Adaptive COVID-19 Treatment Trial (ACTT)
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An Adaptive COVID-19 Treatment Trial (ACTT) is an Adaptive Clinical Trial that evaluates the safety and efficacy of therapeutic agents in hospitalized adults diagnosed with COVID-19.
- AKA: NCT04280705 Clinical Trial.
- Context:
- Example(s):
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- Counter-Example(s):
- See: National Clinical Trial (NCT) Number, Clinical Trial, Decentralized Clinical Trial, Confirmatory Clinical Trial, Pragmatic Clinical Trial, Exploratory Clinical Trial.
References
2020
- (ClinicalTrials.gov, 2021) ⇒ https://clinicaltrials.gov/ct2/show/NCT04280705 Last Update Posted: December 9, 2020.
- QUOTE: 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.