DisCoVeRy

Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults

This study is an adaptive, randomized, open clinical trial to evaluate the safety and efficacy of possible therapeutic agents in hospitalized adult patients diagnosed with COVID-19.

The study will compare different investigational therapeutic agents to a control group managed with the Standard of Care (SoC). There will be interim monitoring to allow early stopping for futility, efficacy, or safety and to introduce new therapies as they become available. If one therapy proves to be superior to others in the trial, this treatment will then become part of the SoC arm for comparison(s) with new experimental treatment(s).

This protocol, therefore, describes a randomised trial among adults (≥18) hospitalised for COVID-19 that randomly allocates them between the 2 arms (since June 29 2020): Standard of Care (SoC) alone versus SoC + remdesivir. Other arms can be added as evidence emerges from other candidate therapeutics.

Population: adult | Intervention type: therapeutic medicinal product

Trial website

ClinicalTrials.gov

EU Clinical Trials Register

#Infectious diseases

Publications

Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group

Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial

Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20-15 DisCoVeRy study