|drug2492||NaCl 0.9% Wiki||0.58|
|drug4141||Umbilical cord Wharton's jelly-derived human Wiki||0.58|
|D012127||Respiratory Distress Syndrome, Newborn NIH||0.15|
|D055371||Acute Lung Injury NIH||0.14|
There are 3 clinical trials
The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise.
This is a single-arm open label trial for hospitalized patients with COVID-19 (Coronavirus). The primary endpoint of the study is to assess the requirement for mechanical ventilation in patients who are admitted to the hospital with COVID-19 infection and a Pulse Oxygen Level = 93% on room air. The primary endpoint analysis will be performed using all enrolled patients.
Description: Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abataceptMeasure: Mechanical ventilation-free survival Time: 30 days
Description: Number of days a patient is on a ventilator, if applicableMeasure: Duration of days on a ventilator Time: 30 days
Description: Number of days until patient recovers with SpO2 > 93%Measure: Days until pulse oxygen is > 93% on room air Time: 30 days
Description: No supplemental oxygen for at least 24 hoursMeasure: Days until supplemental oxygen is no longer required Time: 30 days
Description: Number of days until fever is less than 38°CMeasure: Duration of fever >= 38°C Time: 30 days
Description: Patient survival status through 90 daysMeasure: Overall survival Time: 90 days
Description: Number of Infusion Reactions in patients treated with abataceptMeasure: Infusion reactions Time: 14 days
Description: Number of Secondary infections in patients treated with abataceptMeasure: Secondary infections Time: 90 days
Description: Change in clinical status from baseline, as assessed by a 7-point ordinal scale on Day 14Measure: Change in Clinical Status, based on 7-point ordinal scale Time: 14 days
Description: Viral load at baseline and on Days 7, 14, 21, 28 (each +/- 2 days) after the first abatacept dose.Measure: Viral load Time: 28 days
Description: Improvement in lung findings based on CXR (chest x-ray)Measure: Radiographic Improvement Time: 14 days
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective. The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population.
Description: time to recovery by Day 29Measure: Number of patients that recovered from COVID-19 Time: days 1-29
Description: Number of patients hospitalized on invasive mechanical ventilationMeasure: Change in number of patients hospitalized on invasive mechanical ventilation Time: Days 15 and 29
Description: 8-point ordinal clinical scale assessedMeasure: number of patients that improved clinically Time: Days 3, 5, 8, 11, 15, 29, and 60
Description: mortality rateMeasure: Number of patient deaths Time: Day 14
Description: compared to baseline the amount of supplementation oxygenMeasure: Number of patients with decreased supplemental oxygenation needed Time: Day 29
Description: assessment of non-invasive ventilation/ high flow oxygen up to day 29Measure: Change in number of patients needing non-invasive ventilation/ high flow oxygen Time: Day 29
Description: number of days in the hospitalMeasure: Number of days patients are in the hospital Time: Days 3, 5, 8, 11, 15, 22, and 29
Description: Cumulative incidence of SAEs and AEs of grade 3 and 4Measure: Number of SAEs and AEs of grade 3 and 4 Time: Days 3, 5, 8, 11, 15, 22, and 29
Description: Number of patients with changes in abnormal WBC countsMeasure: Number of patients with changes in abnormal WBC counts Time: Days 3, 5, 8, 11, 15, and 29
Description: time to discharge or to a NEWS of <=2 and maintained for 24 hoursMeasure: Number of patients with National Early Warning Scores (NEWS) <=2 Time: Days 3, 5, 8, 11, 15, and 29
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