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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
Athersys Investigational Site 107
Chicago, Illinois, United States
RECRUITINGAthersys Investigational Site 103
Akron, Ohio, United States
RECRUITINGAthersys Investigational Site 101
Cleveland, Ohio, United States
RECRUITINGVentilator-Free Days
Time frame: Day 0 through Day 28.
Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.
Time frame: Day 28
All-cause mortality
Time frame: Day 60
Ranked hierarchical composite outcome of alive and ventilator-free
Time frame: Day 28
Ventilator-free days
Time frame: Day 0 through Day 60
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Athersys Investigational Site 102
Cleveland, Ohio, United States
RECRUITING