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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05487040
Recruitment Status : Recruiting
First Posted : August 4, 2022
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: PF-07321332 (nirmatrelvir)/ritonavir Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 7, 2022
Estimated Primary Completion Date : August 4, 2023
Estimated Study Completion Date : August 4, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
 Drug: PF-07321332 (nirmatrelvir)/ritonavir
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
Other Name: Paxlovid
Experimental: PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment not on hemodialysis
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
 Drug: PF-07321332 (nirmatrelvir)/ritonavir
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
Other Name: Paxlovid


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent AEs and SAEs (TEAEs) [ Time Frame: Through Day 34 ]
  2. Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events and Serious Adverse Events [ Time Frame: Through Day 34 ]

Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of PF-07321332 (nirmatrelvir) [ Time Frame: Treatment Day 1 to Day 5 ]
  2. Apparent Oral Clearance (CL/F) of PF-07321332 (nirmatrelvir) [ Time Frame: Treatment Day 1 to Day 5 ]
  3. Apparent Volume of Distribution (Vz/F) of PF-07321332 (nirmatrelvir) [ Time Frame: Treatment Day 1 to Day 5 ]
  4. Area Under the Curve from Time Zero to end of dosing interval (AUC 0-tau) PF-07321332 (nirmatrelvir) [ Time Frame: Treatment Day 1 to Day 5 ]
  5. Plasma Decay Half-Life (t1/2) of PF-07321332 (nirmatrelvir) [ Time Frame: Treatment Day 1 to Day 5 ]
  6. Pre-dose Plasma Concentration (Ctrough) of PF-07321332 (nirmatrelvir) [ Time Frame: Treatment Day 1 to Day 5 ]
  7. Dialyzer Clearance (CLd) (nirmatrelvir) [ Time Frame: 0 Hour to approximately 4 Hours ]
  8. Fraction of drug removed during dialysis (Fd) (nirmatrelvir) [ Time Frame: 0 Hour to approximately 4 Hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05487040


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05487040    
Other Study ID Numbers: C4671028
EPIC-SRI ( Other Identifier: Alias Study Number )
First Posted: August 4, 2022    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
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
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ritonavir
 Nirmatrelvir
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors