COVID-19 Studie

DisCoVeRy

INSERM_DisCoVeRy

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

Synopsis

Short title: DisCoVeRy

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

Status: closed

Start: May 2020 (in Austria)

Coordinating Investigator: Univ. Prof. Dr. Richard Greil (in Austria)

EudraCT Number: 2020-000936-23

ClinicalTrialsID: NCT04315948

Number of patients: 3100 (international)

Sponsor: INSERM – Institut national de la santé et de la recherche médicale, AGMT Sponsor representative in Austria

Design

This study is an adaptive, randomized, open trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a multicentre/country trial that will be conducted in various sites in Europe.
This randomised study among adults (≥18) hospitalised for COVID-19 randomly allocates them between 2 arms: SoC alone versus SoC + remdesivir
DisCoVeRy is an add-on trial to WHO SOLIDARITY trial and the global randomization tool of SOLIDARITY will be used.

Primary objective:

The overall objective of the study is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adult patients hospitalized with COVID-19.

Secondary objectives:
  • Evaluate the clinical efficacy of different investigational therapeutics as compared to the control arm as assessed by clinical severity, hospitalization and mortality.
  • Evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm.
  • Other exploratory objectives

Inclusion/Exclusion criteria

Inclusion criteria:
  • Adult ≥18 years of age at time of enrolment.
  • Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to randomization.
  • Hospitalized patients with illness of any duration, and at least one of the following:
    • Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, OR
    • Requiring supplemental oxygen, high flow oxygen devices, non invasive ventilation and/or mechanical ventilation
  • Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.
Exclusion criteria (selected):
  • Refusal to participate expressed by patient or legally authorized representative if they are present.
  • Liver enzymes ALT/AST > 5 times the upper limit of normal.
  • Stage 4 severe chronic kidney disease or requiring dialysis.
  • Patients treated with one of the antivirals evaluated in the study (i.e. remdesivir) in the past 29 days
  • Contraindication to any study medication including allergy.

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