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

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT05487040

Acronym / sponsor ID

C4671028

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

Phase

Phase 1

Study type

Interventional

Recruitment status

TerminatedReason stopped: Decision to terminate study was due to slow enrolment and FDA input that available data may be enough for dosing recommendations for severe renal disease (subject to review by FDA).

Enrolment

15 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

7 Sep 2022 (actual)

Primary completion

11 Jul 2023 (actual)

Study completion

11 Jul 2023 (actual)

First posted

4 Aug 2022 (actual)

Results

Posted 23 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Non-randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

   Time frame: From start of treatment on Day 1 to Day 34

   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.

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

   Time frame: From start of treatment on Day 1 to Day 34

   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.

3. Maximum Plasma Concentration (Cmax) of PF-07321332 (Nirmatrelvir)

   Time frame: Treatment Day 1 to Day 5, see description for details

   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).

4. Apparent Volume of Distribution (Vz/F) of Nirmatrelvir

   Time frame: Treatment Day 1 to Day 5

   Vz/F was estimated at steady state.

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

   Time frame: 24 Hours after each dose on Treatment Day 1 to Day 5

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

6. Terminal Half-Life (T1/2) of Nirmatrelvir

   Time frame: Treatment Day 1 to Day 5

   T1/2 was observed directly from data.

7. Trough Concentration (Ctrough) of Nirmatrelvir

   Time frame: 24 Hours after each dose on Treatment Day 1 to Day 5

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

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 41823072Gerhart J, Bramson CR, Goulding M, Shi H, Oladoyinbo O, Chan PLS, Chime S, Hammond J. Safety, Pharmacokinetics, and Dose Recommendations for Nirmatrelvir/Ritonavir in Individuals with Mild to Moderate COVID-19 and Severe Renal Impairment. Clin Pharmacol Ther. 2026 Jun;119(6):1604-1613. doi: 10.1002/cpt.70252. Epub 2026 Mar 13.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.
• Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

52 sites in 1 country: see every site and its status.