IMPAACT 2032: IMPAACT 2032: Pharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the United States

Study Status Study Restriction

In Development

US & Non-US

What is IMPAACT 2032?

IMPAACT 2032 is a Phase I 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.

Study Documents

Sites where the study is implemented:

CRS ID Site Name City Country

3801

Texas Childrens Hosp. CRS

Houston

United States of America

4001

Chicago Children's CRS

Chicago

United States of America

4201

University of Miami Pediatric/Perinatal HIV/AIDS

Miami

United States of America

4601

UCSD Mother-Child-Adolescent HIV Program

San Diego

United States of America

5011

Boston Medical Center Pediatric HIV Program

Boston

United States of America

5013

Jacobi Medical Center Bronx

Bronx

United States of America

5030

Emory University School of Medicine NICHD CRS

Atlanta

United States of America

5040

SUNY Stony Brook

Stony Brook

United States of America

5048

University of Southern California LA

Los Angeles

United States of America

5051

University of Florida Jacksonville

Jacksonville

United States of America

5052

University of Colorado Denver NICHD CRS

Aurora

United States of America

5083

Rush University Cook County Hospital Chicago NICHD CRS

Chicago

United States of America

5092

Johns Hopkins University, Baltimore

Baltimore

United States of America

5112

UCLA - David Geffen School of Medicine

Los Angeles

United States of America

5114

Bronx-Lebanon Hospital IMPAACT

Bronx

United States of America

6501

St. Jude/UTHSC CRS

Memphis

United States of America

6601

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

San Juan

United States of America

Study contacts:

Study Chair: Mark Mirochnick

Study Vice-Chair: Brookie Best

Study Vice-Chair: Diana Clarke

Clinical Trials Specialist: Kathleen George

Clinical Trials Specialist: Elizabeth Greene

Medical Officer: Nahida Chakhtoura

Medical Officer: Patrick Jean-Philippe

Medical Officer: Dwight Yin

Pharmacologist: Kristina Brooks

Pharmacologist: Jeremiah Momper

Senior Statistician: David Shapiro

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.