Report Sections

See All Reports

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

D053120: Respiratory Aspiration

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 (22)


Name (Synonyms) Correlation
drug2830 Remdesivir-HU Wiki 0.28
drug2391 PSG Wiki 0.28
drug1908 LungFit™ Wiki 0.28
Name (Synonyms) Correlation
drug1218 Ethanol with Asprin Wiki 0.28
drug3653 Water Without an Elevated Level of KELEA Wiki 0.28
drug3893 inspiratory muscle traiing Wiki 0.28
drug1986 Meditation Therapy Wiki 0.28
drug2828 Remdesivir (RDV) Wiki 0.28
drug1978 Media Intervention Wiki 0.28
drug3891 inhaled hydroxychloroquine Wiki 0.28
drug1763 KELEA Excellerated Water Wiki 0.28
drug3527 UNI911 INHALATION Wiki 0.28
drug1998 Melphalan Wiki 0.28
drug2201 Nitric Oxide delivered via LungFit™ system Wiki 0.28
drug2399 PUL-042 Inhalation Solution Wiki 0.20
drug3688 Yoga Wiki 0.16
drug2198 Nitric Oxide Wiki 0.14
drug2717 Quality-of-Life Assessment Wiki 0.10
drug2732 Questionnaire Administration Wiki 0.08
drug2192 Nitazoxanide Wiki 0.07
drug3199 Standard of care Wiki 0.05
drug2490 Placebo Wiki 0.04

Correlated MeSH Terms (7)


Name (Synonyms) Correlation
D012120 Respiration Disorders NIH 0.12
D012140 Respiratory Tract Diseases NIH 0.11
D011024 Pneumonia, Viral NIH 0.09
Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.02
D007239 Infection NIH 0.01

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.04

Clinical Trials

Navigate: Correlations   HPO

There are 13 clinical trials


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

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

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

Primary Outcomes

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

Measure: Severity of COVID-19

Time: 28 days

Secondary Outcomes

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

Measure: SARS-CoV-2 infection

Time: 28 days

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

Measure: Severity of COVID-19 over 14 days

Time: 14 days

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

Measure: Severity of COVID-19 symptoms

Time: 28 days

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

Measure: ICU admission

Time: 28 days

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

Measure: Mechanical Ventilation

Time: 28 days

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

Measure: Mortality

Time: 28 days
2 Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS

Most patients in intensive care units (ICUs) experience severe sleep disruption. Sleep disruption and sleep alteration may have an influence on the ability to breathe spontaneously. But, the cause of altered sleep remains unknown. Previous studies have shown that decreasing nocturnal respiratory muscle activity through mechanical ventilation might improve sleep quality. Nocturnal respiratory muscle activity may be one of the potential factor which contribute to alter sleep in the ICU. Therefore, the aim of this study is to analyse the presence of NIM activation during the night and it's consequence in an ICU population with the same pathology (COVID 19 ARDS).

NCT04371029
Conditions
  1. ARDS
  2. COVID-19
Interventions
  1. Other: PSG
MeSH:Respiratory Aspiration

Primary Outcomes

Description: Comparison between patients with NIM activation during the night and patients without NIM activation during the night, in patients COVID 19 ARDS with altered spleep. A Polysomnography (PSG) will be performed the night before extubation.

Measure: Proportion of patients with altered spleep

Time: At day 10 after inclusion

Secondary Outcomes

Description: Thanks to a PSG the night befor discharge, the seep architecture will be estimated.

Measure: Sleep architecture at hospital discharge

Time: At day 28 after inclusion

Description: Thanks to actimetry measure during hospitalization in the post ICU ward.

Measure: Sleep monitoring during hospital stay after ICU discharge

Time: At day 18 after ICU discharge

Description: Sleep quality will be evaluate by the Pittsburgh sleep quality index. The 7 components of the score add up for give an overall score ranging from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.

Measure: Sleep quality

Time: 3 months after hospiotal discharge

Description: Thanks to a PSG at 3 months, the seep architecture will be estimated.

Measure: Sleep architecture at month-3

Time: 3 months after hospital discharge

Description: all cost will be estimated during ICU hospitalization.

