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NCT04429555 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS
A Phase 2 study, sponsored by MediciNova.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT04429555: Completed Phase 2 study, sponsored by MediciNova.
NCT04429555 is a Phase 2 study that has completed, run by MediciNova. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04429555, a Phase 2 study, has completed, sponsored by MediciNova.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Ibudilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2024-08-07 |
| Phase | Phase 2 |
What the finished NCT04429555 record still lists
NCT04429555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04429555 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04429555 about?
NCT04429555 is a clinical study titled "Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS". 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:...
What is the current status of trial NCT04429555?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2021-01-11. Estimated completion is 2024-08-07.
What interventions are being tested in trial NCT04429555?
The interventions under investigation include: Placebo (DRUG), Ibudilast (DRUG).
Who is sponsoring clinical trial NCT04429555?
This trial is sponsored by MediciNova, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04429555's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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