A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

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. The study is a multicenter trial that will be conducted in up to approximately 100
sites globally. The study will compare different investigational therapeutic agents to a
control arm. There will be interim monitoring to introduce new arms and allow early stopping
for futility, efficacy, or safety. If one therapy proves to be efficacious, then this
treatment may become the control arm for comparison(s) with new experimental treatment(s).
Any such change would be accompanied by an updated sample size. 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. 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. To evaluate the clinical efficacy, as assessed by time to recovery, of different
investigational therapeutics as compared to the control arm.