Measure: Cost of ICU hospitalization

Time: From inclusion to ICU discharge, up to 10 days after inclusion
3 Single-center, Prospective, Open-label, Comparator Study, Blind for Central Accessor to Access the Efficacy, Safety, and Tolerability of Inhalations of Low-doses of Melphalan in Patients With Pneumonia With Confirmed or Suspected COVID-19

This single-center, prospective, open-label, comparator study, blind for central accessor evaluates the efficacy, safety of inhalations of low-doses of melphalan in patients with pneumonia with confirmed or suspected COVID-19. All patients will receive 0,1 mg of melphalan in 7-10 daily inhalations 1 time per day.

NCT04380376
Conditions
  1. COVID-19
  2. Viral Pneumonia
Interventions
  1. Drug: Melphalan
  2. Other: Standard of care
MeSH:Pneumonia, Viral Pneumonia Respiratory Aspiration
HPO:Pneumonia

Primary Outcomes

Description: The number of patients with the clinical improvement is defined as an improvement of two points (from the status at baseline) on an ordinal scale of clinical improvement on day 28 or discharge from hospital ( whatever occurs earlier) Death Hospitalized with Invasive mechanical ventilation plus additional organ support - ECMO / pressors / RRT Hospitalized with intubation and mechanical ventilation Hospitalized on non-invasive ventilation or high flow oxygen. Hospitalized on a mask or nasal prongs. Hospitalized no oxygen therapy. Ambulatory, with limitation of activities. Ambulatory, no limitation of activities. I. No clinical or virological evidence of infection.

Measure: The changes of COVID Ordinal Outcomes Scale

Time: baseline vs Day 14, day 28

Description: Percentage of the patients with clinical recovery which is defined as a normalisation of fever, respiratory rate, and oxygen saturation, and improvement of cough, sustained for at least 72 hours, or live hospital discharge, whichever comes first. Normalization and improvement criteria: Fever - <37°C, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.

Measure: Percentage of the patients with Clinical Recovery

Time: baseline vs day 7, day 14, day 28

Description: The evaluation of changes in modified Borg dyspnea scale. From 0 to 10 units.A lower score means a better clinical result (0 is the absence of dyspnea, and 10 - is maximal dyspnea). Minimal clinically important difference is 1 unit.

Measure: The changes of the Borg's scale

Time: Baseline vs day 7, day 14, day 28

Secondary Outcomes

Description: Change in C-reactive protein (CRP) level from baseline in mg/ml. A lower level of CRP means a better clinical result.

Measure: CRP level

Time: baseline, day 7, Day 14, Day 28

Description: Change in blood absolute lymphocyte count from baseline. A higher number of lymphocytes means a better clinical result.

Measure: Lymphocyte count

Time: baseline, day 7, Day 14, Day 28

Description: Change in blood D-dimer level from baseline. A lower level of D-dimer means a better clinical result.

Measure: D-dimer

Time: baseline, day 7, Day 14, Day 28

Description: Change in peripheral blood IL-6 level from baseline. A lower level of IL-6 means a better clinical result.

Measure: IL-6

Time: baseline, day 7, Day 14, Day 28

Description: Percentage of patients without artificial lung ventilation during the study. A lower percentage of patients means a better clinical result.

Measure: Percentage of patients without artificial lung ventilation

Time: baseline, day 7, Day 14, Day 28
4 Prevention of COVID-19 Progression Through Early Administration of Inhaled Nitric Oxide.

This is a pilot randomized-controlled (2:1) open label investigation of inhaled NO to prevent progression to more advanced disease in 42 hospitalized patients with COVID-19, at risk for worsening, based on baseline systemic oxygenation and 2 or more of the major risk factors of age > 60 years, type II DM, hypertension, and obesity.

NCT04388683
Conditions
  1. COVID-19
Interventions
  1. Drug: Nitric Oxide
MeSH:Respiratory Aspiration

Primary Outcomes

Description: Prevention of progressive systemic de-oxygenation, with escalation to higher levels of oxygen and ventilatory support or death, assessed using a 7-point severity scale (See statistical methods). Between-group differences in the average maximum disease severity assessed through 28 days, through the following severity scores: a) increased liter oxygen flow, through a high flow nasal cannula; b) non-invasive ventilation; c) intubation or institution of ECMO; or d) death.

Measure: Prevention of progressive systemic de-oxygenation, with escalation to higher levels of oxygen and ventilatory support or death, assessed using a 7-point severity scale.

Time: 28 days

Secondary Outcomes

Measure: Prevention of progression assessed by an alternate severity scale

Time: 28 days

Measure: Time to reaching maximal severity score

Time: 28 days

Measure: Proportion of patients in each stage at maximum severity

Time: 28 days

Measure: PaO2/FIO2 or SaO2/FIO2 ratio, measured daily

Time: 28 days

Measure: Length of hospital Stay (death assigned as worst case)

Time: 28 days

Measure: Frequency of Intubation, ECMO, or need to intubate with "Do Not Resuscitate" order

Time: 28 days

Measure: Mortality

Time: 28 days

Measure: IL6 level

Time: 7 days

Measure: TNF-alpha level

Time: 7 days

Measure: Fibrinogen level

Time: 7 days

Measure: CRP level

Time: 7 days

Measure: Ferritin Level

Time: 7 days

Measure: D-dimer level

Time: 7 days
5 Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)

The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.

NCT04397692
Conditions
  1. Corona Virus Infection
  2. COVID-19
  3. SARS-CoV 2
  4. Nitric Oxide
  5. Respiratory Disease
  6. Pneumonia, Viral
  7. Inhaled Nitric Oxide
Interventions
  1. Device: Nitric Oxide delivered via LungFit™ system
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Aspiration Respiration Disord Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: Time to deterioration measured by need for NIV, HFNC or intubation

Measure: Time to deterioration

Time: 14 Days

Secondary Outcomes

Description: Time to non-invasive ventilation

Measure: Time to NIV

Time: 14 Days

Description: Time to high flow nasal cannula

Measure: Time to HFNC

Time: 14 Days

Description: Time to intubation

Measure: Time to intubation

Time: 14 days

Description: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%

Measure: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%

Time: 14 days

Other Outcomes

Description: Need for supplemental oxygen

Measure: Need for supplemental oxygen

Time: 14 days

Description: Change in viral load

Measure: Change in viral load

Time: 30 days

Description: Duration of the Hospital Length of Stay (LOS)

Measure: Duration of the Hospital Length of Stay (LOS)

Time: 14 days

Description: Mortality rate at Day 30

Measure: Mortality rate at Day 30

Time: 30 days
6 Breathing Techniques and Meditation for Health Care Workers During COVID-19

This phase I trial investigates breathing techniques and meditation for health care workers during COVID-19 pandemic. Breathing techniques and medication may help manage stress and improve lung health. The goal of this trial is to learn if breathing techniques and meditation may help to reduce stress and improve lung health in health care workers during the COVID-19 pandemic.

NCT04482647
Conditions
  1. COVID-19 Infection
Interventions
  1. Other: Media Intervention
  2. Procedure: Meditation Therapy
  3. Other: Quality-of-Life Assessment
  4. Other: Questionnaire Administration
  5. Procedure: Yoga
MeSH:Respiratory Aspiration

Primary Outcomes

Description: Feasibility will be defined as recruitment of 50 participants to the study within 2 months.

Measure: Study recruitment

Time: Within 2 months

Description: Defined as more than 50% of participants perceive the intervention as useful.

Measure: Acceptability of study

Time: Up to 2 years

Secondary Outcomes

Description: Will determine the adherence to the practice assessed as at least 50% of participants implement the intervention for 3 or more times in a week by the end of week 1/day 7 (+ 3 days).

Measure: Adherence to the practice

Time: Up to 28 days

Description: Measured by the Brief Resilient Coping Scale among health care workers questionnaire.

Measure: Change in resilience

Time: Day 0 to 28

Description: Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.

Measure: Perceive stress and psychological impact

Time: Day 0 to 28

Description: Will determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.

Measure: Breath holding time

Time: Up to 28 days
7 Can Inhalation of KELEA Excellerated Water Reduce the Time Required for Covid-19 Infected Individuals to Become Symptom-Free and to Test Negative Using Either the PCR or Antigen Assay

Preliminary reports have been received from several sources that the periodic inhaling of water with a heightened level of kinetic activity has lessened the severity of symptoms in Covid-19 infected patients. On at least several occasions, a repeat PCR test performed two days after inhaling a particular water-based product was negative. There are no perceived advese effects from inhaling the water using a nebulizer or humidifier. It is important, however, to validate these preliminary findings and to include other similar products in the testing

NCT04490824
Conditions
  1. Covid19
Interventions
  1. Device: KELEA Excellerated Water
  2. Device: Water Without an Elevated Level of KELEA
MeSH:Respiratory Aspiration

Primary Outcomes

Description: Proportion of the Covid-19 PCR or Antigen Positive Participants Who Subsequently Test Negative Using the Same Assay Procedure

Measure: Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

Time: Two days of inhalation prior to the repeat Covid-19testing

Secondary Outcomes

Description: Proportion of the Symptomatic Participants Who Become Asymptomatic

Measure: Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

Time: Symptoms prior to and after two days of inhalation
8 Local Tolerability and Pharmacokinetic Evaluation of Cyclops Dry Powder Hydroxychloroquine Inhalation in Healthy Volunteers; a Pilot Study

Rationale: This protocol describes a study on the local tolerability of dry powder hydroxychloroquine using the Cyclops in healthy volunteers. Objective: - Primary objective is to assess the local tolerability of dry powder hydroxychloroquine sulphate via the Cyclops at different dosages. - Secondary objective is to investigate systemic pharmacokinetic parameters of dry powder hydroxychloroquine sulphate via the Cyclops at different dosages. Study design: single center, ascending dose study Study population: twelve healthy volunteers Main study parameters/endpoints: The local tolerability of the inhalation of dry powder hydroxychloroquine sulphate (5, 10 and 20 mg) defined by a lung function deterioration (a drop of forced expiratory volume in 1 second (FEV1) of >15%), cough, or any other reported adverse event. Pharmacokinetic parameters will be derived from calculated actual inhaled dose (dose minus remainder in inhaler after inhalation) and in blood samples drawn pre-dose, at 0.5 and 2 and 3.5 hrs after inhalation. The inspiratory parameters during the inhalation maneuver are critical to explore predictors for drug exposure. The following parameters will be measured/calculated: dPmax (maximum pressure drop), Vi (inhaled volume), Ti (total inhalation time), PIF (peak inspiratory flow rate), MIF (mean inspiratory flow rate) and the FIR (average flow increase rate between 20% and 80% of PIF). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants included are healthy volunteers. They will receive three different doses of hydroxychloroquine sulphate using the dry powder inhaler (DPI) with (at least) seven days in between doses. Before using the dry powder inhaler (DPI), they will receive instructions and their inspiratory flow will be tested. To investigate local tolerability, lung function tests will be performed, and the occurrence of adverse events will be scored. Furthermore, before each test dose an indwelling cannula will be inserted and blood samples will be taken before and after each test dose. Four blood samples will be collected with each inhaled dose. Finally, five ECGs will be obtained to monitor for QT prolongation, one at the screenings visit, one at base-line and one after each inhalation.

NCT04497519
Conditions
  1. Covid19
Interventions
  1. Drug: inhaled hydroxychloroquine
MeSH:Respiratory Aspiration

Primary Outcomes

Description: Number of patients with a lung function deterioration (a drop of forced expiratory volume in 1 second (FEV1) of >15%.

Measure: Local tolerability

Time: 35 minutes after inhalation

Description: Number of patients with a lung function deterioration (a drop of forced expiratory volume in 1 second (FEV1) of >15%.

Measure: Local tolerability

Time: 95 minutes after inhalation

Description: Number of patients that report cough, or any other adverse event after inhalation.

Measure: Local tolerability

Time: 5 hours

Secondary Outcomes

Description: Calculated actual inhaled dose

Measure: Pharmacokinetic parameter

Time: 0,5 hour

Description: Cmax

Measure: Pharmacokinetic parameter

Time: 3,5 hours

Description: Tmax

Measure: Pharmacokinetic parameter

Time: 3,5 hours
9 A Phase 1b/2a Study in Participants With Early Stage COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation

The primary objective of this study is to characterize the impact of inhaled remdesivir (RDV) on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in participants with early stage coronavirus disease 2019 (COVID-19).

NCT04539262
Conditions
  1. COVID-19
Interventions
  1. Drug: Remdesivir (RDV)
  2. Drug: Placebo
MeSH:Respiratory Aspiration

Primary Outcomes

Description: Time-weighted Average Change in SARS-CoV-2 viral load is defined as area under the concentration versus time curve (AUC) of viral load change divided by time between baseline through Day 7

Measure: Time-weighted Average Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7

Time: Baseline, Day 7

Secondary Outcomes

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

Time: First dose date up to 5 days plus 30 days

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

Time: First dose date up to 5 days plus 30 days

Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation

Time: First dose date up to 5 days plus 30 days

Measure: Proportion of Participants Progressing From Early Stage Coronavirus Disease 2019 (COVID-19) to Hospitalization or Death by Day 14

Time: Day 14

Description: AUC0-24h is defined as the concentration of drug over time between time 0 to time 24 hours. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: Pharmacokinetic (PK) Parameter: AUC0-24h of Remdesivir (RDV) and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Description: AUClast is defined as the concentration of drug from time zero to the last observable concentration. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: PK Parameter: AUClast of RDV and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Description: CLss/F is defined as apparent oral clearance at steady state after administration of the drug. CLss/F = Dose/AUCtau, where "Dose" is the dose of the drug Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: PK Parameter: CLss/F of RDV and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Description: t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: PK Parameter: t1/2 of RDV and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Description: Vz/F is defined as the apparent volume of distribution of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: PK Parameter: Vz/F of RDV and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Description: Cmax is defined as the maximum observed concentration of drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: PK Parameter: Cmax of RDV and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Description: Tmax is defined as the time (observed time point) of Cmax. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: PK Parameter: Tmax of RDV and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Description: Clast is defined as the last observable concentration of drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: PK Parameter: Clast of RDV and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Description: Tlast is defined as the time (observed time point) of Clast. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: PK Parameter: Tlast of RDV and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: PK Parameter: AUCtau of RDV and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Description: λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: PK Parameter: λz of RDV and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Description: Ctau is defined as the observed drug concentration at the end of the dosing interval. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Measure: PK Parameter: Ctau of RDV and its Metabolites (GS-441524 and GS-704277)

Time: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Measure: Change in SARS-CoV-2 Viral Load From Baseline to Day 4

Time: Baseline, Day 4

Measure: Change in SARS-CoV-2 Viral Load From Baseline to Day 7

Time: Baseline, Day 7

Measure: Change in SARS-CoV-2 Viral Load From Baseline to Day 14

Time: Baseline, Day 14

Measure: Time to Negative SARS-CoV-2 Polymerase Chain Reaction (PCR)

Time: First dose date up to 14 days
10 Disinfection of SARS-COV-2 ( COVID-19 ) in Human Respiratory Tract by Controlled Ethanol Vapor Inhalation Combined With Oral Asprin .

Since ARDS is a major complication of COVID - 19 with subsequent formation of non-cardiogenic pulmonary edema , worsening the oxygenation of the patients and foamy and even bloody sputum formation, so the idea is to use alcohol inhalation as it reduce surface tension on the alveoli and markedly decrease sputum formation with improvement on oxygenation beside its cytolethal effect on virus lipid bilayer. A lot of researches and publications proved the role of alcohol inhalation in treatment of pulmonary edema. Alcohol inhalation may has inflammatory effect and dangerous effect on patients but this can be controlled by the actual concentration used and the way we use it according to general condition of the patient and with the help of anti - inflammatory action of Asprin .

NCT04554433
Conditions
  1. Covid-19
  2. Drug Effect
Interventions
  1. Drug: Ethanol with Asprin
MeSH:Respiratory Aspiration

Primary Outcomes

Description: Destruction of COVID-19 in human respiratory tract and treatment of the patients with COVID 19 and Negative PCR test .

Measure: Disinfection of COVID-19 in human respiratory tract .

Time: Negative PCR test within 7 days from starting the protocol .

Secondary Outcomes

Description: Decrease mortality rate of mechanically ventilated patients with COVID-19 . Protection of health care workers . Negative PCR test .

Measure: Improvement of general condition of mechanically ventilated patients confirmed COVID-19 positive ..

Time: Negative PCR test within 10 days from starting the protocol .
11 Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults With COVID-19

This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults with COVID-19

NCT04576312
Conditions
  1. COVID-19
Interventions
  1. Drug: UNI911 INHALATION
MeSH:Respiratory Aspiration

Primary Outcomes

Description: AE frequency in each cohort and treatment group

Measure: Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency

Time: Up to Day 6

Other Outcomes

Description: Maximum concentration of active drug molecules in blood (Cmax)

Measure: Pharmacokinetic Parameters: Cmax

Time: Up to Day 4 of participant treatment

Description: Time to reach maximum level (Tmax)

Measure: Pharmacokinetic Parameters: Tmax

Time: Up to Day 4 of participant treatment

Description: Area Under the Curve of drug level in blood versus time (AUC)

Measure: Pharmacokinetic Parameters: AUC

Time: Up to Day 4 of participant treatment

Description: Half life

Measure: Pharmacokinetic Parameters: Half life

Time: Up to Day 4 of participant treatment
12 Adjunctive Inspiratory Muscle Training for Patients With COVID-19

This study aims to investigate whether adjunctive inspiratory muscle training (IMT) can enhance the benefits of pulmonary rehabilitation (PR) in patients with COVID-19. 120 patients will be randomized into an interventional group (PR plus IMT) and a control group (sham IMT plus PR). Improvement in quality of life, peak VO2 and VE/VCO2 slope will be defined as a primary outcome. Maximal inspiratory pressure, inspiratory muscle endurance, pulmonary function testing, severity of fatigue, cost-effectiveness and six minute walk test will be defined as the secondary outcomes.

NCT04595097
Conditions
  1. Covid19
  2. Exercise
Interventions
  1. Device: inspiratory muscle traiing
MeSH:Respiratory Aspiration

Primary Outcomes

Description: EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually

Measure: Health- related quality of life

Time: change from baseline in EQ-5D score at 8 weeks and 6 months

Description: Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight.

Measure: Peak VO2

Time: change from baseline in Peak VO2 at 8 weeks and 6 months

Description: The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless.

Measure: Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)

Time: change from baseline in VE/VCO2 Slope at 8 weeks and 6 months

Description: The modified Medical Research Council Dyspnea Scale (mMRC). A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with respiratory limitations. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 represents a person who are to breathless to leave the house, or breathless when dressing/undressing.

Measure: Dyspnea

Time: change from baseline in mMRC score at 8 weeks and 6 months

Secondary Outcomes

Description: Pulmonary function test with Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements

Measure: Respiratory muscle strength

Time: change from baseline in MIP and MEP at 8 weeks and 6 months

Description: Six minute walking test ia a field test designed to measure exercise capacity

Measure: Exercise Capacity

Time: change from baseline in distance during Six minute walking test at 8 weeks and 6 months

Description: Fatigue severity scale (FSS) is a questionnaire consisting of 9 questions showing the degree of fatigue of patients. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome

Measure: severity of fatigue

Time: change from baseline in FSS score at 8 weeks and 6 months

Description: Hospital anxiety and depression scale (HADS) is a 14-item questionnaire for screening anxiety (7 items) and depression (7 items). Each item is scored from 0-3 (a 4-point severity scale). Highest anxiety or depression score is 21. Patients are defined as having anxiety or depression or both if the score is 8 or more in the each subscale.

Measure: Anxiety and Depression

Time: Change from baseline in HADS score at 8 weeks and 6 months

Description: Utility will be measured by Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D 5L) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.

Measure: incremental cost-utility ratio

Time: 6 months
13 Prospective, Open-label, Randomized, Multi-Center Study for Safety and Efficacy Evaluation of Inhaled Nitric Oxide (NO) Given Intermittently to Adults With Viral Pneumonia

The purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia

NCT04606407
Conditions
  1. Viral Pneumonia
  2. Nitric Oxide
  3. Respiratory Disease
  4. Pneumonia, Viral
  5. Inhaled Nitric Oxide
  6. Covid19
  7. SARS-CoV Infection
Interventions
  1. Device: LungFit™
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)

Measure: incidence of Serious Adverse Events

Time: 30 days

Secondary Outcomes

Description: Time to fever resolution

Measure: fever resolution

Time: Baseline to 30 days

Description: Number of patients requiring admission to ICU

Measure: ICU admission

Time: Baseline to 30 days

Description: Time until patient no longer requires supportive oxygen

Measure: Oxygen support

Time: Baseline to 30 days

Description: b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower

Measure: Stable room air saturation

Time: Baseline to 30 days

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on January 01, 2021.

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

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook