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

Stopped early · Phase 1

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05487040

Run by

Pfizer

People needed

15

Starts

2022-09-07

Expected to finish

2023-07-11

Last updated by the study team

2024-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Covid-19 infection
• Severe kidney disease (on hemodialysis or not on hemodialysis)

You may not qualify if…

• 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.

Where it is running

• Fresenius Kidney Care Rocket City — Huntsville, Alabama, United States
• Apogee Clinical Research, LLC — Huntsville, Alabama, United States
• Nephrology Consultants — Huntsville, Alabama, United States
• Fresenius Kidney Care Chase — Huntsville, Alabama, United States
• Fresenius Kidney Care Endeavour — Huntsville, Alabama, United States
• Fresenius Kidney Care Parkway — Huntsville, Alabama, United States
• Amicis Research Center - Granada Hills — Granada Hills, California, United States
• Amicis Research Center — Granada Hills, California, United States
• DaVita Inglewood Dialysis — Inglewood, California, United States
• Northridge Kidney Center — Northridge, California, United States
• Clinnova Research - Redondo Beach — Redondo Beach, California, United States
• Santa Clarita Dialysis — Santa Clarita, California, United States
• laurel Canyon Dialysis — Sun Valley, California, United States
• Desert Cities Diaylsis — Victorville, California, United States
• Desert Cities Dialysis - Hesperia — Victorville, California, United States
• Fresenius Kidney Care Ft Lauderdale #2036 — Fort Lauderdale, Florida, United States
• South Florida Research Institute — Lauderdale Lakes, Florida, United States
• Fresenius Kidney Care Florida Kidney Center #1095 — Lauderhill, Florida, United States
• GCP Research, Global Clinical professionals — St. Petersburg, Florida, United States
• Fresenius Kidney Care Tamarac-JV #6606 — Tamarac, Florida, United States
• Fresenius Kidney Care Hillsborough #100706 — Tampa, Florida, United States
• Genesis Clinical Research, LLC — Tampa, Florida, United States
• Fresenius Kidney Care Tampa #1130 — Tampa, Florida, United States
• Fresenius Kidney Care Ybor City #1863 — Tampa, Florida, United States
• Fresenius Kidney Care Huntsville — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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