| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04429555 | Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS | PHASE2 | COMPLETED | 34 | — | — | Jan 11, 2021 | Aug 7, 2024 | Oct 30, 2024 | 2 | United States |
Participants were considered "responders" if they did not meet the need for supplemental oxygen requirements (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at the end of the 7-day double-blind treatment.
Number (percentage) of participants with at least a 1-point improvement in clinical status on Day 7. Clinical status is measured by the National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
| Arm | Type | Description |
|---|---|---|
| Active Treatment Group | EXPERIMENTAL | - |
| Placebo Treatment Group | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ibudilast | DRUG | 50 mg (5 x 10 mg capsules) twice daily for 7 days |
| Placebo | DRUG | 0 mg (5 matching capsules) 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, computerized tomography (CT) scan or lung ultrasound) with abnormalities consistent with CO...