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

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.

Timeline

Start

2022-09-07

Primary completion

2023-07-11

Completion

2023-07-11

Outcome

Outcome not reported

Stopped: “Decision to terminate study was due to slow enrolment and FDA input that available data may be enough for dosing recommendations for severe renal disease (subject to review by FDA).”

Publications

• Gerhart J, Bramson CR, Goulding M, Shi H, Oladoyinbo O, Chan PLS, Chime S, Hammond J. Safety, Pharmacokinetics, and Dose Recommendations for Nirmatrelvir/Ritonavir in Individuals with Mild to Moderate COVID-19 and Severe Renal Impairment. Clin Pharmacol Ther. 2026 Jun;119(6):1604-1613. doi: 10.1002/cpt.70252. Epub 2026 Mar 13.

Drugs

Indications