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PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US

NCT04582266 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2023-06-09

Study results available
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Summary

IMPAACT 2032 was a Phase IV prospective, open label, non-randomized opportunistic study. The objectives of this study were to describe the pharmacokinetic (PK) properties and safety of remdesivir (RDV) administered intravenously as part of clinical care among hospitalized pregnant and non-pregnant women of childbearing potential with coronavirus disease of 2019 (COVID-19). RDV was provided and managed by the participant's treating physician and was not provided as part of this study.

Conditions

Interventions

DRUG

Remdesivir

RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Mark Mirochnick, MD · Department of Pediatrics, Boston University Chobanian and Avedisian School of Medicine

  • Diana Clarke, PharmD · Pediatric Infectious Diseases, Boston Medical Center

  • Brookie Best, PharmD, MAS · University of California, San Diego

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2022-04-13
Completion
2022-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04582266 on ClinicalTrials.gov