Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials?
Identifieur interne : 000B12 ( Main/Corpus ); précédent : 000B11; suivant : 000B13Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials?
Auteurs : Faizan Mazhar ; Muhammad Abdul Hadi ; Chia Siang Kow ; Albaraa Mohammed N. Marran ; Hamid A. Merchant ; Syed Shahzad HasanSource :
- International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases [ 1878-3511 ] ; 2020.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Chloroquine, Hydroxychloroquine.
- drug therapy : COVID-19.
- standards : Randomized Controlled Trials as Topic.
- Humans, SARS-CoV-2.
Abstract
OBJECTIVES
We critically evaluated the quality of evidence and quality of harm reporting in clinical trials that evaluated the effectiveness of hydroxychloroquine (HCQ) or chloroquine (CQ) for the treatment of coronavirus disease 2019 (COVID-19).
STUDY DESIGN AND SETTING
Scientific databases were systematically searched to identify relevant trials of HCQ/CQ for the treatment of COVID-19 published up to 10 September 2020. The Cochrane risk-of-bias tools for randomized trials and non-randomized trials of interventions were used to assess risk of bias in the included studies. A 10-item Consolidated Standards of Reporting Trials (CONSORT) harm extension was used to assess quality of harm reporting in the included trials.
RESULTS
Sixteen trials, including fourteen randomized trials and two non-randomized trials, met the inclusion criteria. The results from the included trials were conflicting and lacked effect estimates adjusted for baseline disease severity or comorbidities in many cases, and most of the trials recruited a fairly small cohort of patients. None of the clinical trials met the CONSORT criteria in full for reporting harm data in clinical trials. None of the 16 trials had an overall 'low' risk of bias, while four of the trials had a 'high', 'critical', or 'serious' risk of bias. Biases observed in these trials arise from the randomization process, potential deviation from intended interventions, outcome measurements, selective reporting, confounding, participant selection, and/or classification of interventions.
CONCLUSION
In general, the quality of currently available evidence for the effectiveness of CQ/HCQ in patients with COVID-19 is suboptimal. The importance of a properly designed and reported clinical trial cannot be overemphasized amid the COVID-19 pandemic, and its dismissal could lead to poorer clinical and policy decisions, resulting in wastage of already stretched invaluable health care resources.
DOI: 10.1016/j.ijid.2020.09.1470
PubMed: 33007453
PubMed Central: PMC7524513
Links to Exploration step
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Sacco, "Luigi Sacco" University Hospital, Università di Milano, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Hadi, Muhammad Abdul" sort="Hadi, Muhammad Abdul" uniqKey="Hadi M" first="Muhammad Abdul" last="Hadi">Muhammad Abdul Hadi</name><affiliation><nlm:affiliation>School of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Birmingham, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Kow, Chia Siang" sort="Kow, Chia Siang" uniqKey="Kow C" first="Chia Siang" last="Kow">Chia Siang Kow</name><affiliation><nlm:affiliation>School of Postgraduate Studies, International Medical University, Kuala Lumpur, Malaysia.</nlm:affiliation></affiliation></author><author><name sortKey="Marran, Albaraa Mohammed N" sort="Marran, Albaraa Mohammed N" uniqKey="Marran A" first="Albaraa Mohammed N" last="Marran">Albaraa Mohammed N. Marran</name><affiliation><nlm:affiliation>Department of Pharmaceutical Care, Prince Mohammed Bin Nasser Hospital, Jizan, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Merchant, Hamid A" sort="Merchant, Hamid A" uniqKey="Merchant H" first="Hamid A" last="Merchant">Hamid A. Merchant</name><affiliation><nlm:affiliation>School of Applied Sciences, University of Huddersfield, Huddersfield, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Hasan, Syed Shahzad" sort="Hasan, Syed Shahzad" uniqKey="Hasan S" first="Syed Shahzad" last="Hasan">Syed Shahzad Hasan</name><affiliation><nlm:affiliation>School of Applied Sciences, University of Huddersfield, Huddersfield, United Kingdom. Electronic address: s.hasan@hud.ac.uk.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:33007453</idno><idno type="pmid">33007453</idno><idno type="doi">10.1016/j.ijid.2020.09.1470</idno><idno type="pmc">PMC7524513</idno><idno type="wicri:Area/Main/Corpus">000B12</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000B12</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials?</title><author><name sortKey="Mazhar, Faizan" sort="Mazhar, Faizan" uniqKey="Mazhar F" first="Faizan" last="Mazhar">Faizan Mazhar</name><affiliation><nlm:affiliation>Department of Biomedical and Clinical Sciences L. Sacco, "Luigi Sacco" University Hospital, Università di Milano, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Hadi, Muhammad Abdul" sort="Hadi, Muhammad Abdul" uniqKey="Hadi M" first="Muhammad Abdul" last="Hadi">Muhammad Abdul Hadi</name><affiliation><nlm:affiliation>School of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Birmingham, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Kow, Chia Siang" sort="Kow, Chia Siang" uniqKey="Kow C" first="Chia Siang" last="Kow">Chia Siang Kow</name><affiliation><nlm:affiliation>School of Postgraduate Studies, International Medical University, Kuala Lumpur, Malaysia.</nlm:affiliation></affiliation></author><author><name sortKey="Marran, Albaraa Mohammed N" sort="Marran, Albaraa Mohammed N" uniqKey="Marran A" first="Albaraa Mohammed N" last="Marran">Albaraa Mohammed N. Marran</name><affiliation><nlm:affiliation>Department of Pharmaceutical Care, Prince Mohammed Bin Nasser Hospital, Jizan, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Merchant, Hamid A" sort="Merchant, Hamid A" uniqKey="Merchant H" first="Hamid A" last="Merchant">Hamid A. Merchant</name><affiliation><nlm:affiliation>School of Applied Sciences, University of Huddersfield, Huddersfield, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Hasan, Syed Shahzad" sort="Hasan, Syed Shahzad" uniqKey="Hasan S" first="Syed Shahzad" last="Hasan">Syed Shahzad Hasan</name><affiliation><nlm:affiliation>School of Applied Sciences, University of Huddersfield, Huddersfield, United Kingdom. Electronic address: s.hasan@hud.ac.uk.</nlm:affiliation></affiliation></author></analytic><series><title level="j">International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases</title><idno type="eISSN">1878-3511</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>COVID-19 (drug therapy)</term><term>Chloroquine (therapeutic use)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Randomized Controlled Trials as Topic (standards)</term><term>SARS-CoV-2 (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Randomized Controlled Trials as Topic</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term><term>SARS-CoV-2</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVES</b></p><p>We critically evaluated the quality of evidence and quality of harm reporting in clinical trials that evaluated the effectiveness of hydroxychloroquine (HCQ) or chloroquine (CQ) for the treatment of coronavirus disease 2019 (COVID-19).</p></div><div type="abstract" xml:lang="en"><p><b>STUDY DESIGN AND SETTING</b></p><p>Scientific databases were systematically searched to identify relevant trials of HCQ/CQ for the treatment of COVID-19 published up to 10 September 2020. The Cochrane risk-of-bias tools for randomized trials and non-randomized trials of interventions were used to assess risk of bias in the included studies. A 10-item Consolidated Standards of Reporting Trials (CONSORT) harm extension was used to assess quality of harm reporting in the included trials.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Sixteen trials, including fourteen randomized trials and two non-randomized trials, met the inclusion criteria. The results from the included trials were conflicting and lacked effect estimates adjusted for baseline disease severity or comorbidities in many cases, and most of the trials recruited a fairly small cohort of patients. None of the clinical trials met the CONSORT criteria in full for reporting harm data in clinical trials. None of the 16 trials had an overall 'low' risk of bias, while four of the trials had a 'high', 'critical', or 'serious' risk of bias. Biases observed in these trials arise from the randomization process, potential deviation from intended interventions, outcome measurements, selective reporting, confounding, participant selection, and/or classification of interventions.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>In general, the quality of currently available evidence for the effectiveness of CQ/HCQ in patients with COVID-19 is suboptimal. The importance of a properly designed and reported clinical trial cannot be overemphasized amid the COVID-19 pandemic, and its dismissal could lead to poorer clinical and policy decisions, resulting in wastage of already stretched invaluable health care resources.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" IndexingMethod="Curated" Owner="NLM"><PMID Version="1">33007453</PMID><DateCompleted><Year>2020</Year><Month>12</Month><Day>31</Day></DateCompleted><DateRevised><Year>2021</Year><Month>05</Month><Day>18</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1878-3511</ISSN><JournalIssue CitedMedium="Internet"><Volume>101</Volume><PubDate><Year>2020</Year><Month>Dec</Month></PubDate></JournalIssue><Title>International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases</Title><ISOAbbreviation>Int J Infect Dis</ISOAbbreviation></Journal><ArticleTitle>Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials?</ArticleTitle><Pagination><MedlinePgn>107-120</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1201-9712(20)32186-X</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ijid.2020.09.1470</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">We critically evaluated the quality of evidence and quality of harm reporting in clinical trials that evaluated the effectiveness of hydroxychloroquine (HCQ) or chloroquine (CQ) for the treatment of coronavirus disease 2019 (COVID-19).</AbstractText><AbstractText Label="STUDY DESIGN AND SETTING" NlmCategory="METHODS">Scientific databases were systematically searched to identify relevant trials of HCQ/CQ for the treatment of COVID-19 published up to 10 September 2020. The Cochrane risk-of-bias tools for randomized trials and non-randomized trials of interventions were used to assess risk of bias in the included studies. A 10-item Consolidated Standards of Reporting Trials (CONSORT) harm extension was used to assess quality of harm reporting in the included trials.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Sixteen trials, including fourteen randomized trials and two non-randomized trials, met the inclusion criteria. The results from the included trials were conflicting and lacked effect estimates adjusted for baseline disease severity or comorbidities in many cases, and most of the trials recruited a fairly small cohort of patients. None of the clinical trials met the CONSORT criteria in full for reporting harm data in clinical trials. None of the 16 trials had an overall 'low' risk of bias, while four of the trials had a 'high', 'critical', or 'serious' risk of bias. Biases observed in these trials arise from the randomization process, potential deviation from intended interventions, outcome measurements, selective reporting, confounding, participant selection, and/or classification of interventions.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">In general, the quality of currently available evidence for the effectiveness of CQ/HCQ in patients with COVID-19 is suboptimal. The importance of a properly designed and reported clinical trial cannot be overemphasized amid the COVID-19 pandemic, and its dismissal could lead to poorer clinical and policy decisions, resulting in wastage of already stretched invaluable health care resources.</AbstractText><CopyrightInformation>Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mazhar</LastName><ForeName>Faizan</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Department of Biomedical and Clinical Sciences L. Sacco, "Luigi Sacco" University Hospital, Università di Milano, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hadi</LastName><ForeName>Muhammad Abdul</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>School of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Birmingham, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kow</LastName><ForeName>Chia Siang</ForeName><Initials>CS</Initials><AffiliationInfo><Affiliation>School of Postgraduate Studies, International Medical University, Kuala Lumpur, Malaysia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marran</LastName><ForeName>Albaraa Mohammed N</ForeName><Initials>AMN</Initials><AffiliationInfo><Affiliation>Department of Pharmaceutical Care, Prince Mohammed Bin Nasser Hospital, Jizan, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Merchant</LastName><ForeName>Hamid A</ForeName><Initials>HA</Initials><AffiliationInfo><Affiliation>School of Applied Sciences, University of Huddersfield, Huddersfield, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hasan</LastName><ForeName>Syed Shahzad</ForeName><Initials>SS</Initials><AffiliationInfo><Affiliation>School of Applied Sciences, University of Huddersfield, Huddersfield, United Kingdom. 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