Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
The study aims to evaluate MN-166 (ibudilast) in patients with COVID-19 who are at risk of developing acute respiratory distress syndrome. Subjects will be screened, randomly assigned to MN-166 or placebo groups, receive study drug on Days 1-7, and followed up on Day 14 and Day 28.
Description: Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirements (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Day 7
Measure: Proportion of subjects free from respiratory failure Time: 7 daysDescription: Mean change from baseline in clinical status based on the NIAID 8-point scale (1= death, 8= not hospitalized, no limitations on activities) at Day 7. A higher score indicates improvement.
Measure: Mean change from baseline in clinical status using the NIAID 8-point ordinal scale at Day 7 Time: 7 daysDescription: Percentage of patients with at least a one-point improvement in clinical status using the NIAID 8-point ordinal scale (1= death, 8= not hospitalized, no limitations on activities) at Day 7. A higher score indicates improvement.
Measure: Percentage of patients with improvement in clinical status Time: 7 daysDescription: Mean change from baseline (baseline = 1-fold; any value above 1.0 indicates elevation in cytokine levels; any value below 1.0 indicates reduction in cytokine levels) in migration inhibitory factor (MIF), (interleukin 1-beta (IL-1β), interleukin 6 (IL-6), tumor necrosis factor (TNF-α), and C-reactive protein (CRP) at Day 7.
Measure: Change in cytokine levels from baseline Time: 7 daysDescription: Incidence, frequency, and severity of adverse events at Day 7 and Day 14
Measure: Adverse event Incidence, severity, relationship to study drug, and study discontinuations Time: Days 7, 14Description: Incidence of out-of-normal-range values and markedly abnormal change from baseline in laboratory safety test variables by treatment group.
Measure: Changes in laboratory values from baseline Time: 7 daysDescription: Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirement (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Day 14
Measure: Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirement (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Day 14 Time: 14 daysDescription: Mean change from baseline in clinical status using the NIAID 8-point ordinal scale at Day 14 and Day 28
Measure: Mean change from baseline in clinical status Time: Days 14, 28Description: Proportion of subjects receiving mechanical ventilation or intubation.
Measure: Incidence of mechanical ventilation or intubation Time: Days 7, 14Description: Proportion of subjects requiring submission to the intensive care unit
Measure: Intensive care unit admission Time: 7 daysDescription: Blood sample collection to determine plasma concentrations of ibudilast.
Measure: Plasma concentrations of Ibudilast Time: 7 daysDescription: Number of deaths from any cause
Measure: All cause mortality Time: Days 7, 14, 28Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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