PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis for COVID19 (disease)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
COVID19 (disease)+5 More
PF-07321332 (nirmatrelvir)/ritonavir - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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.

Eligible Conditions
  • COVID19 (disease)
  • COVID-19

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for COVID19 (disease)

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Through Day 34

Hour 4
Dialyzer Clearance (CLd) (nirmatrelvir)
Fraction of drug removed during dialysis (Fd) (nirmatrelvir)
Through Day 34
Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events and Serious Adverse Events
Number of Participants With Treatment Emergent AEs and SAEs (TEAEs)
Day 5
Apparent Oral Clearance (CL/F) of PF-07321332 (nirmatrelvir)
Apparent Volume of Distribution (Vz/F) of PF-07321332 (nirmatrelvir)
Area Under the Curve from Time Zero to end of dosing interval (AUC 0-tau) PF-07321332 (nirmatrelvir)
Maximum Observed Plasma Concentration (Cmax) of PF-07321332 (nirmatrelvir)
Plasma Decay Half-Life (t1/2) of PF-07321332 (nirmatrelvir)
Pre-dose Plasma Concentration (Ctrough) of PF-07321332 (nirmatrelvir)

Trial Safety

Safety Progress

1 of 3

Other trials for COVID19 (disease)

Side Effects for

Oral Ritonvir
8%Anxiety
8%nausea
This histogram enumerates side effects from a completed 2016 Phase 1 & 2 trial (NCT01668147) in the Oral Ritonvir ARM group. Side effects include: Anxiety with 8%, nausea with 8%.

Trial Design

2 Treatment Groups

PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment o...
1 of 2
PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment n...
1 of 2
Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis · No Placebo Group · Phase 1

PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis
Drug
Experimental Group · 1 Intervention: PF-07321332 (nirmatrelvir)/ritonavir · Intervention Types: Drug
PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment not on hemodialysis
Drug
Experimental Group · 1 Intervention: PF-07321332 (nirmatrelvir)/ritonavir · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through day 34

Who is running the clinical trial?

PfizerLead Sponsor
4,260 Previous Clinical Trials
7,104,941 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,248 Previous Clinical Trials
4,820,621 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.