Importance of Inclusion of Pregnant and Breastfeeding Women in COVID-19 Therapeutic Trials.
Identifieur interne : 001966 ( Main/Corpus ); précédent : 001965; suivant : 001967Importance of Inclusion of Pregnant and Breastfeeding Women in COVID-19 Therapeutic Trials.
Auteurs : Sylvia Lacourse ; Grace John-Stewart ; Kristina M. Adams WaldorfSource :
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [ 1537-6591 ] ; 2020.
English descriptors
- KwdEn :
- Antiviral Agents (therapeutic use), Betacoronavirus (drug effects), Breast Feeding (MeSH), COVID-19 (MeSH), Coronavirus Infections (drug therapy), Coronavirus Infections (virology), Drug Administration Schedule (MeSH), Female (MeSH), Humans (MeSH), Hydroxychloroquine (therapeutic use), Off-Label Use (MeSH), Outpatients (MeSH), Pandemics (MeSH), Pneumonia, Viral (drug therapy), Pneumonia, Viral (virology), Post-Exposure Prophylaxis (methods), Pregnancy (MeSH), Pregnancy Complications, Infectious (drug therapy), Pregnancy Complications, Infectious (virology), SARS-CoV-2 (MeSH), Time Factors (MeSH).
- MESH :
- chemical , therapeutic use : Antiviral Agents, Hydroxychloroquine.
- drug effects : Betacoronavirus.
- drug therapy : Coronavirus Infections, Pneumonia, Viral, Pregnancy Complications, Infectious.
- methods : Post-Exposure Prophylaxis.
- virology : Coronavirus Infections, Pneumonia, Viral, Pregnancy Complications, Infectious.
- Breast Feeding, COVID-19, Drug Administration Schedule, Female, Humans, Off-Label Use, Outpatients, Pandemics, Pregnancy, SARS-CoV-2, Time Factors.
Abstract
Investigators are employing unprecedented innovation in the design of clinical trials to rapidly and rigorously assess potentially promising therapies for coronavirus disease 2019 (COVID-19); this is in stark contrast to the continued near-universal regressive practice of exclusion of pregnant and breastfeeding women from these trials. The few trials that allow their inclusion focus on postexposure prophylaxis or outpatient treatment of milder disease, limiting the options available to pregnant women with severe COVID-19 to compassionate use of remdesivir, or off-label drug use of hydroxychloroquine or other therapies. These restrictions were put in place despite experience with these drugs in pregnant women. In this Viewpoint, we call attention to the need and urgency to engage pregnant women in COVID-19 treatment trials now in order to develop data-driven recommendations regarding the risks and benefits of therapies in this unique but not uncommon population.
DOI: 10.1093/cid/ciaa444
PubMed: 32296817
PubMed Central: PMC7184504
Links to Exploration step
pubmed:32296817Le document en format XML
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Adams Waldorf</name><affiliation><nlm:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32296817</idno><idno type="pmid">32296817</idno><idno type="doi">10.1093/cid/ciaa444</idno><idno type="pmc">PMC7184504</idno><idno type="wicri:Area/Main/Corpus">001966</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001966</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Importance of Inclusion of Pregnant and Breastfeeding Women in COVID-19 Therapeutic Trials.</title><author><name sortKey="Lacourse, Sylvia" sort="Lacourse, Sylvia" uniqKey="Lacourse S" first="Sylvia" last="Lacourse">Sylvia Lacourse</name><affiliation><nlm:affiliation>Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Global Center for Integrated Health of Women, Adolescents and Children (Global WACh), University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation></author><author><name sortKey="John Stewart, Grace" sort="John Stewart, Grace" uniqKey="John Stewart G" first="Grace" last="John-Stewart">Grace John-Stewart</name><affiliation><nlm:affiliation>Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Global Center for Integrated Health of Women, Adolescents and Children (Global WACh), University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Pediatrics, University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Adams Waldorf, Kristina M" sort="Adams Waldorf, Kristina M" uniqKey="Adams Waldorf K" first="Kristina M" last="Adams Waldorf">Kristina M. Adams Waldorf</name><affiliation><nlm:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</title><idno type="eISSN">1537-6591</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral Agents (therapeutic use)</term><term>Betacoronavirus (drug effects)</term><term>Breast Feeding (MeSH)</term><term>COVID-19 (MeSH)</term><term>Coronavirus Infections (drug therapy)</term><term>Coronavirus Infections (virology)</term><term>Drug Administration Schedule (MeSH)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Off-Label Use (MeSH)</term><term>Outpatients (MeSH)</term><term>Pandemics (MeSH)</term><term>Pneumonia, Viral (drug therapy)</term><term>Pneumonia, Viral (virology)</term><term>Post-Exposure Prophylaxis (methods)</term><term>Pregnancy (MeSH)</term><term>Pregnancy Complications, Infectious (drug therapy)</term><term>Pregnancy Complications, Infectious (virology)</term><term>SARS-CoV-2 (MeSH)</term><term>Time Factors (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Betacoronavirus</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term><term>Pregnancy Complications, Infectious</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Post-Exposure Prophylaxis</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term><term>Pregnancy Complications, Infectious</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Breast Feeding</term><term>COVID-19</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Off-Label Use</term><term>Outpatients</term><term>Pandemics</term><term>Pregnancy</term><term>SARS-CoV-2</term><term>Time Factors</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Investigators are employing unprecedented innovation in the design of clinical trials to rapidly and rigorously assess potentially promising therapies for coronavirus disease 2019 (COVID-19); this is in stark contrast to the continued near-universal regressive practice of exclusion of pregnant and breastfeeding women from these trials. The few trials that allow their inclusion focus on postexposure prophylaxis or outpatient treatment of milder disease, limiting the options available to pregnant women with severe COVID-19 to compassionate use of remdesivir, or off-label drug use of hydroxychloroquine or other therapies. These restrictions were put in place despite experience with these drugs in pregnant women. In this Viewpoint, we call attention to the need and urgency to engage pregnant women in COVID-19 treatment trials now in order to develop data-driven recommendations regarding the risks and benefits of therapies in this unique but not uncommon population.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32296817</PMID><DateCompleted><Year>2020</Year><Month>08</Month><Day>10</Day></DateCompleted><DateRevised><Year>2021</Year><Month>04</Month><Day>28</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1537-6591</ISSN><JournalIssue CitedMedium="Internet"><Volume>71</Volume><Issue>15</Issue><PubDate><Year>2020</Year><Month>07</Month><Day>28</Day></PubDate></JournalIssue><Title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</Title><ISOAbbreviation>Clin Infect Dis</ISOAbbreviation></Journal><ArticleTitle>Importance of Inclusion of Pregnant and Breastfeeding Women in COVID-19 Therapeutic Trials.</ArticleTitle><Pagination><MedlinePgn>879-881</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/cid/ciaa444</ELocationID><Abstract><AbstractText>Investigators are employing unprecedented innovation in the design of clinical trials to rapidly and rigorously assess potentially promising therapies for coronavirus disease 2019 (COVID-19); this is in stark contrast to the continued near-universal regressive practice of exclusion of pregnant and breastfeeding women from these trials. The few trials that allow their inclusion focus on postexposure prophylaxis or outpatient treatment of milder disease, limiting the options available to pregnant women with severe COVID-19 to compassionate use of remdesivir, or off-label drug use of hydroxychloroquine or other therapies. These restrictions were put in place despite experience with these drugs in pregnant women. In this Viewpoint, we call attention to the need and urgency to engage pregnant women in COVID-19 treatment trials now in order to develop data-driven recommendations regarding the risks and benefits of therapies in this unique but not uncommon population.</AbstractText><CopyrightInformation>© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>LaCourse</LastName><ForeName>Sylvia</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Global Center for Integrated Health of Women, Adolescents and Children (Global WACh), University of Washington, Seattle, Washington, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>John-Stewart</LastName><ForeName>Grace</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Global Center for Integrated Health of Women, Adolescents and Children (Global WACh), University of Washington, Seattle, Washington, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pediatrics, University of Washington, Seattle, Washington, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Adams Waldorf</LastName><ForeName>Kristina M</ForeName><Initials>KM</Initials><AffiliationInfo><Affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>K23 AI120793</GrantID><Acronym>AI</Acronym><Agency>NIAID NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D052061">Research Support, N.I.H., Extramural</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Infect Dis</MedlineTA><NlmUniqueID>9203213</NlmUniqueID><ISSNLinking>1058-4838</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance 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