Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
400 participants in 2 patient groups, including a placebo group
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Central trial contact
Athersys Clinical Trials Group
Data sourced from clinicaltrials.gov
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