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

Study Overview
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Brief Summary
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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.

Official Title
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A PHASE 1, OPEN-LABEL, NON-RANDOMIZED STUDY TO INVESTIGATE THE SAFETY AND PK FOLLOWING MULTIPLE ORAL DOSES OF PF-07321332 (NIRMATRELVIR)/RITONAVIR IN ADULT PARTICIPANTS WITH COVID-19 AND SEVERE RENAL IMPAIRMENT EITHER ON HEMODIALYSIS OR NOT ON HEMODIALYSIS

Conditions
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COVID-19

Intervention / Treatment
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* Drug: PF-07321332 (nirmatrelvir)/ritonavir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis<br>Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth. | Drug: PF-07321332 (nirmatrelvir)/ritonavir<br>* Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.<br>* Other names: Paxlovid;|
| Experimental: PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment not on hemodialysis<br>Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth. | Drug: PF-07321332 (nirmatrelvir)/ritonavir<br>* Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.<br>* Other names: Paxlovid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent AEs and SAEs (TEAEs) |  | Through Day 34 | 
| Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events and Serious Adverse Events |  | Through Day 34 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of PF-07321332 (nirmatrelvir) |  | Treatment Day 1 to Day 5 | 
| Apparent Oral Clearance (CL/F) of PF-07321332 (nirmatrelvir) |  | Treatment Day 1 to Day 5 | 
| Apparent Volume of Distribution (Vz/F) of PF-07321332 (nirmatrelvir) |  | Treatment Day 1 to Day 5 | 
| Area Under the Curve from Time Zero to end of dosing interval (AUC 0-tau) PF-07321332 (nirmatrelvir) |  | Treatment Day 1 to Day 5 | 
| Plasma Decay Half-Life (t1/2) of PF-07321332 (nirmatrelvir) |  | Treatment Day 1 to Day 5 | 
| Pre-dose Plasma Concentration (Ctrough) of PF-07321332 (nirmatrelvir) |  | Treatment Day 1 to Day 5 | 
| Dialyzer Clearance (CLd) (nirmatrelvir) |  | 0 Hour to approximately 4 Hours | 
| Fraction of drug removed during dialysis (Fd) (nirmatrelvir) |  | 0 Hour to approximately 4 Hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), kidney disease, kidney failure, renal disease, renal failure, dialysis, renal dialysis, hemodialysis, coronavirus disease 2019 (COVID-19), COVID, Paxlovid, antiviral, nirmatrelvir, mild to moderate COVID-19, high risk