|D045169||Severe Acute Respiratory Syndrome NIH||0.04|
|D018352||Coronavirus Infections NIH||0.04|
There is one clinical trial.
This study will assess the safety and efficacy of TSC as a treatment for participants who are infected with SARS-CoV-2 (COVID-19).
Description: Lead-in phase: Serious adverse events and DLTs, defined as any study drug related grade 3 or 4 adverse event during the treatment period, with the exception of pulmonary events in the CTCAE that are known complications of SARS-CoV-2 infection: ARDS, Cough, Dyspnea, Hypoxia, Pneumonitis, Pulmonary Edema, Respiratory Failure, or Respiratory, Thoracic and Mediastinal disorders - Other.Measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Time: 5 days
Description: Randomized phase: Time to achieve (and maintain through Day 28) a World Health Organization (WHO) ordinal COVID-19 severity scale score of 1, 2 or 3 with a minimum 1-point improvement from baseline. The scale assesses clinical status and the range is 0-9, as follows: 0. Uninfected - No clinical or virological evidence of infection Ambulatory - No limitation of activities Ambulatory - Limitation of activities Hospitalized, Mild Disease - Hospitalized, no oxygen therapy Hospitalized, Mild Disease - Oxygen by mask or nasal prongs Hospitalized Severe Disease - Non-invasive ventilation or high-low oxygen Hospitalized Severe Disease - Intubation and mechanical ventilation Hospitalized Severe Disease - Ventilation + additional organ support (pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO) Dead - DeathMeasure: Time to recovery through Day 28 Time: 28 days
Description: Proportion of subjects with WHO ordinal severity scale score of 6 or 7 at any time through Day 28Measure: WHO Ordinal Severity Scale Time: 28 days
Description: Time to an improvement of one category (i.e., a 1-point improvement) from baselineMeasure: WHO Ordinal Severity Scale - Time to Improvement Time: 28 days
Description: Change from baseline in WHO scale score at days 2, 4, 7, 10, 14 and 28, as a categorical improvement or worsening Mean change in WHO ordinal severity scale score from baseline through days 2, 4, 7, 10, 14 and 28Measure: WHO Ordinal Severity Scale - Change from Baseline Time: 28 days
Description: • The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first The NEWS score determines the degree of illness of a patient and prompts critical care intervention. The following physiological parameters are assessed on a scale of 0 to 3, with a higher score indicating a more critical condition: Respiration rate Oxygen saturation (SpO2) Air or oxygen Systolic blood pressure Pulse rate Level of consciousness or new confusion TemperatureMeasure: National Early Warning Score (NEWS) Time: 28 days
Description: Change from baseline through days 2, 4, 7, 10, 14 and 28 in NEWSMeasure: National Early Warning Score (NEWS) - Change from Baseline Time: 28 days
Description: Ventilator free days in the first 28 days (to day 29).Measure: Mechanical Ventilation Time: 28 days
Description: Incidence and duration of new mechanical ventilation use during the trialMeasure: Mechanical Ventilation - Duration Time: 28 days
Description: Hospital length of stay by Day 29 ICU length of stay by Day 29Measure: Hospitalization Time: 28 days
Description: Oxygenation free days in the first 28 days from start of therapy Days on extracorporeal membrane oxygenation (ECMO)Measure: Oxygenation Time: 28 days
Description: Incidence and duration of new oxygen use during the trialMeasure: Oxygenation - New Oxygen Use Time: 28 days
Description: Proportion on mechanical ventilation, ECMO, noninvasive ventilation and high-flow nasal cannula oxygen delivery and return to room air or baseline oxygen requirementMeasure: Oxygenation - Advanced Therapies Time: 28 days
Description: Time to return to room air or baseline oxygen requirementMeasure: Oxygenation - Time to Return to Baseline Time: 28 days
Description: Blood oxygenation by recorded continuous pulse oximetry (SpO2:FiO2 ratio)Measure: Oxygenation - Pulse Oximetry Time: 28 days
Description: Blood oxygenation by serial arterial blood gas measurements collected prior to the first dose of TSC and at 1 minute, 10 minutes, 30 minutes, 1.5 hours, 3 hours and 6 hours post TSC administration by calculated PaO2:FiO2 ratiosMeasure: Oxygenation - ABG Measurements Time: 28 days
Description: 15-day mortality 28-day mortality All-cause mortality at day 29 In hospital mortality Mortality at Day 60Measure: Mortality Time: Up to 60 days
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