DisCoVeRy: Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults (COV201001)

Summary (French or Dutch)

This study is an international multi-centre, adaptive, randomized, open clinical trial of the safety and efficacy of treatments for COVID-19 in hospitalized adults. The study will be conducted in various sites in Europe with Inserm (France) as sponsor. DisCoVeRy (INSERM) is the daughter study of Solidarity (WHO). The study will be coordinated by Erasme Hospital in Belgium.

Adults, hospitalized for COVID-19 with reduced oxygen in their blood OR with acute respiratory failure requiring supplemental oxygen or ventilatory support will be randomized between initially 5 treatment arms, each to be given in addition to the usual standard of care (SoC) in the participating hospital. The treatment arms were; (1) SoC alone, (2) SoC + remdesivir, (3) SoC + lopinavir/ritonavir, (4) SoC + lopinavir/ritonavir + IFN ß-1a and (5) SoC + hydroxychloroquine however currently only the remdesivir and SoC arms are including patients. The primary endpoint is subject clinical status (on a 7-point ordinal scale) on Day 15. An individual subject will complete the study in about 29 days.

The study is designed to evaluate multiple interventions. The drug candidates to be evaluated were selected based on their broad antiviral activity, the in vitro and in vivo data showing activity against coronaviruses and extensive clinical safety database. As a consequence, they were considered suitable options for rapid implementation in clinical trials. Other arms can be added as evidence emerges from other candidate therapeutics.