CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


IbudilastWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D011024 Pneumonia, Viral NIH 0.13
D011014 Pneumonia NIH 0.06

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.06

There is one clinical trial.

Clinical Trials


1 A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, Tolerability, Biomarkers and Pharmacokinetics of Ibudilast (MN-166) in COVID-19 Subjects at Risk for Developing Acute Respiratory Distress Syndrome

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.

NCT04429555 Pneumonia, Viral Drug: Ibudilast Drug: Placebo
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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 days

Description: 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 days

Description: 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 days

Description: 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 days

Secondary Outcomes

Description: 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, 14

Description: 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 days

Description: 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 days

Description: 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, 28

Description: Proportion of subjects receiving mechanical ventilation or intubation.

Measure: Incidence of mechanical ventilation or intubation

Time: Days 7, 14

Description: Proportion of subjects requiring submission to the intensive care unit

Measure: Intensive care unit admission

Time: 7 days

Description: Blood sample collection to determine plasma concentrations of ibudilast.

Measure: Plasma concentrations of Ibudilast

Time: 7 days

Description: Number of deaths from any cause

Measure: All cause mortality

Time: Days 7, 14, 28


Related HPO nodes (Using clinical trials)