Efficacy and safety outcomes of proposed randomized controlled trials investigating hydroxychloroquine and chloroquine during the early stages of the COVID-19 pandemic.
Identifieur interne : 000521 ( Main/Exploration ); précédent : 000520; suivant : 000522Efficacy and safety outcomes of proposed randomized controlled trials investigating hydroxychloroquine and chloroquine during the early stages of the COVID-19 pandemic.
Auteurs : Daniela R. Junqueira [Canada] ; Brian H. Rowe [Canada]Source :
- British journal of clinical pharmacology [ 1365-2125 ] ; 2021.
Descripteurs français
- KwdFr :
- Antiviraux (effets indésirables), Antiviraux (usage thérapeutique), Bases de données factuelles (MeSH), Chloroquine (effets indésirables), Chloroquine (usage thérapeutique), Détermination du point final (MeSH), Essais contrôlés randomisés comme sujet (MeSH), Facteurs temps (MeSH), Femelle (MeSH), Humains (MeSH), Hydroxychloroquine (effets indésirables), Hydroxychloroquine (usage thérapeutique), Mâle (MeSH), Plan de recherche (MeSH), Résultat thérapeutique (MeSH).
- MESH :
- effets indésirables : Antiviraux, Chloroquine, Hydroxychloroquine.
- usage thérapeutique : Antiviraux, Chloroquine, Hydroxychloroquine.
- Bases de données factuelles, Détermination du point final, Essais contrôlés randomisés comme sujet, Facteurs temps, Femelle, Humains, Mâle, Plan de recherche, Résultat thérapeutique.
English descriptors
- KwdEn :
- Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), COVID-19 (diagnosis), COVID-19 (drug therapy), COVID-19 (virology), Chloroquine (adverse effects), Chloroquine (therapeutic use), Databases, Factual (MeSH), Endpoint Determination (MeSH), Female (MeSH), Humans (MeSH), Hydroxychloroquine (adverse effects), Hydroxychloroquine (therapeutic use), Male (MeSH), Randomized Controlled Trials as Topic (MeSH), Research Design (MeSH), Time Factors (MeSH), Treatment Outcome (MeSH).
- MESH :
- chemical , adverse effects : Antiviral Agents, Chloroquine, Hydroxychloroquine.
- chemical , therapeutic use : Antiviral Agents, Chloroquine, Hydroxychloroquine.
- diagnosis : COVID-19.
- drug therapy : COVID-19.
- virology : COVID-19.
- Databases, Factual, Endpoint Determination, Female, Humans, Male, Randomized Controlled Trials as Topic, Research Design, Time Factors, Treatment Outcome.
Abstract
AIMS
To assess whether randomized clinical trials (RCTs) proposed to evaluate the treatment of patients with COVID-19 with hydroxychloroquine (HQ) or chloroquine early in the pandemic included plans to measure outcomes that would translate into meaningful efficacy/effectiveness and safety outcomes.
METHODS
The World Health Organization International Clinical Trials Registry Platform database was searched for registers of RCTs evaluating HQ or chloroquine, alone or in combination, compared with other treatments for patients diagnosed with COVID-19. The final search was performed on 8 April 2020.
RESULTS
Among 51 registered RCTs (median sample size 262; interquartile range: 100, 520), 34 (67%) reported a clinical outcome, 12 (24%) a surrogate outcome, and 5 (10%) a combination of clinical and surrogate outcomes as primary endpoints. Six (15%) trials included the World Health Organization scale for clinical improvement as a primary clinical outcome. Clinical improvement and mortality accounted for 45% of the unique domains among 18 clinical outcome domains of efficacy. Twenty-four (47%) RCTs did not describe plans to assess safety outcomes; when assessed, safety outcomes were determined in generic terms of total, severe or serious adverse events.
CONCLUSION
The RCTs investigating HQ or chloroquine during the early stages of the COVID-19 pandemic included heterogeneous and insufficient approaches to measure efficacy/effectiveness and safety relevant to patients and clinical practice. These findings provide insights to inform clinical and regulatory decisions that can be drawn about the efficacy/effectiveness and safety of these agents in patients with COVID-19. Trialists need to adapt quickly to the research progress on COVID-19, ensuring that core outcome measures are assessed in ongoing RCTs.
DOI: 10.1111/bcp.14598
PubMed: 33047848
PubMed Central: PMC7675266
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Rowe</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Emergency Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB</wicri:regionArea><wicri:noRegion>AB</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>School of Public Health, University of Alberta, Edmonton, AB, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>School of Public Health, University of Alberta, Edmonton, AB</wicri:regionArea><wicri:noRegion>AB</wicri:noRegion></affiliation></author></analytic><series><title level="j">British journal of clinical pharmacology</title><idno type="eISSN">1365-2125</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral Agents (adverse effects)</term><term>Antiviral Agents (therapeutic use)</term><term>COVID-19 (diagnosis)</term><term>COVID-19 (drug therapy)</term><term>COVID-19 (virology)</term><term>Chloroquine (adverse effects)</term><term>Chloroquine (therapeutic use)</term><term>Databases, Factual (MeSH)</term><term>Endpoint Determination (MeSH)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (adverse effects)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Male (MeSH)</term><term>Randomized Controlled Trials as Topic (MeSH)</term><term>Research Design (MeSH)</term><term>Time Factors (MeSH)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Antiviraux (effets indésirables)</term><term>Antiviraux (usage thérapeutique)</term><term>Bases de données factuelles (MeSH)</term><term>Chloroquine (effets indésirables)</term><term>Chloroquine (usage thérapeutique)</term><term>Détermination du point final (MeSH)</term><term>Essais contrôlés randomisés comme sujet (MeSH)</term><term>Facteurs temps (MeSH)</term><term>Femelle (MeSH)</term><term>Humains (MeSH)</term><term>Hydroxychloroquine (effets indésirables)</term><term>Hydroxychloroquine (usage thérapeutique)</term><term>Mâle (MeSH)</term><term>Plan de recherche (MeSH)</term><term>Résultat thérapeutique (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antiviraux</term><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antiviraux</term><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Databases, Factual</term><term>Endpoint Determination</term><term>Female</term><term>Humans</term><term>Male</term><term>Randomized Controlled Trials as Topic</term><term>Research Design</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Bases de données factuelles</term><term>Détermination du point final</term><term>Essais contrôlés randomisés comme sujet</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Plan de recherche</term><term>Résultat thérapeutique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>AIMS</b></p><p>To assess whether randomized clinical trials (RCTs) proposed to evaluate the treatment of patients with COVID-19 with hydroxychloroquine (HQ) or chloroquine early in the pandemic included plans to measure outcomes that would translate into meaningful efficacy/effectiveness and safety outcomes.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>The World Health Organization International Clinical Trials Registry Platform database was searched for registers of RCTs evaluating HQ or chloroquine, alone or in combination, compared with other treatments for patients diagnosed with COVID-19. The final search was performed on 8 April 2020.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Among 51 registered RCTs (median sample size 262; interquartile range: 100, 520), 34 (67%) reported a clinical outcome, 12 (24%) a surrogate outcome, and 5 (10%) a combination of clinical and surrogate outcomes as primary endpoints. Six (15%) trials included the World Health Organization scale for clinical improvement as a primary clinical outcome. Clinical improvement and mortality accounted for 45% of the unique domains among 18 clinical outcome domains of efficacy. Twenty-four (47%) RCTs did not describe plans to assess safety outcomes; when assessed, safety outcomes were determined in generic terms of total, severe or serious adverse events.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>The RCTs investigating HQ or chloroquine during the early stages of the COVID-19 pandemic included heterogeneous and insufficient approaches to measure efficacy/effectiveness and safety relevant to patients and clinical practice. These findings provide insights to inform clinical and regulatory decisions that can be drawn about the efficacy/effectiveness and safety of these agents in patients with COVID-19. Trialists need to adapt quickly to the research progress on COVID-19, ensuring that core outcome measures are assessed in ongoing RCTs.