Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS

Summary

The goal of this study is to evaluate the effects of Ibudilast (MN-166) versus placebo in hospitalized patients infected with COVID-19 at risk for developing acute respiratory distress syndrome (ARDS) receiving standard of care (including anticoagulation therapy) by measuring the following outcomes: 1) the need for oxygen therapy at Days 7, 14, and 28, 2) clinical status as measured by the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale at Days 7, 14, and 28, and 3) safety (as measured by incidence of adverse events and clinical laboratory findings) and tolerability of Ibudilast.

Timeline

Start

2021-01-11

Primary completion

2022-06-30

Completion

2024-08-07

Publications

• Wyles DL, Matsuda K, Iwaki Y, Klonowski E. 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. BMC Pulm Med. 2026 Apr 2;26(1):218. doi: 10.1186/s12890-026-04261-8.

Drugs

Indications