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NCT05386472 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT05386472 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 25 participants.
The verdict
NCT05386472, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as its safety, and the extent to which side effects can be tolerated for treatment of pregnant women with mild or moderate COVID-19 compared to non-pregnant women with mild or moderate COVID-19. This study is seeking participants who: * are expecting a healthy baby and are in their second or third trimester pregnancy and have mild or moderate COVID-19 * are not pregnant and have mild or moderate COVID-19. All participants in this study will take Paxlovid by mouth every 12 hours for 5 days. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe. All participants will take part in this study for at least 34 days; pregnant participants will take part until their delivery, so that the study duration may be up to 6 months, depending on their delivery date. During this time, participants will have 7to 8 visits and, if pregnant, a visit at delivery. Around 2 to 3 visits and the delivery visit will be done in person (at the clinic or at the participant's home). The other 5 visits may be done over the phone, unless in-person visit is necessary as decided by the doctor. Blood samples will be collected on the first 4 to 5 study visits (and at other study visits, if necessary).
Interventions
- DRUG nirmatrelvir
- DRUG ritonavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-06-22 |
| Est. Completion | 2025-05-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05386472
The ClinicalTrials.gov registry entry for NCT05386472 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which nirmatrelvir is the first listed.
NCT05386472 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05386472 about?
NCT05386472 is a clinical study titled "A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19". The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as its safety, and the extent to which side effects can be tolerated for treatment of pregnant women with mild or moderate CO...
What is the current status of trial NCT05386472?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2022-06-22. Estimated completion is 2025-05-12.
What interventions are being tested in trial NCT05386472?
The interventions under investigation include: nirmatrelvir (DRUG), ritonavir (DRUG).
Who is sponsoring clinical trial NCT05386472?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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