Importance of Inclusion of Pregnant and Breastfeeding Women in COVID-19 Therapeutic Trials

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 pregn...

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Bibliographic Details
Published in:Clinical infectious diseases 2020-07, Vol.71 (15), p.879-881
Main Authors: LaCourse, Sylvia, John-Stewart, Grace, Adams Waldorf, Kristina M
Format: Article
Language:English
Subjects:
Antiviral Agents - therapeutic use
Betacoronavirus - drug effects
Breast Feeding
Coronavirus Infections - drug therapy
Coronavirus Infections - virology
COVID-19
Drug Administration Schedule
Female
Humans
Hydroxychloroquine - therapeutic use
Obstetrics, Gynecology and Reproductive Medicine
Off-Label Use
Outpatients
Pandemics
Pneumonia, Viral - drug therapy
Pneumonia, Viral - virology
Post-Exposure Prophylaxis - methods
Pregnancy
Pregnancy Complications, Infectious - drug therapy
Pregnancy Complications, Infectious - virology
Reproduktionsmedicin och gynekologi
SARS-CoV-2
Time Factors
treatment
trial
Viewpoints
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Summary: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. In this Viewpoint, we call attention to the need and urgency to engage pregnant women in COVID-19 treatment trials now, to ensure rapid development of data-driven recommendations regarding the risks and benefits of therapies for which they may benefit.
ISSN:1058-4838
1537-6591
1537-6591
DOI:10.1093/cid/ciaa444