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.
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.
Drug: Ibudilast
Ibudilast orally administered, 50 mg twice daily for 7 days.
Other Name: MN-166
Drug: Placebo
Placebo orally administered, 50 mg twice daily for 7 days.
Inclusion Criteria:
- SARS-CoV-2 infection confirmed with WHO criteria (including a positive PCR of any
specimen, e.g., blood, respiratory, stool, urine, or any other body fluid)
- Chest imaging (radiograph, CT scan or lung ultrasound) with abnormalities consistent
with COVID-19 pneumonia
- SpO2 ≤ 92% on room air (RA), RR ≥24 breaths per min on RA, and/or requirement for
supplemental oxygen
- At least 1 risk factor which may put patient at higher risk for more severe illness
from COVID-19: Age > 65, underlying serious heart disease, chronic lung disease,
moderate to severe asthma, body mass index of ≥ 40 or diabetes
Exclusion Criteria:
- Suspected active bacterial, fungal, viral, or other cause of respiratory failure other
than COVID-19
- Subject is already intubated and on ventilator support
- Known or suspected immunosuppression with immunosuppressant medications or
chemotherapeutic agents
- Subject is on dialysis
- On home ventilator support or continuous domiciliary O2 therapy for baseline lung
disease
- Active tuberculosis (TB) infection
Denver Health and Hospital Authority
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Kazuko Matsuda, MD PhD MPH, Study Chair
Medicinova Inc