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).
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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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)
Timeframe: From start of treatment on Day 1 to Day 34
Number of Participants With Permanent Discontinuation From Study or Study Intervention Due to Adverse Events and Serious Adverse Events
Timeframe: From start of treatment on Day 1 to Day 34
Maximum Plasma Concentration (Cmax) of PF-07321332 (Nirmatrelvir)
Timeframe: Treatment Day 1 to Day 5, see description for details
Apparent Volume of Distribution (Vz/F) of Nirmatrelvir
Timeframe: Treatment Day 1 to Day 5
Area Under the Curve Over a Dosing Interval (AUC0-tau) of Nirmatrelvir
Timeframe: 24 Hours after each dose on Treatment Day 1 to Day 5
Terminal Half-Life (T1/2) of Nirmatrelvir
Timeframe: Treatment Day 1 to Day 5
Trough Concentration (Ctrough) of Nirmatrelvir
Timeframe: 24 Hours after each dose on Treatment Day 1 to Day 5