Multi-Centre, Adaptive, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients: Master Protocol | NLM

Disaster Information Management Research Center | NLM

Multi-Centre, Adaptive, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients: Master Protocol

02/24/2020 12:00 AM EST

Source: World Health Organization (WHO). Published: 2/24/2020. This 68-page protocol is a multi-center, adaptive, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of investigational therapeutic agents in combination with standard-of-care for the treatment of hospitalized patients with novel coronavirus disease (COVID-19). It describes a study that is a multi-center trial that will be conducted in up to 50 sites globally with multiple sponsors. Using a Master Protocol can speed the implementation of clinical trials. (PDF)