| Primary | 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. | The analysis population was the SAS which was all participants assigned to study intervention and who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | From start of treatment on Day 1 to Day 34 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| Participants with treatment emergent AEs | | | | Participants with treatment emergent SAEs | | |
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| Primary | 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. | The analysis population was the SAS which was all participants assigned to study intervention and who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | From start of treatment on Day 1 to Day 34 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Primary | 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). | All participants assigned to study intervention and treated who had at least 1 PK parameter measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | Treatment Day 1 to Day 5, see description for details | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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| Primary | Apparent Volume of Distribution (Vz/F) of Nirmatrelvir | Vz/F was estimated at steady state. | All participants assigned to study intervention and treated who had at least 1 PK parameter measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | Treatment Day 1 to Day 5 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Primary | Area Under the Curve Over a Dosing Interval (AUC0-tau) of Nirmatrelvir | AUC0-tau was measured at 24 hours post-dose. | All participants assigned to investigational product and treated who had at least 1 PK parameter measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | | 24 Hours after each dose on Treatment Day 1 to Day 5 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Primary | Terminal Half-Life (T1/2) of Nirmatrelvir | T1/2 was observed directly from data. | All participants assigned to study intervention and treated who had at least 1 of PK parameter measured. | Posted | | Mean | Standard Deviation | Hour (hr) | | Treatment Day 1 to Day 5 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Primary | 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. | All participants assigned to study intervention and treated who had at least 1 PK parameter measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 24 Hours after each dose on Treatment Day 1 to Day 5 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Hemodialysis Clearance (CLd) of Nirmatrelvir | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per minute (mL/min) | | Pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose on Day 3 and Day 4 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Fraction of Drug Removed During Dialysis (Fd) of Nirmatrelvir | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Percentage of drug removed | | Pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose on Day 3 and Day 4 | | | | ID | Title | Description |
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| OG000 | 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. |
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