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NCT05487040 · ClinicalTrials.gov registry record · Phase 1
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT05487040 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 15 participants.
The verdict
NCT05487040, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to learn about the side effects (safety) of the study medicine PF-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate COVID-19 infection in adults with severe renal impairment. The study will also look at the amounts of study drug in your blood. There will be 24 participants in this study; 12 of them will have severe renal impairment and not be on hemodialysis and 12 of them will be on hemodialysis. All participants in this study will take PF-07321332 (nirmatrelvir)/ritonavir by mouth for 5 days. During this time, they will have to collect blood samples to measure the study drug levels in their blood. After taking the study drug for 5 days, the participants will have follow-up visits for about another 28 days for a total of about 34 days in the study. The study team will check how each participant is doing during regular visits at the study clinic.
Interventions
- DRUG PF-07321332 (nirmatrelvir)/ritonavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-09-07 |
| Est. Completion | 2023-07-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05487040
The ClinicalTrials.gov registry entry for NCT05487040 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 15 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 1 intervention - of which PF-07321332 (nirmatrelvir)/ritonavir is the first listed.
NCT05487040 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05487040 about?
NCT05487040 is a clinical study titled "A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease". The purpose of this study is to learn about the side effects (safety) of the study medicine PF-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate COVID-19 infection in adults with severe renal impairment. The study will also look at the amounts of study drug in your blood. There...
What is the current status of trial NCT05487040?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2022-09-07. Estimated completion is 2023-07-11.
What interventions are being tested in trial NCT05487040?
The interventions under investigation include: PF-07321332 (nirmatrelvir)/ritonavir (DRUG).
Who is sponsoring clinical trial NCT05487040?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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