Protocol for the DisCoVeRy trial: multicentre, adaptive,
randomised trial of the safety and efficacy of treatments for
COVID-19 in hospitalised adults

J 2020

Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults

ADER, F.

Basic information

Original name

Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults

Authors

ADER, F. (guarantor)

Edition

BMJ Open, London, BMJ Publishing Group, 2020, 2044-6055

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30230 Other clinical medicine subjects

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

DisCoVeRy trial

Impact factor

Impact factor: 2.692

RIV identification code

RIV/00216224:14110/20:00124331

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1136/bmjopen-2020-041437

UT WoS

000575220500015

Keywords (in Czech)

clinical trials; infectious diseases; respiratory infections; public health; intensive & critical care

Keywords in English

clinical trials; infectious diseases; respiratory infections; public health; intensive & critical care

Abstract

V originále

Introduction To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19. Methods and analysis DisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-beta-1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included. Ethics and dissemination Inserm is the sponsor of DisCoVeRy. Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals.

Links

90128, large research infrastructures

Name: CZECRIN III

Citovat

ADER, F. Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults. BMJ Open. London: BMJ Publishing Group, 2020, vol. 10, No 9, p. 1-11. ISSN 2044-6055. Available from: https://dx.doi.org/10.1136/bmjopen-2020-041437.

@article{1837960,
   author = {Ader, F.},
   article_location = {London},
   article_number = {9},
   doi = {http://dx.doi.org/10.1136/bmjopen-2020-041437},
   keywords = {clinical trials; infectious diseases; respiratory infections; public health; intensive & critical care},
   language = {eng},
   issn = {2044-6055},
   journal = {BMJ Open},
   note = {EU-RESPONSE},
   title = {Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults},
   url = {https://bmjopen.bmj.com/content/10/9/e041437},
   volume = {10},
   year = {2020}
}

TY  - JOUR
ID  - 1837960
AU  - Ader, F.
PY  - 2020
TI  - Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults
JF  - BMJ Open
VL  - 10
IS  - 9
SP  - 1-11
EP  - 1-11
PB  - BMJ Publishing Group
SN  - 20446055
N1  - EU-RESPONSE
KW  - clinical trials
KW  - infectious diseases
KW  - respiratory infections
KW  - public health
KW  - intensive &
KW  - critical care
UR  - https://bmjopen.bmj.com/content/10/9/e041437
N2  - Introduction To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19. Methods and analysis DisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-beta-1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included. Ethics and dissemination Inserm is the sponsor of DisCoVeRy. Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals.
ER  -

ADER, F. Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults. \textit{BMJ Open}. London: BMJ Publishing Group, 2020, vol.~10, No~9, p.~1-11. ISSN~2044-6055. Available from: https://dx.doi.org/10.1136/bmjopen-2020-041437.

Detailed Information on Publication Record