Sample size and ending enrollment in evaluating 28-day mortality and other clinical outcomes in a randomized controlled trial of Dexamethasone (DEX) among hospitalized COVID-19 patients in RECOVERY trial
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Sample size not established prior to experiment beginning due to not knowing what to expect from pandemic
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During trial, Steering Committee, who did not know study results, determined that “28-day mortality was 20% then a comparison of at least 2000 patients allocated to active drug and 4000 to usual care alone would yield at least 90% power at two-sided P=0.01 to detect a clinically relevant absolute difference of 4 percentage points between the two groups (a proportional reduction of one-fifth).”
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Enrollment was stopped after reaching 2000 participants on June 8, 2020
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SARS-CoV-2 (COVID-19)
Biomedical Sciences
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Study design for evaluating 28-day mortality and other clinical outcomes in a randomized controlled trial of Dexamethasone (DEX) among hospitalized COVID-19 patients in RECOVERY trial
Sample size and ending enrollment in evaluating 28-day mortality and other clinical outcomes in a randomized controlled trial of Dexamethasone (DEX) among hospitalized COVID-19 patients in RECOVERY trial
Statistical analysis for evaluating 28-day mortality and other clinical outcomes in a randomized controlled trial of Dexamethasone (DEX) among hospitalized COVID-19 patients in RECOVERY trial
RECOVERY trial: a system for evaluating COVID-19 treatments