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NCT04582266 · ClinicalTrials.gov registry record
PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 54
- Enrollment target
NCT04582266: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04582266 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 54 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04582266 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 54 participants
- Enrollment target
Study 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.
Primary Outcome
AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). Intensive PK sampling occurred once, on the day of the 3rd, 4th, or 5th infusion.
Interventions
- DRUG Remdesivir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-03-31 |
| Est. Completion | 2022-04-13 |
What the finished NCT04582266 record still lists
NCT04582266 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 54 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Remdesivir is the first listed.
NCT04582266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04582266 about?
NCT04582266 is a clinical study titled "PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US". 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 w...
What is the current status of trial NCT04582266?
This trial is currently completed. The enrollment target is 54 participants. The study started on 2021-03-31. Estimated completion is 2022-04-13.
What interventions are being tested in trial NCT04582266?
The interventions under investigation include: Remdesivir (DRUG).
Who is sponsoring clinical trial NCT04582266?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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