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

NCT05487040 | Terminated Phase 1 Results FDA Drug

• 3 other identifiers: C4671028EPIC-SRI2023-503870-19
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 52

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.

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

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the following criteria: 1. results in death. 2. is life-threatening. 3. Requires inpatient hospitalization or prolongation of existing hospitalization. 4. Results in persistent or significant disability/incapacity. 5. Is a congenital anomaly/birth defect. 6. Is a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic. 7. other important medical events. Any events occurring following start of treatment were considered treatment emergent.

  From start of treatment on Day 1 to Day 34

• Number of Participants With Permanent Discontinuation From Study or Study Intervention Due to Adverse Events and Serious Adverse Events

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the following criteria: 1. results in death. 2. is life-threatening. 3. Requires inpatient hospitalization or prolongation of existing hospitalization. 4. Results in persistent or significant disability/incapacity. 5. Is a congenital anomaly/birth defect. 6. Is a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic. 7. other important medical events. Any events occurring following start of treatment were considered treatment emergent.

  From start of treatment on Day 1 to Day 34

• Maximum Plasma Concentration (Cmax) of PF-07321332 (Nirmatrelvir)

  Nirmatrelvir plasma concentration data were analyzed using nonlinear mixed effects models. Time frame was: For Cohort 1: Day 1 (anytime between 1-3 hours post-dose), Day 2 (anytime between 4-8 hours post-dose), Day 3 (anytime between 9-15 hours post-dose), Day 4 (pre-dose, anytime between 1-4 hours post-dose), Day 5 (pre-dose, anytime between 0.5-6 hours post-dose, anytime between 9-15 hours post-dose). For Cohort 2: Day 1 (anytime between 1-3 hours post-dose), Day 3 (pre-HD), Day 4 (pre-HD, pre-dose, anytime between 0.5-3 hours post-dose, anytime between 4-8 hours post-dose, anytime between 9-15 hours post-dose).

  Treatment Day 1 to Day 5, see description for details

• Apparent Volume of Distribution (Vz/F) of Nirmatrelvir

  Vz/F was estimated at steady state.

  Treatment Day 1 to Day 5

• Area Under the Curve Over a Dosing Interval (AUC0-tau) of Nirmatrelvir

  AUC0-tau was measured at 24 hours post-dose.

  24 Hours after each dose on Treatment Day 1 to Day 5

• Terminal Half-Life (T1/2) of Nirmatrelvir

  T1/2 was observed directly from data.

  Treatment Day 1 to Day 5

• Trough Concentration (Ctrough) of Nirmatrelvir

  Ctrough was measured at 24 hours post-dose (pre the next dose). It was analyzed using nonlinear mixed effect models.

  24 Hours after each dose on Treatment Day 1 to Day 5

Secondary Outcomes (2)

• Hemodialysis Clearance (CLd) of Nirmatrelvir

  Pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose on Day 3 and Day 4

• Fraction of Drug Removed During Dialysis (Fd) of Nirmatrelvir

  Pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose on Day 3 and Day 4

Study Arms (2)

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

EXPERIMENTAL

Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

Drug: PF-07321332 (nirmatrelvir)/ritonavir

PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment not on hemodialysis

EXPERIMENTAL

Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

Drug: PF-07321332 (nirmatrelvir)/ritonavir

Interventions

PF-07321332 (nirmatrelvir)/ritonavir DRUG

Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

Also known as: Paxlovid

PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment not on hemodialysis; PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Covid-19 infection
• Severe kidney disease (on hemodialysis or not on hemodialysis)

You may not qualify if:

• Hospitalized
• Take medications that are not allowed
• Renal transplant patients
• HIV infection

Sponsors & Collaborators

• Pfizer: lead

Study Sites (52)

Fresenius Kidney Care Huntsville

Huntsville, Alabama, 35801, United States

Location

Fresenius Kidney Care Rocket City

Huntsville, Alabama, 35802, United States

Location

Apogee Clinical Research, LLC

Huntsville, Alabama, 35805, United States

Location

Nephrology Consultants

Huntsville, Alabama, 35805, United States

Location

Fresenius Kidney Care Chase

Huntsville, Alabama, 35810, United States

Location

Fresenius Kidney Care Endeavour

Huntsville, Alabama, 35816, United States

Location

Fresenius Kidney Care Parkway

Huntsville, Alabama, 35816, United States

Location

Amicis Research Center - Granada Hills

Granada Hills, California, 91344, United States

Location

Amicis Research Center

Granada Hills, California, 91344, United States

Location

DaVita Inglewood Dialysis

Inglewood, California, 90301, United States

Location

Northridge Kidney Center

Northridge, California, 91324, United States

Location

Clinnova Research - Redondo Beach

Redondo Beach, California, 90277, United States

Location

Santa Clarita Dialysis

Santa Clarita, California, 91355, United States

Location

laurel Canyon Dialysis

Sun Valley, California, 91352, United States

Location

Desert Cities Diaylsis

Victorville, California, 92392, United States

Location

Desert Cities Dialysis - Hesperia

Victorville, California, 92395, United States

Location

Fresenius Kidney Care Ft Lauderdale #2036

Fort Lauderdale, Florida, 33312, United States

Location

South Florida Research Institute

Lauderdale Lakes, Florida, 33313, United States

Location

Fresenius Kidney Care Florida Kidney Center #1095

Lauderhill, Florida, 33319, United States

Location

GCP Research, Global Clinical professionals

St. Petersburg, Florida, 33705, United States

Location

Fresenius Kidney Care Tamarac-JV #6606

Tamarac, Florida, 33321, United States

Location

Fresenius Kidney Care Hillsborough #100706

Tampa, Florida, 33603, United States

Location

Genesis Clinical Research, LLC

Tampa, Florida, 33603, United States

Location

Fresenius Kidney Care Tampa #1130

Tampa, Florida, 33609, United States

Location

Fresenius Kidney Care Ybor City #1863

Tampa, Florida, 33610, United States

Location

Fresenius Kidney Care Town and Country #100474

Tampa, Florida, 33615, United States

Location

Fresenius Kidney Care Carrollwood #1805

Tampa, Florida, 33624, United States

Location

Fresenius Kidney Care-Boise

Boise, Idaho, 83702, United States

Location

Fresenius Kidney Care- Caldwell

Caldwell, Idaho, 83605, United States

Location

Fresenius Kidney Care-Meridian

Meridian, Idaho, 83642, United States

Location

Liberty Dialysis- Nampa

Nampa, Idaho, 83686, United States

Location

Boise Kidney & Hypertension Institute, PLLC

Nampa, Idaho, 83687, United States

Location

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

NorthShore University HealthSystem - Evanston Hospital

Evanston, Illinois, 60201, United States

Location

DaVita Evanston Renal Center

Evanston, Illinois, 60202, United States

Location

DaVita Glen Dialysis

Glenview, Illinois, 60026, United States

Location

NorthShore University HealthSystem - Glenbrook Hospital

Glenview, Illinois, 60026, United States

Location

NorthShore University HealthSystem - Highland Park Hospital

Highland Park, Illinois, 60035, United States

Location

NorthShore University HealthSystem - Skokie Hospital

Skokie, Illinois, 60076, United States

Location

NorthShore Immediate Care Center - Skokie at Old Orchard Woods

Skokie, Illinois, 60077, United States

Location

NorthShore University HealthSystem - Clinical Trials Center

Skokie, Illinois, 60077, United States

Location

Piedmont Dialysis Center

Winston-Salem, North Carolina, 27101, United States

Location

Brookview Hills Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

Northside Dialysis Center

Winston-Salem, North Carolina, 27105, United States

Location

Fresenius Kidney Care / Roane County #2829

Harriman, Tennessee, 37748, United States

Location

Fresenius Kidney Care / Fort Sanders #1597

Knoxville, Tennessee, 37921, United States

Location

Fresenius Kidney Care / Cedar Bluff #6942

Knoxville, Tennessee, 37923, United States

Location

Knoxville Kidney Center, PLLC

Knoxville, Tennessee, 37923, United States

Location

Arlington Nephrology

Arlington, Texas, 76015, United States

Location

South Arlington Dialysis Center

Arlington, Texas, 76015, United States

Location

Grand Prairie Dialysis Center

Grand Prairie, Texas, 75051, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19; Kidney Diseases; Renal Insufficiency

Interventions

nirmatrelvir; nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: September 7, 2022
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2023
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (52)