Clinical trial NCT05487040: A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID-19
Keywords: 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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: From start of treatment on Day 1 to Day 34
measure: Number of Participants With Permanent Discontinuation From Study or Study Intervention Due to Adverse Events and Serious Adverse Events
timeFrame: From start of treatment on Day 1 to Day 34
measure: Maximum Plasma Concentration (Cmax) of PF-07321332 (Nirmatrelvir)
timeFrame: Treatment Day 1 to Day 5, see description for details
measure: Apparent Volume of Distribution (Vz/F) of Nirmatrelvir
timeFrame: Treatment Day 1 to Day 5
measure: Area Under the Curve Over a Dosing Interval (AUC0-tau) of Nirmatrelvir
timeFrame: 24 Hours after each dose on Treatment Day 1 to Day 5
measure: Terminal Half-Life (T1/2) of Nirmatrelvir
timeFrame: Treatment Day 1 to Day 5
measure: Trough Concentration (Ctrough) of Nirmatrelvir
timeFrame: 24 Hours after each dose on Treatment Day 1 to Day 5
Secondary outcomes:
measure: Hemodialysis Clearance (CLd) of Nirmatrelvir
timeFrame: Pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose on Day 3 and Day 4
measure: Fraction of Drug Removed During Dialysis (Fd) of Nirmatrelvir
timeFrame: Pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose on Day 3 and Day 4
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Fresenius Kidney Care Huntsville
state: Alabama
city: Huntsville
country: United States
facility: Fresenius Kidney Care Rocket City
state: Alabama
city: Huntsville
country: United States
facility: Apogee Clinical Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Nephrology Consultants
state: Alabama
city: Huntsville
country: United States
facility: Fresenius Kidney Care Chase
state: Alabama
city: Huntsville
country: United States
facility: Fresenius Kidney Care Endeavour
state: Alabama
city: Huntsville
country: United States
facility: Fresenius Kidney Care Parkway
state: Alabama
city: Granada Hills
country: United States
facility: Amicis Research Center - Granada Hills
state: California
city: Granada Hills
country: United States
facility: Amicis Research Center
state: California
city: Inglewood
country: United States
facility: DaVita Inglewood Dialysis
state: California
city: Northridge
country: United States
facility: Northridge Kidney Center
state: California
city: Redondo Beach
country: United States
facility: Clinnova Research - Redondo Beach
state: California
city: Santa Clarita
country: United States
facility: Santa Clarita Dialysis
state: California
city: Sun Valley
country: United States
facility: laurel Canyon Dialysis
state: California
city: Victorville
country: United States
facility: Desert Cities Diaylsis
state: California
city: Victorville
country: United States
facility: Desert Cities Dialysis - Hesperia
state: California
city: Fort Lauderdale
country: United States
facility: Fresenius Kidney Care Ft Lauderdale #2036
state: Florida
city: Lauderdale Lakes
country: United States
facility: South Florida Research Institute
state: Florida
city: Lauderhill
country: United States
facility: Fresenius Kidney Care Florida Kidney Center #1095
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research, Global Clinical professionals
state: Florida
city: Tamarac
country: United States
facility: Fresenius Kidney Care Tamarac-JV #6606
state: Florida
city: Tampa
country: United States
facility: Fresenius Kidney Care Hillsborough #100706
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Fresenius Kidney Care Tampa #1130
state: Florida
city: Tampa
country: United States
facility: Fresenius Kidney Care Ybor City #1863
state: Florida
city: Tampa
country: United States
facility: Fresenius Kidney Care Town and Country #100474
state: Florida
city: Tampa
country: United States
facility: Fresenius Kidney Care Carrollwood #1805
state: Florida
city: Boise
country: United States
facility: Fresenius Kidney Care-Boise
state: Idaho
city: Caldwell
country: United States
facility: Fresenius Kidney Care- Caldwell
state: Idaho
city: Meridian
country: United States
facility: Fresenius Kidney Care-Meridian
state: Idaho
city: Nampa
country: United States
facility: Liberty Dialysis- Nampa
state: Idaho
city: Nampa
country: United States
facility: Boise Kidney & Hypertension Institute, PLLC
state: Idaho
city: Chicago
country: United States
facility: Swedish Covenant Hospital
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem - Evanston Hospital
state: Illinois
city: Evanston
country: United States
facility: DaVita Evanston Renal Center
state: Illinois
city: Glenview
country: United States
facility: DaVita Glen Dialysis
state: Illinois
city: Glenview
country: United States
facility: NorthShore University HealthSystem - Glenbrook Hospital
state: Illinois
city: Highland Park
country: United States
facility: NorthShore University HealthSystem - Highland Park Hospital
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem - Skokie Hospital
state: Illinois
city: Skokie
country: United States
facility: NorthShore Immediate Care Center - Skokie at Old Orchard Woods
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem - Clinical Trials Center
state: Illinois
city: Winston-Salem
country: United States
facility: Piedmont Dialysis Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Northside Dialysis Center
state: North Carolina
city: Harriman
country: United States
facility: Fresenius Kidney Care / Roane County #2829
state: Tennessee
city: Knoxville
country: United States
facility: Fresenius Kidney Care / Fort Sanders #1597
state: Tennessee
city: Knoxville
country: United States
facility: Fresenius Kidney Care / Cedar Bluff #6942
state: Tennessee
city: Knoxville
country: United States
facility: Knoxville Kidney Center, PLLC
state: Tennessee
city: Arlington
country: United States
facility: Arlington Nephrology
state: Texas
city: Arlington
country: United States
facility: South Arlington Dialysis Center
state: Texas
city: Grand Prairie
country: United States
facility: Grand Prairie Dialysis Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: