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

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.

Trial Description
Title

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

Participants (P)

Hospitalised adult (≥18 years old) patients with COVID-19

Intervention (I)

(2) SoC + remdesivir,

(3) SoC + lopinavir/ritonavir, (stopped 04/07/2020)

(4) SoC + lopinavir/ritonavir + IFN ß-1a and (stopped 04/07/2020)

(5) SoC + hydroxychloroquine. (suspended 24/05/2020, then stopped 17/06/2020)

Other arms can be added as evidence emerges from other candidate therapeutics

Control (C)

(1) Standard of Care (SOC)

Outcome (O)

The primary endpoint is subject clinical status (on a 7-point ordinal scale) on Day 15

Trial Design

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

Sample Size

3,200 planned in Europe

150 planned in Belgium

Trial duration

13 months

Budget

€630,000

Status

Open to recruitment

 

Trial team

Sponsor

Inserm - Pôle Recherche Clinique (PRC)

Biopark, Bâtiment A, 8 rue de la Croix Jarry, 75013 Paris

Chief Investigator

Dr Florence Ader

Coordinating Investigator BE

Dr Maya Hites, PhD - Hospital Erasme

Participating investigators

Hospital Erasme (BCC), CHR Liège Citadelle, UCL Saint-Luc

Documents
Protocol  
Report

Q2 2021

Publication

 

References

Clinicaltrials.gov: NCT04315948

Webpage: