Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Mar;47(3):195-204.
doi: 10.1007/s40264-023-01377-2. Epub 2023 Nov 16.

The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations

Diego F Wyszynski  1 , Aris T Papageorghiou  2 , Cheryl Renz  3 , Torri D Metz  4 , Sonia Hernández-Díaz  5
Affiliations

The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations

Diego F Wyszynski et al. Drug Saf. 2024 Mar.

Abstract

Background and objective: Over the past 2 years, several drugs have been approved for coronavirus disease 2019 (COVID-19) treatment, but their safety during pregnancy remains poorly understood. This study aims to assess the relative risk of obstetric, neonatal, and infant outcomes associated with the use of drugs specifically indicated for the treatment of COVID-19 compared with other drug treatment strategies. The purpose of this article is to present elements of the study protocol.

Methods: The COVID-19 International Drug Pregnancy Registry (COVID-PR) is a noninterventional, postmarketing cohort study. Pregnant women receiving treatment with monoclonal antibodies (mAbs) or antiviral drugs for mild, moderate, or severe COVID-19 are matched 1:1 with pregnant women not receiving these study-specific drugs, based on calendar time, country, gestational age at enrollment, and COVID-19 severity. Participants complete online questionnaires at enrollment, during pregnancy, and for 12 months after delivery of liveborn infants. The study began enrolling participants on 1 December 2021 and is set to span 5 years for each drug of interest.

Discussion: The COVID-PR is designed to evaluate the safety profile of each studied drug. Additionally, it may allow for an analysis of the effects of COVID-19 drug exposure during relevant gestational periods on specific neonatal outcomes. Although the sample size will be too small to detect associations with rare outcomes, the study has the potential to generate hypotheses for future research. Ultimately, these data can provide valuable insights for evidence-based decisions about COVID-19 treatment during pregnancy.

Trial registration: ClinicalTrials.gov: NCT05013632. EU PAS EUPAS42517.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

References

    1. Adam S, Pheiffer C, Dias S, Hlongwane T, Vannevel V, Soma-Pillay P, et al. Coronavirus and pregnancy: the challenges of the 21(st) century: a review. Front Microbiol. 2022;13: 923546. - DOI - PubMed - PMC
    1. Jamieson DJ, Rasmussen SA. An update on COVID-19 and pregnancy. Am J Obstet Gynecol. 2022;226(2):177–86. - DOI - PubMed
    1. Villar J, Ariff S, Gunier RB, Thiruvengadam R, Rauch S, Kholin A, et al. Maternal and neonatal morbidity and mortality among pregnant women with and without COVID-19 infection: the INTERCOVID Multinational Cohort Study. JAMA Pediatr. 2021;175(8):817–26. - DOI - PubMed
    1. Villar J, Soto CCP, Gunier RB, Ariff S, Craik R, Cavoretto PI, et al. Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study. Lancet. 2023;401(10375):447–57. - DOI - PubMed - PMC
    1. Ellington S, Strid P, Tong VT, Woodworth K, Galang RR, Zambrano LD, et al. Characteristics of women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status—United States, January 22–June 7, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(25):769–75. - DOI - PubMed - PMC

Associated data