A new study funded by the National Institutes of Health will evaluate the effects of remdesivir in pregnant women who have been prescribed the drug to treat COVID-19. The study, which will be conducted at 17 sites in the continental United States and Puerto Rico, aims to determine how pregnant women metabolize the drug and whether there are any potential side effects.
“Pregnant women with COVID-19 are at high risk for hospitalization, for intensive care admission and for needing ventilator support,” said Diana W. Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). “There is an urgent need to identify effective treatments for this population and to determine whether drugs prescribed for other adults are appropriate for use in pregnancy.”
The study is funded by NICHD, the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Mental Health, all part of NIH. Additional funding is provided by Gilead Sciences, Inc. Called IMPAACT 2032, the study will be conducted by the NIH-funded International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network.
Originally developed to treat Ebola and Marburg virus infections, remdesivir was shown in a NIAID-funded clinical trial to accelerate recovery in patients with advanced COVID-19 disease. Remdesivir has since been approved by the U.S. Food and Drug Administration for the treatment of COVID-19 in adults and children over age 12 years.
Although it has not been approved specifically for use in pregnancy, remdesivir can be prescribed to pregnant women if their physicians believe the drug may benefit them. However, physicians currently lack scientific evidence for the safety and efficacy of remdesivir for treating pregnant women with COVID-19. Because pregnancy may influence a drug’s effects, IMPAACT 2032 will compare remdesivir use in pregnant and non-pregnant women of reproductive age who are hospitalized with COVID-19.
The study will evaluate remdesivir’s pharmacokinetics—how a drug is absorbed, moves through the body and is broken down and eliminated in pregnant women and nonpregnant women of childbearing potential who receive it as part of clinical care. For women who received the drug within five days of delivery, samples from the plasma and umbilical cord will be analyzed for insight into remdesivir’s pharmacokinetics in the placenta. Breast milk will also be tested for remdesivir among women who are lactating. Researchers will also document potential side effects and adverse events that could occur with use of the drug.
Additional information about IMPAACT 2032 and a list of participating institutions is available on ClinicalTrials.gov under study identifier NCT04582266 and on the IMPAACT Network website .
Pharmacokinetics and safety of remdesivir for treatment of COVID-19 in pregnant and non-pregnant women in the United States: A Study of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit https://www.nichd.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov.