Trial reportBMC pulmonary medicine2026
Effect of MN-166 (ibudilast) on acute respiratory failure prevention in hospitalized participants with COVID-19: a randomized, double-blind, placebo-controlled phase 2 study.
Trial report in BMC pulmonary medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04429555 (A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, Tolerability, Biomarkers and Pharmacokinetics of Ibudilast), which is not on this map. Not yet cited in PubMed.
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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
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4 authors.
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Abstract
backgroundMN-166 (ibudilast) is an orally available small molecule drug candidate that inhibits macrophage migration inhibitory factor and phosphodiesterase 4 and 10. The rationale for using MN-166 to prevent Acute Respiratory Failure (ARF) is based upon its cellular and molecular target actions and recent research in LPS-induced ARF animal model.
methodsIn this double-blind, randomized (1:1), placebo-controlled study conducted at two centers in the United States, we evaluated MN-166 (100 mg/day: 50 mg twice daily for 7 days) compared to placebo in hospitalized participants with COVID-19 at risk for ARF. The study’s co-primary endpoints were the proportion of participants free of respiratory failure at Day 7 and the proportion of participants with at least a one-point clinical status improvement in the National Institute of Allergy and Infectious Diseases 8-point ordinal scale at Day 7. All randomized participants received a study drug and were evaluated for efficacy and safety.
resultsA total of 34 participants were randomly assigned to either MN-166 or placebo (17 in each treatment group). The study achieved one of the co-primary endpoints, a statistically significant difference (P < 0.02) between groups related to the proportion of participants free from respiratory failure. Two-fold of participants in the MN-166 treatment group were free from respiratory failure on Day 7 versus the placebo group (70.6% vs. 35.3%; percentage difference: 35.3% [95% CI: 1.98 to 59.46]; P < 0.02). Sensitivity analysis showed similar differences among participants receiving interleukin-6 antibody therapy, with a statistically significant percentage difference from the placebo group (71.4% vs. 25%; 46.4%, 95% CI: 1.48 to 91.38, P < 0.05). MN 166 treatment was better tolerated than placebo. Two deaths were reported in the placebo group and none in the MN-166 treatment group.
conclusionsMN-166 treatment was associated with faster recovery from respiratory failure in participants with COVID-19, independent of interleukin-6 antibody therapy. MN-166 was well-tolerated with fewer adverse events compared to placebo.
trial registrationClinicalTrials.gov NCT04429555, Registered 11 June 2020,
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