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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis 		Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
  • Drug: PF-07321332 (nirmatrelvir)/ritonavir
    Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
    Other names:
    • Paxlovid
Experimental
PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment not on hemodialysis 		Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
  • Drug: PF-07321332 (nirmatrelvir)/ritonavir
    Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
    Other names:
    • Paxlovid

Recruiting Locations

More Details

NCT ID
NCT05487040
Status
Terminated
Sponsor
Pfizer

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.