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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: COVID-19

Treatments: Drug: PF-07321332 (nirmatrelvir)/ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT05487040

EPIC-SRI (Other Identifier)

2023-503870-19 (EudraCT Number)

C4671028

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

This is not a complete list. Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: PF-07321332 (nirmatrelvir)/ritonavir

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

Experimental group

Description:

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

Treatment:

Drug: PF-07321332 (nirmatrelvir)/ritonavir