Trial Outcomes & Findings for A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease (NCT NCT05487040)
NCT ID: NCT05487040
Last Updated: 2024-09-23
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
From start of treatment on Day 1 to Day 34
Results posted on
2024-09-23
Participant Flow
The study was terminated early following completion of Cohort 2. The decision to terminate was not due to safety, but was based on an assessment that available pharmacokinetic (PK) and safety data are sufficient to inform dosing recommendations for participants with severe renal impairment (SRI).
Participant milestones
| Measure |
Cohort 1 (No HD)
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
12
|
|
Overall Study
COMPLETED
|
3
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
Baseline characteristics by cohort
| Measure |
Cohort 1 (No HD)
n=3 Participants
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
n=12 Participants
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION 29.10 • n=5 Participants
|
52.8 Years
STANDARD_DEVIATION 13.24 • n=7 Participants
|
54.7 Years
STANDARD_DEVIATION 16.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment on Day 1 to Day 34Population: The analysis population was the SAS which was all participants assigned to study intervention and who took at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Cohort 1 (No HD)
n=3 Participants
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
n=12 Participants
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)
Participants with treatment emergent AEs
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)
Participants with treatment emergent SAEs
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of treatment on Day 1 to Day 34Population: The analysis population was the SAS which was all participants assigned to study intervention and who took at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Cohort 1 (No HD)
n=3 Participants
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
n=12 Participants
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Number of Participants With Permanent Discontinuation From Study or Study Intervention Due to Adverse Events and Serious Adverse Events
Permanent Discontinuation From Study
|
0 Participants
|
0 Participants
|
|
Number of Participants With Permanent Discontinuation From Study or Study Intervention Due to Adverse Events and Serious Adverse Events
Permanent Discontinuation From Study Intervention
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Treatment Day 1 to Day 5, see description for detailsPopulation: All participants assigned to study intervention and treated who had at least 1 PK parameter measured.
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).
Outcome measures
| Measure |
Cohort 1 (No HD)
n=2 Participants
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
n=12 Participants
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of PF-07321332 (Nirmatrelvir)
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
There were only 2 participants with evaluable data. Per the Sponsor's clinical pharmacology rule book, only minimum and maximum values were presented for a parameter with less than 3 evaluable measurements. The minimum value was 3040 ng/mL and the maximum value was 5600 ng/mL.
|
3280 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
PRIMARY outcome
Timeframe: Treatment Day 1 to Day 5Population: All participants assigned to study intervention and treated who had at least 1 PK parameter measured.
Vz/F was estimated at steady state.
Outcome measures
| Measure |
Cohort 1 (No HD)
n=2 Participants
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
n=12 Participants
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Nirmatrelvir
|
NA Liter (L)
Geometric Coefficient of Variation NA
There were only 2 participants with evaluable data. Per the Sponsor's clinical pharmacology rule book, only minimum and maximum values were presented for a parameter with less than 3 evaluable measurements. The minimum value was 79.2 L and the maximum value was 73.3 L.
|
99.8 Liter (L)
Geometric Coefficient of Variation 49
|
PRIMARY outcome
Timeframe: 24 Hours after each dose on Treatment Day 1 to Day 5Population: All participants assigned to investigational product and treated who had at least 1 PK parameter measured.
AUC0-tau was measured at 24 hours post-dose.
Outcome measures
| Measure |
Cohort 1 (No HD)
n=2 Participants
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
n=12 Participants
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Area Under the Curve Over a Dosing Interval (AUC0-tau) of Nirmatrelvir
|
NA nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation NA
There were only 2 participants with evaluable data. Per the Sponsor's clinical pharmacology rule book, only minimum and maximum values were presented for a parameter with less than 3 evaluable measurements. The minimum value was 69800 ng\*hr/mL and the maximum value was 131000 ng\*hr/mL.
|
65740 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 59
|
PRIMARY outcome
Timeframe: Treatment Day 1 to Day 5Population: All participants assigned to study intervention and treated who had at least 1 of PK parameter measured.
T1/2 was observed directly from data.
Outcome measures
| Measure |
Cohort 1 (No HD)
n=2 Participants
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
n=12 Participants
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Terminal Half-Life (T1/2) of Nirmatrelvir
|
NA Hour (hr)
Standard Deviation NA
There were only 2 participants with evaluable data. Per the Sponsor's clinical pharmacology rule book, only minimum and maximum values were presented for a parameter with less than 3 evaluable measurements. The minimum value was 45.7 hr and the maximum value was 102 hr.
|
78.93 Hour (hr)
Standard Deviation 49.761
|
PRIMARY outcome
Timeframe: 24 Hours after each dose on Treatment Day 1 to Day 5Population: All participants assigned to study intervention and treated who had at least 1 PK parameter measured.
Ctrough was measured at 24 hours post-dose (pre the next dose). It was analyzed using nonlinear mixed effect models.
Outcome measures
| Measure |
Cohort 1 (No HD)
n=2 Participants
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
n=12 Participants
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Trough Concentration (Ctrough) of Nirmatrelvir
|
NA ng/mL
Geometric Coefficient of Variation NA
There were only 2 participants with evaluable data. Per the Sponsor's clinical pharmacology rule book, only minimum and maximum values were presented for a parameter with less than 3 evaluable measurements. The minimum value was 2720 ng/mL and the maximum value was 5490 ng/mL.
|
2188 ng/mL
Geometric Coefficient of Variation 81
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose on Day 3 and Day 4Population: All participants assigned to study intervention and treated who had at least 1 of the PK parameters of interest measured. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
CLd of nirmatrelvir was calculated for Cohort 2 using non-compartmental analysis of arterial and venous port plasma concentration-time data. Only participants in Cohort 2 were on hemodialysis.
Outcome measures
| Measure |
Cohort 1 (No HD)
n=11 Participants
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Hemodialysis Clearance (CLd) of Nirmatrelvir
|
30.53 milliliter per minute (mL/min)
Geometric Coefficient of Variation 35
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose on Day 3 and Day 4Population: All participants assigned to study intervention and treated who had at least 1 of the PK parameters of interest measured. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
Fd of nirmatrelvir was calculated for Cohort 2 using non-compartmental analysis of arterial and venous port plasma concentration-time data. Only participants in Cohort 2 were on hemodialysis.
Outcome measures
| Measure |
Cohort 1 (No HD)
n=11 Participants
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Fraction of Drug Removed During Dialysis (Fd) of Nirmatrelvir
|
6.937 Percentage of drug removed
Geometric Coefficient of Variation 138
|
—
|
Adverse Events
Cohort 1 (No HD)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 (Intermittent HD)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (No HD)
n=3 participants at risk
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
n=12 participants at risk
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From start of treatment on Day 1 to Day 34
|
8.3%
1/12 • Number of events 1 • From start of treatment on Day 1 to Day 34
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • From start of treatment on Day 1 to Day 34
|
8.3%
1/12 • Number of events 1 • From start of treatment on Day 1 to Day 34
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.00%
0/3 • From start of treatment on Day 1 to Day 34
|
8.3%
1/12 • Number of events 1 • From start of treatment on Day 1 to Day 34
|
Other adverse events
| Measure |
Cohort 1 (No HD)
n=3 participants at risk
Participants in Cohort 1 had SRI (defined as estimated glomerular filtration \[eGFR\] rate \< 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\]) not on hemodialysis (HD) and mild to moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg once daily (QD) from Day 2 to Day 5.
|
Cohort 2 (Intermittent HD)
n=12 participants at risk
Participants in Cohort 2 had SRI on HD and mild-to-moderate COVID-19 disease with confirmed SARS-CoV-2 infection and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of treatment assignment. All eligible participants were assigned to receive a single dose of PF-07321332 (nirmatrelvir)/ritonavir 300 mg/100 mg orally on Day 1 followed by PF-07321332 (nirmatrelvir)/ritonavir 150 mg/100 mg QD from Day 2 to Day 5.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • From start of treatment on Day 1 to Day 34
|
0.00%
0/12 • From start of treatment on Day 1 to Day 34
|
|
General disorders
Chills
|
0.00%
0/3 • From start of treatment on Day 1 to Day 34
|
8.3%
1/12 • From start of treatment on Day 1 to Day 34
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/3 • From start of treatment on Day 1 to Day 34
|
8.3%
1/12 • From start of treatment on Day 1 to Day 34
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From start of treatment on Day 1 to Day 34
|
16.7%
2/12 • From start of treatment on Day 1 to Day 34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclosure previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER