration to calculate thickening fraction

Measure: diaphragm thickening fraction

Time: up to 6 weeks
41 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
42 An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Dapagliflozin in Respiratory Failure in Patients With COVID-19

This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with COVID-19 in the US and other countries with high prevalence of COVID-19. The study is evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily for 30 days in addition to background local standard of care therapy, in reducing disease progression, complications, and all-cause mortality.

NCT04350593
Conditions
  1. COVID-19
Interventions
  1. Drug: Dapagliflozin 10 MG
  2. Drug: Placebo
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Respiratory decompensation (e.g., invasive or non-invasive mechanical ventilation) New or worsening congestive HF Requirement for vasopressor therapy and/or inotropic or mechanical circulatory support Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest Initiation of renal replacement therapy

Measure: Time to first occurrence of either death from any cause or new/worsened organ dysfunction through 30 days of follow up, defined as at least one of the following:

Time: Randomization through Day 30

Secondary Outcomes

Description: Time to death from any cause Time to new/worsened organ dysfunction (as defined in the primary outcome measure) Clinical status at Day 30 for patients still hospitalized and without any worsening organ dysfunction (using points 3 to 5 of a 7-point ordinal scale) Time to hospital discharge

Measure: Hierarchical composite outcome measures including time to death from any cause, time to new/worsened organ dysfunction, clinical status at day 30 and time to hospital discharge

Time: Randomization through Day 30

Description: Time to hospital discharge

Measure: Time to hospital discharge

Time: Randomization through Day 30

Description: Total number of days alive, out of hospital, and/or free from mechanical ventilation

Measure: Total number of days alive, out of hospital, and/or free from mechanical ventilation

Time: Randomization through Day 30

Description: Total number of days alive, not in the ICU, and free from mechanical ventilation (as defined in the primary outcome measure)

Measure: Total number of days alive, not in the ICU, and free from mechanical ventilation (as defined in the primary outcome measure)

Time: Randomization through Day 30

Description: Time to death from any cause

Measure: Time to death from any cause

Time: Randomization through Day 30

Description: Time to new/worsened organ dysfunction

Measure: Time to new/worsened organ dysfunction

Time: Randomization through Day 30

Description: Time to acute kidney injury (defined as doubling of s-Creatinine compared to baseline)

Measure: Time to acute kidney injury (defined as doubling of s-Creatinine compared to baseline)

Time: Randomization through Day 30
43 Low-flow Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform for Correction of Hypercapnia in COVID-19-associated Acute Respiratory Distress Syndrome

The study aims to investigate the efficacy of extracorporeal CO2 removal for correction of hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distress syndrome

NCT04351906
Conditions
  1. ARDS
  2. Hypercapnic Respiratory Failure
  3. AKI
Interventions
  1. Device: ECCO2R
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury

Primary Outcomes

Description: Delta partial pressure of carbon dioxide change during ECCO2R treatment

Measure: Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment

Time: Up to 72 hours

Secondary Outcomes

Description: Epinephrine and norepinephrine dose, mcg/kg/min

Measure: Change in vasopressor use during ECCO2R

Time: Up to 72 hours

Description: Assessment of changes in tidal volume

Measure: Assessment of changes in tidal volume during ECCO2R

Time: Up to 72 hours

Description: Assessment of changes in pH

Measure: Assessment of changes in pH during ECCO2R

Time: Up to 72 hours

Description: Assessment of changes in Positive End-Expiratory Pressure

Measure: Assessment of changes in Positive End-Expiratory Pressure during ECCO2R

Time: Up to 72 hours

Description: Adverse events directly related to ECCO2R are infection at the catheter site, hemorrhage at the cannulation site, air entry in the circuit.

Measure: Number of participants with adverse events directly related to ECCO2R

Time: Up to 72 hours

Description: Adverse events directly related to ECCO2R are clotting of the circuit.

Measure: Rate of technical adverse events related to ECCO2R

Time: Up to 72 hours

Description: Delta change in delta venous partial pressure of carbon dioxide before and after ECCO2R membrane

Measure: Delta change in venous partial pressure of carbon dioxide before and after ECCO2R membrane

Time: Up to 72 hours
44 A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Mechanically Ventilated Intubated Patients With Respiratory Failure Due to COVID-19

This study will assess the feasibility of administering multiple doses of convalescent plasma (from people who have recovered form SARS-CoV-2) to Covid-19 positive patients in the Intensive Care Unit receiving mechanical ventilation. Donor plasma will not be obtained under this protocol, but all plasma used will follow FDA guidelines for Investigational COVID-19 Convalescent Plasma use. Patients may receive single or double plasma units infused on days 0, 3, and 6. This decision may be based on availability of blood plasma. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose. The secondary study endpoint is overall survival at day 60 after first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow up on days 14, 28, and 60.

NCT04353206
Conditions
  1. Covid-19
  2. Sars-CoV2
Interventions
  1. Biological: Multiple Doses of Anti-SARS-CoV-2 convalescent plasma
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Feasibility of administering convalescent plasma to patients in the ICU who are intubated and mechanically ventilated due to COVID-19-induced respiratory failure will be assessed based on the proportion of subjects who consent and receive at least one dose of CP. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose.

Measure: Proportion of subjects who consent to the study and receive at least one dose of convalescent plasma.

Time: 60 days

Secondary Outcomes

Description: Overall survival (days, until Day 60). This will be quantified as number of trial patients alive at Day 60 after first dose of CP / total number of patients who received at least one dose of CP.

Measure: Overall survival of patients in the ICU receiving at least once dose of convalescent plasma for Covid-19-induced respiratory failure.

Time: 60 days
45 Early and Late Pulmonary and Systemic Inflammation in Critically Ill, Mechanically Ventilated Patients With Verified COVID-19

The aim of the present study is to examine the inflammatory response in the pulmonary compartment and blood of critically ill patients admitted to the ICU with COVID-19.

NCT04354584
Conditions
  1. COVID-19
  2. Respiratory Failure
MeSH:Respiratory Insufficiency Inflammation

Primary Outcomes

Description: Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood

Measure: White blood cell counts

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood

Measure: White blood cell counts

Time: Day 7

Description: Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood

Measure: Lymphocyte populations

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood

Measure: Lymphocyte populations

Time: Day 7

Secondary Outcomes

Description: Multiplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha, HMGB1)

Measure: Cytokines

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: Multiplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha, HMGB1)

Measure: Cytokines

Time: Day 7

Description: MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma

Measure: Lectin complement pathway

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma

Measure: Lectin complement pathway

Time: Day 7

Description: Growth of pathogenic microorganisms in body fluids (e.g. urine, blood, bronchoalveolar lavage fluid)

Measure: Microorganisms

Time: Up to 12 weeks

Description: Respiratory filmarray PCR for testing for pathogens

Measure: Respiratory pathogens

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: Respiratory filmarray PCR for testing for pathogens

Measure: Respiratory pathogens

Time: Day 7

Description: 16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid

Measure: Ribosomal RNA in the airways

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: 16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid

Measure: Ribosomal RNA in the airways

Time: Day 7

Description: Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid

Measure: Levels of SARS-CoV-2 in the airways

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid

Measure: Levels of SARS-CoV-2 in the airways

Time: Day 7

Other Outcomes

Description: ICU mortality

Measure: Mortality

Time: Up to 6 months

Description: In hospital mortality

Measure: Mortality II

Time: Up to 6 months

Description: C-reactive protein, procalcitonin, ferritin

Measure: Blood markers of inflammation

Time: Daily assessment in the ICU up to 12 weeks

Description: Platelets, creatinine, urea, sodium, potassium, D-dimer, lactate dehydrogenase, bilirubin, lactate

Measure: Blood markers of organ dysfunction

Time: Daily assessment in the ICU up to 12 weeks

Description: Number of participants with unilateral infiltrates or bilateral infiltrates and/or air bronchogram

Measure: Infiltrates on conventional chest x-ray

Time: Up to 12 weeks
46 Assesment of Usefulness of Ventil Device for Mechanical Ventilation in ICU Patients

During Covid-19 pandemic many patients require mechanical ventilation due to disastrous impact of SARS-CoV-2 on lungs. In several countries there is a shortage of ICU beds and ventilators. Critically ill patients are treated outside ICUs. Doctors are facing ethical dilemmas who they should treat with ventilation, who should receive ventilator and who should but will not. In ICUs or step down units or in nursery homes there are also patients beyond hope treated - very often they are dependent on mechanical ventilation. Some attempts to invent a device that could replace complex machines in patients with anticipated poor outcome have been made. Ventil was used in clinical scenarios for separate lung ventilation with good effect. As a flow divider it has a potential to ventilate 2 patients at the same time. In the study Ventil will ventilate one patient and instead of the second there will be an artificial lung. Tidal volumes, minute ventilation, PEEP set and final will be checked. Ppeak, Pmean, Pplat, Cdyn, airway resistance, EtCO2, Sat O2, HR, SAP, DAP will be monitored every 2 hrs, as well as blood-gas analysis (every 8 hrs).

NCT04355754
Conditions
  1. Respiratory Insufficiency
Interventions
  1. Device: Ventil - a gas flow divider
MeSH:Respiratory Insufficiency Pulmonary Valve Insufficiency
HPO:Pulmonary insufficiency

Primary Outcomes

Description: Ventil will be removed from the patient-ventilator circiuit in case of episodes of desaturation <90% (in pts without COPD) without reversibel reason; need for FiO2 increase by 10%; need for switch to other than CMV mode of ventillation need for neuromucular blockade or for deepen sedation because of assynchrony between patient and venilator cummulation of CO2>45 mm Hg (in pts without COPD) not responding to the increase of minute ventilation for 30 minutes; if Pplat >30 cmH2O; in case of new haemodynamic disturbances that cannot be explaned by other reasons; in case of increase or decrease of BP by 20%; increase or decrease of HR by 20%; in case of occurence of clinically important heart rhythm disturbances

Measure: Number of cases in which it was necessary to stop using Ventil and to step- back to ventilation without this flow divider

Time: 48 hours
47 Non-Invasive Monitoring of Respiratory Function in Spontaneously Breathing Patients With COVID-19 Infection

This study uses the AirGo band to monitor changes in tidal ventilation in spontaneously breathing patients with COVID-19 associated respiratory failure. It aims to recognize patterns of ventilation associated with worsening respiratory failure in this patient population. If successful, this study will lead to the development of new robust methods for real-time, continuous monitoring of respiratory function in patients with respiratory failure. In turn, such monitoring methods may enable improvements in the medical management of respiratory failure and timing of interventions.

NCT04356443
Conditions
  1. Respiratory Failure
  2. Ventilatory Failure
  3. COVID-19
  4. Pneumonia
  5. ARDS, Human
Interventions
  1. Device: AirGo Respiratory Monitor
MeSH:Pneumonia Respiratory Insufficiency Respiratory Distress Syndrome, Adult Hypoventilation
HPO:Hypoventilation Pneumonia

Primary Outcomes

Description: Progression of respiratory failure to require endotracheal intubation (and mechanical ventilation)

Measure: Endotracheal intubation during present hospitalization, recorded through chart review

Time: Up to three weeks

Secondary Outcomes

Description: Maintenance of SpO2 >=90% on no or low flow supplemental oxygen (=< 1 liter by nasal cannula or CPAP, or return of supplemental oxygen to baseline if required supplemental O2 for another indication, prior to onset of COVID-19 infection)

Measure: Improvement in hypoxemia as indicated by oxygen saturation and requirement for supplemental oxygen, recorded through chart review

Time: Up to three weeks

Description: Patient or care provider may request removal of the band for any reason prior to the patient reaching the outcome

Measure: Premature need for removal of the band, recorded through investigator report

Time: Up to three weeks

Description: Death from any cause while in the hospital

Measure: In-hospital mortality, recorded through chart review

Time: Up to 24 weeks
48 suPAR-guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE Open-label, Non-randomized Single-arm Trial

In the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure. Also due to the potential co-existing immunodysfunction in the context of SARS-CoV-2 infection patients will also receive trimethoprim/sulfamethoxazole as part of chemoprophylaxis.

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

Primary Outcomes

Description: The primary study endpoint is the ratio of patients who will not develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered non-achieving the primary endpoint.

Measure: The ratio of patients who will not develop serious respiratory failure (SRF)

Time: Visit study day 14

Secondary Outcomes

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

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

Time: Visit study day 14

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

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

Time: Visit study day 1, visit study day 7

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

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

Time: Visit study day 1, visit study day 14

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

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

Time: Visit study day 1, visit study day 7

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

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

Time: Visit study day 1, visit study day 14

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

Measure: Change of cytokine production between days 1 and 7

Time: Visit study day 1, visit study day 7

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

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

Time: Visit study day 1, visit study day 7
49 Efficacy of Intravenous Almitrine in Reducing the Need for Mechanical Ventilation in Patients With Hypoxemic Acute Respiratory Failure Due to Covid-19-related Pneumonia: a Randomized Controlled Double-blind Study From the Skip-icu Consortium

The COVID-19 outbreak is associated with a surge in ICU bed requirement and substantial mortality (estimated between 0.5% and 3.6%). Admission in the intensive care unit (ICU) and need for mechanical ventilation is reportedly associated with an estimated hospital mortality of more than 30%. Furthermore, the surge in ICU bed requirement is a worldwide-shared issue, leading to sub-optimal ICU management. In acute respiratory failure due to COVID-19-related pneumonia, vasoplegia with vascular enlargement inside the lung lesions and dilation of small vessels seen on chest CT scan largely account for severe hypoxemia whose physiological response is hyperventilation leading to hypocapnia. Almitrine, initially described to reduce intrapulmonary shunt by enhancement of hypoxic pulmonary vasoconstriction in combination with inhaled nitric oxide (iNO), redistributes pulmonary blood flow from shunt areas to lung units with normal ventilation/perfusion (VA/Q) ratio. Low dose of intravenous almitrine (2 µg.kg-1.min-1) alone also improves oxygenation (without combination with iNO) by selective pulmonary vasoconstriction of precapillary pulmonary arteries perfusing lung areas exposed to a hypoxic challenge with a slight increase in mean arterial pulmonary. Therefore, our hypothesis is that 5 days of low dose of almitrine therapy may improve the ventilation-perfusion (VA/Q) ratio at a relatively early stage of this specific lung disease and limit respiratory worsening and subsequent need for mechanical ventilation.

NCT04357457
Conditions
  1. Covid 19
  2. Hypoxemic Respiratory Failure
Interventions
  1. Drug: Almitrine
  2. Drug: Placebo
MeSH:Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: Endotracheal intubation within 7 days after randomization Death will be considered as a failure (endotracheal intubation).

Measure: Rate of endotracheal intubation

Time: 7 days

Secondary Outcomes

Measure: 28-day mortality

Time: 28 days

Measure: In-hospital mortality

Time: 28-day

Measure: Number of ventilator-free days

Time: 28 days

Measure: Number of days in the ICU

Time: 28 days

Measure: Number of days in the hospital

Time: 28 days

Description: safety assessment: discontinuation rate of the treatment for arterial lactate more than 4 mmol/L, ALT/AST levels greater than 3 times the upper limit, and diagnosis of pulmonary arterial hypertension or acute cor pulmonale documented by echocardiography.

Measure: Discontinuation rate of the treatment

Time: 28 days
50 Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection: A Phase 2a Clinical Trial

The global pandemic COVID-19 has overwhelmed the medical capacity to accommodate a large surge of patients with acute respiratory distress syndrome (ARDS). In the United States, the number of cases of COVID-19 ARDS is projected to exceed the number of available ventilators. Reports from China and Italy indicate that 22-64% of critically ill COVID-19 patients with ARDS will die. ARDS currently has no evidence-based treatments other than low tidal ventilation to limit mechanical stress on the lung and prone positioning. A new therapeutic approach capable of rapidly treating and attenuating ARDS secondary to COVID-19 is urgently needed. The dominant pathologic feature of viral-induced ARDS is fibrin accumulation in the microvasculature and airspaces. Substantial preclinical work suggests antifibrinolytic therapy attenuates infection provoked ARDS. In 2001, a phase I trial 7 demonstrated the urokinase and streptokinase were effective in patients with terminal ARDS, markedly improving oxygen delivery and reducing an expected mortality in that specific patient cohort from 100% to 70%. A more contemporary approach to thrombolytic therapy is tissue plasminogen activator (tPA) due to its higher efficacy of clot lysis with comparable bleeding risk 8. We therefore propose a phase IIa clinical trial with two intravenous (IV) tPA treatment arms and a control arm to test the efficacy and safety of IV tPA in improving respiratory function and oxygenation, and consequently, successful extubation, duration of mechanical ventilation and survival.

NCT04357730
Conditions
  1. Severe Acute Respiratory Syndrome
  2. Respiratory Failure
  3. Acute Respiratory Distress Syndrome
Interventions
  1. Drug: Alteplase 50 MG [Activase]
  2. Drug: Alteplase 100 MG [Activase]
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Syndrome

Primary Outcomes

Description: Ideally, the PaO2/FiO2 will be measured with the patient in the same prone/supine position as in baseline, as change in positions may artificially reduce the improvement attributable to the study drug. However, given the pragmatic nature of the trial, the prone/supine position will be determined by the attending physician, in which case, we will use as an outcome the PaO2/FiO2 closest to the 48 hours obtained prior to the change in position as the outcome.

Measure: PaO2/FiO2 improvement from pre-to-post intervention

Time: at 48 hours post randomization

Secondary Outcomes

Description: Achievement of PaO2/FiO2 ≥ 200 or 50% increase in PaO2/FiO2 (whatever is lower)

Measure: Achievement of PaO2/FiO2 ≥ 200 or 50% increase in PaO2/FiO2

Time: at 48 hours post randomization

Description: This score is based on seven clinical features (respiration rate, hypercapnic respiratory failure, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness) and determines the degree of illness of a patient and prompts critical care intervention.

Measure: National Early Warning Score 2 (NEWS2)

Time: at 48 hours post randomization

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

Measure: National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale

Time: at 48 hours post randomization

Description: 48 hour mortality for hospitalized patients

Measure: 48 hour in-hospital mortality

Time: at 48 hours post randomization

Description: 14 days mortality for hospitalized patients

Measure: 14 days in-hospital mortality

Time: 14 days post randomization

Description: 28 days mortality for hospitalized patients

Measure: 28 days in-hospital mortality

Time: 28 days post randomization

Description: ICU-free days will be calculated based on (28 - number of days spent in the ICU) formula

Measure: ICU-free days

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)

Description: In-hospital coagulation-related events include bleeding, stroke, myocardial infarction and venous thromboembolism (VTE). In-hospital coagulation-related event-free (arterial and venous) days will be calculated based on (28 - number of days without coagulation-related event) formula.

Measure: In-hospital coagulation-related event-free (arterial and venous) days

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)

Description: Ventilator-free days will be calculated based on (28 - number of days on mechanical ventilation) formula.

Measure: Ventilator-free days

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)

Description: Calculated for patients who was on a mechanical ventilation any period of time during hospitalization. The extubation will be considered successful if no re-intubation occurred for more than 3 days have passed after the initial extubation.

Measure: Successful extubation

Time: Day 4 after initial extubation

Description: Calculated for patients who was on paralytics at the time of randomization. The weaning will be considered successful if no paralytics were used for more than 3 days have passed after termination of paralytics.

Measure: Successful weaning from paralysis

Time: Day 4 after initial termination of paralytics

Description: Is counted for the patients who was alive at the time of discharge.

Measure: Survival to discharge

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)
51 Plasma Adsorption in Patients With Confirmed COVID-19 Infection

To characterize the ability of the D2000 Cartridge in combination with the Optia SPD Protocol to reduce the morbidity and mortality associated with SARS-CoV-2 infection in patients admitted to the ICU.

NCT04358003
Conditions
  1. Respiratory Failure
  2. ARDS
Interventions
  1. Device: Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)
MeSH:Respiratory Insufficiency

Primary Outcomes

Measure: All-cause mortality

Time: Day 28

Secondary Outcomes

Description: Scale of 0-24 with a higher number indicating a worse outcome

Measure: Change in Sequential Organ Failure Assessment [SOFA] scores

Time: Day 28
52 Long Term Outcomes of Patients With COVID-19

The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.

