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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05487040
Other study ID # C4671028
Secondary ID EPIC-SRI
Status Terminated
Phase Phase 1
First received
Last updated
Start date September 7, 2022
Est. completion date July 11, 2023

Study information

Verified date December 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date July 11, 2023
Est. primary completion date July 11, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
PF-07321332 (nirmatrelvir)/ritonavir
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

Locations

Country Name City State
United States Arlington Nephrology Arlington Texas
United States South Arlington Dialysis Center Arlington Texas
United States Fresenius Kidney Care-Boise Boise Idaho
United States Fresenius Kidney Care- Caldwell Caldwell Idaho
United States University of Virginia Health System Charlottesville Virginia
United States Swedish Covenant Hospital Chicago Illinois
United States DaVita Evanston Renal Center Evanston Illinois
United States NorthShore University HealthSystem - Evanston Hospital Evanston Illinois
United States Fresenius Kidney Care Ft Lauderdale #2036 Fort Lauderdale Florida
United States DaVita Glen Dialysis Glenview Illinois
United States NorthShore University HealthSystem - Glenbrook Hospital Glenview Illinois
United States Amicis Research Center Granada Hills California
United States Amicis Research Center - Granada Hills Granada Hills California
United States Grand Prairie Dialysis Center Grand Prairie Texas
United States Fresenius Kidney Care / Roane County #2829 Harriman Tennessee
United States NorthShore University HealthSystem - Highland Park Hospital Highland Park Illinois
United States Apogee Clinical Research, LLC Huntsville Alabama
United States Fresenius Kidney Care Chase Huntsville Alabama
United States Fresenius Kidney Care Endeavour Huntsville Alabama
United States Fresenius Kidney Care Huntsville Huntsville Alabama
United States Fresenius Kidney Care Parkway Huntsville Alabama
United States Fresenius Kidney Care Rocket City Huntsville Alabama
United States Nephrology Consultants Huntsville Alabama
United States DaVita Inglewood Dialysis Inglewood California
United States Fresenius Kidney Care / Cedar Bluff #6942 Knoxville Tennessee
United States Fresenius Kidney Care / Fort Sanders #1597 Knoxville Tennessee
United States Knoxville Kidney Center, PLLC Knoxville Tennessee
United States South Florida Research Institute Lauderdale Lakes Florida
United States Fresenius Kidney Care Florida Kidney Center #1095 Lauderhill Florida
United States Fresenius Kidney Care-Meridian Meridian Idaho
United States Boise Kidney & Hypertension Institute, PLLC Nampa Idaho
United States Liberty Dialysis- Nampa Nampa Idaho
United States Northridge Kidney Center Northridge California
United States Clinnova Research - Redondo Beach Redondo Beach California
United States GCP Research, Global Clinical professionals Saint Petersburg Florida
United States Santa Clarita Dialysis Santa Clarita California
United States NorthShore Immediate Care Center - Skokie at Old Orchard Woods Skokie Illinois
United States NorthShore University HealthSystem - Clinical Trials Center Skokie Illinois
United States NorthShore University HealthSystem - Skokie Hospital Skokie Illinois
United States laurel Canyon Dialysis Sun Valley California
United States Fresenius Kidney Care Tamarac-JV #6606 Tamarac Florida
United States Fresenius Kidney Care Carrollwood #1805 Tampa Florida
United States Fresenius Kidney Care Hillsborough #100706 Tampa Florida
United States Fresenius Kidney Care Tampa #1130 Tampa Florida
United States Fresenius Kidney Care Town and Country #100474 Tampa Florida
United States Fresenius Kidney Care Ybor City #1863 Tampa Florida
United States Genesis Clinical Research, LLC Tampa Florida
United States Desert Cities Dialysis - Hesperia Victorville California
United States Desert Cities Diaylsis Victorville California
United States Brookview Hills Research Associates Winston-Salem North Carolina
United States Northside Dialysis Center Winston-Salem North Carolina
United States Piedmont Dialysis Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment Emergent AEs and SAEs (TEAEs) Through Day 34
Primary Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events and Serious Adverse Events Through Day 34
Secondary Maximum Observed Plasma Concentration (Cmax) of PF-07321332 (nirmatrelvir) Treatment Day 1 to Day 5
Secondary Apparent Oral Clearance (CL/F) of PF-07321332 (nirmatrelvir) Treatment Day 1 to Day 5
Secondary Apparent Volume of Distribution (Vz/F) of PF-07321332 (nirmatrelvir) Treatment Day 1 to Day 5
Secondary Area Under the Curve from Time Zero to end of dosing interval (AUC 0-tau) PF-07321332 (nirmatrelvir) Treatment Day 1 to Day 5
Secondary Plasma Decay Half-Life (t1/2) of PF-07321332 (nirmatrelvir) Treatment Day 1 to Day 5
Secondary Pre-dose Plasma Concentration (Ctrough) of PF-07321332 (nirmatrelvir) Treatment Day 1 to Day 5
Secondary Dialyzer Clearance (CLd) (nirmatrelvir) 0 Hour to approximately 4 Hours
Secondary Fraction of drug removed during dialysis (Fd) (nirmatrelvir) 0 Hour to approximately 4 Hours
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