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

NCT05487040

TerminatedPhase 1

Sponsor: Pfizer

Conditions: COVID-19

Interventions: PF-07321332 (nirmatrelvir)/ritonavir

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (52)
  • Huntsville, Alabama, United States
  • Huntsville, Alabama, United States
  • Huntsville, Alabama, United States
  • Huntsville, Alabama, United States
  • Huntsville, Alabama, United States
  • Huntsville, Alabama, United States
  • Huntsville, Alabama, United States
  • Granada Hills, California, United States
  • Granada Hills, California, United States
  • Inglewood, California, United States
  • Northridge, California, United States
  • Redondo Beach, California, United States
  • Santa Clarita, California, United States
  • Sun Valley, California, United States
  • Victorville, California, United States
  • Victorville, California, United States
  • Fort Lauderdale, Florida, United States
  • Lauderdale Lakes, Florida, United States
  • Lauderhill, Florida, United States
  • St. Petersburg, Florida, United States
  • Tamarac, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Boise, Idaho, United States
  • Caldwell, Idaho, United States
  • Meridian, Idaho, United States
  • + 22 more on CT.gov