NIH to evaluate remdesivir treatment for COVID during pregnancy


FILE – In this Thursday Oct. 15, 2020 file photo, A bottle containing the drug Remdesivir is held by a health worker at the Institute of Infectology of Kenezy Gyula Teaching Hospital of the University of Debrecen in Debrecen, Hungary. Health officials around the world are clashing over the use of certain drugs for COVID-19, leading to different treatment options for patients depending on where they live. The World Health Organization guidelines panel advised against using the antiviral remdesivir for hospitalized patients, saying there’s no evidence it improves survival or avoids the need for breathing machines. (Zsolt Czegledi/MTI via AP, File)

WASHINGTON (NEWS10) — The National Institutes of Health (NIH) is funding a study into the effects of prescription remdesivir on those who are both pregnant and COVID-positive. Called “IMPAACT 2032,” the study, conducted at 17 sites in the U.S., will examine how pregnant people metabolize and digest the drug, and whether it poses side effects.

“Pregnant women with COVID-19 are at high risk for hospitalization, for intensive care admission, and for needing ventilator support,” said Dr. Diana W. Bianchi, director of NIH’s 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 will compare remdesivir’s effect in pregnant and nonpregnant women of reproductive age who are hospitalized with COVID-19. Subjects who receive the drug within five days of delivery will provide samples from the plasma and umbilical cord for analysis, and breast milk will be tested for remdesivir content.

Remdesivir was originally developed to combat Ebola and Marburg virus, and a clinical trial by the National Institute of Allergy and Infectious Diseases showed that it can speed up recovery from COVID. It has since been approved by the Food and Drug Administration for treating COVID-19 in adults and children over 12.

It has not been approved specifically for use in pregnancy, but physicians can prescribe remdesivir to pregnant patients. The IMPAACT 2032 study will help build a rigorous body of scientific evidence about the safety and efficacy of using remdesivir during pregnancy, which can change how a drug works.

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