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IMPAACT 2032

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

DAIDS Number

38746

IND Number

154,388

Clinical Trials Link

Summary

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.

Study Start-up Trainings: September 2020 and January 2021

Study Chair

Study Vice-Chair

DAIDS Medical Officer

Clinical Research Manager

Community Program Manager

Data Manager

Investigator

Laboratory Data Manager (LDM)

Laboratory Technologist

Westat Representative

Abstracts

IMPAACT 2032: REMDESIVIR PK & SAFETY IN PREGNANT AND NON-PREGNANT WOMEN WITH COVID-19

Conference

CROI 2022

Study

IMPAACT 2032

Authors

Kristina M. Brooks, Kristin Baltrusaitis, Jeremiah Momper, Elizabeth Greene, Frederic Bone, Kira Bacon, Rita Humeniuk, Dwight E. Yin, Nahida Chakhtoura, Alice M. Stek, Edmund Capparelli, Mark Mirochnick, Diana F. Clarke, Brookie Best, IMPAACT 2032 Study Team