Any such change would be accompanied by an updated sample size. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. The study will compare different investigational therapeutic agents to a control arm. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects.

Why Should I Register and Submit Results?.

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