This is a randomized (1:1) double-blind, placebo-controlled, parallel-group study of ibudilast in hospitalized COVID-19 subjects at risk for developing ARDS receiving standard of care including anticoagulation. The study will consist of a Screening Phase followed by a Treatment and Follow-up Phase. Following the Screening Phase, if the subject meets eligibility criteria, subject will be administered treatment with MN-166 (ibudilast) or placebo. Subjects will receive ibudilast 100 mg/d (50 mg b.i.d) or placebo every day for 7 days. Upon completion of the 7-day Treatment Phase, subject will be followed-up at Day 14 and at Day 28 post baseline. Subjects discharged prior to Day 7 will be given the remainder of their study medication to be taken at home twice daily and will be given a pulse oximeter to measure their oxygen levels once daily until Day 14.~The following screening assessments will be performed upon signing the ICF: inclusion/exclusion criteria review, physical exam, assess vital signs and O2 use, clinical status using the National Institute of Allergy and Infectious Diseases scale, 12-lead ECG, draw blood for plasma biomarkers that include: migration inhibitory factor (MIF), (interleukin 1-beta (IL-1β), interleukin 6 (IL-6), tumor necrosis factor (TNFα), and C-reactive protein (CRP). A complete blood count (CBC), comprehensive metabolic panel (CMP), D-dimer and coagulation tests will also be drawn. A serum pregnancy test will be done in pre-menopausal females. Prior concomitant medications taken within the last 7 days prior to study drug administration will be recorded.~During the Treatment Phase, hospitalized subjects will be treated with MN-166 or placebo for a 7-day period. During the Treatment Phase, subjects will undergo study-related procedures including physical exam, ECG, Oxygen use assessment, biomarkers and pharmacokinetic samples draw, CBC, CMP, D-dimer blood collection, clinical assessment using the NIAID scale, and information on adverse events and concomitant medications will be recorded.~On Study Day 14, conduct physical examination, clinical status, vital signs and oxygen use, ECG, CBC, CMP, D-dimer, and coagulation tests, biomarkers, AE and concomitant medications review. On Day 28, subject's clinical status and survival status will be recorded.
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.