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A Study to Measure the Amount...

A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease

Last Updated: 2024-09-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-07

Study Completion Date

2023-07-11

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis

Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

Group Type EXPERIMENTAL

PF-07321332 (nirmatrelvir)/ritonavir

Intervention Type DRUG

Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment not on hemodialysis

Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

Group Type EXPERIMENTAL

PF-07321332 (nirmatrelvir)/ritonavir

Intervention Type DRUG

Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

Interventions

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PF-07321332 (nirmatrelvir)/ritonavir

Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

Intervention Type DRUG

Other Intervention Names

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Paxlovid

Eligibility Criteria

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Inclusion Criteria

* Covid-19 infection
* Severe kidney disease (on hemodialysis or not on hemodialysis)

Exclusion Criteria

* Hospitalized
* Take medications that are not allowed
* Renal transplant patients
* HIV infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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