The "sex gap" in COVID-19 trials: a scoping review.
Identifieur interne : 000717 ( Main/Corpus ); précédent : 000716; suivant : 000718The "sex gap" in COVID-19 trials: a scoping review.
Auteurs : Veronique M M M. Schiffer ; Emma B N J. Janssen ; Bas C T. Van Bussel ; Laura L M. Jorissen ; Jeanette Tas ; Jan-Willem E M. Sels ; Dennis C J J. Bergmans ; Trang H T. Dinh ; Sander M J. Van Kuijk ; Anisa Hana ; Jannet Mehagnoul-Schipper ; Clarissa I E. Scheeren ; Dieter Mesotten ; Bjorn Stessel ; Gernot Marx ; Arnoud W J Van T. Hof ; Marc E A. Spaanderman ; Walther N K A. Van Mook ; Iwan C C. Van Der Horst ; Chahinda Ghossein-DohaSource :
- EClinicalMedicine [ 2589-5370 ] ; 2020.
Abstract
Background
Many studies investigate the role of pharmacological treatments on disease course in Corona Virus Disease 2019 (COVID-19). Sex disparities in genetics, immunological responses, and hormonal mechanisms may underlie the substantially higher fatality rates reported in male COVID-19 patients. To optimise care for COVID-19 patients, prophylactic and therapeutic studies should include sex-specific design and analyses. Therefore, in this scoping review, we investigated whether studies on pharmacological treatment in COVID-19 were performed based on a priori sex-specific design or post-hoc sex-specific analyses.
Methods
We systematically searched PubMed, EMBASE, UpToDate, clinical trial.org, and MedRxiv for studies on pharmacological treatment for COVID-19 until June 6th, 2020. We included case series, randomized controlled trials, and observational studies in humans (≥18 years) investigating antiviral, antimalarial, and immune system modulating drugs. Data were collected on 1) the proportion of included females, 2) whether sex stratification was performed (a priori by design or post-hoc), and 3) whether effect modification by sex was investigated.
Findings
30 studies were eligible for inclusion, investigating remdesivir (
Interpretation
Analyses assessing potential interference of sex with (side-)effects of pharmacological therapy for COVID-19 are rarely reported. Considering sex differences in case-fatality rates and genetic, immunological, and hormonal mechanisms, studies should include sex-specific analyses in their design to optimise COVID-19 care.
Funding
None.
DOI: 10.1016/j.eclinm.2020.100652
PubMed: 33283178
PubMed Central: PMC7701906
Links to Exploration step
pubmed:33283178Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">The "sex gap" in COVID-19 trials: a scoping review.</title><author><name sortKey="Schiffer, Veronique M M M" sort="Schiffer, Veronique M M M" uniqKey="Schiffer V" first="Veronique M M M" last="Schiffer">Veronique M M M. Schiffer</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>GROW, School for Oncology and Developmental Biology, Maastricht University, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Janssen, Emma B N J" sort="Janssen, Emma B N J" uniqKey="Janssen E" first="Emma B N J" last="Janssen">Emma B N J. Janssen</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Bussel, Bas C T" sort="Van Bussel, Bas C T" uniqKey="Van Bussel B" first="Bas C T" last="Van Bussel">Bas C T. Van Bussel</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Care and Public Health Research Institute (CAPHRI), Maastricht University, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Jorissen, Laura L M" sort="Jorissen, Laura L M" uniqKey="Jorissen L" first="Laura L M" last="Jorissen">Laura L M. Jorissen</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Tas, Jeanette" sort="Tas, Jeanette" uniqKey="Tas J" first="Jeanette" last="Tas">Jeanette Tas</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Sels, Jan Willem E M" sort="Sels, Jan Willem E M" uniqKey="Sels J" first="Jan-Willem E M" last="Sels">Jan-Willem E M. Sels</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Bergmans, Dennis C J J" sort="Bergmans, Dennis C J J" uniqKey="Bergmans D" first="Dennis C J J" last="Bergmans">Dennis C J J. Bergmans</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Dinh, Trang H T" sort="Dinh, Trang H T" uniqKey="Dinh T" first="Trang H T" last="Dinh">Trang H T. Dinh</name><affiliation><nlm:affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Kuijk, Sander M J" sort="Van Kuijk, Sander M J" uniqKey="Van Kuijk S" first="Sander M J" last="Van Kuijk">Sander M J. Van Kuijk</name><affiliation><nlm:affiliation>Department of Clinical Epidemiology and Medical Technology Assessment, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Hana, Anisa" sort="Hana, Anisa" uniqKey="Hana A" first="Anisa" last="Hana">Anisa Hana</name><affiliation><nlm:affiliation>Department of Intensive Care, Laurentius Ziekenhuis, Roermond, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Mehagnoul Schipper, Jannet" sort="Mehagnoul Schipper, Jannet" uniqKey="Mehagnoul Schipper J" first="Jannet" last="Mehagnoul-Schipper">Jannet Mehagnoul-Schipper</name><affiliation><nlm:affiliation>Department of Intensive Care, VieCuri Medisch Centrum, Venlo, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Scheeren, Clarissa I E" sort="Scheeren, Clarissa I E" uniqKey="Scheeren C" first="Clarissa I E" last="Scheeren">Clarissa I E. Scheeren</name><affiliation><nlm:affiliation>Department of Intensive Care, Zuyderland Medisch Centrum, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Mesotten, Dieter" sort="Mesotten, Dieter" uniqKey="Mesotten D" first="Dieter" last="Mesotten">Dieter Mesotten</name><affiliation><nlm:affiliation>Department of Intensive Care, Ziekenhuis Oost-Limburg, Genk, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Stessel, Bjorn" sort="Stessel, Bjorn" uniqKey="Stessel B" first="Bjorn" last="Stessel">Bjorn Stessel</name><affiliation><nlm:affiliation>Department of Intensive Care, Jessa Hospital, Hasselt, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Marx, Gernot" sort="Marx, Gernot" uniqKey="Marx G" first="Gernot" last="Marx">Gernot Marx</name><affiliation><nlm:affiliation>Department of Intensive Care, Uniklinik RWTH Aachen, Aachen, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Hof, Arnoud W J Van T" sort="Hof, Arnoud W J Van T" uniqKey="Hof A" first="Arnoud W J Van T" last="Hof">Arnoud W J Van T. Hof</name><affiliation><nlm:affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Spaanderman, Marc E A" sort="Spaanderman, Marc E A" uniqKey="Spaanderman M" first="Marc E A" last="Spaanderman">Marc E A. Spaanderman</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Mook, Walther N K A" sort="Van Mook, Walther N K A" uniqKey="Van Mook W" first="Walther N K A" last="Van Mook">Walther N K A. Van Mook</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>School of Health Professions Education, Academy for Postgraduate Medical Training, Maastricht University, Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Der Horst, Iwan C C" sort="Van Der Horst, Iwan C C" uniqKey="Van Der Horst I" first="Iwan C C" last="Van Der Horst">Iwan C C. Van Der Horst</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Ghossein Doha, Chahinda" sort="Ghossein Doha, Chahinda" uniqKey="Ghossein Doha C" first="Chahinda" last="Ghossein-Doha">Chahinda Ghossein-Doha</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:33283178</idno><idno type="pmid">33283178</idno><idno type="doi">10.1016/j.eclinm.2020.100652</idno><idno type="pmc">PMC7701906</idno><idno type="wicri:Area/Main/Corpus">000717</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000717</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">The "sex gap" in COVID-19 trials: a scoping review.</title><author><name sortKey="Schiffer, Veronique M M M" sort="Schiffer, Veronique M M M" uniqKey="Schiffer V" first="Veronique M M M" last="Schiffer">Veronique M M M. Schiffer</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>GROW, School for Oncology and Developmental Biology, Maastricht University, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Janssen, Emma B N J" sort="Janssen, Emma B N J" uniqKey="Janssen E" first="Emma B N J" last="Janssen">Emma B N J. Janssen</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Bussel, Bas C T" sort="Van Bussel, Bas C T" uniqKey="Van Bussel B" first="Bas C T" last="Van Bussel">Bas C T. Van Bussel</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Care and Public Health Research Institute (CAPHRI), Maastricht University, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Jorissen, Laura L M" sort="Jorissen, Laura L M" uniqKey="Jorissen L" first="Laura L M" last="Jorissen">Laura L M. Jorissen</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Tas, Jeanette" sort="Tas, Jeanette" uniqKey="Tas J" first="Jeanette" last="Tas">Jeanette Tas</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Sels, Jan Willem E M" sort="Sels, Jan Willem E M" uniqKey="Sels J" first="Jan-Willem E M" last="Sels">Jan-Willem E M. Sels</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Bergmans, Dennis C J J" sort="Bergmans, Dennis C J J" uniqKey="Bergmans D" first="Dennis C J J" last="Bergmans">Dennis C J J. Bergmans</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Dinh, Trang H T" sort="Dinh, Trang H T" uniqKey="Dinh T" first="Trang H T" last="Dinh">Trang H T. Dinh</name><affiliation><nlm:affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Kuijk, Sander M J" sort="Van Kuijk, Sander M J" uniqKey="Van Kuijk S" first="Sander M J" last="Van Kuijk">Sander M J. Van Kuijk</name><affiliation><nlm:affiliation>Department of Clinical Epidemiology and Medical Technology Assessment, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Hana, Anisa" sort="Hana, Anisa" uniqKey="Hana A" first="Anisa" last="Hana">Anisa Hana</name><affiliation><nlm:affiliation>Department of Intensive Care, Laurentius Ziekenhuis, Roermond, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Mehagnoul Schipper, Jannet" sort="Mehagnoul Schipper, Jannet" uniqKey="Mehagnoul Schipper J" first="Jannet" last="Mehagnoul-Schipper">Jannet Mehagnoul-Schipper</name><affiliation><nlm:affiliation>Department of Intensive Care, VieCuri Medisch Centrum, Venlo, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Scheeren, Clarissa I E" sort="Scheeren, Clarissa I E" uniqKey="Scheeren C" first="Clarissa I E" last="Scheeren">Clarissa I E. Scheeren</name><affiliation><nlm:affiliation>Department of Intensive Care, Zuyderland Medisch Centrum, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Mesotten, Dieter" sort="Mesotten, Dieter" uniqKey="Mesotten D" first="Dieter" last="Mesotten">Dieter Mesotten</name><affiliation><nlm:affiliation>Department of Intensive Care, Ziekenhuis Oost-Limburg, Genk, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Stessel, Bjorn" sort="Stessel, Bjorn" uniqKey="Stessel B" first="Bjorn" last="Stessel">Bjorn Stessel</name><affiliation><nlm:affiliation>Department of Intensive Care, Jessa Hospital, Hasselt, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Marx, Gernot" sort="Marx, Gernot" uniqKey="Marx G" first="Gernot" last="Marx">Gernot Marx</name><affiliation><nlm:affiliation>Department of Intensive Care, Uniklinik RWTH Aachen, Aachen, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Hof, Arnoud W J Van T" sort="Hof, Arnoud W J Van T" uniqKey="Hof A" first="Arnoud W J Van T" last="Hof">Arnoud W J Van T. Hof</name><affiliation><nlm:affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Spaanderman, Marc E A" sort="Spaanderman, Marc E A" uniqKey="Spaanderman M" first="Marc E A" last="Spaanderman">Marc E A. Spaanderman</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Mook, Walther N K A" sort="Van Mook, Walther N K A" uniqKey="Van Mook W" first="Walther N K A" last="Van Mook">Walther N K A. Van Mook</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>School of Health Professions Education, Academy for Postgraduate Medical Training, Maastricht University, Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Der Horst, Iwan C C" sort="Van Der Horst, Iwan C C" uniqKey="Van Der Horst I" first="Iwan C C" last="Van Der Horst">Iwan C C. Van Der Horst</name><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Ghossein Doha, Chahinda" sort="Ghossein Doha, Chahinda" uniqKey="Ghossein Doha C" first="Chahinda" last="Ghossein-Doha">Chahinda Ghossein-Doha</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.</nlm:affiliation></affiliation></author></analytic><series><title level="j">EClinicalMedicine</title><idno type="eISSN">2589-5370</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>Background</b></p><p>Many studies investigate the role of pharmacological treatments on disease course in Corona Virus Disease 2019 (COVID-19). Sex disparities in genetics, immunological responses, and hormonal mechanisms may underlie the substantially higher fatality rates reported in male COVID-19 patients. To optimise care for COVID-19 patients, prophylactic and therapeutic studies should include sex-specific design and analyses. Therefore, in this scoping review, we investigated whether studies on pharmacological treatment in COVID-19 were performed based on a priori sex-specific design or post-hoc sex-specific analyses.</p></div><div type="abstract" xml:lang="en"><p><b>Methods</b></p><p>We systematically searched PubMed, EMBASE, UpToDate, clinical trial.org, and MedRxiv for studies on pharmacological treatment for COVID-19 until June 6th, 2020. We included case series, randomized controlled trials, and observational studies in humans (≥18 years) investigating antiviral, antimalarial, and immune system modulating drugs. Data were collected on 1) the proportion of included females, 2) whether sex stratification was performed (a priori by design or post-hoc), and 3) whether effect modification by sex was investigated.</p></div><div type="abstract" xml:lang="en"><p><b>Findings</b></p><p>30 studies were eligible for inclusion, investigating remdesivir (</p></div><div type="abstract" xml:lang="en"><p><b>Interpretation</b></p><p>Analyses assessing potential interference of sex with (side-)effects of pharmacological therapy for COVID-19 are rarely reported. Considering sex differences in case-fatality rates and genetic, immunological, and hormonal mechanisms, studies should include sex-specific analyses in their design to optimise COVID-19 care.</p></div><div type="abstract" xml:lang="en"><p><b>Funding</b></p><p>None.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33283178</PMID><DateRevised><Year>2020</Year><Month>12</Month><Day>18</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2589-5370</ISSN><JournalIssue CitedMedium="Internet"><Volume>29</Volume><PubDate><Year>2020</Year><Month>Dec</Month></PubDate></JournalIssue><Title>EClinicalMedicine</Title><ISOAbbreviation>EClinicalMedicine</ISOAbbreviation></Journal><ArticleTitle>The "sex gap" in COVID-19 trials: a scoping review.</ArticleTitle><Pagination><MedlinePgn>100652</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.eclinm.2020.100652</ELocationID><Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">Many studies investigate the role of pharmacological treatments on disease course in Corona Virus Disease 2019 (COVID-19). Sex disparities in genetics, immunological responses, and hormonal mechanisms may underlie the substantially higher fatality rates reported in male COVID-19 patients. To optimise care for COVID-19 patients, prophylactic and therapeutic studies should include sex-specific design and analyses. Therefore, in this scoping review, we investigated whether studies on pharmacological treatment in COVID-19 were performed based on a priori sex-specific design or post-hoc sex-specific analyses.</AbstractText><AbstractText Label="Methods" NlmCategory="UNASSIGNED">We systematically searched PubMed, EMBASE, UpToDate, clinical trial.org, and MedRxiv for studies on pharmacological treatment for COVID-19 until June 6th, 2020. We included case series, randomized controlled trials, and observational studies in humans (≥18 years) investigating antiviral, antimalarial, and immune system modulating drugs. Data were collected on 1) the proportion of included females, 2) whether sex stratification was performed (a priori by design or post-hoc), and 3) whether effect modification by sex was investigated.</AbstractText><AbstractText Label="Findings" NlmCategory="UNASSIGNED">30 studies were eligible for inclusion, investigating remdesivir (<i>n</i> = 2), lopinavir/ritonavir (<i>n</i> = 5), favipiravir (<i>n</i> = 1), umifenovir (<i>n</i> = 1), hydroxychloroquine/chloroquine (<i>n</i> = 8), convalescent plasma (<i>n</i> = 6), interleukin-6 (IL-6) pathway inhibitors (<i>n</i> = 5), interleukin-1 (IL-1) pathway inhibitors (<i>n</i> = 1) and corticosteroids (<i>n</i> = 3). Only one study stratified its data based on sex in a post-hoc analysis, whereas none did a priori by design. None of the studies investigated effect modification by sex. A quarter of the studies included twice as many males as females.</AbstractText><AbstractText Label="Interpretation" NlmCategory="UNASSIGNED">Analyses assessing potential interference of sex with (side-)effects of pharmacological therapy for COVID-19 are rarely reported. Considering sex differences in case-fatality rates and genetic, immunological, and hormonal mechanisms, studies should include sex-specific analyses in their design to optimise COVID-19 care.</AbstractText><AbstractText Label="Funding" NlmCategory="UNASSIGNED">None.</AbstractText><CopyrightInformation>© 2020 The Authors.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Schiffer</LastName><ForeName>Veronique M M M</ForeName><Initials>VMMM</Initials><AffiliationInfo><Affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>GROW, School for Oncology and Developmental Biology, Maastricht University, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Janssen</LastName><ForeName>Emma B N J</ForeName><Initials>EBNJ</Initials><AffiliationInfo><Affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van Bussel</LastName><ForeName>Bas C T</ForeName><Initials>BCT</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Care and Public Health Research Institute (CAPHRI), Maastricht University, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jorissen</LastName><ForeName>Laura L M</ForeName><Initials>LLM</Initials><AffiliationInfo><Affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tas</LastName><ForeName>Jeanette</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sels</LastName><ForeName>Jan-Willem E M</ForeName><Initials>JEM</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bergmans</LastName><ForeName>Dennis C J J</ForeName><Initials>DCJJ</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dinh</LastName><ForeName>Trang H T</ForeName><Initials>THT</Initials><AffiliationInfo><Affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van Kuijk</LastName><ForeName>Sander M J</ForeName><Initials>SMJ</Initials><AffiliationInfo><Affiliation>Department of Clinical Epidemiology and Medical Technology Assessment, MUMC+, Maastricht, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hana</LastName><ForeName>Anisa</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, Laurentius Ziekenhuis, Roermond, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mehagnoul-Schipper</LastName><ForeName>Jannet</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, VieCuri Medisch Centrum, Venlo, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Scheeren</LastName><ForeName>Clarissa I E</ForeName><Initials>CIE</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, Zuyderland Medisch Centrum, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mesotten</LastName><ForeName>Dieter</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, Ziekenhuis Oost-Limburg, Genk, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stessel</LastName><ForeName>Bjorn</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, Jessa Hospital, Hasselt, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marx</LastName><ForeName>Gernot</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, Uniklinik RWTH Aachen, Aachen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hof</LastName><ForeName>Arnoud W J van T</ForeName><Initials>AWJVT</Initials><AffiliationInfo><Affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Spaanderman</LastName><ForeName>Marc E A</ForeName><Initials>MEA</Initials><AffiliationInfo><Affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van Mook</LastName><ForeName>Walther N K A</ForeName><Initials>WNKA</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>School of Health Professions Education, Academy for Postgraduate Medical Training, Maastricht University, Maastricht, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van der Horst</LastName><ForeName>Iwan C C</ForeName><Initials>ICC</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ghossein-Doha</LastName><ForeName>Chahinda</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Intensive Care, MUMC+, Maastricht, the Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Cardiology, MUMC+, Maastricht, MD 6200, the Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>11</Month><Day>30</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>EClinicalMedicine</MedlineTA><NlmUniqueID>101733727</NlmUniqueID><ISSNLinking>2589-5370</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">Clinical trials</Keyword><Keyword MajorTopicYN="N">Diversity</Keyword><Keyword MajorTopicYN="N">Sex</Keyword><Keyword MajorTopicYN="N">Therapy</Keyword></KeywordList><CoiStatement>Dr. Marx reports grants and personal fees from Bbraun Melsungen AG, grants and personal fees from Sphingotec AG, grants and personal fees from 4TEEN4 Pharmaceuticals GmbH, outside the submitted work. In addition, Dr. Marx has a patent Modulation ofTLR4 signalling European Patent 2855519/US Patent: US9,745,369 B2 issued, and a patent Combination of C1-Inh and Lung surfactant for the treatment of respiratory disorders PatentÐo.: US 7053,176 B1 PCT/EP99/06845 issued. All other authors declare no interest. Furthermore, there are no known conflicts of interest associated with this publication, and there has been no significant financial support for this work that could have influenced its outcome. We confirm that the manuscript has been read and approved by all named authors and that there are no other persons who satisfied the criteria for authorship but are not listed. We further confirm that all have approved the order of authors listed in the manuscript.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>08</Month><Day>05</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>10</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>10</Month><Day>30</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>12</Month><Day>8</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>12</Month><Day>8</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>12</Month><Day>7</Day><Hour>5</Hour><Minute>37</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33283178</ArticleId><ArticleId IdType="doi">10.1016/j.eclinm.2020.100652</ArticleId><ArticleId IdType="pii">S2589-5370(20)30396-5</ArticleId><ArticleId IdType="pmc">PMC7701906</ArticleId></ArticleIdList><pmc-dir>pmcsd</pmc-dir>
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