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

Purpose

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.

Condition

  • Pneumonia, Viral

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, double-blind, placebo-controlled, parallel-group study.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MN-166 (ibudilast) 		MN-166 capsules, 50 mg twice daily, for 7 days.
  • Drug: Ibudilast
    Ibudilast orally administered, 50 mg twice daily for 7 days.
    Other names:
    • MN-166
Placebo Comparator
Placebo 		Placebo capsules, 50 mg twice daily, for 7 days.
  • Drug: Placebo
    Placebo orally administered, 50 mg twice daily for 7 days.

Recruiting Locations

More Details

NCT ID
NCT04429555
Status
Completed
Sponsor
MediciNova

Detailed Description

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.