COV201001:Multicentric and randomized trial: Bewertung der Wirksamkeit und Sicherheit von Behandlungen für hospitalisierte Patienten mit COVID-19 (DisCoVeRy)

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

Trial Description
Title

Multicentrische en gerandomiseerde studie: evaluatie van de werkzaamheid en veiligheid van behandelingen voor gehospitaliseerde patiënten met COVID-19

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

DOKUMENTE
Protocol  
Report

Q2 2021

Publication

 

REFERENZEN

Clinicaltrials.gov: NCT04315948

Webpage: