Veklury Use While Pregnant to be Studied
A recent study funded by the National Institutes of Health (NIH) will evaluate the effects of Veklury (remdesivir) in pregnant women who are being treated for COVID-19.
This NIH study announced on February 17, 2021, aims to determine how pregnant women metabolize Veklury and any potential side effects.
The study will be conducted at 17 sites in the continental United States and Puerto Rico. It will be led 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 an 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 to treat COVID-19 in adults and children over age 12 years.
Although it has not been explicitly approved 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.
Breast milk will also be tested for remdesivir among women who are lactating.
“Pregnant women with COVID-19 are at high risk for hospitalization, for intensive care admission, and for needing ventilator support,” stated Diana W. Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in a press release.
“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 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.
Researchers will also document potential side effects and adverse events that could occur with the use of the drug.
Additional information about IMPAACT 2032 and a list of participating institutions is available on ClinicalTrials.gov under study identifier NCT04582266.
The NIH is 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. For more information about NIH and its programs, visit NIH.
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