NCT04360538
Conditions
  1. Critical Illness
  2. Corona Virus Infection
  3. Respiratory Failure
  4. Covid-19
Interventions
  1. Other: Quality of Life
  2. Other: Impact Event Score
  3. Other: Hospital anxiety and depression scale
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Critical Illness

Primary Outcomes

Description: SF-36 score

Measure: Quality of Life score

Time: up to 12 months after discharge

Secondary Outcomes

Description: Montreal Cognitive Assessment (MoCA) score

Measure: cognitive dysfunction

Time: up to 12 months after discharge

Description: (FSS-ICU)

Measure: Functional Status Score

Time: up to 12 months after discharge

Description: MRC neuromuscular Assessment

Measure: Physical Disability

Time: up to 12 months after discharge

Description: Impact Event Score

Measure: Psychological Sequelae

Time: up to 12 months after discharge

Other Outcomes

Description: hospital anxiety and depression scale

Measure: hospital anxiety and depression

Time: up to 12 months after discharge

Description: including ventilator associated pneumonia, GI hemorrhage, Deep Vein Thrombosis (DVT) /Pulmonary Embolus (PE), sacral decubitus ulcer, delirium, ICU acquired weakness

Measure: ICU related complications

Time: hospitalization up to 6 weeks

Description: measure the location (home, rehabilitation center, nursing home

Measure: hospital discharge location

Time: hospital discharge up to 6 weeks

Description: number of days admitted to the ICU

Measure: lCU length of stay

Time: hospitalization up to 6 weeks

Description: number of days admitted to the hospital

Measure: hospital length of stay

Time: hospitalization up to 6 weeks
53 COVID-19 in Liver Transplant Recipients in Spain: a Nationwide Prospective Study

Prospective observational study aimed at analyzing the incidence, clinical characteristics and outcomes of COVID-19 in LT in Spain.

NCT04361591
Conditions
  1. Liver Transplant; Complications
  2. COVID19
  3. Respiratory Failure
Interventions
  1. Other: Observational only
MeSH:Respiratory Insufficiency

Primary Outcomes

Measure: Incidence of COVID19 in LT recipients

Time: 12 months

Measure: Clinical characteristics of COVID19 in LT recipients

Time: 12 months

Measure: Survival and Mechanical ventilation / respiratory support

Time: 3 months

Measure: Observed treatments and immunosuppression management

Time: 12 months
54 Recovery in Patients With SARS-CoV-2 Associated Respiratory Failure

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of the current pandemic of coronavirus disease (COVID-19) that can lead to respiratory failure requiring oxygen therapy. Some patients develop acute respiratory distress syndrome (ARDS) and may die despite intensive care therapy. Currently it is unknown a) how fast patients recover after being discharged from hospital and b) what underlying predictors may influence recovery.

NCT04365595
Conditions
  1. SARS-CoV 2
  2. COVID
Interventions
  1. Other: Questionnaires, spirometry
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: European Quality of Life - 5 Dimensions - 5 Levels Instrument (EQ-5D-5L). Scoring: Index ranges from 1 to <0, with lower scores indicating more limitations.

Measure: Health-related quality-of-life

Time: 3 months

Secondary Outcomes

Description: Hospital Axiety and Depression Score (HADS). Scoring: Scores range from 0 to 42, with higher scores indicating more anxiety or depression symptoms.

Measure: Anxiety and depression

Time: 3 months

Description: COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms due to respiratory limitations.

Measure: Symptom burden

Time: 3 months

Description: Forced expiratory volume in one second (FEV1) in liters and percent predicted.

Measure: Spirometry

Time: 1 month

Description: Forced vital capacity (FVC) in liters and percent predicted.

Measure: Spirometry

Time: 1 month
55 Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization

Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes. Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for >12 hours in severe ARDS is strongly recommended by clinical practice guidelines. The aim of this study is to compare the outcomes of prone positioning versus usual care positioning in non-intubated patients hospitalized for COVID-19.

NCT04368000
Conditions
  1. Respiratory Failure
  2. COVID-19
Interventions
  1. Behavioral: Intermittent prone positioning instructions
  2. Behavioral: Usual care positioning with no instructions
MeSH:Respiratory Insufficiency

Primary Outcomes

Measure: Change in imputed partial pressure of oxygen over fraction of inspired oxygen (PaO2/FiO2) from peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)

Time: 72 hours

Secondary Outcomes

Measure: Change in imputed PaO2/FiO2 from SpO2/FiO2

Time: 48 hours

Measure: Proportion of participants requiring endotracheal intubation

Time: Up to 8 weeks

Measure: Proportion of participants requiring mechanical ventilation

Time: Up to 8 weeks

Measure: Proportion of participants transferred to intensive care for worsening respiratory failure

Time: Up to 8 weeks

Measure: Proportion of participants who had escalated oxygen delivery needs

Time: Up to 8 weeks

Measure: Average number of days hospitalized

Time: Up to 8 weeks

Measure: Average number of ventilator-free days

Time: Up to 8 weeks

Measure: Proportion of participants discharged from hospital on hospice

Time: Up to 8 weeks

Measure: Proportion of participants with all-cause inpatient mortality

Time: Up to 8 weeks
56 Platelet Inhibition With GP IIb/IIIa Inhibitor in Critically Ill Patients With Coronavirus Disease 2019 (COVID-19). A Compassionate Use Protocol

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

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

Primary Outcomes

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

Measure: P/F ratio

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

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

Measure: PaO2 difference

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

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

Measure: A-a O2 difference

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

Secondary Outcomes

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

Measure: CPAP duration

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

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

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

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

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

Measure: PaCO2 difference

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

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

Measure: HCO3- difference

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

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

Measure: Lactate difference

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

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

Measure: Hb difference

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

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

Measure: Plt difference

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

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

Measure: Adverse effects

Time: From the first day of study drugs administration until day 30 post study drugs administration
57 Main Features and Ventilatory Management of Patients With ARDS Caused by COVID-19

Patients with the acute respiratory distress syndrome (ARDS) have markedly varied clinical presentations. Main characteristics of mechanically ventilated ARDS caused by COVID-19, and adherence to lung-protective ventilation strategies are not well known.

NCT04368975
Conditions
  1. Acute Respiratory Failure With Hypoxia
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Measure: Discontinuation from mechanical ventilation

Time: 28 days
58 A Repeated Measures Trial of Temporary Automated Manual Ventilation Versus Noninvasive Oxygenation or Conventional Ventilation for the Treatment of COVID-19 ARDS

The COVID-19 pandemic has led to a potential shortage of life-saving mechanical ventilators. The purpose of this study is to determine whether a novel simpler to device, the automated bag-valve-mask (BVM) compressor, can be used to provide assisted ventilation temporarily to patients in need. This includes patients with COVID-19 lung infection and respiratory failure. If successful, this would increase the pool of total available ventilator hours to alleviate any shortage.

NCT04369274
Conditions
  1. Respiratory Failure
Interventions
  1. Device: Mechanical ventilation with the automated BVM compressor
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Arterial oxygenation obtained as measured by noninvasive pulse oximetry and arterial blood gas.

Measure: Arterial oxygenation

Time: Measurement 10 minutes after onset of initial period of automatic compressed ventilations

Description: Arterial oxygenation obtained as measured by noninvasive pulse oximetry and arterial blood gas.

Measure: Arterial oxygenation

Time: Measurement 20 minutes after onset of second period of automatic compressed ventilations

Secondary Outcomes

Description: Expired carbon dioxide (CO2) pressure will be measured continuously with a monitor in the airway circuit.

Measure: Expired pressure of carbon dioxide.

Time: 2 hour total study period.

Description: The pressure (cm H2O) of inspired and expired air in the airway circuit while the subject is mechanically ventilated will be measured continuously using a Nico monitor.

Measure: Airway pressure

Time: 2 hour total study period.

Description: Subject heart rate (beats per minute) will be measured continuously using a telemetry monitor,

Measure: Heart rate

Time: 2 hour total study period.

Description: Subject blood pressure (mm Hg) will be measured episodically every 5 minutes using an automated arm cuff.

Measure: Blood pressure

Time: 2 hour total study period.

Description: The flow (L/min) of inspired and expired air in the airway circuit while the subject is mechanically ventilated will be measured continuously using a Nico monitor.

Measure: Airway flow

Time: 2 hour total study period.

Other Outcomes

Description: The subject will be followed clinically to assess for recovery and survival or death.

Measure: Mortality

Time: Duration of hospitalization, up to 2 months
59 Construction of a Composite Clinical-echo Score Predictive of a Risk of Short-term Aggravation of Respiratory Impairment in Patients Suspected of Covid-19

With the influx of patients suspected of Covid-19 and the limited number of hospital beds, there is a need for sensitive triage to detect patients at risk of pulmonary complications and therefore requiring hospitalization, but also specific triage to safely discharge patients without risk factors or signs of clinical or ultrasound severity. The use of pulmonary ultrasound in addition to clinical assessment seems appropriate. Indeed, it allows early detection of signs of pneumopathy which, in the current context, most often correspond to Covid-19. These signs include B-lines, which indicate interstitial pulmonary oedema, and an anfractuous and thickened pleural line, or even centimetric parenchymal condensations with a low level of pleural effusion. Conversely, the presence of a medium to large pleural effusion is not very suggestive of the diagnosis of Covid-19. In addition, a lung ultrasound score has been developed and validated to assess the severity of acute respiratory distress and predict the occurrence of acute respiratory distress syndrome. It is based on the performance of a 12-point (6 per hemi-thorax) pulmonary ultrasound with the collection of the presence of B-lines, condensation or pleural effusion. In the hands of a trained operator, this examination takes only a few minutes. The aim of the study is to develop a score based on clinical and ultrasound evidence to allow early and safer referral than that based on clinical evidence alone. To do this, the study will retrospectively collect clinical and lung ultrasound data from departments that use this technique on a daily basis.

NCT04370249
Conditions
  1. Acute Respiratory Distress Syndrome
  2. COVID-19
Interventions
  1. Other: pulmonary ultrasound
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Respiratory Insufficiency

Primary Outcomes

Description: Multivariate model predictive of clinical worsening of respiratory impairment within 48 hours post-admission : intubation, oxygenotherapy, need of vasoactive drugs, worsening of state,age, gender, body surface, LUScore (pulmonary ultrasound), FiO2, need of ventral decubitus, risk factor (obesity, asthma...), time from the beginning of the first symptoms

Measure: Construction of a composite clinical-echo score (VIRUScore) predictive of risk of worsening respiratory impairment in COVID-19 adult patients admitted to the Emergency Department

Time: 48 hours post-admission

Secondary Outcomes

Description: Sensitivity, specificity, positive predictive value, negative predictive value of VIRUScore on risk of pulmonary aggravation

Measure: Evaluate the prognostic performance of the VIRUScore on the risk of pulmonary aggravation

Time: 48 hours post-admission

Description: Sensitivity, specificity, positive predictive value, negative predictive value of VIRUScore on the risk of severe pulmonary aggravation defined by resuscitation admission and/or death.

Measure: Evaluate the prognostic performance of the VIRUScore on the risk of severe pulmonary aggravation defined by resuscitation admission and/or death at D14 (sensitivity, specificity, positive predictive value, negative predictive value).

Time: 14 days post-admission

Description: Research of VIRUScore cut-off values maximizing the negative predictive value and construction of a decisional algorithm maximizing returns home and transfers to non-specialized hospitals or clinics without loss of individual chance.

Measure: Construction of a decisional algorithm for triage and management of COVID-19 patients.

Time: 14 days post-admission

Description: Search for "Ultrasound signature" (lung fields and/or severity of damage) associated with mild vs. moderate (oxygen therapy) vs. severe (resuscitation/death) clinical forms.

Measure: Search for "ultrasound signature" (lung fields and/or severity of involvement) associated with mild (return home) vs. moderate (oxygen therapy) vs. severe (resuscitation/death) clinical forms.

Time: 14 days post-admission

Description: Diagnostic concordance of the LUScore and CT score with the severity grades defined by the French Radiology Society

Measure: Evaluate the analytical concordance between the pulmonary ultrasound (LUScore) and the Gold-standard CT-scan (CT score)

Time: 14 days post-admission

Description: Predictive Score for Aggravation in Patients Returned Home

Measure: Construction of a score predictive of aggravation in the sub-population of patients returned home

Time: 14 days post-admission
60 Automated Quantification of Radiological Pulmonary Involvement in Acute Respiratory Failure

Acute respiratory failure (ARF) is a common condition and a common reason for urgent medical consultation. Assessing the extent of respiratory impairment is important to improve the management of patients with ARF. When Acute respiratory failure is caused by pathology of the pulmonary parenchyma, quantification of pulmonary radiographic involvement may be a component of the initial assessment of severity. This radiographic quantification would only be usable in clinical routine if it can be automated and provide a real-time result. The objective of this work is to assess the feasibility of an automated technique for quantifying radiological lung damage in situations of known or potential ARF.

NCT04374734
Conditions
  1. SARS (Severe Acute Respiratory Syndrome)
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Insufficiency

Primary Outcomes

Measure: Retrospective study of the relationship between severe forms of ARF and the extent of lung involvement

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

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

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

Primary Outcomes

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

Measure: Percentage of Participants Alive and Without Respiratory Failure

Time: Day 28

Secondary Outcomes

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

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

Time: Day 14

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

Measure: Median Reduction in Days Spent on Supplemental Oxygen

Time: Up to Day 28

Description: Percentage of participants with mortality from any cause.

Measure: All-Cause Mortality

Time: Up to Day 28

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

Measure: Percentage of Participants Experiencing Respiratory Failure or Death

Time: Up to Day 28

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

Measure: Mechanical Ventilation-Free Survival

Time: Up to Day 56

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

Measure: Days on Mechanical Ventilation

Time: Up to Day 56

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

Measure: Duration of hospitalization

Time: Up to Day 56

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

Measure: Time to Discharge

Time: Up to Day 56

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

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

Time: Up to Day 56

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

Measure: Oxygenation Index

Time: Up to Day 56

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

Measure: Number of Participants With Adverse Events

Time: Up to Day 56

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

Measure: Number of Participants With Abnormal Laboratory Findings

Time: Up to Day 56
62 A Phase II Study of IL-6 Receptor Antagonist Tocilizumab to Prevent Respiratory Failure and Death in Patients With Severe COVID-19 Infection

The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.

NCT04377659
Conditions
  1. COVID-19
Interventions
  1. Drug: Tocilizumab
MeSH:Infection Respiratory Insufficiency

Primary Outcomes

Description: The primary endpoint for this cohort is progression of respiratory failure (binary yes/no while hospitalized). Progression of respiratory failure will be defined as a sustained increase in oxygen requirement (FiO2) or need for intubation/mechanical ventilation.

Measure: Progression of respiratory failure or death

Time: 14 days
63 Prognostic Value of Point of Care Cardiac and Lung Ultrasound in COVID-19

This is a protocol-driven observational study of lung ultrasound and focused echocardiography images obtained in the Emergency Department (ED) and Intensive Care Unit (ICU) settings as a part of existing standard of care. The objectives of this study are as follows: 1. To characterize various clinical and cardiopulmonary ultrasound findings and describe their relationship with the clinical course of patients with COVID-19 in the ED and ICU. 2. To describe, develop, and validate a prediction tool that can accurately predict the need for invasive mechanical ventilation (IMV) and acute respiratory failure in COVID-19 patients using clinical, laboratory, and ultrasound data.

NCT04379544
Conditions
  1. Coronavirus
  2. Respiratory Failure
Interventions
  1. Other: Observation only
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Number of patients requiring invasive mechanical ventilation and suffers from acute respiratory failure.

Measure: Patient requires invasive mechanical ventilation and suffers from acute respiratory failure.

Time: 1 Year

Description: Number of patients that do not require hospitalization and is able to safely recover from COVID-19 at home.

Measure: Patient is discharged

Time: 1 Year

Description: Number of patients that must be hospitalized to recover from COVID-19, but does not require invasive mechanical ventilation and may or may not suffer from some degree of acute respiratory failure.

Measure: Patient is hospitalized, but does not require mechanical ventilation through the duration of hospital stay.

Time: 1 Year

Secondary Outcomes

Description: Any lung ultrasound findings including, but not limited to b-lines, a-lines, consolidations, pleural effusions and regularities. All of these findings are consolidated to a single score which will be the measure of the severity of lung ultrasound findings.

Measure: Lung ultrasound findings

Time: 1 year

Description: Any cardiac ultrasound findings including, but not limited to IVC status, pericardial effusions, LV EF (%), RV function. All of these findings are consolidated to a single score which will be the measure of the severity of cardiac ultrasound findings.

Measure: Cardiac ultrasound findings

Time: 1 year
64 Almitrine and Severe COVID-19 Patients in ICU [Almitrine et Patients COVID-19 en Reanimation (French)]

In severe COVID-19 pulmonary failure, the profound hypoxemia is mainly related to pulmonary vasodilation with altered hypoxic pulmonary vasoconstriction (HPV). Besides prone positioning, other non-ventilatory strategies may reduce the intrapulmonary shunt. This study has investigated almitrine, a pharmacological option used in standard care to improve oxygenation. A case control series of mechanically ventilated confirmed COVID-19 patients was recorded. At stable ventilatory settings, consecutive patients received two doses of almitrine (4 and 12 mcg/kg/min) at 30-45 min interval each, and were compared to 7 "control" COVID-matched patients conventionally treated. The end-point was the reduction of intra-pulmonary shunt, with an increase in partial pressure of arterial oxygen (PaO2) and central venous oxygen saturation (ScvO2).

NCT04380727
Conditions
  1. COVID-19
  2. Hypoxic Respiratory Failure
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Partial pressure of oxygen in arterial blood

Measure: Changes from baseline PaO2 (mmHg)

Time: 45 minutes after almitrine infusion

Description: central venous oxygen saturation

Measure: Changes from baseline ScvO2 (%)

Time: baseline and 45 minutes after almitrine infusion

Secondary Outcomes

Description: partial pressure of oxygen in arterial blood

Measure: Changes from baseline PaO2 (mmHg)

Time: 8 hours

Description: central venous oxygen saturation

Measure: Changes from baseline ScvO2 (%)

Time: 8 hours
65 High Flow Nasal Oxygen Versus Continuous Positive Airway Pressure Helmet Evaluation: A Randomized Crossover Trial in COVID-19 Pneumonia

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

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

Primary Outcomes

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

Measure: Ventilator-Free Days (VFD)

Time: 28 days

Secondary Outcomes

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

Measure: ICU and Hospital Length of Stay

Time: 28 days

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

Measure: Intubation

Time: 28 days

Description: Incidence of RRT after the time of enrollment

Measure: Renal Replacement Therapy (RRT)

Time: 28 days

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

Measure: Mortality

Time: 28 days, 90 days
66 Phase 2, Randomized, Controlled, Open Label Multi-center Study to Assess Efficacy and Safety of DFV890 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infected Patients With Coronavirus Disease 2019 (COVID-19) Pneumonia and Impaired Respiratory Function

The study will assess the efficacy and safety of DFV890 for the treatment of SARS-Cov-2 infected patients with COVID-19 pneumonia and impaired respiratory function.

NCT04382053
Conditions
  1. COVID 19 Pneumonia, Impaired Respiratory Function
Interventions
  1. Drug: DFV890
  2. Drug: Standard of Care (SoC)
MeSH:Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: The APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death. Worst case imputation for death will be applied.

Measure: APACHE II severity of disease score on Day 15 or on the day of discharge (whichever is earlier)

Time: up to Day 15

Secondary Outcomes

Description: C-reactive protein (CRP) is a blood test marker for inflammation in the body. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L). It will be analyzed on a log-scale fitting a repeated measures mixed model including treatment group, study day, the three stratification factors and log transformed baseline CRP as a covariate.

Measure: Serum C-reactive protein (CRP) levels

Time: up to Day 29

Description: Clinical status is measured with the 9-point ordinal scale. The scoring is - Uninfected patients have a score 0 (no clinical or virological evidence of infection). - Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as SpO2 ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)). - Patients who die have a score 8.

Measure: Clinical status over time

Time: up to Day 29

Description: Proportion of participants not requiring mechanical ventilation for survival.

Measure: Proportion of participants not requiring mechanical ventilation for survival.

Time: Day 15, Day 29

Description: Clinical status is measured with the 9-point ordinal scale. The scoring is - Uninfected patients have a score 0 (no clinical or virological evidence of infection). - Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as SpO2 ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)). - Patients who die have a score 8.

Measure: Proportion of participants with at least one-point improvement from baseline in clinical status

Time: Baseline, Day 15, Day 29
67 A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII)

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

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

Primary Outcomes

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

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

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

Secondary Outcomes

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

Measure: evaluate cytokine trends

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

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

Measure: evaluate supplemental oxygen requirements

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

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

Measure: decrease mortality of CoViD-19 patients

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

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

Measure: delay onset of ventilation

Time: From the time of randomization until the time of initiation of mechanical ventilation, assessed up to day of discharge or death, whichever occurs first,assessed up to 3 months
68 A Phase 2, Randomized, Placebo-controlled, Participant and Investigator Blinded, Multi-center Study to Assess Efficacy and Safety of MAS825 for the Treatment of SARS-CoV-2 Infected Patients With COVID-19 Pneumonia and Impaired Respiratory Function

The study will assess the efficacy and safety of MAS825 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function

NCT04382651
Conditions
  1. COVID-19 Pneumonia, Impaired Respiratory Function
Interventions
  1. Drug: MAS825
  2. Drug: Matching placebo
MeSH:Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: The APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death. Worst case imputation for death will be applied.

Measure: APACHE II severity of disease score on Day 15 or on day of discharge (whichever is earlier)

Time: Up to 15 days

Secondary Outcomes

Description: C-reactive protein (CRP) is a blood test marker for inflammation in the body. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L). It will be analyzed on a logscale fitting a repeated measures mixed model including treatment group, study day, the three stratification factors and log transformed baseline CRP as a covariate.

Measure: Serum C-reactive protein (CRP levels)

Time: Up to 15 days

Description: Ferritin is a blood test marker for inflammation in the body. For a standard Ferritin test, a normal reading is less than 300 micrograms per liter (μg/L). It will be analyzed on a logscale fitting a repeated measures mixed model including treatment group, study day, the three stratification factors and log transformed baseline Ferritin as a covariate.

Measure: Ferritin levels

Time: Up to 15 days

Description: Proportion of participants without the need for invasive mechanical ventilation for survival.

Measure: Proportion of participants without the need for invasive mechanical ventilation

Time: Day 15, Day 29

Description: Clinical status is measured with the 9-point ordinal scale. The scoring is - Uninfected patients have a score 0 (no clinical or virological evidence of infection). - Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities). -Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as SpO2 ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (noninvasive ventilation or highflow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)). - Patients who die have a score 8.

Measure: Proportion of participants with at least one level improvement in clinical status

Time: Day 15, Day 29

Description: Clinical status is measured with the 9-point ordinal scale. The scoring is - Uninfected patients have a score 0 (no clinical or virological evidence of infection). - Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities). -Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as SpO2 ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (noninvasive ventilation or highflow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)). - Patients who die have a score 8.

Measure: Clinical status over time

Time: Up to 15 days
69 A Prospective, Randomized, Open-label, Interventional Study to Investigate the Efficacy of Complement C5 Inhibition With Zilucoplan® in Improving Oxygenation and short-and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure

The study is a randomized controlled, open-label trial comparing subcutaneous Zilucoplan® with standard of care to standard of care alone. In the active group, Zilucoplan® will be administered subcutaneously once daily for 14 days or till discharge from the hospital, whichever comes first. The hypothesis of the proposed intervention is that Zilucoplan® (complement C5 inhibitor) has profound effects on inhibiting acute lung injury post COVID-19, and can promote lung repair mechanisms, that lead to a 25% improvement in lung oxygenation parameters. This hypothesis is based on experiments performed in mice showing that C5a blockade can prevent mortality and prevent ARDS in mice with post-viral acute lung injury. Eligible patients include patients with confirmed COVID-19 infection suffering from hypoxic respiratory failure defined as O2 saturation below 93% on minimal 2l/min O2 therapy and/or ratio PaO2/FiO2 below 350.

NCT04382755
Conditions
  1. COVID-19
Interventions
  1. Drug: Zilucoplan®
  2. Drug: Placebo
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: defined by Pa02/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio

Measure: Mean change in oxygenation

Time: at predose, day 6 and day 15 (or at discharge, whichever comes first)

Description: defined by Pa02/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio

Measure: Median change in oxygenation

Time: at predose, day 6 and day 15 (or at discharge, whichever comes first)

Secondary Outcomes

Measure: number of AE's (Adverse Events)

Time: during hospital admission (up to 28 days)

Measure: number of SAE's (Serious Adverse Events)

Time: during hospital admission (up to 28 days)]

Description: 6-point ordinal scale defined as Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: mean change in 6-point ordinal scale change

Time: between day 1 and respectively day 6, day 15 (or discharge, whichever comes first) and day 28 (by phone call).

Description: defined as independence from supplemental oxygen

Measure: Time since randomization until improvement in oxygenation

Time: during hospital admission (up to 28 days)

Description: defined as SpO2 < 93% breathing room air or the dependence on supplemental oxygen

Measure: Number of days with hypoxia

Time: during hospital admission (up to 28 days)

Measure: Number of days of supplemental oxygen use

Time: during hospital admission (up to 28 days)

Measure: Time to absence of fever (defined as 37.1°C or more) for more than 48h without antipyretic

Time: during hospital admission (up to 28 days)

Description: defined as 37.1°C or more

Measure: Number of days with fever

Time: during hospital admission (up to 28 days)

Measure: Mean change in CRP levels between day 1 and day 6

Time: day 1, day 6

Measure: Mean change in CRP levels between day 1 and day 15 (or discharge whichever comes first)

Time: day 1, day 15

Measure: Mean change in ferritin levels between day 1 and day 6

Time: day 1, day 6

Measure: Mean change in ferritin levels between day 1 and day 15 (or discharge, whichever comes first)

Time: day 1, day 15

Measure: Incidence of AE's

Time: during hospital admission (up to 28 days)

Measure: Incidence of SAE's

Time: at 10-20 weeks follow-up

Measure: Incidence of SUSAR's (Suspected Unexpected Serious Adverse Reaction)

Time: during hospital admission (up to 28 days)

Measure: Incidence of SAR's (Serious Adverse Reaction)

Time: during hospital admission (up to 28 days)

Measure: Duration of hospital stay

Time: during hospital admission (up to 28 days)

Measure: Duration of hospital stay in survivors

Time: during hospital admission (up to 28 days)

Description: SOFA score: 0 (best) - 24 (worse)

Measure: Mean change of SOFA score between day 1 and day 6 (or on discharge, whichever is first)

Time: day 1, day 6 or on discharge, whichever is first

Description: SOFA score: 0 (best) - 24 (worse)

Measure: Mean change of SOFA score between day 1 and day 15 or on discharge, whichever is first)

Time: day 1, day 15 or on discharge, whichever is first

Description: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale at randomization, day 6 and 15 (or discharge, whichever comes first) and day 28 (phone call)

Time: day 1, day 6, day 15 (or discharge, whichever comes first)

Description: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: 6-point Ordinal Scale at 6 and 15 days (or discharge whichever comes first) and day 28 (phone call), in relation to serum D-dimers and complement C5a levels at randomization

Time: day 1, day 6, day 15 (or discharge, whichever comes first)

Measure: Incidence of nosocomial bacterial or invasive fungal infection for 28 days (phone call) after enrolment in trial

Time: day 28

Measure: Time since randomization until first use of high-flow oxygen devices in non-ventilated patients

Time: during hospital admission (up to 28 days)

Measure: Time since randomization until first use of non-invasive mechanical ventilation in non-ventilated patients

Time: during hospital admission (up to 28 days)

Measure: Time since randomization until first use of invasive mechanical ventilation in non-ventilated patients

Time: during hospital admission (up to 28 days)

Measure: Number of ventilator-free days

Time: day 1, day 28 or discharge whichever comes first

Measure: Duration of invasive and non-invasive mechanical ventilation in ventilated patients

Time: during hospital admission (up to 28 days)

Measure: Duration of ICU stay in patients that enrolled in trial on invasive or non-invasive mechanical ventilation for less than 24h prior to or after randomization

Time: during hospital admission (up to 28 days)

Description: criteria-defined ARDS criteria-defined ARDS according to the adapted Berlin criteria as follow: within 1 week of a known Clinical insult or new or worsening respiratory symptoms bilateral infiltrates not supposed to be of cardiac origin or fluid overload PaO2/FiO2 < 300 mmHg

Measure: Time since randomization to progression to ARDS (Acute Respiratory Distress Syndrome)

Time: during hospital admission (up to 28 days)

Measure: Time to progression to ARDS in ventilated patients according to D-dimers at randomization

Time: during hospital admission (up to 28 days)

Measure: Time to progression to ARDS in ventilated patients according to complement C5a at randomization

Time: during hospital admission (up to 28 days)

Measure: All-cause mortality rate (excluding group that entered during ventilation)

Time: at day 28

Measure: All-cause mortality rate (including group that entered during ventilation)

Time: at day 28

Measure: Percentage of patients in clinical status on 6-point Ordinal Scale

Time: at 12-22 weeks follow-up

Measure: Incidence of lung function abnormalities at follow up

Time: at 12-22 weeks follow-up

Measure: Incidence of lung fibrosis on chest CT scan at follow up

Time: at 12-22 weeks follow-up

Measure: All cause mortality for the entire study population

Time: at follow up 12-22 weeks
70 Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation - Randomized, Controlled, Open-label Intervention, Multi-center Trial (CYCOV-II-study)

In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. The aim of the study is to investigate the influence of extracorporeal cytokine adsorption on interleukin-6-levels and time to successful ECMO explantation under controlled conditions in patients with particularly severe COVID-19 disease requiring extracorporeal membrane oxygenation.

NCT04385771
Conditions
  1. Coronavirus Infection
  2. COVID
  3. SARS-CoV 2
  4. Respiratory Failure
  5. Cytokine Storm
  6. Extracorporeal Membrane Oxygenation
Interventions
  1. Device: vv-ECMO + cytokine adsorption (Cytosorb adsorber)
  2. Device: vv-ECMO only (no cytokine adsorption)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)

Measure: IL-6 reduction by 75% or more after 72 hours as compared to the baseline measurement

Time: 72 hours

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

Measure: time to successful ECMO-explantation

Time: 30 days

Secondary Outcomes

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

Measure: Ventilator free days (VFD)

Time: 30 days

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

Measure: Time to extubation from ventilation and explantation from ECMO

Time: 30 days

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

Measure: Overall survival time

Time: 30 days

Description: Days on intensive care unit (ICU)

Measure: Days on intensive care unit (ICU)

Time: 30 days

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

Measure: Vasopressor dosage

Time: 24, 48, 72 hours

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

Measure: Fluid substitution and fluid balance

Time: 24, 48, 72 hours

Description: Serum lactate at 24, 48, 72 h

Measure: Serum lactate

Time: 24, 48, 72 hours

Description: Urine output at 24, 48, 72 h

Measure: Urine output

Time: 24, 48, 72 hours

Description: Willebrand factor at 24, 48, 72 h

Measure: Willebrand factor

Time: 24, 48, 72 hours

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

Measure: d-dimers

Time: 24, 48, 72 hours

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

Measure: interleukin-6 levels

Time: 24, 48, 72 hours

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

Measure: SOFA-Score

Time: 24, 48, 72 hours

Description: serious complications or malfunctions related to the CytoSorb device

Measure: serious adverse device effects

Time: 30 days

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

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

Time: 30 days

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

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

Time: 30 days

Description: major bleeding events

Measure: adverse event of special interest: bleeding complications

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

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

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

Primary Outcomes

Description: values of ROX index during ICU stay

Measure: Changes in ROX index

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

Secondary Outcomes

Description: percentage of patients requiring intubation

Measure: NHF failure

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

Description: level of flow used with NHF

Measure: NHF flow

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

Description: level of inspired fraction in oxygen used with NHF

Measure: NHF inspired fraction in oxygen

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

Description: level of pulse oxymetry during NHF therapy

Measure: oxygenation

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

Description: respiratory rate during NHF therapy

Measure: respiratory status

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

Description: defining the values of ROX index associated with intubation

Measure: prediction of intubation

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

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

Measure: prediction of NHF success

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
72 Is Photobiomodulation Therapy (PBMT) Combined With Static Magnetic Field (sMF) Able to Decrease the Intensive Care Unit (ICU) Length of Stay for Patients With COVID-19?

Coronavirus disease 2019 (COVID-19) is a disease caused by a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). The most characteristic symptom of patients with COVID-19 is respiratory distress, leading to inability to sustain spontaneous breathing. In addition, patients with COVID-19 have dyspnea and respiratory muscle fatigue. Therefore, it is necessary to use strategies that minimize the impact of COVID-19 on the respiratory muscles, accelerating the ventilatory weaning process and optimizing the functional capacity of the involved muscles. Over the past years, evidence has shown the effectivity of photobiomodulation therapy (PBMT) combined with static magnetic field (sMF) (PBMT/sMF) in delaying muscle fatigue, decrease in markers of inflammatory damage and oxidative stress of skeletal muscle. These effects result in an improvement in the functional capacity of the irradiated muscles by PBMT/sMF. However, do date, there is a lack of evidence regarding the effects of PBMT/sMF on the respiratory muscles. Therefore, the irradiation of PBMT/sMF may result in improvement in the functional capacity of respiratory muscles in patients with COVID-19, accelerating the ventilatory weaning process of the patients intubated due to respiratory failure. In addition, the irradiation of PBMT/sMF may induce the increase of anti-inflammatory mediators' activity in patients with COVID-19. Thus, the aim of this project is to investigate the effects of PBMT/sMF on respiratory muscles of patients admitted to the Intensive Care Unit (ICU) with COVID-19 using invasive mechanical ventilation.

NCT04386694
Conditions
  1. COVID-19
  2. Respiratory Failure
Interventions
  1. Device: Active PBMT/sMF
  2. Device: Placebo PBMT/sMF
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Number of days hospitalized in the ICU until discharge or death.

Measure: Time until discharge

Time: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days.

Secondary Outcomes

Description: Rate of how many people survived and were discharged and how many died.

Measure: Survival rate

Time: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days.

Description: Diaphragm thickness will be measured by ultrasound.

Measure: Diaphragm muscle function

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: Platelet count will be measured by blood test.

Measure: Platelet count

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: Leukogram will be measured by blood test.

Measure: Leukogram

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: Erythrogram will be measured by blood test.

Measure: Erythrogram

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: C-reactive protein will be measured by blood test.

Measure: C-reactive protein

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: D-dimer will be measured by blood test.

Measure: D-dimer

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: Immunoglobulin G will be measured by blood test.

Measure: Immunoglobulin G

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: Immunoglobulin M will be measured by blood test.

Measure: Immunoglobulin M

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: The levels of PEEP will be measured using a mechanical ventilator.

Measure: Levels of positive end-expiratory pressure (PEEP)

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: The levels of FiO2 will be measured using a mechanical ventilator.

Measure: Fraction of inspired oxygen (FiO2)

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: PO2 will be measured by arterial blood gas analysis.

Measure: Arterial partial pressure of oxygen (PO2)

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: PO2/FiO2 ratio will be measured by arterial blood gas analysis.

Measure: Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: Levels of TNF-α will be measured by blood test.

Measure: Levels of tumor necrosis factor-α (TNF-α)

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Description: Levels of vitamin D will be measured by blood test.

Measure: Levels of vitamin D

Time: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
73 Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic

Ophthalmologic damages secondary to COVID-19 coronavirus infection are little described. The ocular involvement is probably multiple, ranging from pathologies of the anterior segment such as conjunctivitis and anterior uveitis to disorders that threaten vision such as retinitis or optic neuropathy. On the other hand, in addition to this impairment, when patients are hospitalized for acute respiratory failure, complications related to possible resuscitation, medication prescriptions, positioning and oxygenation. COVID-19 itself, has several components: - An apoptotic action of the viral attack which will generate cellular destruction, whether pulmonary, cardiac or renal or maybe ocular - A secondary autoimmune action with the development of major vascular inflammation, possibly reaching the retinal, choroidal, and optic nerve vessels. A secondary "hyper" inflammatory syndrome with flashing hypercytokinemia and multi-organ decompensation is described in 3,7% to 4 ,3% of severe cases. - A thromboembolic action

NCT04387292
Conditions
  1. COVID19
  2. Ophthalmopathy
Interventions
  1. Procedure: Ophthalmologic exam
MeSH:Respiratory Insufficiency Eye Diseases
HPO:Abnormality of the eye

Primary Outcomes

Description: Multimodal ophthalmologic imaging

Measure: Description of the ophthalmological problems observed

Time: 6 months after discharge of hospitalization
74 Blood Ozonization in Patients With SARS-CoV-2 Respiratory Failure

Aim. The emerging outbreak of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread worldwide. Beside the prescription of some promising drugs as chloroquine, azithromycin, antivirals (lopinavir/ritonavir, darunavir/cobicistat) and immunomodulating agents (steroids, tocilizumab), in our patients with mild to moderate pneumonia due to SARS-CoV-2 we planned a randomize study to evaluate, respect the best available therapy (BAT), the use of autohemotherapy treatement with an oxygen/ozone (O3) gaseous mixture as adjuvant therapy. Design. Multicentric, randomized study. Participants. Clinical presentations are based upon clinical phenotypes identified by the Italian Society of Emergency and Urgency Medicine (SIMEU - Società Italiana di Medicina di Emergenza-Urgenza) and patients that meet criteria of phenotypes 2 to 4 were treat with best available therapy (BAT), and randomized to receive or not O3-autohemotherapy. Main outcome measures. The end-point were the time of respiratory improvement and earlier weaning from oxygen support: these parameters were included in the SIMEU clinical phenotypes classification.

NCT04388514
Conditions
  1. SARS-CoV-2 Respiratory Failure
Interventions
  1. Procedure: Medical Ozone procedure
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Evaluation of ABG paramethers the day after the last blood ozonization procedure (Day 3)

Measure: Time of respiratory improvement and earlier weaning from oxygen support

Time: 3 days

Description: Evaluation of ABG paramethers the one week after the last blood ozonization procedure (Day 10)

Measure: The time of respiratory improvement and earlier weaning from oxygen support

Time: 10 days

Secondary Outcomes

Description: Asse the lenghth of hospital stay in the two arms

Measure: Assessment of the length of hospitalization

Time: up to 90 days

Description: Asse the lenghth of ICU stay in the two arms

Measure: Assessment of the length of Intensive Care Unit (ICU) stay

Time: up to 90 days

Description: improving, worsening or stability of the chest imaging (chest CT, Chest XR and/or Point-of-Care Ultrasound) finding in the two arms

Measure: Improvment in chest imaging finding

Time: 10 days

Description: Evaluation of plasmatic cytochine (IL-6, lymphocyte typing for CD4, CD3, CD8, HLA-DR, CD45) response in the two arms

Measure: Improvment in cytokine release syndrome

Time: 10 days
75 A Phase 2/3 Study to Evaluate the Safety and Efficacy of Dociparstat Sodium for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure

A randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of DSTAT in patients with Acute Lung Injury (ALI) due to COVID-19. This study is designed to determine if DSTAT can accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.

NCT04389840
Conditions
  1. COVID-19
  2. Acute Lung Injury
  3. SARS-CoV-2
Interventions
  1. Drug: Dociparastat sodium
  2. Drug: Placebo
MeSH:Respiratory Insufficiency Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: Alive and free of invasive mechanical ventilation

Measure: Proportion of participants who are alive and free of invasive mechanical ventilation

Time: Through Day 28

Secondary Outcomes

Description: Time to all-cause mortality

Measure: All-cause mortality

Time: Through Day 28
76 COVID-19 Related Lockdown Effects On Chronic Diseases

The containment associated with the VIDOC-19 pandemic creates an unprecedented societal situation of physical and social isolation. Our hypothesis is that in patients with chronic diseases, confinement leads to changes in health behaviours, adherence to pharmacological treatment, lifestyle rules and increased psychosocial stress with an increased risk of deterioration in their health status in the short, medium and long term. Some messages about the additional risk/danger associated with taking certain drugs in the event of COVID disease have been widely disseminated in the media since March 17, 2020, the date on which containment began in France. This is the case, for example, for corticosteroids, non-steroidal anti-inflammatory drugs but also for converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (ARBs2). These four major classes of drugs are widely prescribed in patients with chronic diseases, diseases specifically selected in our study (corticosteroids: haematological malignancies, multiple sclerosis, Horton's disease; ACE inhibitors/ARAs2: heart failure, chronic coronary artery disease). Aspirin used at low doses as an anti-platelet agent in coronary patients as a secondary prophylaxis after a myocardial infarction can be stopped by some patients who consider aspirin to be a non-steroidal anti-inflammatory drug. Discontinuation of this antiplatelet agent, which must be taken for life after an infarction, exposes the patient to a major risk of a new cardiovascular event. The current difficulty of access to care due to travel restrictions (a theoretical limit in the context of French confinement but a priori very real), the impossibility of consulting overloaded doctors, or the cancellation of medical appointments, medical and surgical procedures due to the reorganization of our hospital and private health system to better manage COVID-19 patients also increases the risk of worsening the health status of chronic patients who by definition require regular medical monitoring. Eight Burgundian cohorts of patients with chronic diseases (chronic coronary artery disease, heart failure, multiple sclerosis, Horton's disease, AMD, haemopathic malignancy, chronic respiratory failure (idiopathic fibrosis, PAH) haemophilia cohort) will study the health impact of the containment related to the COVID-19 pandemic.

NCT04390126
Conditions
  1. Chronic Coronary Syndrome
  2. Heart Failure
  3. AMD and Macular Edema
  4. Chronic Respiratory Failure
  5. Hemophilia
  6. Malignant Hemopathy
  7. Multiple Sclerosis
  8. Horton's Disease
Interventions
  1. Other: life questionnaires
  2. Other: questionnaire
MeSH:Polymyalgia Rheumatica Respiratory Insufficiency Multiple Sclerosis Giant Cell Arteritis Macular Edema Chronic Disease
HPO:Cystoid macular edema Macular edema

Primary Outcomes

Description: increase in dose, decrease in dose, discontinuation or no change for each drug class)

Measure: % adherence to each pharmacological class

Time: during the period from 20 April 2020 to 7 May 2020

Description: (mortality, hospitalizations and relevant criteria for each pathology all related to the chronic disease)

Measure: number of occurrence of medical events at 1 year

Time: throughout the study for 12 months

Secondary Outcomes

Description: Smoking/Smoking/sweetening, Alcohol consumption/recovery, Decreased physical activity, Weight change

Measure: Expressed in %: Non-pharmacological treatment/lifestyle:

Time: during the period from 20 April 2020 to 7 May 2020

Measure: Expressed in %: Difficulties accessing care: medical appointments, prescriptions, medication

Time: during the period from 20 April 2020 to 7 May 2020

Measure: Measurement of psychological distress: Kessler's specific questionnaire (score between 0 and 24)

Time: during the period from 20 April 2020 to 7 May 2020
77 Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS

Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients. Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation. Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation. Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care. Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.

NCT04391140
Conditions
  1. COVID
  2. ARDS
  3. Acute Respiratory Distress Syndrome
  4. Acute Respiratory Failure
  5. Corona Virus Infection
Interventions
  1. Other: Prone position
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury

Primary Outcomes

Description: Therapeutic failure: death or intubation

Measure: Therapeutic failure death or intubation

Time: 28 days within randomization

Secondary Outcomes

Description: Comfort measurement using a visual-analog scale. Presence of complications related with prone position and the use of high-flow nasal cannula: Skin ulcers. Intravascular lines displacement HFNC related events (hot air feeling, nasal lesions)

Measure: Feasibility and safety of prone position in HFNC patients

Time: 28 days within randomization

Description: Evolution of the oxygenation (SpO2/FiO2) in prone position. Efficacy Length of HFNC therapy Length of ICU stay Length of mechanical ventilation (in those who require intubation) ICU and hospital mortality

Measure: Efficacy of prone position in HFNC patients

Time: 28 days within randomization
78 Effects of Cardiovascular and Pulmonary Optimisation on Cerebral Oxygenation in COVID-19 Patients With Severe ARDS

The aim of the present study is to examine whether cerebral oxygenation could be a more useful parameter than peripheral oxygen saturation to guide clinical titration of permissive hypoxemia in COVID-19 ARDS patients

NCT04392089
Conditions
  1. COVID-19
  2. Respiratory Failure
Interventions
  1. Device: Masimo, LidCO
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Cardiovascular and pulmonary optimization: Step 0 = Baseline, Step 1 = Derecruitment, Step 2 = Recruitment, Step 3 = Norepinephrine challenge, Step 4 = FiO2 increase, Step 5 = FiO2 decrease, Step 6 = Baseline 2

Measure: Changes in cerebral oxygenation (ScO2) during cardiovascular and pulmonary optimization

Time: 1 hour

Secondary Outcomes

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in peripheral oxygen saturation (SatO2) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in systolic arterial pressure (SAP) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in diastolic arterial pressure (DAP) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in mean arterial pressure (MAP) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in heart rate (HR) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in stroke volume (SV) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in cardiac output (CO) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in systemic vascular resistance (SVR) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in peripheral perfussion index (PPI) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in pH during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in PaO2 during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in PaCO2 during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in arterial saturation (SaO2) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in PvO2 during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in PvCO2 during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in mixed venous saturation (SvO2) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in lacatate during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in hemoglobine concentration (Hb) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Changes in muscular oxygenation (SmO2) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and peripheral oxygen saturation (SatO2) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and systemic arterial pressure (SAP) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and diastolic arterial pressure (DAP) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and mean arterial pressure (MAP) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and stroke volume (SV) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and heart rate (HR) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and cardiac output (CO) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and systemic vascular resistance (SVR) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and peripheral perfussion index (PPI) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and pH during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and PaO2 during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and PaCO2 during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and arterial saturation (SaO2) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and PvO2 during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and PvCO2 during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and mixed venous saturation (SvO2) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and lactate during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and hemoglobine concentration (Hb) during cardiovascular and pulmonary optimization

Time: 1 hour

Description: Cardiovascular and pulmonary optimization as described above

Measure: Association between cerebral oxygenation (ScO2) and muscular oxygenation (SmO2) during cardiovascular and pulmonary optimization

Time: 1 hour
79 A Phase 2/3, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ABX464 in Treating Inflammation and Preventing COVID-19 Associated Acute Respiratory Failure in Patients Aged ≥ 65 and Patients Aged ≥18 With at Least One Additional Risk Factor Who Are Infected With SARS-CoV-2.

A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing acute respiratory failure in patients aged ≥65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2 (the MiR-AGE study).

NCT04393038
Conditions
  1. COVID-19
Interventions
  1. Drug: ABX464
  2. Drug: Placebo
MeSH:Respiratory Insufficiency Inflammation

Primary Outcomes

Measure: Rate of patients with no invasive or non-invasive mechanical ventilation (IMV and NIV, respectively), but excluding simple nasal/mask oxygen supplementation, and who are alive

Time: at the end of the 28-day treatment period

Secondary Outcomes

Measure: Rate of patients hospitalized

Time: 28-day treatment period

Description: 7-point ordinal scale is defined as Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death

Measure: Percentage of patients reporting each severity rating on a 7-point ordinal scale

Time: 28-day treatment period

Measure: Change from enrolment in inflammatory markers in plasma and in immune phenotype and assessment of cell-activation markers in PBMCs

Time: at each study visit during the 28-day treatment period

Measure: Rate of patients requiring oxygen supplementation

Time: 28-day treatment period

Measure: Time to hospitalization

Time: 28-day treatment period

Measure: Time to assisted ventilation and oxygen supplementation

Time: 28-day treatment period

Measure: Change from baseline in microRNA-124 levels

Time: at each study visit during the 28-day treatment period

Measure: Change from baseline in CRP, Troponin I & T and D-dimer

Time: at each study visit during the 28-day treatment period

Description: Nasopharyngeal sample and/or in blood

Measure: SARS-CoV-2 viral load

Time: at each study visit during the 28-day treatment period

Measure: Number and rates of participants with Treatment Emergent Adverse Event

Time: 28-day treatment period
80 Inflammatory, Pulmonary, Physical & Neuropsychological Sequelae of COVID-19 Acute Respiratory Failure: A 1-Year Longitudinal Study

The novel SARS-CoV-2 virus has quickly spread worldwide, with substantial morbidity and mortality. There is very limited understanding of the short- and longer-term inflammatory/immunological and clinical course. However, the investigators expect survivors from severe COVID-19 to experience persistent functional impairments, as demonstrated in prior studies of patients with acute respiratory distress syndrome (ARDS) and other acute viral illnesses. Notably, however, few studies have ever investigated the biologic mechanisms underlying these functional impairments. Understanding these features of COVID-19 will improve the ability to design acute therapies and recovery-focused interventions. To address these knowledge gaps, the investigators propose a two-center, 225 patient longitudinal prospective cohort study of hospitalized COVID-19 patients with acute respiratory failure. Researchers will perform an in-depth evaluation of inflammatory/immunological biomarkers, and physical, pulmonary, and neuropsychological clinical outcomes during hospitalization, and over 3-, 6-, and 12-month follow-up.

NCT04393155
Conditions
  1. COVID-19
  2. Acute Respiratory Failure
Interventions
  1. Other: COVID-19+ observational
MeSH:Respiratory Insufficiency Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: Exercise capacity

Measure: Six minute walk distance (6MWD)

Time: 3 months after hospital admission

Secondary Outcomes

Description: Exercise capacity

Measure: Six minute walk distance (6MWD)

Time: 6 months, 12 months after hospital admission

Description: Symptoms of anxiety and depression. Both anxiety and depression subscales are scored from 0-21, with higher scores indicating more symptoms.

Measure: Hospital Anxiety and Depression Scale (HADS)

Time: 3 months, 6 months, 12 months after hospital admission

Description: Health-related quality of life. The EQ-5D-5L is scored from 0-100, with a higher score indicating better health status.

Measure: EuroQol Group standardized measure of health status (EQ-5D-5L)

Time: 3 months, 6 months, 12 months after hospital admission

Description: Mental and Cognitive Functioning. The MoCA-BLIND is scored from 1-22, with higher scores indicating better cognitive function.

Measure: MoCA-BLIND

Time: 3 months, 6 months, 12 months after hospital admission

Description: Health Care Utilization

Measure: Health Care Utilization Survey (HUS)

Time: 3 months, 6 months, 12 months after hospital admission

Description: Mortality

Measure: Death

Time: 3 months, 6 months, 12 months after hospital admission

Description: The maximum volume of gas expired when the patient exhales as forcefully and rapidly as possible after a maximal inspiration. Obtained by spirometry.

Measure: Forced vital capacity (FVC)

Time: 3 months, 6 months, 12 months after hospital admission

Description: Measure of the volume expired over the first second of an FVC maneuver. Obtained by spirometry

Measure: Forced expiratory volume in 1 second (FEV1)

Time: 3 months, 6 months, 12 months after hospital admission

Description: Gait speed

Measure: 4-meter timed walk

Time: 3 months, 6 months, 12 months after hospital admission

Description: Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.

Measure: Peripheral blood mononuclear cell type: CD4+ T cells (#cells/ml)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission

Description: Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.

Measure: Peripheral blood mononuclear cell type: CD8+ T cells (#cells/ml)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission

Description: Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.

Measure: Peripheral blood mononuclear cell type: B cells (#cells/ml)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission

Description: Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.

Measure: Peripheral blood mononuclear cell type: NK cells (#cells/ml)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission

Description: Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.

Measure: Peripheral blood mononuclear cell type: monocytes (#cells/ml)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission

Description: Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.

Measure: Circulating markers of inflammation: C-Reactive Protein (CRP) (mg/l)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission

Description: Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.

Measure: Circulating markers of inflammation: Interleukin 6 (IL-6) (pg/ml)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission

Description: Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.

Measure: Circulating markers of inflammation: Interleukin 8 (IL-8) (pg/ml)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission

Description: Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.

Measure: Circulating markers of inflammation: Interferon gamma (IFNg) (pg/ml)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission

Description: Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.

Measure: Circulating markers of inflammation: Interferon alpha (IFNa) (pg/ml)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission

Description: Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.

Measure: Circulating markers of inflammation: Tumor necrosis factor alpha (TNFa) (pg/ml)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission

Description: Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.

Measure: Circulating markers of inflammation: Interleukin 1 beta (IL-1b) (pg/ml)

Time: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
81 Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19

Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality. Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.

NCT04395144
Conditions
  1. Coron
  2. Coronavirus Infection
  3. COVID
  4. Severe Acute Respiratory Syndrome
  5. Respiratory Failure
  6. Respiratory Insufficiency
  7. Respiratory Distress Syndrome
  8. ARDS
  9. Lung Diseases
Interventions
  1. Procedure: Awake Prone Positioning
  2. Procedure: Standard care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Lung Diseases Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Pulmonary Valve Insufficiency Syndrome
HPO:Abnormal lung morphology Pulmonary insufficiency

Primary Outcomes

Measure: Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death

Time: Up to 28 days after randomization

Secondary Outcomes

Measure: Intubation rate

Time: Up to 28 days after randomization

Measure: Mortality

Time: Up to 28 days after randomization

Measure: Days spent on mechanical ventilation

Time: Until discharge, up to 24 weeks after randomization

Measure: Days spent in the ICU

Time: Until discharge, up to 24 weeks after randomization

Measure: Hospital stay (in days)

Time: From admission to discharge, up to 24 weeks after randomization

Other Outcomes

Description: Total time spent in prone position, as recorded by nursing or respiratory therapists

Measure: Time in prone position

Time: Up to 28 days post randomization

Description: Daily evolution of oxygenation

Measure: Oxygenation (SpO2/FiO2 ratio)

Time: Until HFNC weaning, or up to 14 days after randomization, whichever is first
82 Helmet Continuous Positive Airway Pressure Versus High-Flow Nasal Cannula in COVID-19: A Pragmatic Randomised Clinical Trial

We aim to investigate whether the use of Continuous Positive Airway Pressure using a Helmet device (Helmet CPAP) will increase the number of days alive and free of ventilator within 28 days compared to the use of a High Flow Nasal Cannula (HFNC) in patients admitted to Helsingborg Hospital, Sweden, suffering from COVID-19 and an acute hypoxic respiratory failure.

NCT04395807
Conditions
  1. COVID
  2. Acute Hypoxemic Respiratory Failure
Interventions
  1. Device: Helmet CPAP
  2. Device: HFNC
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Number of days alive and free of mechanical ventilation within 28 days. Patients who die within 28 days will be counted as 0 VFD. Time in ventilator will be counted in hours and rounded to whole days.

Measure: Ventilator-Free Days (VFD)

Time: 28 days

Secondary Outcomes

Description: Peripheral oxygen saturation divided by fraction of inspired oxygen

Measure: SpO2/FiO2-ratio

Time: 1 hour after randomisation

Description: Visual scale (1-10)

Measure: Patient comfort

Time: 24 hours after randomisation

Description: Min 0, Max 1

Measure: Frequency of endotracheal intubation

Time: 28 days

Description: Defined as pCO2 > 6 kPa in a venous blood gas. Min 0, Max ∞

Measure: Frequency of carbon dioxide rebreathing

Time: 28 days

Description: All-cause mortality. (180 days endpoint not in primary publication)

Measure: Days alive within

Time: 28 days and 180 days
83 A Randomized, Double Blind, Placebo-controlled Trial of Mavrilimumab for Acute Respiratory Failure Due to COVID-19 Pneumonia With Hyper-inflammation (the COMBAT-19 Trial)

This study is a prospective, phase II, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of mavrilimumab in hospitalized patients with acute respiratory failure requiring oxygen supplementation in COVID- 19 pneumonia and a hyper-inflammatory status. The study will randomize patients to mavrilimumab or placebo, in addition to standard of care per local practice. The total trial duration will be 12 weeks after single mavrilimumab or placebo dose.

NCT04397497
Conditions
  1. Covid-19
  2. Acute Respiratory Failure
  3. ARDS, Human
  4. Sars-CoV2
  5. Viral Pneumonia
Interventions
  1. Drug: Mavrilimumab
  2. Drug: Placebo
MeSH:Pneumonia, Viral Pneumonia Respiratory Insufficiency Respiratory Distress Syndrome, Adult Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Time to the absence of need for oxygen supplementation (time to first period of 24 hrs with a SpO2 of 94%) within day 14 of treatment, stated as Kaplan- Mayer estimates of the proportion of patients on room air at day 14 and median time to room air attainment in each arm

Measure: Reduction in the dependency on oxygen supplementation

Time: within day 14 of treatment

Secondary Outcomes

Description: Response is defined as a 7-point ordinal scale of 3 or less, i.e. no supplemental oxygen

Measure: Proportion of responders (using the WHO 7-point ordinal scale)

Time: Day 7, 14, and 28

Description: Time from date of randomization to the date with a 7-point ordinal scale of 3 or less, i.e. no supplemental oxygen

Measure: Time to response (using the WHO 7-point ordinal scale)

Time: Within day 28 of intervention

Description: Proportion of patients with at least two-point improvement in clinical status

Measure: Proportion of improving patients (using the WHO 7-point ordinal scale)

Time: At day 7, 14, and 28

Description: Time to resolution of fever (for at least 48 hours) in absence of antipyretics, or discharge, whichever is sooner

Measure: Time to resolution of fever

Time: Within day 28 of intervention

Description: COVID-19-related death

Measure: Reduction in case fatality

Time: Within day 28 of intervention

Description: Proportion of hospitalized patients who died or required mechanical ventilation (WHO Categories 6 or 7)

Measure: Proportion of patient requiring mechanical ventilation/deaths

Time: Within day 14 of intervention

Description: Change of the following serological markers over follow-up (C-reactive protein; Ferritin; D-Dimer)

Measure: Change in biochemical markers

Time: Within day 28 of intervention or discharge -whatever comes first

Description: Median changes of NEWS2 score from baseline

Measure: Median changes in the National Early Warning Score 2 (NEWS2)

Time: At day 7, 14, and 28

Description: Time to clinical improvement (as defined as a NEWS2 score of 2 or less maintained for at least 24 hours or discharge, whichever comes first)

Measure: Time to clinical improvement as evaluated with the National Early Warning Score 2 (NEWS2)

Time: Within day 28 of intervention or discharge -whatever comes first

Description: Variations from baseline to subsequent timepoints (when available) in terms of percentage of lung involvement, modifications in the normal parenchyma, ground glass opacities (GGO), crazy paving pattern,parenchymal consolidations, and evolution towards fibrosis.

Measure: Variations in radiological findings

Time: Within day 28 of intervention or discharge -whatever comes first

Description: Number of patients with treatment- related side effects (as assessed by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0), serious adverse events, adverse events of special interest, clinically significant changes in laboratory measurements and vital signs

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

Time: By day 84

Other Outcomes

Description: To evaluate the primary and secondary endpoints in different subgroups of patients: mild respiratory failure: PaO2/FiO2 ≤ 300 and > 200 mmHg; moderate respiratory failure: PaO2/FiO2 ≤ 200 and > 100 mmHg

Measure: Clinical efficacy of mavrilimumab compared to the control arm by clinical severity

Time: Within day 28 of intervention

Description: Median changes in serum IL-6

Measure: Changes in serum IL-6 (exploratory biomarker)

Time: By day 84

Description: Median changes in serum IL-1 receptor antagonist

Measure: Changes in serum IL-1RA (exploratory biomarker)

Time: By day 84

Description: Median changes in serum TNF-alpha

Measure: Changes in serum TNF-alpha (exploratory biomarker)

Time: By day 84

Description: Median variations in haemoglobin and leucocyte counts

Measure: Changes in CBC + differential (exploratory biomarker)

Time: By day 84

Description: Median titres od anti-SARS-CoV2 antibodies

Measure: Level of anti-SARS-CoV2 antibodies (exploratory biomarker)

Time: By day 84

Description: Proportion of patients with a positive swab for SARS-CoV2 by PCR

Measure: Virus eradication (exploratory biomarker)

Time: By day 84

Description: Proportion of patients who developed anti-drug antibodies

Measure: Anti-drug antibodies (exploratory biomarker)

Time: By day 84
84 Randomized Controlled Trial Of A Delivered Continuously By Nasal Cannula For The Treatment Of Patients With COVID-19 And Mild To Moderate Hypoxemia Requiring Supplemental Oxygen

This randomized, controlled trial will assess the efficacy and safety of pulsed iNO in subjects with COVID-19 who are hospitalized and require supplemental oxygen.

NCT04398290
Conditions
  1. COVID-19
  2. Hypoxemia
  3. Hypoxemic Respiratory Failure
Interventions
  1. Drug: Inhaled nitric oxide (iNO)
  2. Drug: Nitrogen gas
  3. Drug: Oxygen gas
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: As assessed per treating physician's discretion.

Measure: Incidence of treatment emergent adverse events

Time: Up to 14 days

Description: Incidence of hypoxemia and hypotension as assessed per treating physician's discretion.

Measure: Incidence of adverse events

Time: Up to 6 hours

Description: Incidence of increase to > 5% total methemoglobin as assessed by pulse oximetry.

Measure: Incidence of methemoglobinemia

Time: Up to 14 days

Secondary Outcomes

Description: Worsening respiratory status as defined by any one of the following: Implementation of High Flow Nasal Cannula (HFNC), non-rebreather mask, non-invasive ventilation, intubation and mechanical ventilation or need for intubation (in the event the patient is not intubated due to do not intubate (DNI) or do not resuscitate (DNR) status).

Measure: Number of participants with progression of respiratory failure

Time: Up to 14 days

Description: The number of days until hypoxemia is resolved as per treating physician assessment

Measure: Time until resolution of hypoxemia

Time: Up to 14 days

Description: Incidence of death during hospitalization and after discharge up to 28 days

Measure: Incidence of mortality

Time: Up to 28 days

Description: Number of days of hospitalization

Measure: Duration of hospitalization

Time: Up to 28 days
85 Mavrilimumab to Reduce Progression of Acute Respiratory Failure in Patients With Severe COVID-19 Pneumonia and Systemic Hyper-inflammation

The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.

NCT04399980
Conditions
  1. COVID 19
  2. SARS-CoV 2
  3. Pneumonia
Interventions
  1. Drug: Mavrilimumab
  2. Drug: Placebos
MeSH:Pneumonia Respiratory Insufficiency Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Number of subjects alive and off of oxygen

Measure: Proportion of subjects alive and off of oxygen at day 14

Time: Day 14

Secondary Outcomes

Description: Number of subjects that are alive

Measure: Proportion of subjects alive at 28 days

Time: Day 28

Description: Number of subjects alive and without respiratory failure

Measure: Proportion of subjects alive and without respiratory failure at 28 days

Time: Day 28
86 Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study

This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation.

NCT04401527
Conditions
  1. COVID-19
  2. Acute Respiratory Distress Syndrome
  3. Acute Respiratory Failure
Interventions
  1. Drug: Sodium Nitrite
  2. Drug: Normal Saline
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Lung Injury

Primary Outcomes

Description: Proportion of study subjects who are alive and free of respiratory failure at Day 28

Measure: Survival with Unassisted Breathing

Time: Day 28

Secondary Outcomes

Description: Number of days alive without mechanical ventilation from start of study through Day 28

Measure: Survival without Mechanical Ventilation

Time: Day 28

Description: Number of days alive and not in the intensive care unit from start of study through Day 28.

Measure: Survival without Intensive Care

Time: Day 28

Description: Number of days alive and not in hospital from start of study through Day 28.

Measure: Survival without Hospitalization

Time: Day 28

Description: Alive on Day 28 and no use of ECMO therapy any time between start of study and Day 28.

Measure: Survival without ECMO

Time: Day 28

Description: Alive on Day 28

Measure: Survival

Time: Day 28

Other Outcomes

Description: Oxygenation index (PaO2/FIO2) at Day 14

Measure: Lung Status

Time: Day 14

Description: Blood urea nitrogen (BUN) at Day 14

Measure: Kidney Status (1)

Time: Day 14

Description: Creatinine at Day 14

Measure: Kidney Status (2)

Time: Day 14

Description: Liver function tests (ALT and AST) at Day 14

Measure: Liver Status

Time: Day 14
87 A Prospective Randomized Trial of Prone Positioning Versus Usual Care for Patients With Do-not-intubate Goals of Care and Hypoxemic Respiratory Failure During the Coronavirus SARS-CoV-2 (COVID-19) Pandemic

The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.

NCT04402879
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. COVID-19
  3. Acute Respiratory Distress Syndrome
  4. ARDS
  5. Hypoxemic Respiratory Failure
Interventions
  1. Procedure: Prone Positioning (PP)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Syndrome

Primary Outcomes

Description: In-hospital mortality or discharge to hospice at Day 60.

Measure: Hospital mortality or discharge to hospice

Time: 60 days

Secondary Outcomes

Description: An Adverse Event (AE) is any unfavourable or other finding (including clinically significant laboratory tests), symptom or disease occurring during the during of the study, whether or not it is considered to be related to the medicinal (investigational) product, not explicitly classified elsewhere in this protocol, and whether or not it is expected. A Serious Adverse Event (AE) is any unfavourable medical finding (including clinically significant laboratory tests) at any dose that: Results in death (primary outcome) Is life threatening Results in persistent of significant disability or incapacity Requires in in-patient hospitalisation or prolongation of Hospitalisation

Measure: Adverse Events and Serious Adverse Events

Time: 60 days

Description: Change in SpO2 during each PP session (SpO2 in prone position - SpO2 prior to prone positioning). Clinicians will be asked to record this change for the first proning session per shift (for 12 hour shifts this will result in 2 proning sessions being documented per 24 hour period, and for 8 hour shifts this will result in 3 proning sessions being documented per 24 hour period).

Measure: Change in SpO2

Time: 60 days

Description: Number of hospital free days in the 60 days after enrolment.

Measure: Hospital free days

Time: 60 days

Description: Admission to the Intensive Care Unit.

Measure: Admission to ICU

Time: 60 days

Description: Patient is intubated and requires mechanical ventilation.

Measure: Intubation and mechanical ventilation

Time: 60 days

Description: Patient requires non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).

Measure: Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).

Time: 60 days

Description: The number of oxygen-free days at Day 60 (censored at discharge).

Measure: Oxygen-free days

Time: 60 days

Description: Time from admission to all-cause in-hospital death.

Measure: In-hospital death (time)

Time: 60 days

Description: Death at 90 days.

Measure: Death at 90 days

Time: 90 days
88 "STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE" GERONIMO 19

According to recent data, death rate is more than 20% for 75 years old hospitalized patients and older. In case of aggravation, according to the latest observations, if they are refused for mechanical ventilation in intensive care, their death rate could reach 60% even for patients without comorbidity. Apart from an increase in oxygen therapy, no specific treatment is currently proposed. The control of the inflammatory component seems to be a key element to be able to influence the patients' health evolution. Polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties with a favorable safety profile for these elderly patients and several clinical cases lead to positive impact in the caring for Covid patients. This study objective is evaluation of the efficacy of polyvalent IVIg in combination with the standard management of patients aged 75 and over with SARSCov2 infection with acute respiratory failure (saturation ≤ 95%) requiring oxygen therapy> 5 L / min (i.e. patients considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02≤200) and disqualified from a care in the ICU.

NCT04403269
Conditions
  1. Sars-CoV2
Interventions
  1. Drug: IgIV
MeSH:Respiratory Insufficiency

Primary Outcomes

Measure: Mortality

Time: Day 14

Secondary Outcomes

Measure: Total number of days of full hospitalization

Time: 3 and 6 months

Measure: Duration of oxygen therapy

Time: 3 and 6 months

Measure: Ferritin level in the blood

Time: 3 and 6 months

Measure: CRP level in the blood

Time: 3 and 6 months

Measure: LDH level in the blood

Time: 3 and 6 months

Measure: Lymphocyte level in the blood

Time: 3 and 6 months

Measure: PNN level in the blood

Time: 3 and 6 months

Measure: platelet level in the blood

Time: 3 and 6 months

Measure: WHO performance index

Time: 3 and 6 months

Measure: WHOQOL-OLD questionnaire

Time: 3 and 6 months

Measure: Lung function by pulmonary computed tomography

Time: 3 and 6 months

Measure: Lung function by EFR

Time: 3 and 6 months

Measure: Mortality

Time: 3 and 6 months

Measure: Readmission Rates

Time: 3 and 6 months
89 The Use of Oxygen Hoods as Compared to Conventional High-flow Oxygen Delivery Systems, the Effects on Oxygenation, Mechanical Ventilation and Mortality Rates in Hypoxic Patients With COVID-19. A Prospective Controlled Cohort Study.

To determine whether the use of oxygen hoods as compared to conventional high-flow oxygen delivery systems, and the effects on oxygenation, mechanical ventilation and mortality rates in hypoxic patients with COVID-19.

NCT04407260
Conditions
  1. COVID -19
  2. Respiratory Failure
  3. Hypoxia
Interventions
  1. Device: Oxygen Hood
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Continuous pulse oximetry monitoring

Measure: Oxygen saturation

Time: 3/6/2020 - 5/1/2020

Description: Intubation/mechanical Ventilation at any point during hospitalization.

Measure: In-hospital Intubation/Mechanical Ventilation Status

Time: 3/6/2020 - 5/1/2020

Description: In-hospital Mortality status

Measure: In-hospital Mortality

Time: 3/6/2020 - 5/1/2020

Description: Duration of hospitalization

Measure: Length of Hospitalization

Time: 3/6/2020 - 5/1/2020
90 Awake Proning in Patients With COVID-19-Induced Acute Hypoxemic Respiratory Failure

The purpose of this study is to retrospectively review clinical data to determine whether awake proning improves oxygenation in spontaneously breathing patients with COVID-19 severe hypoxemic respiratory failure.

NCT04408222
Conditions
  1. Oxygen Deficiency
  2. Coronavirus Infection
Interventions
  1. Other: Awake proning
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: SpO2 was measured by peripheral pulse oximetry.

Measure: Change in SpO2

Time: Before proning and 1 hour after initiation of the prone position

Secondary Outcomes

Description: The mean risk difference in intubation rates for patients with SpO2 ≥95% vs. <95% 1 hour after initiation of the prone position was assessed.

Measure: Mean Risk Difference in Intubation Rates

Time: Duration of hospitalization or up to 1 month from admission
91 AKI Biomarkers for Prediction of Acute Kidney Injury in Critically Ill Patients With COVID-19 and Respiratory Disease

This research aims to investigate the role of daily measurement of urinary cell cycle arrest markers and other serum and urinary biomarkers to predict the development of acute kidney injury in critically ill patients with COVID-19 and acute respiratory disease.

NCT04408248
Conditions
  1. COVID
  2. Acute Respiratory Failure
  3. Acute Kidney Injury
MeSH:Respiratory Insufficiency Acute Kidney Injury
HPO:Acute kidney injury

Primary Outcomes

Description: As defined by Kidney Diseases: Improving Global Outcome

Measure: Any stage of acute kidney injury

Time: 7 days

Secondary Outcomes

Description: Renal replacement therapy requirement at the clinicians' discretion

Measure: need for RRT in first 7 days

Time: 7 days

Description: ICU mortality

Measure: Mortality

Time: 7 and 28 days

Description: Duration

Measure: Duration of mechanical ventilation

Time: 7 and 28 days

Description: Duration

Measure: Duration of vasopressor support

Time: 7 and 28 days
92 Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial

Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days) vs late (after at least 10 days) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality will be evaluated and compared.

NCT04412356
Conditions
  1. Covid-19
  2. ARDS
  3. Tracheostomy Complication
  4. Respiratory Insufficiency
  5. Corona Virus Infection
Interventions
  1. Procedure: Tracheotomy
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Pulmonary Valve Insufficiency
HPO:Pulmonary insufficiency

Primary Outcomes

Description: Number of days without mechanical ventilation

Measure: Mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Number of days at ICU

Measure: ICU stay

Time: 28 days

Description: Number of days with need of additional oxygen support

Measure: Oxygen support

Time: 28 days

Description: Number of days with the need of sedation

Measure: Sedation

Time: 28 days

Description: Various adverse events associated with the tracheotomy/tracheostomy

Measure: Adverse events

Time: 28 days

Description: Mortality

Measure: Mortality

Time: 90 days
93 Efficacy and Safety of 72-hour Infusion of Prostacyclin (1 Nanogram(ng)/ Kilo(kg)/Minute(Min)) in Patients With COVID-19 Induced Pulmonary Endotheliopathy

The purpose of this trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 80 patients with COVID-19 suffering from respiratory failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in COVID-19 patients suffering from respiratory failure caused by endothelial breakdown, ultimately improving survival. Given that the pulmonary system, apart from the brain, is the most highly vascularized vital organ in the body, extensive endothelial damage is a central feature of acute respiratory distress syndrome (ARDS) with respiratory failure being the rationale for the current study COMBAT-COVID-19.

NCT04420741
Conditions
  1. COVID-19
  2. Respiratory Failure
Interventions
  1. Drug: Iloprost
  2. Drug: Isotonic saline
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Days alive without mechanical ventilation in the ICU within 28 days

Measure: Mechanical ventilation free days

Time: Until ICU discharge, maximun 28 days after randomization

Secondary Outcomes

Description: Vital status of the patient at day 28 and day 90

Measure: 28 and 90-day mortality

Time: Day 28 and 90 after randomization

Description: Mean daily modified SOFA score in the intensive care unit (scores for each of five systems range from 0 to 4, with higher scores indicating more severe dysfunction; range score 0-20).

Measure: Modified Sequential Organ Failure Assessment (SOFA)

Time: Until ICU discharge, maximun 90 days after randomization

Description: Days alive without vasopressor in the ICU within 28-and 90 days

Measure: Vasopressor free days

Time: Until ICU discharge, maximun 90 days after randomization

Description: Days without renal replacement in the ICU within 28 -and 90 days

Measure: Renal replacement free days

Time: Until ICU discharge, maximun 90 days after randomization

Description: Days alive without mechanical ventilation in the ICU within 90 days

Measure: Mechanical ventilation free days

Time: Until ICU discharge, maximun 90 days after randomization

Description: Numbers of serious adverse reactions within the first 7 days

Measure: Serious adverse reactions (SARs)

Time: Until day 7 after randomization

Description: Numbers of serious adverse events within the first 7 days

Measure: Serious adverse events (SAEs)

Time: Until day 7 after randomization
94 Data Collection on the Application of Cytokine Adsorption Therapy on Patients With Acute Respiratory Failure Caused by COVID-19

Severe sepsis and septic shock are some of the leading causes of mortality in intensive care unit (ICU) admitted COVID-19 patients. The main cause of early mortality is the uncontrolled release of inflammatory mediators leading to cardiovascular failure. CytoSorb, a recently developed, highly biocompatible hemadsorption device has been tested, which can selectively remove inflammatory mediators from the circulation. This device is currently commercially available, and in Europe, it has been approved for clinical use. Based on experience to date, this adsorption technique may influence the immune function; removing inflammatory mediators from the blood may improve organ functions and even increase the chances of survival. CYTOAID is an observational, non-interventional study to assess the effectiveness of early cytokine adsorption therapy in critically ill patients who have been admitted to the ICU because of COVID-19 infection. Data on the applied therapy on COVID-19 patients in ICU will be collected and analyzed. The patient's examination and therapy will be applied according to the current regulations at the clinics and the current professional standards. The study does not require any additional examination or intervention.

NCT04422626
Conditions
  1. SARS-CoV-2
  2. COVID-19
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Change in the PaO2/FiO2 ratio after CytoSorb therapy as compared to baseline

Measure: Change in the partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio after CytoSorb therapy

Time: 24 months

Secondary Outcomes

Description: Change in white blood cell count and c-reactive protein levels during treatment compared to the baseline

Measure: Change in inflammatory biomarker levels during treatment

Time: 24 months

Description: measured by sequential organ failure assessment (SOFA/sub-SOFA) score during treatment assessed by the treating physician

Measure: change in organ function

Time: 24 months

Description: given in days, assessed by the treating physician

Measure: length of stay in ICU

Time: 24 months

Description: given in days, assessed by the treating physician

Measure: length of hospital stay

Time: 24 months

Description: given in days, assessed by the treating physician

Measure: Duration of mechanical ventilation

Time: 24 months

Description: given in days, assessed by the treating physician

Measure: Duration of vasopressor therapy

Time: 24 months

Description: given in days, assessed by the treating physician

Measure: Duration of renal replacement therapy

Time: 24 months

Description: assessed by the treating physician

Measure: Occurrence of critical illness polyneuropathy and/or myopathy

Time: 24 months

Description: Number of patients progressing to the need for ECMO assessed by the treating physician

Measure: need for extracorporeal membrane oxygenation (ECMO)

Time: 24 months

Description: The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed.

Measure: cost calculation

Time: 24 months

Description: Number of patients with device-related adverse and serious adverse events assessed by the treating physician

Measure: device-related adverse and serious adverse events

Time: 24 months

Description: Number of patients, who died during their hospital stay, assessed by the treating physician

Measure: In-hospital mortality

Time: 24 months
95 the Effect of HFNC Treatment on Mortality and Length of ICU Stay in Patient With COVID-19 Pneumonia

coronavirus disease 2019 related pneumonia is causing acute respiratory failure and this is the most common reason for ICU admission. We have several different way for respiratory support. HFNC is one of the new technics for oxygen support. Our main purpose to observe the effect of HFNC on coronavirus disease 2019 patients' ICU stay and mortality.

NCT04424836
Conditions
  1. Coronavirus Infection
  2. Pneumonia, Viral
  3. Acute Respiratory Failure
Interventions
  1. Device: high flow nasal cannula device
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: the mortality rate of patients

Measure: short term mortality

Time: in 28 days.

Description: means the stay day of patients in intensive care unit

Measure: icu stay

Time: up to 28 days

Secondary Outcomes

Description: partial oxygen pressure, partial carbon dioxide pressure . both measured in mmhg

Measure: blood gases

Time: at the admission time and 24th hour
96 Handling Oxygenation Targets in COVID-19 Patients With Acute Hypoxaemic Respiratory Failure in the Intensive Care Unit: A Randomised Clinical Trial of a Lower Versus a Higher Oxygenation Target

Patients with COVID-19 and hypoxaemic respiratory failure and admitted to the intensive care unit (ICU) are treated with supplementary oxygen as a standard. However, quality of quantity evidence regarding this practise is low. The aim of the HOT-COVID trial is to evaluate the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen therapy in acutely ill adult COVID-19 patients with hypoxaemic respiratory failure at ICU admission.

NCT04425031
Conditions
  1. Hypoxemic Respiratory Failure
  2. Oxygen Toxicity
Interventions
  1. Drug: Oxygen
  2. Drug: Oxygen
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy

Measure: Days alive without organ support

Time: Within 90 days

Secondary Outcomes

Description: All-cause mortality 90 days after randomisation

Measure: 90-days mortality

Time: 90 days

Description: Percentage of days alive out of the hospital

Measure: Days alive out of the hospital

Time: Within 90 days

Description: Serious adverse events are defined as new episode of shock and new episodes of ischaemic events including myocardial or intestinal ischaemia or ischaemic stroke

Measure: Number of patients with one or more serious adverse events

Time: Until ICU discharge, maximum 90 days

Description: All-cause mortality 1 year after randomisation

Measure: 1-year mortality

Time: 1 year

Description: EQ-5D-5L 1-year after randomisation

Measure: Quality of life assessement using the EuroQoL EQ-5D-5L telephone interview

Time: 1 year

Description: RBANS score 1 year after randomisation at selected sites. The overall RBANS global cognition score, as well as each cognitive domain score, range from 40 to 160 with 100 ± 15 being the age-adjusted mean ± standard deviation. Higher scores indicate better performance.

Measure: Cognitive function 1-year after randomisation as assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score in selected sites

Time: 1 year

Description: Carbon monoxide diffusion capacity (DLCO) 1 year after randomisation at selected sites.

Measure: Carbon monoxide diffusion capacity

Time: 1 year

Description: Cost-effectiveness versus cost-minimisation analyses after completion of the trial, based on the primary outcome.

Measure: A health economic analysis

Time: 90 days
97 The Effect of Early Prone Position on Prognosis in Acute Respiratory Failure Due to Coronavirus Disease 2019 Pneumonia

the purpose of this study to evaluate the effect of early awake PP (prone position)application on oxygenation and intubation requirement in patients with acute respiratory failure due to coronavirus disease 2019 pneumonia.

NCT04427969
Conditions
  1. Coronavirus Infection
  2. Acute Respiratory Failure
Interventions
  1. Behavioral: prone position
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Insufficiency Respiratory Distress Syndrome, Adult
HPO:Pneumonia

Primary Outcomes

Description: the duration of icu stay day

Measure: intensive care unit stay

Time: up to 28 days

Description: mortality percent

Measure: short term mortality

Time: up to 28 days

Secondary Outcomes

Description: partial oxygen pressure: mmhg , partial carbondiocsit pressure mmhg

Measure: blood gases

Time: up to 24 hours
98 Effectiveness of Adding Standard Plasma or COVID-19 Convalescent Plasma to Standard Treatment, Versus Standard Treatment Alone, in Patients With Recent Onset of COVID-19 Respiratory Failure. A Randomized, Three-arms, Phase 2 Trial

To date no specific treatment has been proven to be effective for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2) infection. It is possible that convalescent plasma that contains antibodies to SARS-Cov-2 might be effective against the progression of infection. Promising results have been shown by preliminary data from China cases. The investigators planned to compare effectiveness of adding COVID-19 convalescent plasma to standard therapy protocol (STP) versus adding plasma donated in pre-COVID era versus STP alone in patient with COVID-19 within 5 days from the onset of respiratory distress. STP at enrolment is the best evidence based therapy approved for treatment of COVID patients by regional Health system emergency committee.

NCT04428021
Conditions
  1. COVID-19
Interventions
  1. Drug: Standard Therapy Protocol (STP)
  2. Other: STP + Standard Plasma (SP)
  3. Other: STP + COVID-19 Convalescent Plasma (CP)
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Proportion of patients alive 30 days after randomization

Measure: 30-days survival

Time: 30 days after randomization

Secondary Outcomes

Description: Cumulative incidence of mechanical ventilation or death

Measure: Ventilator free survival

Time: 30 days after randomization

Description: Probability of being alive at 6 months after randomization

Measure: 6-months survival

Time: 6 months after randomization

Description: Proportion of patients developing any serious medical or procedure related complications

Measure: Incidence of complications

Time: Within 12 months

Description: Proportion of days spent in ICU on the total length of hospital stay

Measure: Days in intensive care units (ICU)

Time: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 12 months

Description: Proportion of patients showing seroconversion to Immunoglobulin G (IgG) anti-SARS-Cov-2

Measure: Positivity for Immunoglobulin G to SARS-Cov-2

Time: On day 0, 2, 4, 6,10,14, 21, 28 after randomization and at date of discharge or death from any cause, whichever came first, assessed up to 12 months

Description: Proportion of patients showing viral clearance by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on plasma and respiratory tract samples

Measure: Clearance of viral load

Time: On day 0, 2, 4, 6,10,14, 21, 28 after randomization and at date of discharge or death from any cause, whichever came first, assessed up to 12 months

Description: Variations in SOFA Score (range 0-24; higher score mean a worse outcome)

Measure: Sequential Organ Failure Assessment (SOFA) score

Time: On day 0, 2, 4, 6, 10, 14, 28 after randomization and at date of discharge or death from any cause, whichever came first, assessed up to 12 months

Description: Proportion of patients needing introduction of new drug or discontinuation of drug from standard therapy protocol

Measure: Any variation from Standard Therapy Protocol

Time: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed daily up to 2 months
99 Epidemiological and Demographic Data From 150 Patients Diagnosed With Coronavirus Disease 2019 Pneumonia in Intensive Care Unit- a Retrospective, Observational Study in Istanbul, Turkey

In this study, the investigator examined epidemiological and demographic characteristics, risk factors and 28-day mortality of patients admitted to the intensive care unit with the diagnosis of coronavirus disease 2019 pneumonia.

NCT04430023
Conditions
  1. Corona Virus Infection
  2. Pneumonia
  3. Acute Respiratory Failure
Interventions
  1. Other: epidemiological and demographic characteristics
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: mortality rate

Measure: mortality

Time: up to 28 days

Description: Patients' age, gender, BMI, medical history

Measure: demographic characteristics

Time: up to 28 days
100 A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of PB1046, a Sustained-Release VIP (Vasoactive Intestinal Peptide) ANalogue, in Hospitalized COVID-19 Patients at HiGh Risk for Rapid Clinical Deterioration and ARDS (PB1046 VANGARD Study)

This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of PB1046 by improving the clinical outcomes and increasing days alive and free of respiratory failure in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.

NCT04433546
Conditions
  1. Acute Respiratory Distress Syndrome
  2. Coronavirus
  3. Hypoxic Respiratory Failure
  4. Hypoxemic Respiratory Failure
  5. Respiratory Complication
  6. Respiratory Insufficiency
  7. Cardiac Dysfunction
  8. Pneumonia
  9. Pulmonary Edema
  10. Pulmonary Inflammation
  11. Respiratory Failure
  12. Cytokine Storm
  13. COVID 19
  14. SARS-CoV-2
  15. Cardiac Event
  16. Cardiac Complication
  17. Cardiac Failure
  18. Cardiac Infarct
Interventions
  1. Drug: PB1046
  2. Drug: Low Dose (10 mg) Control
MeSH:Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Pulmonary Edema Pulmona Pulmonary Valve Insufficiency Heart Failure Syndrome Inflammation Clinical Deterioration
HPO:Congestive heart failure Left ventricular dysfunction Pneumonia Pulmonary edema Pulmonary insufficiency Right ventricular failure

Primary Outcomes

Measure: Days alive and free of respiratory failure from initiation of PB1046

Time: 28 days

Secondary Outcomes

Measure: Time to clinical recovery (being well enough for hospital discharge or returning to normal baseline activity level prior to discharge)

Time: 28 days

Description: PaO2:FiO2 ratio is the ratio of partial pressure of arterial oxygen to percentage of inspired oxygen

Measure: Development of ARDS (PaO2:FiO2 ratio < 300 mm Hg) during hospitalization

Time: Any time point between injection initiation and Day 28

Measure: All-cause mortality

Time: 28 days

Description: Composite of: Total hospital days, Total ICU days, Total days of ventilator use, Total days of ECMO, Total days of invasive hemodynamic monitoring, Total days of mechanical circulatory support, Total days of inotropic or vasopressor therapy

Measure: Reduction in hospital resource utilization defined as a composite of:total days: in hospital, in ICU, on ventilator, on ECMO, with invasive hemodynamic monitoring, with mechanical circulatory support, and with inotropic or vasopressor therapy

Time: 28 days

Measure: Time to clinical improvement as defined by reduction of at least 2 points on an 8-category ordinal scale of clinical improvement or discharge from hospital, whichever comes first.

Time: Any time point between injection initiation and Day 28

Measure: Change from baseline in cardiac marker high sensitivity troponin I (hsTnI)

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in cardiac marker NT-proBNP

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in TNF alpha

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in IL-1

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in IL-6

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by clinical adverse events (AEs) and their relationship to PB1046

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by vital signs and their relationship to PB1046

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by laboratory results and their relationship to PB1046

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by electrocardiogram (ECG) abnormalities and their relationship to PB1046

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by incidence of anti-drug antibodies and their relationship to PB1046

Time: Any time point between injection initiation and Day 35+7

Other Outcomes

Measure: Impact on invasive hemodynamic parameters as measured by pulmonary artery pressure if patients require right-heart catherization

Time: Any time point between injection initiation and Day 35+7

Measure: Impact on invasive hemodynamic parameters as measured by cardiac output if patients require right-heart catherization

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence of multi-system organ failure (MSOF)

Time: Any time point between injection initiation and Day 35+7

Measure: Number of multi-system organ failure (MSOF) free days

Time: Any time point between injection initiation and Day 35+7

Measure: Number of subjects requiring extracorporeal membrane oxygenation (ECMO)

Time: Any time point between injection initiation and Day 35+7
101 Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19

Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive effect on oxygen status and a decrease in the duration of respiratory failure

NCT04435353
Conditions
  1. Respiratory Distress Syndrome
  2. Hypoxemia
Interventions
  1. Device: VibroLUNG
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Regression of respiratory failure under the influence of vibroacoustic therapy

Measure: Recovery respiratory fail

Time: 5-7 days
102 Inhaled Iloprost for the Treatment of Suspected COVID-19 Respiratory Failure

Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by the rapid onset of widespread inflammation in the lungs. ARDS is thought to be the main cause of respiratory failure in COVID-19 patients. Research is still ongoing to further elucidate the different ARDS subtypes that may exist in COVID-19. It is crucial to find new targets for treatment and support of COVID-19 patients with respiratory failure.

NCT04445246
Conditions
  1. COVID-19
  2. ARDS, Human
  3. Hypoxemic Respiratory Failure
Interventions
  1. Drug: Inhaled ILOPROST
MeSH:Respiratory Insufficiency Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: change in oxygen saturation and PaO2/FiO2 ratio by 20% on day 6 compared to baseline values prior to Iloprost initiation.

Measure: change in oxygenation parameters

Time: 5 days

Secondary Outcomes

Description: likelihood to require intubation in the cohort treated with Iloprost

Measure: Rates of endotracheal intubation

Time: 28 days

Description: in days in the cohort treated with Iloprost

Measure: Invasive ventilation duration

Time: 28 days

Description: in days in the cohort treated with Iloprost

Measure: ICU length of stay

Time: 28 days

Description: in days in the cohort treated with Iloprost

Measure: Hospital Length of stay

Time: 28 days

Description: likelihood to require proning in the cohort treated with Iloprost

Measure: Rates of proning therapy

Time: 28 days

Description: likelihood to require ECMO cannulation in the cohort treated with Iloprost

Measure: Rates of ECMO cannulation

Time: 28 days

Description: likelihood to die of any cause within 28 days of initial hospital presentation

Measure: Mortality

Time: 28 days
103 Double Blind Randomized Phase 2 Placebo Controlled Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure

This Phase 2 Randomized Placebo Controlled Trial will determine if administering nebulized Dornase Alpha (rhDNase) to COVID-19 patients with respiratory failure is safe and will reduce 28-day mortality.

NCT04445285
Conditions
  1. Covid19
Interventions
  1. Drug: Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)
  2. Drug: 0.9%sodium chloride
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: All Cause Mortality at 28 days

Measure: Mortality at 28 days

Time: 28 days after enrollment

Description: To assess the effect of Pulmozyme® on the severity of respiratory failure, systemic inflammatory response, and multi-organ failure.

Measure: Systemic Therapeutic Response

Time: 5 days after enrollment

Secondary Outcomes

Description: Proportion of patients alive and free of invasive mechanical ventilation at 28 days invasive mechanical ventilation at 28 days

Measure: Respiratory Response

Time: 28 days

Description: Proportion of patients alive and discharged from the ICU at 28 days discharged from the ICU at 28 days

Measure: Legnth of ICU Stay

Time: 28 days

Description: Proportion of patients alive and discharged from the hospital at 28 days

Measure: Legnth of Hospital Stay

Time: 28 days

Description: Alive, respiratory failure-free days at 28 days

Measure: Respiratory Response

Time: 28 days

Description: Pulmonary Function Ratio at 5 days

Measure: Pulmonary Function

Time: 5 days
104 Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure: Multicentral Observational Study

Data on respiratory mechanics and gas exchange in acute respiratory failure in COVID-19 patients is limited. Knowledge of respiratory mechanics and gas exchange in COVID-19 can lead to different selection of mechanical ventilation strategy, reduce ventilator-associated lung injury and improve outcomes. The objective of the study is to evaluate the respiratory mechanics, lung recruitability and gas exchange in COVID-19 -associated acute respiratory failure during the whole course of mechanical ventilation - invasive or non-invasive.

NCT04445961
Conditions
  1. SARS Pneumonia
Interventions
  1. Diagnostic Test: Respiratory mechanics measurement
  2. Diagnostic Test: Gas exchange measurement
MeSH:Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)

Measure: Optimum positive end-expiratory pressure (PEEP) level

Time: On day 1 during mechanical ventilation

Description: Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)

Measure: Optimum positive end-expiratory pressure (PEEP) level

Time: On day 7 during mechanical ventilation

Description: Peripheral capillary oxygen saturation (SpO2) change from 90% after recruitment maneuver (doubled tidal volume for 15 respiratory cycles) - if peripheral capillary oxygen saturation (SpO2) after recruitment maneuver more than 95%-recruitable

Measure: Number of patients with recruitable lung

Time: On day 1 during mechanical ventilation

Description: Peripheral capillary oxygen saturation (SpO2) change from 90% after recruitment maneuver (doubled tidal volume for 15 respiratory cycles) - if peripheral capillary oxygen saturation (SpO2) after recruitment maneuver more than 95%-recruitable

Measure: Number of patients with recruitable lung

Time: On day 7 during mechanical ventilation

Secondary Outcomes

Description: Calculation of the alveolar dead space using end-tidal carbon dioxide measurement and arterial carbon dioxide tension measurement

Measure: Change in alveolar dead space

Time: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation

Description: Measurement of plethysmogram variability before and during recruitment maneuver

Measure: Change in plethysmogram variability during recruitment maneuver

Time: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation

Description: Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement

Measure: Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio

Time: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation

Description: Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)

Measure: Optimum positive end-expiratory pressure (PEEP) level

Time: On day 3, 5, 10, 14, 21 during mechanical ventilation

Description: Driving pressure calculation at different positive end-expiratory pressure (PEEP) levels (8, 10, 12, 14)

Measure: Change in driving pressure with different positive end-expiratory pressure (PEEP) levels

Time: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
105 DSC-COVID-19: An Open-label Study on the Safety and Efficacy of Decidual Stromal Cells in Respiratory Failure Induced by COVID-19

This is a research study to see how safe and effective decidual stromal cells are in treating patients with respiratory failure (breathing problem where not enough oxygen is passed from the lungs into the blood) caused by COVID-19.

NCT04451291
Conditions
  1. COVID-19
  2. Acute Respiratory Distress Syndrome
Interventions
  1. Biological: Decidual Stromal Cells (DSC)
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury

Primary Outcomes

Measure: Number of ventilator free days following infusion of decidual stromal cells

Time: 28 days

Secondary Outcomes

Measure: Mortality rate from COVID-19

Time: 28 days

Measure: Mortality rate from COVID-19

Time: 60 days

Measure: Mortality rate from COVID-19

Time: 180 days

Measure: All-cause morality rate

Time: 28 days

Measure: All-cause morality rate

Time: 60 days

Measure: All-cause morality rate

Time: 180 days

Measure: Average number of days in ICU

Time: 180 days

Measure: Average number of days of hospital admittance

Time: 180 days

Measure: Average days not requiring vasopressors

Time: 180 days

Measure: Overall survival rate

Time: 180 days

Measure: Average viral clearance

Time: 180 days

Measure: Average number of days of supplemental oxygenation

Time: 180 days

Measure: Average number of day without supplemental oxygen

Time: 180 days

Measure: Mean PaO2/FiO2 as compared to patient baseline

Time: 180 days
106 The Safety of High Flow Nasal Cannula and Noninvasive Ventilation for Treatment of Patients With COVID-19 Complicated by Respiratory Failure

Background: Patients with COVID-19 have a range of clinical spectrum from asymptomatic infection, mild illness, moderate infection requiring supplemental oxygen and severe infection requiring intensive care support. High flow nasal cannula (HFNC) oxygen therapy and noninvasive ventilation (NIV) may offer respiratory support to patients with COVID-19 complicated by acute hypoxemic respiratory failure if conventional oxygen therapy (COT) fails to maintain satisfactory oxygenation but whether these respiratory therapies would lead to airborne viral transmission is unknown. Aims: This study examines whether SARS-2 virus can be detected in small particles in the hospital isolation rooms in patients who receive a) HFNC, b) NIV via oronasal masks and c) conventional nasal cannula for respiratory failure. Method: A field test to be performed at the Prince of Wales hospital ward 12C single bed isolation room with 12 air changes/hr on patients (n=5 for each category of respiratory therapy) with confirmed COVID-19 who require treatment for respiratory failure with a) HFNC up to 60L/min, b) NIV via oronasal masks and c) conventional nasal cannula up to 5L/min of oxygen. While the patient is on respiratory support, we would position 3 stationary devices in the isolation room (one next to each side of the bed and another at the end of the bed) of the patient with confirmed COVID-19 infection, and sample the air for four hours continuously. Results & implications: If air sampling RTPCR and viral culture is positive, this would objectively confirm that HFNC and NIV require airborne precaution by healthcare workers during application.

NCT04452708
Conditions
  1. Respiratory Failure
Interventions
  1. Device: HFNC
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: quantitative RTPCR from air samples

Measure: detection of viral RNA from one or more participants' air samples

Time: within 4 hours after starting respiratory therapy

Secondary Outcomes

Description: quantitative RTPCR from upper airway swab

Measure: the nasopharyngeal flocked swab and throat swab viral load (log10 copies/mL)

Time: up to 2 weeks
107 RLF-100 (Aviptadil) Intermediate Population Expanded Access Protocol

Patients with Critical COVID-19 and respiratory failure who are ineligible for enrollment in NCT04311697, who live more than 50 miles from an existing collaborating research center, or who are already hospitalized and cannot safely be transferred to a collaborating research facility may be considered for expanded access by the sponsor. Treating physicians must complete FDA Form 3396 and receive a letter of authorization from NeuroRx, along with local IRB authorization. Please refer to FDA guidance for Individual Patient Expanded Access https://www.fda.gov/media/91160/download

NCT04453839
Conditions
  1. Critical COVID-19 With Respiratory Failure
Interventions
  1. Drug: RLF-100 (aviptadil)
MeSH:Respiratory Insufficiency

108 Risk Factors, Personalized Prognoses and 1-year Follow-ups of Patients Admitted to Spanish Intensive Care Units Due to COVID-19

The latest epidemiological data published from Chine reports that up to 30% of hospital-admitted patients required admission to intensive care units (ICU). The cause for ICU admission for most patients is very severe respiratory failure; 80% of the patients present with severe acute respiratory distress syndrome (SARS) that requires protective mechanical ventilation. Five percent of patients with SARS require extracorporeal circulation (ECMO) techniques. Global mortality data has been thus far reported in different individual publications from China. Without accounting for those patients still admitted to hospital, bona fide information (from a hospital in Wuhan) received by the PI of this project estimates that mortality of hospitalized patients is more than 10%. Evidently, mortality is concentrated in patients admitted to the ICU and those patients who require mechanical ventilation and present with SARS. As data in China was globally reported, risk factors and prognosis of patients with and without SARS who require mechanical ventilation are not definitively known. The efficacy of different treatments administered empirically or based on small, observation studies is also not known. With many still admitted at the time of publication, a recent study in JAMA about 1500 patients admitted to the ICU in the region of Lombardy (Italy) reported a crude mortality rate of 25%. The data published until the current date is merely observational, prospective or retrospective. Data has not been recorded by analysis performed with artificial intelligence (machine learning) in order to report much more personalized results. Furthermore, as it concerns patients admitted to the ICU who survive, respiratory and cardiovascular consequences, as well as quality of living are completely unknown. The study further aims to investigate quality of life and different respiratory and cardiovascular outcomes at 6 months, as well as crude mortality within 1 year after discharge of patients with COVID-19 who survive following ICU admission. Lastly, with the objective to help personalize treatment in accordance with altered biological pathways in each patient, two types of studies will be performed: 1) epigenetics and 2) predictive enrichment of biomarkers in plasma. Hypothesis - A significant percentage of patients (20%) admitted to the hospital with COVID-19 infection is expected to require ICU admission, and need mechanical ventilation (80%) and, in a minor percentage (5%), ECMO. - Patients who survive an acute episode during ICU hospitalization will have a yearly accumulated mortality of 40%. Those who then survive will have respiratory consequences, cardiovascular complications and poor quality of life (6 months).

NCT04457505
Conditions
  1. Acute Respiratory Distress Syndrome
  2. Severe Pneumonia
  3. Respiratory Failure
MeSH:Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury
HPO:Pneumonia

Primary Outcomes

Description: People who died after one year of follow up

Measure: One year mortality

Time: At 12 months of ICU admission

Description: People who died after one year of follow up

Measure: Six month mortality

Time: At 6 month of ICU admission
109 Mavrilimumab to Reduce Progression of Acute Respiratory Failure in Patients With Severe COVID-19 Pneumonia and Systemic Hyper-inflammation

The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.

NCT04463004
Conditions
  1. COVID-19
  2. Sars-CoV2
  3. Pneumonia
Interventions
  1. Drug: Mavrilimumab
  2. Drug: Placebos
MeSH:Pneumonia Respiratory Insufficiency Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Number of subjects alive and off of oxygen

Measure: Proportion of subjects alive and off of oxygen at day 14

Time: 14 days

Secondary Outcomes

Description: Number of subjects alive and without respiratory failure

Measure: Proportion of subjects alive and without respiratory failure at 28 days

Time: 28 days
110 To Determine the Efficacy of Neurokinin 1 Receptor Antagonist as a Therapeutic Tool Against Cytokine Storm and Respiratory Failure in Covid-19 Patients

This is a randomized, randomized controlled trial to investigate the efficacy and safety of Neurokinin-1 Receptor (NK-1R) 80 mg orally given daily to treat cytokine storm causing inflammatory lung injury and respiratory failure associated with severe or critical COVID-19 infection. NK-1R is the receptor of Substance P (SP) and responsible for its functionality. Here, we propose that SP via its tachykinin receptor, NK-1R may cause inflammation in Covid-19 infection. It may initiate the cytokine storming via binding to its receptor NK-1 and many inflammatory mediators are released. If SP release is reduced by NK-1R antagonist, it may control the cytokine storming and hence the hyper-responsiveness of the respiratory tract through reduction in cytokine storming It may serve as the treatment strategy for Covid-19 infected patients. Patients fulfilling the inclusion criteria will be enrolled after giving consent. They wll be randomized to treatment with either NK-1R antagonist or placebo in addition to Dexamethasone as a standard treatment given to both groups for Covid-19 infection as per the protocol at the treating hospital. 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.

NCT04468646
Conditions
  1. Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus
Interventions
  1. Drug: NK-1R antagonist
MeSH:Coronavirus Infections Respiratory Insufficiency Inflammation

Primary Outcomes

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

Time: 14 days or discharge

Secondary Outcomes

Measure: total in-hospital days and the total duration

Time: 14 days or discharge

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: 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
111 Elmo Respiratory Support Project for Patients With Hypoxemic Respiratory Insufficiency in Covid-19: Proof Of Concept and Usability

The number of COVID-19 cases has been growing exponentially, so that the industrialized economies are facing a significant shortage in the number of ventilators available to meet the demands imposed by the disease. Noninvasive ventilatory support can be valuable for certain patients, avoiding tracheal intubation and its complications. However, non-invasive techniques have a high potential to generate aerosols during their implementation, especially when masks are used in which it is virtually impossible to completely prevent air leakage and the dispersion of aerosols with viral particles. In this context, a helmet-like interface system with complete sealing and respiratory isolation of the patient's head can allow the application of ventilatory support without intubation and with safety and comfort for healthcare professionals and patients. This type of device is not accessible in Brazil, nor is it available for immediate import, requiring the development of a national product. Meanwhile, a task force under the coordination of the School of Public Health (ESP) and Fundação Cearense de Apoio à Pesquisa (FUNCAP), with support from SENAI / FIEC and the Federal Universities of Ceará (UFC) and the University of Fortaleza (UNIFOR) advanced in the development of a prototype and accessory system capable of providing airway pressurization through a helmet-type interface, which was called the Elmo System.

NCT04470258
Conditions
  1. COVID-19
  2. Respiratory Failure With Hypoxia
Interventions
  1. Other: ELMO PROJECT AT COVID-19: STUDY IN HUMANS
  2. Device: ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Usability test with the description of the identified problems of the main basic skills necessary for the correct handling of the non-invasive respiratory device (ELMO), through realistic simulations, severity scale and usability.

Measure: Usability tests of the Elmo system using Euristic usability principles

Time: One week after all tests

Description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through peripheral oxygen saturation (%) before, during and after the application of Elmo.

Measure: Evaluation of the effectiveness of the ELMO system using physiological parameters

Time: One week after all tests

Secondary Outcomes

Description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through respiratory rate (irpm) before, during and after the application of Elmo.

Measure: Evaluation of the effectiveness of the ELMO system using physiological parameters

Time: One week after all tests

Description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through heart rate before, during and after the application of Elmo.

Measure: Evaluation of the effectiveness of the ELMO system using physiological parameters

Time: One week after all tests

Description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through blood pressure before, during and after the application of Elmo.

Measure: Evaluation of the effectiveness of the ELMO system using physiological parameters

Time: One week after all tests

Description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through CO2 measurement at the end of exhalation (mmHg) before, during and after the application of Elmo.

Measure: Evaluation of the effectiveness of the ELMO system using physiological parameters

Time: One week after all tests
112 Use of Lung Ultrasound for COVID-19 Patient's Initial Triage Assessment and Early Monitoring: a Pilot Study

The QUICK study main aim is to assess the predictive value at Day 1, of a model built on lung ultrasound (LUS) and clinical data, both recorded at hospital admission of COVID-19 patients.

NCT04474236
Conditions
  1. COVID-19
  2. Acute Respiratory Failure
  3. Triage
  4. Lung Ultrasound
  5. CT Scan
Interventions
  1. Other: thoracic lung ultrasound
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Area Under the Curve (AUC) of a predictive model at 24h from hospital admission (Favorable vs Unfavorable), built on LUS (12 thoracic regions) and clinical (Q-SOFA, SpiO2/FiO2) data recorded at hospital admission.

Measure: Area Under the Curve (AUC) of a predictive model built on LUS and clinical (Q-SOFA, SpiO2/FiO2) data

Time: Day 1

Secondary Outcomes

Description: Area Under the Curve (AUC) of a predictive model at 24h from hospital admission (Favorable vs Unfavorable), built on CT scan and clinical (Q-SOFA, SpiO2/FiO2) data recorded at hospital admission.

Measure: Area Under the Curve (AUC) of a predictive model built on CT scan and clinical (Q-SOFA, SpiO2/FiO2) data

Time: Day 1

Description: mortality

Measure: mortality

Time: Day 28
113 Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units

Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This syndrome has been associated with high mortality, estimated to be about 1.7% of all infected in the US, though in those who develop acute respiratory distress syndrome (ARDS) in the context of the infection, mortality rates appear to be much higher, perhaps up to 70%. To avoid transmission of the virus, patient isolation has become the standard of care, with many hospitals eliminating visitors of any type, and particularly eliminating visitation to patients infected with COVID-19. These necessary, but restrictive, measures add stress to the ICU and particularly to the family members who are not only left with fear, but also many unanswered questions. In contrast to the Society of Critical Care Guidelines (SCCM) which recommend family engagement in the ICU and recent data from this study team which suggests engaging families in end-of-life situations reduces symptoms of Post-Traumatic Stress Disorder (PTSD) in family members, family members are now unable to say good-bye and unable to provide support to their loved-one throughout the process of the patients' ICU stay. The study hypothesizes is that these restrictive visiting regulations will increase rates of Post-intensive care syndrome- family (PICS-F) which includes symptoms of PTSD, depression, and anxiety and aim to evaluate for factors that either exacerbate these symptoms or protect from them.

NCT04476914
Conditions
  1. Respiratory Failure
  2. SARS-CoV 2
  3. Corona Virus Infection
  4. Post Intensive Care Unit Syndrome
  5. Family Members
  6. Post Traumatic Stress Disorder
  7. Anxiety
  8. Depression
MeSH:Coronavirus Infections Severe Acute Respiratory Syn Severe Acute Respiratory Syndrome Respiratory Insufficiency Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Using Impact of Events Scale-Revised-6 , family members will be screened for symptoms of PTSD. Scale returns scores of 0-24, with higher scores indicating more likely to have symptoms of PTSD

Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD)

Time: 90-120 days after admission of patient to the ICU

Secondary Outcomes

Description: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of anxiety. The HADS anxiety scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of anxiety

Measure: Symptoms of Anxiety

Time: 90-120 days after admission of patient to the ICU

Description: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of Depression. The HADS depression scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of depression

Measure: Symptoms of Depression

Time: 90-120 days after admission of patient to the ICU

Description: Using preselected questions from the Family Satisfaction in the ICU-27 questionnaire, we will survey families to evaluate their satisfaction with communication and decision making. Higher scores will indicate more satisfication

Measure: Family Satisfaction with Communication and Decision Making

Time: 90-120 days after admission of patient to the ICU
114 Helmet Non-Invasive Ventilation for COVID-19 Patients

Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce 28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia and acute hypoxemic respiratory failure

NCT04477668
Conditions
  1. COVID-19
  2. Acute Hypoxemic Respiratory Failure
Interventions
  1. Device: Helmet non-invasive ventilation
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: all cause mortality

Measure: 28-day all-cause mortality

Time: 28 days from randomization

Secondary Outcomes

Description: endotracheal intubation

Measure: Requirement for endotracheal intubation within 28 days

Time: 28 days from randomization

Description: ICU death

Measure: ICU mortality

Time: 180 days from randomization

Description: hospital death

Measure: Hospital mortality

Time: 180 days from randomization

Description: days not in ICU

Measure: ICU free days at day 28

Time: 28 days from randomization

Description: days without ventilator support

Measure: Ventilator free days at day 28

Time: 28 days from randomization

Description: days without renal replacement therapy received

Measure: Renal replacement therapy free days at day 28

Time: 28 days from randomization

Description: days without vasopressor support

Measure: Vasopressor free days at day 28

Time: 28 days from randomization

Description: presence of pressure ulcers

Measure: Skin pressure ulcers

Time: 28 days from randomization

Description: tolerance to intervention

Measure: Tolerance of helmet (>1-hour use)

Time: 28 days from randomization

Description: vital status

Measure: 180-day mortality

Time: 180 days from randomization

Description: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

Measure: 180-day 5-level EQ-5D version

Time: 180 days from randomization
115 Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of Acute Respiratory Distress Syndrome (RAPA-CARDS)

This study assesses the clinical effectiveness of mammalian target of rapamycin (mTOR) inhibition with rapamycin in minimizing or decreasing the severity of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in participants infected with mild to moderate COVID-19 virus.

NCT04482712
Conditions
  1. Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
  2. Respiratory Failure
  3. Sars-CoV2
Interventions
  1. Drug: Rapamycin
  2. Drug: Placebo
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Lung Injury Syndrome

Primary Outcomes

Description: The proportion of participants who survive without respiratory failure

Measure: Survival rate

Time: 4 weeks

Secondary Outcomes

Description: The WHO ordinal scale is a measure of clinical improvement using a scale score of 0-8, where 0 indicates a better outcome and 8 indicates death: Uninfected, no clinical oor virological evidence of infection 0 Ambulatory, no limitation of activities 1 Ambulatory, limitation of activities 2 Hospitalized Mild disease, no oxygen therapy 3 Hospitalized mild disease, oxygen by mask or nasal prongs 4 Hospitalized Severe Disease, non-invasive ventilation 5 Hospitalized severe disease, intubation and mechanical ventilation 6 Hospitalized severe disease, ventilation+organ support 7 Death 8

Measure: Change in Clinical Status assessed by the World Health Organization (WHO) scale

Time: Baseline to 4 weeks

Description: An ordinal scale for clinical improvement scored from 1 to 8, where 1 represents death and 8 represents recovery to discharge from hospital with no limitation on activities: Death (1) Hospitalized, on invasive mechanical ventilation of extracorporeal membrane oxygenation (ECMO) (2) Hospitalized, on non-invasive ventilation or high flow oxygen devices (3) Hospitalized, requiring supplemental oxygen (4) Hospitalized, not requiring supplemental oxygen or ongoing medical care (6) Not hospitalized, limitation on activities &/or requiring supplemental home oxygen (7) Not hospitalized, no limitation on activities (8)

Measure: Change in Clinical Status assessed by the National Institute of Allergy and Infectious Disease (NIAID) scale

Time: Baseline to 4 weeks

Other Outcomes

Description: Total number of deaths during the study period

Measure: All cause mortality

Time: 4 weeks

Description: Number of days on ECMO

Measure: Duration of ECMO

Time: Up to 4 weeks

Description: Number of days participants are on supplemental oxygen

Measure: Duration of supplemental oxygen

Time: Up to 4 weeks

Description: Days of hospitalization

Measure: Length of hospital stay

Time: Up to 4 weeks

Description: Number of days until there is a negative response to the reverse transcriptase-polymerase chain reaction test (RT-PCR)

Measure: Length of time to SARS-CoV2 negativity

Time: Up to 4 weeks
116 Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation

The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.

NCT04492514
Conditions
  1. COVID 19
  2. SARS-CoV 2
  3. Pneumonia
Interventions
  1. Drug: Mavrilimumab
  2. Drug: Placebo
MeSH:Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: Proportion of subjects alive and off oxygen at day14

Measure: Primary Outcome Measure:

Time: Day 14

Secondary Outcomes

Description: Proportion of subjects alive and without respiratory failure at 28 days

Measure: Secondary Outcome Measures:

Time: 28 days
117 Tenecteplase With Concomitant Anticoagulation for Severe Acute Respiratory Failure in Patients With COVID-19

This is a placebo-controlled, double blind, randomized, Phase II dose escalation study intended to evaluate the potential safety and efficacy of tenecteplase for the treatment of COVID-19 associated respiratory failure. The hypothesis is that administration of the drug, in conjunction with heparin anticoagulation, will improve patients' clinical outcomes.

NCT04505592
Conditions
  1. COVID-19
  2. Respiratory Failure
  3. ARDS
Interventions
  1. Drug: Tenecteplase
  2. Drug: Placebo
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: The number of patients free of respiratory failure defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation at 28 days

Measure: Number of participants free of respiratory failure

Time: 28 Days

Description: Safety as assessed by number of occurrences of intracranial bleeding or major bleeding

Measure: Number of occurrences of bleeding

Time: 28 days

Secondary Outcomes

Measure: Number of participants with in-hospital deaths at 14 days

Time: 14 days

Measure: Number of participants with death at 28 days

Time: 28 days

Measure: Number of ventilator-free days

Time: 28 days

Description: Respiratory failure-free defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation

Measure: Number of respiratory failure-free days

Time: 28 days

Measure: Number of vasopressor-free days

Time: 28 days

Measure: Vasopressor doses at 24 hours

Time: 24 hours

Measure: Vasopressor doses at 72 hours

Time: 72 hours

Description: The P/F ratio equals the arterial pO2 ("P") from the ABG divided by the FIO2 ("F") - the fraction (percent) of inspired oxygen that the patient is receiving expressed as a decimal (40% oxygen = FIO2 of 0.40).

Measure: P/F ratio at 24 hours

Time: 24 hours

Description: The P/F ratio equals the arterial pO2 ("P") from the ABG divided by the FIO2 ("F") - the fraction (percent) of inspired oxygen that the patient is receiving expressed as a decimal (40% oxygen = FIO2 of 0.40).

Measure: P/F ratio at 72 hours

Time: 72 hours

Measure: Number of ICU-free days

Time: 28 days

Measure: Hospital length of stay

Time: 28 days

Measure: Number of participants with new-onset renal failure

Time: 28 days

Measure: Number of participants with need for renal replacement therapy

Time: 28 days
118 Effectiveness and Safety of Telmisartan in Acute Respiratory Failure Due to COVID-19

Rationale: The renin-angiotensin-aldosterone system (RAAS) dysregulation may play a central role in the pathophysiology of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection associated acute lung injury (ALI) / acute respiratory distress syndrome (ARDS). In the RAAS, Angiotensin I (Ang I) is converted to angiotensin II (Ang II) by angiotensin converting enzyme (ACE). Ang II mediates vasoconstrictive, pro-inflammatory and pro-oxidative effects through agonism at Ang II type 1 receptor (AT1R). ACE2 converts Ang II to angiotensin 1-7 (Ang1-7), which finally binds to Mas receptor (MasR) and mediates many beneficial actions, including vasodilation and anti-inflammatory, anti-oxidant and antiapoptotic effects. ACE2, a homologue of ACE, is an integral cell membrane protein with a catalytic domain on the extracellular surface exposed to vasoactive peptides. SARS-CoV-2 penetrates the cell through ACE2, and the increase of this receptor (due to the use of ACE inhibitors or angiotensin receptor blockers [ARBs]) may facilitate SARS-CoV-2 infection, which might increase the risk of developing severe and fatal SARS-CoV-2 infection. However, through upregulation of ACE2, ACE inhibitors/ARBs can exert anti-inflammatory and antioxidative effects, which may be beneficial in preventing ALI and ARDS. Objective: To evaluate the effectiveness and safety of telmisartan in respiratory failure due to COVID-19. Study design: This is an open label, phase 2 clinical trial. Study population: Adult hospitalized SARS-CoV-2-infected patients (n=60). Intervention: The active-treatment arm will receive telmisartan 40 mg daily and the control arm will receive standard care. Treatment duration will be 14 days or up to hospital discharge <14 days or occurrence of the primary endpoint if <14 days. Main study endpoint: The primary study endpoint is the occurrence within 14 days of randomization of either: 1) Mechanical ventilation or 2) Death.

NCT04510662
Conditions
  1. COVID-19
  2. Respiratory Insufficiency
  3. Telmisartan
  4. Respiratory Distress Syndrome, Adult
Interventions
  1. Drug: Telmisartan
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Pulmonary Valve Insufficiency
HPO:Pulmonary insufficiency

Primary Outcomes

Description: Death is defined as all-cause mortality

Measure: Death

Time: Within 30 days

Description: Occurrence of mechanical ventilation

Measure: Mechanical ventilation

Time: Within 14 days

Secondary Outcomes

Description: Defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2

Measure: Occurrence of acute kidney injury

Time: Within 14 days

Description: Incidence of episodes of blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic

Measure: Incidence of hypotension

Time: Within 14 days

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

Measure: Incidence of hypotension requiring vasopressors

Time: Within 14 days

Description: Outcome reported as the number of participants in each arm who experience sepsis, defined as the presence of at least 2 of the following clinical criteria together (qSOFA score): respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less

Measure: Incidence of Sepsis

Time: Within 14 days

Description: Hospital length of stay (days)

Measure: Hospital length of stay

Time: Within 14 days
119 Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure

The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children.

NCT04519411
Conditions
  1. COVID 19
Interventions
  1. Diagnostic Test: Transpulmonary pressure measurements
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Numerical data

Measure: Transpulmonary pressure

Time: Through study complication, usually 2 weeks
120 Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia Multicentric Randomized Comparative Study

Evaluation of the efficacy and safety of Treatments for Patients Hospitalized for COVID-19 Infection without signs of acute respiratory failure, in Tunisia Multicentric Randomized Comparative Study

NCT04528927
Conditions
  1. COVID 19
  2. Patients Hospitalized
Interventions
  1. Drug: HCQ
  2. Drug: Azithromycin
  3. Drug: Doxycycline
  4. Dietary Supplement: Zinc
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: The healing criteria are defined clinically as: disappearance of clinical signs of acute respiratory infection absence of fever

Measure: Evaluate the rate of patients cured at the end of the study.

Time: 2 months

Description: A patient will be defined as pauci-symptomatic if presence: Light dry cough Discomfort, More or less : Headache, Muscle pain

Measure: Evaluate the rate of patients are pauci-symptomatic at the end of the study.

Time: 2 months

Secondary Outcomes

Description: Patients require transfer to intensive care with the appearance of: Acute respiratory failure: PaO2 <60 mmHg in AA gold Signs of circulatory insufficiency: mottling, tachycardia, systolic BP ≤90mmHg or having dropped by 40 mmHg compared to base BP or Confusion or alteration of the state of consciousness

Measure: Evaluate the rate of patients with worsening clinical signs

Time: 2 months
121 Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic

Automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during COVID-19 infection or perioperative medicine, for example. This study aim at assessing the correlation between the amount of radiologic pulmonary alteration and the clinical severity in two clinical situation : 1. SARS-CoV-2 infections 2. Postoperative hypoxemic acute respiratory failure

NCT04534400
Conditions
  1. SARS-CoV-2 Infection
  2. Respiratory Failure With Hypoxia
Interventions
  1. Radiation: thoracic CT-scan
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Measure: Correlation between altered pulmonary volume and ordinal severity scale

Time: 2 days after CT scan

Secondary Outcomes

Measure: Correlation between altered pulmonary volume and ordinal severity scale

Time: 7 days after CT scan
122 Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF) Using Modified Delphi Methodology

The investigators aim to achieve experts consensus on respiratory interventions in management of COVID-19 related acute respiratory failure (C-ARF).

NCT04534569
Conditions
  1. Covid19
  2. Acute Respiratory Failure
  3. Acute Respiratory Distress Syndrome
Interventions
  1. Other: Experts consensus
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury

Primary Outcomes

Description: Survey Questionnaire containing seven point Likert scale and multiple choice questions.

Measure: Consensus using participating experts opinions.

