MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

Phase

2/3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04367077

B04-03

Ages 18-89
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orsystemic infection

Exclusion

Exclusion Criteria: Moribund subject who, in the opinion of the Investigator, is not expected to survive atleast 48 hours and End-stage severe chronic lung disease

Study Design

April 28, 2020

December 31, 2023

Connect with a study center

Athersys Investigational Site 107
Chicago, Illinois 60601
United States
Active - Recruiting
Athersys Investigational Site 103
Akron, Ohio 44304
United States
Active - Recruiting
Athersys Investigational Site 101
Cleveland, Ohio 44106
United States
Active - Recruiting
Athersys Investigational Site 102
Cleveland, Ohio 44109
United States
Active - Recruiting

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