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">33047848</PMID><DateCompleted><Year>2021</Year><Month>03</Month><Day>31</Day></DateCompleted><DateRevised><Year>2021</Year><Month>03</Month><Day>31</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1365-2125</ISSN><JournalIssue CitedMedium="Internet"><Volume>87</Volume><Issue>4</Issue><PubDate><Year>2021</Year><Month>04</Month></PubDate></JournalIssue><Title>British journal of clinical pharmacology</Title><ISOAbbreviation>Br J Clin Pharmacol</ISOAbbreviation></Journal><ArticleTitle>Efficacy and safety outcomes of proposed randomized controlled trials investigating hydroxychloroquine and chloroquine during the early stages of the COVID-19 pandemic.</ArticleTitle><Pagination><MedlinePgn>1758-1767</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1111/bcp.14598</ELocationID><Abstract><AbstractText Label="AIMS">To assess whether randomized clinical trials (RCTs) proposed to evaluate the treatment of patients with COVID-19 with hydroxychloroquine (HQ) or chloroquine early in the pandemic included plans to measure outcomes that would translate into meaningful efficacy/effectiveness and safety outcomes.</AbstractText><AbstractText Label="METHODS">The World Health Organization International Clinical Trials Registry Platform database was searched for registers of RCTs evaluating HQ or chloroquine, alone or in combination, compared with other treatments for patients diagnosed with COVID-19. The final search was performed on 8 April 2020.</AbstractText><AbstractText Label="RESULTS">Among 51 registered RCTs (median sample size 262; interquartile range: 100, 520), 34 (67%) reported a clinical outcome, 12 (24%) a surrogate outcome, and 5 (10%) a combination of clinical and surrogate outcomes as primary endpoints. Six (15%) trials included the World Health Organization scale for clinical improvement as a primary clinical outcome. Clinical improvement and mortality accounted for 45% of the unique domains among 18 clinical outcome domains of efficacy. Twenty-four (47%) RCTs did not describe plans to assess safety outcomes; when assessed, safety outcomes were determined in generic terms of total, severe or serious adverse events.</AbstractText><AbstractText Label="CONCLUSION">The RCTs investigating HQ or chloroquine during the early stages of the COVID-19 pandemic included heterogeneous and insufficient approaches to measure efficacy/effectiveness and safety relevant to patients and clinical practice. These findings provide insights to inform clinical and regulatory decisions that can be drawn about the efficacy/effectiveness and safety of these agents in patients with COVID-19. Trialists need to adapt quickly to the research progress on COVID-19, ensuring that core outcome measures are assessed in ongoing RCTs.</AbstractText><CopyrightInformation>© 2020 British Pharmacological Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Junqueira</LastName><ForeName>Daniela R</ForeName><Initials>DR</Initials><Identifier Source="ORCID">0000-0002-3261-4811</Identifier><AffiliationInfo><Affiliation>Department of Emergency Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rowe</LastName><ForeName>Brian H</ForeName><Initials>BH</Initials><Identifier Source="ORCID">0000-0003-3446-2097</Identifier><AffiliationInfo><Affiliation>Department of Emergency Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>School of Public Health, University of Alberta, Edmonton, AB, Canada.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>SOP 168483</GrantID><Agency>Scientific Director's</Agency><Country></Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>11</Month><Day>24</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Br J Clin Pharmacol</MedlineTA><NlmUniqueID>7503323</NlmUniqueID><ISSNLinking>0306-5251</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance 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MajorTopicYN="N">Chloroquine</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016208" MajorTopicYN="N">Databases, Factual</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D023381" MajorTopicYN="N">Endpoint Determination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012107" MajorTopicYN="N">Research Design</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">COVID-19</Keyword><Keyword MajorTopicYN="Y">adverse events</Keyword><Keyword MajorTopicYN="Y">chloroquine</Keyword><Keyword MajorTopicYN="Y">clinical trials</Keyword><Keyword MajorTopicYN="Y">hydroxychloroquine</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>09</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>05</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>09</Month><Day>24</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>10</Month><Day>14</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>4</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>10</Month><Day>13</Day><Hour>9</Hour><Minute>21</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33047848</ArticleId><ArticleId IdType="doi">10.1111/bcp.14598</ArticleId><ArticleId IdType="pmc">PMC7675266</ArticleId></ArticleIdList><ReferenceList><Title>REFERENCES</Title><Reference><Citation>World Health Organization (WHO). 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