Time: 20 days
123 Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff

Patients are part of a family network. When any person in a family becomes critically unwell and requires the assistance of an Intensive Care Unit (ICU), this has an impact on all members of that family. COVID-19 changed visiting for all patients in hospitals across Scotland. It is not known what effect these restrictions will have on patients' recovery, nor do we understand the impact it may have on their relatives or staff caring for them. This study will look at the implications of the visiting restrictions as a consequence of the COVID-19 pandemic upon patients without COVID-19 who are in the cardiothoracic ICU. It will also explore the impact of these restrictions on them, their relatives and staff. This study will be carried out within a single specialised intensive care unit in Scotland using mixed methods. The first arm of this study will use retrospective data that is routinely collected in normal clinical practice. The investigators will compare patient outcomes prior to COVID-19 with outcomes following the implementation of COVID-19 visiting restrictions. The aim is to establish if the restrictions on visiting has an impact on the duration of delirium. Delirium is an acute mental confusion and is associated with longer hospital stays and worse outcomes in this patient group. The second arm of this study involves semi-structured interviews with patients, relatives and staff that will allow deeper exploration of the issues around current visiting policy. The interviews will last approximately 1 hour and will address these issues. They will then be transcribed word for word and analysed using grounded theory, meaning the theories will develop from the data as it is analysed.

NCT04538469
Conditions
  1. Cardiovascular Diseases
  2. Delirium
  3. Critical Illness
  4. Intensive Care Unit Delirium
  5. Thoracic Diseases
  6. Respiratory Failure
  7. Cardiac Disease
  8. Cardiac Failure
Interventions
  1. Other: COVID visitation restrictions
MeSH:Respiratory Insufficiency Thoracic Diseases Delirium Cardiovascular Diseases Heart Diseases Heart Failure Critical Illness
HPO:Abnormality of the cardiovascular system Congestive heart failure Left ventricular dysfunction Right ventricular failure

Primary Outcomes

Description: Number of days patient found to have delirium using the Confusion Assessment Method for the ICU (CAM-ICU)

Measure: Duration of delirium

Time: From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.

Secondary Outcomes

Description: CAM-ICU

Measure: Incidence of delirium

Time: From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.

Description: Days

Measure: Length of critical care stay

Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.

Description: Days

Measure: Length of hospital stay

Time: From the date of admission to the hospital until discharge from the hospital or death, whichever came first, up to 12 months.

Measure: Doses of specified drugs during ICU admission

Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.

Description: Days

Measure: Length of time ventilated

Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.

Measure: Mortality

Time: 6 months

Other Outcomes

Description: Semi structured interviews

Measure: Exploring the experiences of patients, relatives and staff of the visitation restrictions during the COVID-19 pandemic

Time: 18 months
124 Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19 - a Phase 2, Single-blinded, Randomized Study

Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of aerosolized DNase I to remove NETs and decrease respiratory distress in patients with COVID-19.

NCT04541979
Conditions
  1. COVID-19
Interventions
  1. Drug: aerosolized DNase
  2. Drug: NaCl
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Number of Days to cessation of oxygen therapy after start of treatment

Measure: Time to cessation of oxygen therapy DNase I to that of placebo (NaCl, 0.9%) on time to cessation of oxygen therapy hospitalized patients with COVID-19 and respiratory dysfunction.

Time: 28 days

Secondary Outcomes

Description: Number of diseased patients up to 28 Days after start of treatment

Measure: 28-day mortality

Time: 28 days

Description: Number of Days alive and without ventilator treatment up to 28 Days after start of treatment

Measure: Number of Days alive and without ventilator treatment

Time: 28 days

Description: Number of Days alive and without high flow nasal oxygen treatment (Optiflow) up to 28 Days after start of treatment

Measure: Number of Days alive and without high flow nasal oxygen treatment (Optiflow)

Time: 28 days

Description: Number of Days alive and free of stay in the ICU up to 28 Days after start of treatment

Measure: Number of Days alive and free of stay in the ICU

Time: 28 days

Description: Number of Days alive and outside hospital up to 28 Days after start of treatment

Measure: Number of Days alive and outside hospital

Time: 28 days

Description: Number of Days alive and free of a new episode and with oxygen saturation ≤93% after primary endpoint has been met up to 28 Days after start of treatment

Measure: Number of Days alive and free of a new episode and with oxygen saturation ≤93% after primary endpoint has been met

Time: 28 days

Description: Number of Days alive and without need of supplemental oxygen up to 28 Days after start of treatment

Measure: Number of Days alive and without need of supplemental oxygen

Time: 28 days

Description: Number of patients with adverse reactions reported up to 28 Days after start of treatment

Measure: Number of patients with adverse reactions

Time: 28 days
125 Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to Sars-covid-2: a Randomized Crossover Trial.

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation. Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu. Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.

NCT04543760
Conditions
  1. Covid19
Interventions
  1. Other: Prone position
  2. Other: Supine position
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Oxygenation will be evaluated by the [PaO2 / FiO2] ratio, measured at the beginning (baseline) and at the end of each 2h-sequence by arterial gasometry. The values of this ratio in PP and SP will be compared with each other.

Measure: [PaO2 / FiO2] ratio

Time: 6 hours

Secondary Outcomes

Description: ΔPeso (cm H2O): defined at each inspiratory cycle as the difference between the esophageal pressure at the end of expiration and at the end of inspiration.

Measure: ΔPeso measured using an esophageal balloon catheter

Time: 6 hours

Description: Capnometry measurements by breathing on a mouthpiece connected to an online analyzer. The measurements will be made on a 2 min recording (analysis of the curves over a period of 1 min) at the end of each sequence (PP or SP) and compared with each other.

Measure: Concentration of CO2 at the end of expiration (EtCO2, mmHg)

Time: 6 hours

Description: assessed by the visual analogue scale for dyspnea (collected at the beginning and at the end of each 2h sequence; the values at the end of each sequence will be compared with each other): 0 = no breathlessness to 10 = worst breathlessness possible

Measure: Intensity of dyspnea

Time: 6 hours

Description: measured by the visual analogue scale for pain (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no pain to 10 = worst pain possible

Measure: Tolerance of the technique

Time: 6 hours

Description: measured by the visual analogue scale for discomfort (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no discomfort to 10 = worst discomfort possible

Measure: Tolerance of the technique

Time: 6 hours

Description: Oxygen desaturation (SaO2 <90%), occurrence of hemodynamic instability (Systolic blood pressure <80 mmHg or heart rate >120 mmHg for >1 minute), accidental withdrawal of venous catheter central or peripheral, accidental withdrawal of arterial catheter, accidental withdrawal of urinary catheter.

Measure: The occurrence of side effects due to PP

Time: 6 hours
126 Efficacy of Dexamethasone Treatment for Patients With Acute Hypoxemic Respiratory Failure (Including ARDS) Caused by Infections (Including COVID-19)

Background: There are no proven therapies specific for pulmonary dysfunction in patients with acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial. Methods: This is a multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established AHRF (including ARDS) caused by confirmed pulmonary or systemic infections, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone: either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.

NCT04545242
Conditions
  1. Acute Hypoxemic Respiratory Failure
Interventions
  1. Drug: Dexamethasone
MeSH:Infection Respiratory Insufficiency

Primary Outcomes

Description: All-cause mortality at 60 days after randomization

Measure: 60-day mortality

Time: 60 days

Secondary Outcomes

Description: Number of ventilator-free days (VFDs) at Day 28 (defined as days being alive and free from mechanical ventilation at day 28 after randomization. For patients ventilated 28 days or longer and for subjects who die, VFD is 0.

Measure: Ventilator-free days

Time: 28 days
127 Can Nebulised HepArin Reduce morTality and Time to Extubation in Patients With COVID-19 Requiring Mechanical Ventilation Meta-Trial (CHARTER-MT): Protocol for an Investigator-initiated International Meta-trial of Randomised Studies

This meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled trials and early phase studies. Individual studies will take place in multiple countries, including Australia, Ireland, the USA, Spain and the UK. Mechanically ventilated patients with confirmed or strongly suspected SARS-CoV-2 infection, hypoxaemia and an acute pulmonary opacity in at least one lung quadrant on chest X-ray, will be randomised to nebulised heparin 25,000 Units every 6 hours or standard care (open label studies) or placebo (blinded placebo controlled studies) for up to 10 days while mechanically ventilated. All trials will collect a minimum core dataset. The primary outcome for the meta-trial is the hierarchical composite endpoint the Alive and Ventilator Free Score at day 28. Individual studies may have specific outcome measures in addition to the core set.

NCT04545541
Conditions
  1. Covid19
  2. Respiratory Failure
Interventions
  1. Drug: Nebulised unfractionated heparin (UFH)
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Validated hierarchical composite endpoint, based on mortality and ventilator free days, which is less prone to favour a treatment with discordant effects on survival and days free of ventilation.

Measure: Alive and Ventilator Free Score

Time: Day 28
128 Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19: A Pilot Randomized Controlled Trial

This study aims to determine if a strategy of recommending prone (on stomach) positioning of patients positive or suspected positive for coronavirus disease 2019 (COVID-19) requiring supplemental oxygen, but not mechanically ventilated, Is feasible in the inpatient setting. This study will be performed as a pragmatic pilot clinical trial to gain information relevant to the future conduct of a larger trial.

NCT04547283
Conditions
  1. Covid19
  2. Respiratory Failure
Interventions
  1. Other: Usual Care
  2. Other: APPS
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Average oxygen saturation to fraction of inspired oxygen ratio

Measure: Average S/F ratio

Time: 48 hours from eligibility

Description: Time spent with oxygenation saturation to fraction of inspired oxygen ratio less than 315

Measure: Time spent with S/F ratio < 315

Time: 48 hours from eligibility

Secondary Outcomes

Description: Highest level of supplemental oxygen required

Measure: Highest oxygen support

Time: 48 hours from eligibility

Description: Number of patients requiring ICU admission during study period

Measure: Number of patients requiring ICU admission during study period

Time: 48 hours from eligibility

Description: Number of patients requiring ICU admission during hospitalization

Measure: Number of patients requiring ICU admission during hospitalization

Time: through study completion, Up to 30 days

Description: Number of patients who die prior to hospital discharge

Measure: Number of patients experiencing who die prior to discharge

Time: through study completion, Up to 30 days

Description: Number of patients requiring intubation

Measure: Number of patients requiring intubation

Time: 48 hours From eligibility

Description: Number of days from hospital admission to discharge

Measure: Hospital length of stay

Time: through study completion, Up to 30 days
129 Epidemiologic, Clinical and Molecular Characteristics of Patients With Acute Respiratory Failure Affected by 2019-NCOV: A Retrospective-Prospective Cohort Study.

The main purpose of this study is to identify possible predictor factor of mortality in patients affected by COVID-19 with respiratory failure needing oxygen therapy or ventilatory support. In addiction the study aims to identify factors related to: predisposition to SARS-CoV2 viral infection, different symptoms, response to therapy, predisposition to complications related to the disease. To this end, the haemodynamic parameters and all imaging reports will be evaluated and clinical and laboratory tests as well as cellular and molecular analyzes will be performed in the analyzed patients. In addition, investigations will be carried out on the profile of the alveolar or nasal microbiota and, if possible, of the metabolic products, and estimates on antibody titers.

NCT04552340
Conditions
  1. Covid19
Interventions
  1. Other: Patient with SAR-CoV-2 infection
MeSH:Respiratory Insufficiency

Primary Outcomes

Measure: Mortality predictors in patients with Respiratory Failure who require oxygen therapy in the Intensive Care Unit or ventilatory support.

Time: 1 year

Measure: Molecular profile of cell populations present in the BAL at early timepoint during SARS-CoV2 infection to predict severity of disease progression.

Time: 1 year

Secondary Outcomes

Measure: Type of possible complications such as AKI (Acute Kidney Injury) , infection, shock

Time: 1 year

Measure: SARS-CoV2 mechanisms of infection in alveolar macrophages

Time: 3 years

Measure: SARS-CoV2 genotypes in a cohort of patients representative of the Lombardy population

Time: 3 years

Measure: Number of successful respiratory weaning

Time: 1 year
130 A Multicenter Randomized Trial to Assess the Efficacy of CONvalescent Plasma Therapy in Patients With Invasive COVID-19 and Acute Respiratory Failure Treated With Mechanical Ventilation: the CONFIDENT Trial

The principal objective of the CONFIDENT trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.

NCT04558476
Conditions
  1. Covid19
  2. Mechanical Ventilation Complication
  3. Corona Virus Infection
  4. Respiratory Failure
  5. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Biological: Convalescent Plasma
  2. Other: Standard of Care
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Insufficiency

Primary Outcomes

Description: dead or alive

Measure: Vital status

Time: at day 28

Secondary Outcomes

Description: dead or alive

Measure: day 90 mortality

Time: at day 90

Description: to assess the ventilator free days

Measure: number of ventilator-free days at day 28

Time: at day 28

Description: to assess the number of renal replacement therapy free days

Measure: number of renal replacement therapy free days at day 28

Time: at day 28

Description: to assess the number of vasopressors free-days

Measure: number of vasopressors free-days at day 28

Time: at day 28

Description: to assess if ECMO was required

Measure: use of ECMO before day 28

Time: till day 28

Description: to assess the value of SOFA score

Measure: value of the SOFA score at days 7, 14 and 28

Time: Day 1, 7, 14, 28

Description: to assess the changes in SOFA scores (delta SOFA)

Measure: changes in SOFA scores (delta SOFA) over 7, 14 and 28 days

Time: Day 7, 14 and 28 days

Description: assessment of the SARS-CoV-2 viral load, expressed as cycle threshold, [2] in the tracheal aspirates (for intubated patients) or nasopharyngeal swabs (for extubated patients) at days 7, 14 and 28

Measure: assessment of the SARS-CoV-2 viral load

Time: Days 7, 14 and 28

Description: to assess the concentrations of C reactive protein (CRP)

Measure: blood C reactive protein (CRP) concentration

Time: Days 7, 14 and 28

Description: to assess the concentration of ferritin

Measure: ferritin concentration

Time: Days 7, 14 and 28

Description: to assess the count of lymphocyte

Measure: lymphocyte count

Time: Days 7, 14 and 28

Description: to assess the lenght of stay in the acute care

Measure: length of stay in the acute care hospital

Time: through study completion, 1 year

Description: to assess the location of the patient : acute care hospital, post acute care hospital, long-term residency, home

Measure: location of the patient

Time: Day 90

Description: to assess the Activity Day Living functional Min value: 0 = Low (patient very dependent) Max value: 6 = High (patient independent)

Measure: Katz Index of independence in Activity Day Living functional score

Time: Day 90 and 365

Description: to evaluate the anxiety-depression For each item 0-7 : Normal 8-10 : Bordeline abnormal (borderline case) 11-21 : Abnormal case

Measure: Hospital Anxiety and Depression Scale (HADS)

Time: Day 90 and 365

Description: The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.

Measure: Quality of life scale EQ-5D-5L

Time: Day 90 and 365

Description: to assess the transfusion related adverse events

Measure: Transfusion related adverse events

Time: till 28 days
131 Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure

Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

NCT04565106
Conditions
  1. Covid19
  2. Hypoxemic Respiratory Failure
  3. Hypoxemia
Interventions
  1. Device: Closed-loop control of oxygen supplementation by O2matic
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Time in SpO2 target of 92-96 %

Measure: Time in SpO2 target

Time: 1 week

Secondary Outcomes

Description: Time with SpO2 not more than 2 % outside target

Measure: Time with SpO2 not more than 2 % outside target

Time: 1 week

Description: Time with SpO2 more than 2 % outside target

Measure: Time with SpO2 more than 2 % outside target

Time: 1 week

Description: Time with SpO2 < 85 %

Measure: Time with SpO2 < 85 %

Time: 1 week
132 A Partially Nested RCT to Evaluate the Effectiveness of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program to Reduce Anxiety Among At-Risk Scleroderma Patients

Contagious disease outbreaks, such as the coronavirus disease 2019 (COVID-19) outbreak, and associated restrictions to prevent spread can lead to negative psychological outcomes, including loneliness, depression, and anxiety, particularly in vulnerable populations at risk due to existing medical conditions. To date, no randomized controlled trials have tested interventions to reduce mental health consequences of contagious disease outbreaks. Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease characterized by vasculopathy and excessive collagen production. Systemic Sclerosis can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and heart. Many people with scleroderma are at risk of serious complications from COVID-19 if infected due to lung involvement (> 40% have interstitial lung disease) and common use of immunosuppressant drugs. The objective of The Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate a videoconference-based intervention designed to improve symptoms of anxiety and other mental health outcomes among individuals with systemic sclerosis at risk of poor mental health during the COVID-19 pandemic. The trial is a pragmatic randomized controlled trial that will be conducted using an existing cohort of systemic sclerosis patients. We will use a partially nested design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support.

NCT04335279
Conditions
  1. Scleroderma
  2. Scleroderma, Systemic
  3. Systemic Sclerosis
Interventions
  1. Other: SPIN-CHAT Program
MeSH:Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Localized Sclerosis
HPO:Morphea Scleroderma

Primary Outcomes

Description: The PROMIS Anxiety 4a v1.0 is a 4 item scale that asks participants, in the past 7 days, how often: (1) "I felt fearful"; (2) "I found it hard to focus on anything other than my anxiety"; (3) "My worries overwhelmed me"; and (4) "I felt uneasy". Items are scored on a 5-point scale (range 1-5), and response options include "never", "rarely", "sometimes", "often", and "always". Higher scores represent more anxiety. PROMIS Anxiety 4a v1.0 has been validated in SSc.

Measure: Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0

Time: 4-weeks post-randomization

Secondary Outcomes

Description: The PROMIS Anxiety 4a v1.0 is a 4 item scale that asks participants, in the past 7 days, how often: (1) "I felt fearful"; (2) "I found it hard to focus on anything other than my anxiety"; (3) "My worries overwhelmed me"; and (4) "I felt uneasy". Items are scored on a 5-point scale (range 1-5), and response options include "never", "rarely", "sometimes", "often", and "always". Higher scores represent more anxiety. PROMIS Anxiety 4a v1.0 has been validated in SSc.

Measure: Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0

Time: 10-weeks post-randomization

Description: PHQ-8 items measure depressive symptoms over the last 2 weeks on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day) with higher scores (range 0 to 24) indicating more depressive symptoms. The PHQ-8 performs equivalently to the PHQ-9, which has been shown to be a valid measure of depressive symptoms in patients with scleroderma.

Measure: Depression symptoms: Patient Health Questionnaire (PHQ-8)

Time: 4-weeks post-randomization, 10-weeks post-randomization

Description: The 6-item ULS-6 is a short version of the 20-item ULS, which is designed to assess subjective feelings of loneliness and social isolation. Respondents indicate the degree to which feelings described in each item apply to them. Items are scored on a 4-point scale from 0 (never) to 3 (often); total scores range from 0 to 18.

Measure: Loneliness: University of California, Los Angeles (UCLA) Loneliness Scale (ULS-6)

Time: 4-weeks post-randomization, 10-weeks post-randomization

Description: The full MSBS is a 29-item measure of state boredom with items on five factors that load onto a single higher-order factor. The 8-item MSBS is a short version with scores that correlate very closely to scores from the full MSBS (r = 0.96) Item responses are on a 7-point Likert-type scale from 1 (strongly disagree) to 7 (strongly agree) and assess the degree to which each item reflects the respondant's experience currently. Total scores range from 8 to 56 with higher scores reflecting greater boredom.

Measure: Boredom: Multidimensional State Boredom Scale (MSBS-8)

Time: 4-weeks post-randomization, 10-weeks post-randomization

Description: The 4-item IPAQ-E is a short-form version of the full IPAQ designed to assess physical activity over the last week, including time spent sitting, walking, and in moderate and vigorous physical activity. Compared to other short-form versions of the IPAQ, the IPAQ-E has examples of exercise specific to older adults.

Measure: Physical activity: International Physical Activity Questionnaire - modified for the elderly (IPAQ-E)

Time: 4-weeks post-randomization, 10-weeks post-randomization

Description: Adverse Effects will be assessed by ongoing monitoring during the trial and by asking participants post-intervention to describe any adverse experiences or outcomes that may have occurred.

Measure: Adverse Effects

Time: 4-weeks post-randomization, 10-weeks post-randomization

Description: The COVID-19 Fears Questionnaire for Chronic Medical Conditions is a 10-item scale that ask participants to rate, on a typical day in the last week, how much they were afraid from "not at all" to "extremely" about aspects of COVID-19. Items are scored on a 5-point scale (range 1-5). Higher scores represent greater fear. The scale has been validated among people with scleroderma.

Measure: Fear: COVID-19 Fears Questionnaire for Chronic Medical Conditions

Time: 4-weeks post-randomization, 10-weeks post-randomization

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook