A Multi-centre, Adaptive, Randomized, Double-Blind, PlaceboControlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients

Abstract

This is a multi-centre, 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). This Master Protocol is largely based on a series of deliberations of the WHO R&D Blueprint Clinical Trials Expert Group. The experts included international clinical trialists, coronavirus experts, regulatory and ethics experts and clinicians, including those treating COVID-19 patients. Based on those deliberations, experts at the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health developed the full version of the protocol. The version was then further adjusted to facilitate its implementation internationally.