PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US
Completed
Conditions studied: COVID-19
In brief
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.
Key facts
- Study ID
- NCT04582266
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 54
- Starts
- 2021-03-31
- Expected to finish
- 2022-04-13
- Last updated by the study team
- 2023-06-09
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- At study entry, has started or received the 4th RDV infusion.
- At study entry, evidence of post-menopausal status (medical or surgical), based on medical records and/or participant report.
- At study entry, any contraindications to RDV treatment for COVID-19, based on investigator or designee determination.
- Received or administered any disallowed medications within 48 hours prior to study entry.
- At study entry, has any other condition, that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
Where it is running
- David Geffen School of Medicine at UCLA (Site #: 5112) — Los Angeles, California, United States
- Childrens Hospital (U. Colorado, Denver) NICHD CRS (Site #: 5052) — Denver, Colorado, United States
- Pediatric Perinatal HIV Clinical Trials Unit (Site #: 5127) — Miami, Florida, United States
- Emory University School of Medicine (Site #: 5030) — Atlanta, Georgia, United States
- Rush University Cook County Hospital NICHD CRS (Site #: 5083) — Chicago, Illinois, United States
- Lurie Children's Hospital of Chicago (LCH) CRS (Site #: 4001) — Chicago, Illinois, United States
- Johns Hopkins University NICHD CRS (Site #: 5092) — Baltimore, Maryland, United States
- Stony Brook University Medical Center (Site #: 5040) — Stony Brook, New York, United States
- Bronx-Lebanon Hospital Center (Site #: 5114) — The Bronx, New York, United States
- Texas Children's Hospital (Site #: 5128) — Houston, Texas, United States
Full record on ClinicalTrials.gov
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