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Pharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the United States

Study Status

Participants Off Study and Primary Analysis Completed

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IMPAACT 2032 is a Phase IV prospective, open-label, non-randomized opportunistic pharmacokinetic (PK) study of remdesivir in pregnant and non-pregnant women of childbearing potential for treatment of COVID-19. Women hospitalized for COVID-19 and receiving remdesivir as part of their clinical care (i.e., outside of the study) will be enrolled at study sites located in the United States. The study will describe the PK of remdesivir and its metabolite, GS-441524, and the clinical and laboratory safety outcomes through four weeks after the last administration of remdesivir and, for pregnant women, during delivery.

Site selection was completed in July 2020 and all IMPAACT sites in the United States were invited to participate based on expected availability of remdesivir.

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