Status:
UNKNOWN
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
Lead Sponsor:
Healios K.K.
Conditions:
ARDS
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
PHASE3
Brief 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 subjec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04367077
Start Date
April 28 2020
End Date
December 1 2023
Last Update
September 9 2021
Active Locations (4)
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1
Athersys Investigational Site 107
Chicago, Illinois, United States, 60601
2
Athersys Investigational Site 103
Akron, Ohio, United States, 44304
3
Athersys Investigational Site 101
Cleveland, Ohio, United States, 44106
4
Athersys Investigational Site 102
Cleveland, Ohio, United States, 44109