
Simulating COVID-19 Trial with Bayesian Analysis
Explore a simulated COVID-19 trial focusing on pre-ICU patients receiving Hydroxychloroquine or Placebo, using Bayesian cumulative logistic regression to evaluate treatment effects based on the WHO COVID Ordinal Scale. Dive into the design skeleton, control rate assumptions, and the Bayesian cumulative logistic model for a comprehensive understanding of this trial setup.
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Presentation Transcript
Simulating a COVID-19 Trial An example of a possible trial
Design Skeleton Population: Pre-ICU COVID positive (or presumptive positive) patients Treatment arms: Hydroxychloroquine versus Placebo Fixed 1:1 randomization Endpoint: 8 point WHO COVID Ordinal Scale Primary Analysis: Bayesian cumulative logistic regression, assuming proportional odds effect Success criteria: Pr(OR>1) > 0.975, posterior probability of benefit is at least 97.5%
WHO COVID Ordinal Scale Control Rate Assumptions per level 1: Death 2% 2: IMV or ECMO 1% 3: NIV or HFNC 2% 4: Hospitalized w O2 7% 5: Hospitalized w/o O2 w/ in-patient needs 8% 6: Hospitalized w/o in- patient needs 10% 7: Not hospitalized w limitations 30% 8: Not hospitalized w/o limitations 40%
Bayesian cumulative logistic model ??? log = ??+ ? ??, ? = 1,2, ,7 1 ??? Where ???= Pr ?? ? and ??is a treatment indicator (1 = treated, 0 = control) ? is the log odds ratio, proportional across all levels of the outcome With priors: ??~ ???? 0,1 ? ~ ???? 0,1