Status:
COMPLETED
Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS
Lead Sponsor:
MediciNova
Conditions:
Pneumonia, Viral
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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)...
Detailed Description
This is a randomized (1:1) double-blind, placebo-controlled, parallel-group study evaluating the efficacy of Ibudilast to prevent ARDS in hospitalized patients infected with COVID-19 who are at risk f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04429555
Start Date
January 11 2021
End Date
August 7 2024
Last Update
October 30 2024
Active Locations (2)
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1
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520