Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults.
Identifieur interne : 000D97 ( Main/Exploration ); précédent : 000D96; suivant : 000D98Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults.
Auteurs : Florence Ader [France]Source :
- BMJ open [ 2044-6055 ] ; 2020.
Descripteurs français
- KwdFr :
- AMP (analogues et dérivés), AMP (usage thérapeutique), Adulte (MeSH), Alanine (analogues et dérivés), Alanine (usage thérapeutique), Antiviraux (usage thérapeutique), Association de médicaments (MeSH), Association médicamenteuse (MeSH), Betacoronavirus (MeSH), Durée du séjour (MeSH), Hospitalisation (MeSH), Humains (MeSH), Hydroxychloroquine (usage thérapeutique), Infections à coronavirus (thérapie), Infections à coronavirus (traitement médicamenteux), Interféron bêta-1a (usage thérapeutique), Lopinavir (usage thérapeutique), Mortalité hospitalière (MeSH), Norme de soins (MeSH), Oxygénation extracorporelle sur oxygénateur à membrane (MeSH), Oxygénothérapie (MeSH), Pandémies (MeSH), Pneumopathie virale (thérapie), Pneumopathie virale (traitement médicamenteux), Ritonavir (usage thérapeutique), Résultat thérapeutique (MeSH), Ventilation artificielle (MeSH).
- MESH :
- analogues et dérivés : AMP, Alanine.
- thérapie : Infections à coronavirus, Pneumopathie virale.
- traitement médicamenteux : Infections à coronavirus, Pneumopathie virale.
- usage thérapeutique : AMP, Alanine, Antiviraux, Hydroxychloroquine, Interféron bêta-1a, Lopinavir, Ritonavir.
- Adulte, Association de médicaments, Association médicamenteuse, Betacoronavirus, Durée du séjour, Hospitalisation, Humains, Mortalité hospitalière, Norme de soins, Oxygénation extracorporelle sur oxygénateur à membrane, Oxygénothérapie, Pandémies, Résultat thérapeutique, Ventilation artificielle.
English descriptors
- KwdEn :
- Adenosine Monophosphate (analogs & derivatives), Adenosine Monophosphate (therapeutic use), Adult (MeSH), Alanine (analogs & derivatives), Alanine (therapeutic use), Antiviral Agents (therapeutic use), Betacoronavirus (MeSH), COVID-19 (MeSH), Coronavirus Infections (drug therapy), Coronavirus Infections (therapy), Drug Combinations (MeSH), Drug Therapy, Combination (MeSH), Early Warning Score (MeSH), Extracorporeal Membrane Oxygenation (MeSH), Hospital Mortality (MeSH), Hospitalization (MeSH), Humans (MeSH), Hydroxychloroquine (therapeutic use), Interferon beta-1a (therapeutic use), Length of Stay (MeSH), Lopinavir (therapeutic use), Oxygen Inhalation Therapy (MeSH), Pandemics (MeSH), Pneumonia, Viral (drug therapy), Pneumonia, Viral (therapy), Respiration, Artificial (MeSH), Ritonavir (therapeutic use), SARS-CoV-2 (MeSH), Standard of Care (MeSH), Treatment Outcome (MeSH).
- MESH :
- chemical , analogs & derivatives : Adenosine Monophosphate, Alanine.
- chemical , therapeutic use : Adenosine Monophosphate, Alanine, Antiviral Agents, Hydroxychloroquine, Interferon beta-1a, Lopinavir, Ritonavir.
- drug therapy : Coronavirus Infections, Pneumonia, Viral.
- therapy : Coronavirus Infections, Pneumonia, Viral.
- Adult, Betacoronavirus, COVID-19, Drug Combinations, Drug Therapy, Combination, Early Warning Score, Extracorporeal Membrane Oxygenation, Hospital Mortality, Hospitalization, Humans, Length of Stay, Oxygen Inhalation Therapy, Pandemics, Respiration, Artificial, SARS-CoV-2, Standard of Care, Treatment Outcome.
Abstract
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)-β-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.
TRIAL REGISTRATION NUMBER
NCT04315948 Eudra-CT 2020-000936-23.
DOI: 10.1136/bmjopen-2020-041437
PubMed: 32958495
PubMed Central: PMC7507250
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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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.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS AND ANALYSIS</b></p><p>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)-β-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.</p></div><div type="abstract" xml:lang="en"><p><b>ETHICS AND DISSEMINATION</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION NUMBER</b></p><p>NCT04315948 Eudra-CT 2020-000936-23.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32958495</PMID><DateCompleted><Year>2020</Year><Month>10</Month><Day>05</Day></DateCompleted><DateRevised><Year>2020</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">2044-6055</ISSN><JournalIssue CitedMedium="Internet"><Volume>10</Volume><Issue>9</Issue><PubDate><Year>2020</Year><Month>09</Month><Day>21</Day></PubDate></JournalIssue><Title>BMJ open</Title><ISOAbbreviation>BMJ Open</ISOAbbreviation></Journal><ArticleTitle>Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults.</ArticleTitle><Pagination><MedlinePgn>e041437</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1136/bmjopen-2020-041437</ELocationID><Abstract><AbstractText Label="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.</AbstractText><AbstractText Label="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)-β-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.</AbstractText><AbstractText Label="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.</AbstractText><AbstractText Label="TRIAL REGISTRATION NUMBER">NCT04315948 Eudra-CT 2020-000936-23.</AbstractText><CopyrightInformation>© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Ader</LastName><ForeName>Florence</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Infectious and tropical diseases department, Centre Hospitalier Universitaire de Lyon, F-69004 Lyon, and Inserm 1111-Centre International de Recherche en Infectiologie (CIRI), Université Claude Bernard Lyon 1, CNRS, UMR5308, Ecole Normale Supérieure de Lyon, Univ Lyon, F-69007, Lyon, France florence.ader@chu-lyon.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>Discovery French Trial Management Team</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT04315948</AccessionNumber></AccessionNumberList></DataBank><DataBank><DataBankName>EudraCT</DataBankName><AccessionNumberList><AccessionNumber>Eudra-CT 2020-000936-23</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D000076362">Adaptive Clinical Trial</PublicationType><PublicationType UI="D000078325">Clinical Trial Protocol</PublicationType><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>09</Month><Day>21</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>BMJ Open</MedlineTA><NlmUniqueID>101552874</NlmUniqueID><ISSNLinking>2044-6055</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C558899">lopinavir-ritonavir drug combination</NameOfSubstance></Chemical><Chemical><RegistryNumber>2494G1JF75</RegistryNumber><NameOfSubstance UI="D061466">Lopinavir</NameOfSubstance></Chemical><Chemical><RegistryNumber>3QKI37EEHE</RegistryNumber><NameOfSubstance UI="C000606551">remdesivir</NameOfSubstance></Chemical><Chemical><RegistryNumber>415SHH325A</RegistryNumber><NameOfSubstance UI="D000249">Adenosine Monophosphate</NameOfSubstance></Chemical><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance></Chemical><Chemical><RegistryNumber>O3J8G9O825</RegistryNumber><NameOfSubstance UI="D019438">Ritonavir</NameOfSubstance></Chemical><Chemical><RegistryNumber>OF5P57N2ZX</RegistryNumber><NameOfSubstance UI="D000409">Alanine</NameOfSubstance></Chemical><Chemical><RegistryNumber>XRO4566Q4R</RegistryNumber><NameOfSubstance UI="D000068556">Interferon beta-1a</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000249" MajorTopicYN="N">Adenosine Monophosphate</DescriptorName><QualifierName UI="Q000031" MajorTopicYN="Y">analogs & derivatives</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000409" MajorTopicYN="N">Alanine</DescriptorName><QualifierName UI="Q000031" MajorTopicYN="Y">analogs & derivatives</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000998" MajorTopicYN="N">Antiviral Agents</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000073640" MajorTopicYN="N">Betacoronavirus</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000628" MajorTopicYN="N">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004338" MajorTopicYN="N">Drug Combinations</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000080162" MajorTopicYN="N">Early Warning Score</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015199" MajorTopicYN="N">Extracorporeal Membrane Oxygenation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017052" MajorTopicYN="N">Hospital Mortality</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006760" MajorTopicYN="N">Hospitalization</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000068556" MajorTopicYN="N">Interferon beta-1a</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007902" MajorTopicYN="N">Length of Stay</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D061466" MajorTopicYN="N">Lopinavir</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010102" MajorTopicYN="N">Oxygen Inhalation Therapy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000628" MajorTopicYN="N">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012121" MajorTopicYN="N">Respiration, Artificial</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019438" MajorTopicYN="N">Ritonavir</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D059039" MajorTopicYN="N">Standard of Care</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">clinical trials</Keyword><Keyword MajorTopicYN="Y">infectious diseases</Keyword><Keyword MajorTopicYN="Y">intensive & critical care</Keyword><Keyword MajorTopicYN="Y">public health</Keyword><Keyword MajorTopicYN="Y">respiratory infections</Keyword></KeywordList><CoiStatement>Competing interests: François-Xavier Lescure reports fees for development of educational presentations from Gilead, outside the submitted work. Dominique Costagliola reports personal fees from Merck Switzerland, grants and personal fees from MSD France, personal fees from Gilead France, grants and personal fees from Janssen, outside the submitted work. Jean-François Timsit reports grants and personal fees from Merck, grants and personal fees from Pfizer, grants from biomerieux, personal fees from medimune, personal fees from Paratek, personal fees from Gilead, outside the submitted work. Benjamin Hamze reports personal fees from Sanofi, outside the submitted work. Gilles Peytavin has received travel grants, consultancy fees, honoraria, or study grants from various pharmaceutical companies, including Gilead Sciences, Merck, TheraTechnologies and ViiV Healthcare. 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