"the independent Data Safety Monitoring
Board (DSMB) recommended continuation of the Phase 3 trial of remestemcel-L in patients with
moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection, following
completion of trial’s first interim analysis. The analysis was performed on the first 30% of the total
target of randomized patients, with the DSMB reviewing the trial’s primary endpoint, all-cause
mortality within 30 days of randomization and all safety data"
"The multi-center study includes three interim analyses for stopping accrual early for efficacy or futilitywhen 30%, 45% and 60% of the total target of randomized patients have reached the primaryendpoint."
"The primary endpoint is all-cause mortality within 30 days of randomization. The key
secondary endpoint is days alive off mechanical ventilatory support within 60 days of randomization."
How we understand above? Positive? Negative? Or Neutral?
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- Ann: DSMB Recommends Continuation of Phase 3 COVID-19 Trial
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