Phase 2
Completed N=34
Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS
Pneumonia, Viral
Source: ClinicalTrials.gov NCT04429555 ↗
Enrolled (actual)
34
Serious AEs
55.9%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants Free From Respiratory Failure at Day 7 — 12; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Free From Respiratory Failure at Day 7 |
12; 6 | — |
| PRIMARY Number of Participants With at Least a 1-point Improvement in Clinical Status on Day 7 |
12; 8 | — |
| SECONDARY Number of Participants Receiving Mechanical Ventilation or Intubation |
1; 3; 1; 2; 1; 1 | — |
| SECONDARY All-cause Mortality |
0; 2 | — |
| SECONDARY Number of Participants Discharged From Hospital at Days 7, 14, and 28 |
11; 5; 13; 11; 13; 14 | — |
Eligibility Criteria
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, computerized tomography (CT) scan or lung ultrasound) with abnormalities consistent with COVID-19 pneumonia
- Oxygen saturation (SpO2) ≤92% on room air (RA), respiratory rate ≥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
- Patient is receiving dialysis treatment
- On a home ventilator support or continuous domiciliary oxygen therapy for baseline lung disease
- Active tuberculosis infection
Data sourced from ClinicalTrials.gov (NCT04429555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.