https://clinicaltrials.gov/ct2/show/NCT04371393?term=mesoblast&draw=2&rank=38
This will be a randomized (1:1 ratio), double blind, parallel design, placebo controlled trial. Randomization will be stratified by clinical center and by moderate versus severe ARDS. The study is designed to have three interim analyses for stopping accrual early for efficacy and futility when 30%, 45% and 60% of the 300 patients have reached the primary endpoint using Bayesian predictive probabilities.
Ann: Phase 2/3 Trial in COVID-19 ARDS Begins Enrollment, page-210
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