Hydroxychloroquine for treatment of nonsevere COVID-19 patients: Systematic review and meta-analysis of controlled clinical trials.
Identifieur interne : 000E69 ( Main/Corpus ); précédent : 000E68; suivant : 000E70Hydroxychloroquine for treatment of nonsevere COVID-19 patients: Systematic review and meta-analysis of controlled clinical trials.
Auteurs : Hozaifa Khalil Elsawah ; Mohamed Ahmed Elsokary ; Mahmoud Gamal Elrazzaz ; Ahmed Hanei ElshafieSource :
- Journal of medical virology [ 1096-9071 ] ; 2021.
English descriptors
- KwdEn :
- MESH :
- chemical , adverse effects : Hydroxychloroquine.
- drug therapy : COVID-19.
- chemical , therapeutic use : Hydroxychloroquine.
- Clinical Trials as Topic, Humans.
Abstract
Being a pandemic and having a high global case fatality rate directed us to assess the evidence strength of hydroxychloroquine efficacy in treating coronavirus disease-2019 (COVID-19) arising from clinical trials and to update the practice with the most reliable clinical evidence. A comprehensive search was started in June up to 18 July, 2020 in many databases, including PubMed, Embase, and others. Of 432 studies found, only six studies fulfilled the inclusion criteria, which includes: clinical trials, age more than 12 years with nonsevere COVID-19, polymerase chain reaction-confirmed COVID-19, hydroxychloroquine is the intervention beyond the usual care. Data extraction and bias risk assessment were done by two independent authors. Both fixed-effect and random-effect models were utilized for pooling data using risk difference as a summary measure. The primary outcomes are clinical and radiological COVID-19 progression, severe acute respiratory syndrome coronavirus-2 clearance in the pharyngeal swab, and mortality. The secondary outcomes are the adverse effects of hydroxychloroquine. Among 609 COVID-19 confirmed patients obtained from pooling six studies, 294 patients received hydroxychloroquine and 315 patients served as a control. Hydroxychloroquine significantly prevents early radiological progression relative to control with risk difference and 95% confidence interval of -0.2 (-0.36 to -0.03). On the other hand, hydroxychloroquine did not prevent clinical COVID-19 progression, reduce 5-day mortality, or enhance viral clearance on days 5, 6, and 7. Moreover, many adverse effects were reported with hydroxychloroquine therapy. Failure of hydroxychloroquine to show viral clearance or clinical benefits with additional adverse effects outweigh its protective effect from radiological progression in nonsevere COVID-19 patients. Benefit-risk balance should determine the hydroxychloroquine use in COVID-19.
DOI: 10.1002/jmv.26442
PubMed: 32808712
PubMed Central: PMC7461373
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pubmed:32808712Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Hydroxychloroquine for treatment of nonsevere COVID-19 patients: Systematic review and meta-analysis of controlled clinical trials.</title><author><name sortKey="Elsawah, Hozaifa Khalil" sort="Elsawah, Hozaifa Khalil" uniqKey="Elsawah H" first="Hozaifa Khalil" last="Elsawah">Hozaifa Khalil Elsawah</name><affiliation><nlm:affiliation>Department of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt.</nlm:affiliation></affiliation></author><author><name sortKey="Elsokary, Mohamed Ahmed" sort="Elsokary, Mohamed Ahmed" uniqKey="Elsokary M" first="Mohamed Ahmed" last="Elsokary">Mohamed Ahmed Elsokary</name><affiliation><nlm:affiliation>Department of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt.</nlm:affiliation></affiliation></author><author><name sortKey="Elrazzaz, Mahmoud Gamal" sort="Elrazzaz, Mahmoud Gamal" uniqKey="Elrazzaz M" first="Mahmoud Gamal" last="Elrazzaz">Mahmoud Gamal Elrazzaz</name><affiliation><nlm:affiliation>IQVIA for the Human Data Science, The Fifth Settlement, Cairo, Egypt.</nlm:affiliation></affiliation></author><author><name sortKey="Elshafie, Ahmed Hanei" sort="Elshafie, Ahmed Hanei" uniqKey="Elshafie A" first="Ahmed Hanei" last="Elshafie">Ahmed Hanei Elshafie</name><affiliation><nlm:affiliation>Department of Neuropsychiatry, Shebin Elkom Teaching Hospital, Shebin Elkom, Egypt.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2021">2021</date><idno type="RBID">pubmed:32808712</idno><idno type="pmid">32808712</idno><idno type="doi">10.1002/jmv.26442</idno><idno type="pmc">PMC7461373</idno><idno type="wicri:Area/Main/Corpus">000E69</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000E69</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Hydroxychloroquine for treatment of nonsevere COVID-19 patients: Systematic review and meta-analysis of controlled clinical trials.</title><author><name sortKey="Elsawah, Hozaifa Khalil" sort="Elsawah, Hozaifa Khalil" uniqKey="Elsawah H" first="Hozaifa Khalil" last="Elsawah">Hozaifa Khalil Elsawah</name><affiliation><nlm:affiliation>Department of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt.</nlm:affiliation></affiliation></author><author><name sortKey="Elsokary, Mohamed Ahmed" sort="Elsokary, Mohamed Ahmed" uniqKey="Elsokary M" first="Mohamed Ahmed" last="Elsokary">Mohamed Ahmed Elsokary</name><affiliation><nlm:affiliation>Department of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt.</nlm:affiliation></affiliation></author><author><name sortKey="Elrazzaz, Mahmoud Gamal" sort="Elrazzaz, Mahmoud Gamal" uniqKey="Elrazzaz M" first="Mahmoud Gamal" last="Elrazzaz">Mahmoud Gamal Elrazzaz</name><affiliation><nlm:affiliation>IQVIA for the Human Data Science, The Fifth Settlement, Cairo, Egypt.</nlm:affiliation></affiliation></author><author><name sortKey="Elshafie, Ahmed Hanei" sort="Elshafie, Ahmed Hanei" uniqKey="Elshafie A" first="Ahmed Hanei" last="Elshafie">Ahmed Hanei Elshafie</name><affiliation><nlm:affiliation>Department of Neuropsychiatry, Shebin Elkom Teaching Hospital, Shebin Elkom, Egypt.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Journal of medical virology</title><idno type="eISSN">1096-9071</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>COVID-19 (drug therapy)</term><term>Clinical Trials as Topic (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (adverse effects)</term><term>Hydroxychloroquine (therapeutic use)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Clinical Trials as Topic</term><term>Humans</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Being a pandemic and having a high global case fatality rate directed us to assess the evidence strength of hydroxychloroquine efficacy in treating coronavirus disease-2019 (COVID-19) arising from clinical trials and to update the practice with the most reliable clinical evidence. A comprehensive search was started in June up to 18 July, 2020 in many databases, including PubMed, Embase, and others. Of 432 studies found, only six studies fulfilled the inclusion criteria, which includes: clinical trials, age more than 12 years with nonsevere COVID-19, polymerase chain reaction-confirmed COVID-19, hydroxychloroquine is the intervention beyond the usual care. Data extraction and bias risk assessment were done by two independent authors. Both fixed-effect and random-effect models were utilized for pooling data using risk difference as a summary measure. The primary outcomes are clinical and radiological COVID-19 progression, severe acute respiratory syndrome coronavirus-2 clearance in the pharyngeal swab, and mortality. The secondary outcomes are the adverse effects of hydroxychloroquine. Among 609 COVID-19 confirmed patients obtained from pooling six studies, 294 patients received hydroxychloroquine and 315 patients served as a control. Hydroxychloroquine significantly prevents early radiological progression relative to control with risk difference and 95% confidence interval of -0.2 (-0.36 to -0.03). On the other hand, hydroxychloroquine did not prevent clinical COVID-19 progression, reduce 5-day mortality, or enhance viral clearance on days 5, 6, and 7. Moreover, many adverse effects were reported with hydroxychloroquine therapy. Failure of hydroxychloroquine to show viral clearance or clinical benefits with additional adverse effects outweigh its protective effect from radiological progression in nonsevere COVID-19 patients. Benefit-risk balance should determine the hydroxychloroquine use in COVID-19.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32808712</PMID><DateCompleted><Year>2021</Year><Month>03</Month><Day>02</Day></DateCompleted><DateRevised><Year>2021</Year><Month>03</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1096-9071</ISSN><JournalIssue CitedMedium="Internet"><Volume>93</Volume><Issue>3</Issue><PubDate><Year>2021</Year><Month>03</Month></PubDate></JournalIssue><Title>Journal of medical virology</Title><ISOAbbreviation>J Med Virol</ISOAbbreviation></Journal><ArticleTitle>Hydroxychloroquine for treatment of nonsevere COVID-19 patients: Systematic review and meta-analysis of controlled clinical trials.</ArticleTitle><Pagination><MedlinePgn>1265-1275</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/jmv.26442</ELocationID><Abstract><AbstractText>Being a pandemic and having a high global case fatality rate directed us to assess the evidence strength of hydroxychloroquine efficacy in treating coronavirus disease-2019 (COVID-19) arising from clinical trials and to update the practice with the most reliable clinical evidence. A comprehensive search was started in June up to 18 July, 2020 in many databases, including PubMed, Embase, and others. Of 432 studies found, only six studies fulfilled the inclusion criteria, which includes: clinical trials, age more than 12 years with nonsevere COVID-19, polymerase chain reaction-confirmed COVID-19, hydroxychloroquine is the intervention beyond the usual care. Data extraction and bias risk assessment were done by two independent authors. Both fixed-effect and random-effect models were utilized for pooling data using risk difference as a summary measure. The primary outcomes are clinical and radiological COVID-19 progression, severe acute respiratory syndrome coronavirus-2 clearance in the pharyngeal swab, and mortality. The secondary outcomes are the adverse effects of hydroxychloroquine. Among 609 COVID-19 confirmed patients obtained from pooling six studies, 294 patients received hydroxychloroquine and 315 patients served as a control. Hydroxychloroquine significantly prevents early radiological progression relative to control with risk difference and 95% confidence interval of -0.2 (-0.36 to -0.03). On the other hand, hydroxychloroquine did not prevent clinical COVID-19 progression, reduce 5-day mortality, or enhance viral clearance on days 5, 6, and 7. Moreover, many adverse effects were reported with hydroxychloroquine therapy. Failure of hydroxychloroquine to show viral clearance or clinical benefits with additional adverse effects outweigh its protective effect from radiological progression in nonsevere COVID-19 patients. Benefit-risk balance should determine the hydroxychloroquine use in COVID-19.</AbstractText><CopyrightInformation>© 2020 Wiley Periodicals LLC.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Elsawah</LastName><ForeName>Hozaifa Khalil</ForeName><Initials>HK</Initials><Identifier Source="ORCID">0000-0003-2965-9944</Identifier><AffiliationInfo><Affiliation>Department of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Elsokary</LastName><ForeName>Mohamed Ahmed</ForeName><Initials>MA</Initials><Identifier Source="ORCID">0000-0002-9832-5086</Identifier><AffiliationInfo><Affiliation>Department of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Elrazzaz</LastName><ForeName>Mahmoud Gamal</ForeName><Initials>MG</Initials><AffiliationInfo><Affiliation>IQVIA for the Human Data Science, The Fifth Settlement, Cairo, Egypt.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Elshafie</LastName><ForeName>Ahmed Hanei</ForeName><Initials>AH</Initials><Identifier Source="ORCID">0000-0002-2901-2158</Identifier><AffiliationInfo><Affiliation>Department of Neuropsychiatry, Shebin Elkom Teaching Hospital, Shebin Elkom, Egypt.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D017418">Meta-Analysis</PublicationType><PublicationType UI="D000078182">Systematic Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>09</Month><Day>29</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Med Virol</MedlineTA><NlmUniqueID>7705876</NlmUniqueID><ISSNLinking>0146-6615</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002986" MajorTopicYN="N">Clinical Trials as Topic</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></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">COVID-19</Keyword><Keyword MajorTopicYN="Y">Progression</Keyword><Keyword MajorTopicYN="Y">hydroxychloroquine</Keyword><Keyword MajorTopicYN="Y">mortality</Keyword><Keyword MajorTopicYN="Y">viral clearance</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>07</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>08</Month><Day>13</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>8</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>3</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>8</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32808712</ArticleId><ArticleId IdType="doi">10.1002/jmv.26442</ArticleId><ArticleId IdType="pmc">PMC7461373</ArticleId></ArticleIdList><ReferenceList><Title>REFERENCES</Title><Reference><Citation>Gorbalenya AE, Baker SC, Baric RS, et al. 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