iNDICA NEWS BUREAU-
The National Institutes of Health announced on Wednesday, February 17 that it will be undertaking a study on how pregnant COVID-19 patients metabolize and tolerate remdesivir.
Remdesivir has not been expressly approved for use in pregnant COVID-19 patients due to a lack of data on its safety and efficacy in the population; it is left up to their physicians’ discretion.
The study, which will be conducted at 17 sites in the continental United States and Puerto Rico, will compare remdesivir use in pregnant and non-pregnant patients of reproductive age who are hospitalized with COVID-19.
Researchers will analyze samples from the plasma and umbilical cord for participants who receive the drug within five days of their infant’s delivery, as this will help them understand how remdesivir is absorbed and broken down in the placenta. Breast milk will be analyzed as well in participants who are lactating.
“Pregnant women with COVID-19 are at high risk for hospitalization, for intensive care admission and for needing ventilator support,” Diana Bianchi, MD, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said in a news 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 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.
The study aims to understand how the 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.
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.