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MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

TerminatedPhase 2, Phase 3

Sponsor: Healios K.K.

Conditions: ARDS

Interventions: MultiStem, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 89 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (4)

Chicago, Illinois, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States