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

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

  • COVID-19

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