MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
Purpose
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.
Condition
- ARDS
Eligibility
- Eligible Ages
- Between 18 Years and 89 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Diagnosis of new acute-onset moderate to severe ARDS, as defined by the Berlin criteria, requiring an endotracheal or tracheal tube, Evidence of pneumonia or severe localized or systemic infection
Exclusion Criteria
Moribund subject who, in the opinion of the Investigator, is not expected to survive at least 48 hours and End-stage severe chronic lung disease
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MultiStem |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Athersys Investigational Site 107
Chicago, Illinois 60601
Chicago, Illinois 60601
Athersys Investigational Site 103
Akron, Ohio 44304
Akron, Ohio 44304
Athersys Investigational Site 101
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Athersys Investigational Site 102
Cleveland, Ohio 44109
Cleveland, Ohio 44109
More Details
- NCT ID
- NCT04367077
- Status
- Unknown status
- Sponsor
- Healios K.K.