Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action.
Identifieur interne : 000636 ( Main/Corpus ); précédent : 000635; suivant : 000637Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action.
Auteurs : Melanie M. Taylor ; Loulou Kobeissi ; Caron Kim ; Avni Amin ; Anna E. Thorson ; Nita B. Bellare ; Vanessa Brizuela ; Mercedes Bonet ; Edna Kara ; Soe Soe Thwin ; Hamsadvani Kuganantham ; Moazzam Ali ; Olufemi T. Oladapo ; Nathalie BroutetSource :
- The Lancet. Global health [ 2214-109X ] ; 2021.
English descriptors
- KwdEn :
- MESH :
- drug therapy : COVID-19, Pregnancy Complications, Infectious.
- ethics : Clinical Trials as Topic, Patient Selection.
- standards : Clinical Trials as Topic.
- Eligibility Determination, Female, Humans, Pregnancy, SARS-CoV-2.
Abstract
Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of non-biological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavir-ritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.
DOI: 10.1016/S2214-109X(20)30484-8
PubMed: 33340453
PubMed Central: PMC7832459
Links to Exploration step
pubmed:33340453Le document en format XML
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Electronic address: kobeissil@who.int.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Caron" sort="Kim, Caron" uniqKey="Kim C" first="Caron" last="Kim">Caron Kim</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Amin, Avni" sort="Amin, Avni" uniqKey="Amin A" first="Avni" last="Amin">Avni Amin</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Thorson, Anna E" sort="Thorson, Anna E" uniqKey="Thorson A" first="Anna E" last="Thorson">Anna E. 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Taylor</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland; Department of Global Programmes of HIV, Hepatitis, and STI, WHO, Geneva, Switzerland; Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kobeissi, Loulou" sort="Kobeissi, Loulou" uniqKey="Kobeissi L" first="Loulou" last="Kobeissi">Loulou Kobeissi</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland. Electronic address: kobeissil@who.int.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Caron" sort="Kim, Caron" uniqKey="Kim C" first="Caron" last="Kim">Caron Kim</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Amin, Avni" sort="Amin, Avni" uniqKey="Amin A" first="Avni" last="Amin">Avni Amin</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Thorson, Anna E" sort="Thorson, Anna E" uniqKey="Thorson A" first="Anna E" last="Thorson">Anna E. Thorson</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Bellare, Nita B" sort="Bellare, Nita B" uniqKey="Bellare N" first="Nita B" last="Bellare">Nita B. Bellare</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Brizuela, Vanessa" sort="Brizuela, Vanessa" uniqKey="Brizuela V" first="Vanessa" last="Brizuela">Vanessa Brizuela</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Bonet, Mercedes" sort="Bonet, Mercedes" uniqKey="Bonet M" first="Mercedes" last="Bonet">Mercedes Bonet</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Kara, Edna" sort="Kara, Edna" uniqKey="Kara E" first="Edna" last="Kara">Edna Kara</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Thwin, Soe Soe" sort="Thwin, Soe Soe" uniqKey="Thwin S" first="Soe Soe" last="Thwin">Soe Soe Thwin</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Kuganantham, Hamsadvani" sort="Kuganantham, Hamsadvani" uniqKey="Kuganantham H" first="Hamsadvani" last="Kuganantham">Hamsadvani Kuganantham</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Ali, Moazzam" sort="Ali, Moazzam" uniqKey="Ali M" first="Moazzam" last="Ali">Moazzam Ali</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Oladapo, Olufemi T" sort="Oladapo, Olufemi T" uniqKey="Oladapo O" first="Olufemi T" last="Oladapo">Olufemi T. Oladapo</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Broutet, Nathalie" sort="Broutet, Nathalie" uniqKey="Broutet N" first="Nathalie" last="Broutet">Nathalie Broutet</name><affiliation><nlm:affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Global health</title><idno type="eISSN">2214-109X</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 (ethics)</term><term>Clinical Trials as Topic (standards)</term><term>Eligibility Determination (MeSH)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Patient Selection (ethics)</term><term>Pregnancy (MeSH)</term><term>Pregnancy Complications, Infectious (drug therapy)</term><term>SARS-CoV-2 (MeSH)</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term><term>Pregnancy Complications, Infectious</term></keywords><keywords scheme="MESH" qualifier="ethics" xml:lang="en"><term>Clinical Trials as Topic</term><term>Patient Selection</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Clinical Trials as Topic</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Eligibility Determination</term><term>Female</term><term>Humans</term><term>Pregnancy</term><term>SARS-CoV-2</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of non-biological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavir-ritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">33340453</PMID><DateCompleted><Year>2021</Year><Month>02</Month><Day>25</Day></DateCompleted><DateRevised><Year>2021</Year><Month>04</Month><Day>17</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2214-109X</ISSN><JournalIssue CitedMedium="Internet"><Volume>9</Volume><Issue>3</Issue><PubDate><Year>2021</Year><Month>03</Month></PubDate></JournalIssue><Title>The Lancet. Global health</Title><ISOAbbreviation>Lancet Glob Health</ISOAbbreviation></Journal><ArticleTitle>Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action.</ArticleTitle><Pagination><MedlinePgn>e366-e371</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S2214-109X(20)30484-8</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S2214-109X(20)30484-8</ELocationID><Abstract><AbstractText>Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of non-biological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavir-ritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.</AbstractText><CopyrightInformation>Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Taylor</LastName><ForeName>Melanie M</ForeName><Initials>MM</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland; Department of Global Programmes of HIV, Hepatitis, and STI, WHO, Geneva, Switzerland; Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kobeissi</LastName><ForeName>Loulou</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland. Electronic address: kobeissil@who.int.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Caron</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Amin</LastName><ForeName>Avni</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thorson</LastName><ForeName>Anna E</ForeName><Initials>AE</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bellare</LastName><ForeName>Nita B</ForeName><Initials>NB</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brizuela</LastName><ForeName>Vanessa</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bonet</LastName><ForeName>Mercedes</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kara</LastName><ForeName>Edna</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thwin</LastName><ForeName>Soe Soe</ForeName><Initials>SS</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kuganantham</LastName><ForeName>Hamsadvani</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ali</LastName><ForeName>Moazzam</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Oladapo</LastName><ForeName>Olufemi T</ForeName><Initials>OT</Initials><AffiliationInfo><Affiliation>Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Broutet</LastName><ForeName>Nathalie</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Department of 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