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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: Clinical Trial Phase 1 study, sponsored by Pfizer.
NCT05487040 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the following criteria: 1. results in death. 2. is life-threatening. 3. Requires inpatient hospitalization or prolongation of existing hospitalization. 4. Results in persistent or significant disability/incapacit
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 |
Why NCT05487040 stopped before completion
NCT05487040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which PF-07321332 (nirmatrelvir)/ritonavir is the first listed.
NCT05487040 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05487040's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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