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

Last updated: May 28, 2024
Sponsor: Pfizer
Overall Status: Terminated

Phase

1

Condition

Covid-19

Treatment

PF-07321332 (nirmatrelvir)/ritonavir

Clinical Study ID

NCT05487040
C4671028
2023-503870-19
EPIC-SRI
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Covid-19 infection

  • Severe kidney disease (on hemodialysis or not on hemodialysis)

Exclusion

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

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: PF-07321332 (nirmatrelvir)/ritonavir
Phase: 1
Study Start date:
September 07, 2022
Estimated Completion Date:
July 11, 2023

Connect with a study center

  • Apogee Clinical Research, LLC

    Huntsville, Alabama 35805
    United States

    Site Not Available

  • Fresenius Kidney Care Chase

    Huntsville, Alabama 35810
    United States

    Site Not Available

  • Fresenius Kidney Care Endeavour

    Huntsville, Alabama 35816
    United States

    Site Not Available

  • Fresenius Kidney Care Huntsville

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Fresenius Kidney Care Parkway

    Huntsville, Alabama 35816
    United States

    Site Not Available

  • Fresenius Kidney Care Rocket City

    Huntsville, Alabama 35802
    United States

    Site Not Available

  • Nephrology Consultants

    Huntsville, Alabama 35805
    United States

    Site Not Available

  • Amicis Research Center

    Granada Hills, California 91344
    United States

    Site Not Available

  • Amicis Research Center - Granada Hills

    Granada Hills, California 91344
    United States

    Site Not Available

  • DaVita Inglewood Dialysis

    Inglewood, California 90301
    United States

    Site Not Available

  • Northridge Kidney Center

    Northridge, California 91324
    United States

    Site Not Available

  • Clinnova Research - Redondo Beach

    Redondo Beach, California 90277
    United States

    Site Not Available

  • Santa Clarita Dialysis

    Santa Clarita, California 91355
    United States

    Site Not Available

  • laurel Canyon Dialysis

    Sun Valley, California 91352
    United States

    Site Not Available

  • Desert Cities Dialysis - Hesperia

    Victorville, California 92395
    United States

    Site Not Available

  • Desert Cities Diaylsis

    Victorville, California 92392
    United States

    Site Not Available

  • Fresenius Kidney Care Ft Lauderdale #2036

    Fort Lauderdale, Florida 33312
    United States

    Site Not Available

  • South Florida Research Institute

    Lauderdale Lakes, Florida 33313
    United States

    Site Not Available

  • Fresenius Kidney Care Florida Kidney Center #1095

    Lauderhill, Florida 33319
    United States

    Site Not Available

  • GCP Research, Global Clinical professionals

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Fresenius Kidney Care Tamarac-JV #6606

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Fresenius Kidney Care Carrollwood #1805

    Tampa, Florida 33624
    United States

    Site Not Available

  • Fresenius Kidney Care Hillsborough #100706

    Tampa, Florida 33603
    United States

    Site Not Available

  • Fresenius Kidney Care Tampa #1130

    Tampa, Florida 33609
    United States

    Site Not Available

  • Fresenius Kidney Care Town and Country #100474

    Tampa, Florida 33615
    United States

    Site Not Available

  • Fresenius Kidney Care Ybor City #1863

    Tampa, Florida 33610
    United States

    Site Not Available

  • Genesis Clinical Research, LLC

    Tampa, Florida 33603
    United States

    Site Not Available

  • Fresenius Kidney Care-Boise

    Boise, Idaho 83702
    United States

    Site Not Available

  • Fresenius Kidney Care- Caldwell

    Caldwell, Idaho 83605
    United States

    Site Not Available

  • Fresenius Kidney Care-Meridian

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Boise Kidney & Hypertension Institute

    Nampa, Idaho 83687
    United States

    Active - Recruiting

  • Boise Kidney & Hypertension Institute, PLLC

    Nampa, Idaho 83687
    United States

    Site Not Available

  • Liberty Dialysis- Nampa

    Nampa, Idaho 83686
    United States

    Site Not Available

  • Swedish Covenant Hospital

    Chicago, Illinois 60625
    United States

    Site Not Available

  • DaVita Evanston Renal Center

    Evanston, Illinois 60202
    United States

    Site Not Available

  • NorthShore University HealthSystem - Evanston Hospital

    Evanston, Illinois 60201
    United States

    Site Not Available

  • DaVita Glen Dialysis

    Glenview, Illinois 60026
    United States

    Site Not Available

  • NorthShore University HealthSystem - Glenbrook Hospital

    Glenview, Illinois 60026
    United States

    Site Not Available

  • NorthShore University HealthSystem - Highland Park Hospital

    Highland Park, Illinois 60035
    United States

    Site Not Available

  • NorthShore Immediate Care Center - Skokie at Old Orchard Woods

    Skokie, Illinois 60077
    United States

    Site Not Available

  • NorthShore University HealthSystem - Clinical Trials Center

    Skokie, Illinois 60077
    United States

    Site Not Available

  • NorthShore University HealthSystem - Skokie Hospital

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Brookview Hills Research Associates

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Northside Dialysis Center

    Winston-Salem, North Carolina 27105
    United States

    Site Not Available

  • Piedmont Dialysis Center

    Winston-Salem, North Carolina 27101
    United States

    Site Not Available

  • Fresenius Kidney Care / Crossville #7124

    Crossville, Tennessee 38555
    United States

    Site Not Available

  • Fresenius Kidney Care / Roane County #2829

    Harriman, Tennessee 37748
    United States

    Site Not Available

  • Fresenius Kidney Care / Cedar Bluff #6942

    Knoxville, Tennessee 37923
    United States

    Site Not Available

  • Fresenius Kidney Care / Fort Sanders #1597

    Knoxville, Tennessee 37921
    United States

    Site Not Available

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee 37923
    United States

    Site Not Available

  • Arlington Nephrology

    Arlington, Texas 76015
    United States

    Site Not Available

  • South Arlington Dialysis Center

    Arlington, Texas 76015
    United States

    Site Not Available

  • Grand Prairie Dialysis Center

    Grand Prairie, Texas 75051
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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