Trials / Unknown
UnknownNCT04367077
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
A Phase 2/3 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease (COVID-19)
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Healios K.K. · Industry
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
Summary
Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including COVID-19.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MultiStem | intravenous infusion |
| BIOLOGICAL | Placebo | intravenous infusion |
Timeline
- Start date
- 2020-04-28
- Primary completion
- 2023-01-01
- Completion
- 2023-12-01
- First posted
- 2020-04-29
- Last updated
- 2021-09-09
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04367077. Inclusion in this directory is not an endorsement.