COVID-19 Clinical Trial
Official title:
Phase 1, Open-label, Non-randomized Study to Investigate Safety and PK Following Multiple Oral Doses of PF-07321332 (Nirmatrelvir)/Ritonavir in Adults With COVID-19 and Severe Renal Impairment Either on Hemodialysis or Not on Hemodialysis
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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| NCT number | NCT05487040 |
| Study type | Interventional |
| Source | Pfizer |
| Contact | Pfizer CT.gov Call Center |
| Phone | 1-800-718-1021 |
| [email protected] | |
| Status | Not yet recruiting |
| Phase | Phase 1 |
| Start date | August 29, 2022 |
| Completion date | January 4, 2023 |
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|---|---|---|---|
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