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

• Status: Not yet recruiting
• Trial end date: 2023-01-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Ritonavir

Criteria

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.