Trial Outcomes & Findings for A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia (NCT NCT06016556)

NCT ID: NCT06016556

Last Updated: 2025-06-05

Results Overview

Education level classification: no formal education, primary school, secondary school, undergraduate university degree, master's degree and Doctor of Philosophy (PhD) or doctorate. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

• Recruitment status: COMPLETED
• Target enrollment: 250 participants
• Primary outcome timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study
• Results posted on: 2025-06-05

Participant Flow

Eligible participants who were prescribed nirmatrelvir, ritonavir (PAXLOVIDTM) in the Kingdom of Saudi Arabia (KSA) any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period) for corona virus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus (SARSCoV-2)- their data was included in this retrospective observational study.

Data was extracted from medical records of the participants and data was evaluated per objectives of this study in approximately 6 months of this study (study start date: 17-Oct-2023 to study completion date: 09-Apr-2024).

Participant milestones

Measure	All Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Overall Study STARTED	248
Overall Study COMPLETED	248
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia

Baseline characteristics by cohort

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Age, Continuous	49.85 Years STANDARD_DEVIATION 18.73 • n=5 Participants
Sex: Female, Male Female	148 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Arab	247 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian/Pacific Islander	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.

Education level classification: no formal education, primary school, secondary school, undergraduate university degree, master's degree and Doctor of Philosophy (PhD) or doctorate. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=140 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Classified According to Education Level at Index Date No formal education	32 Participants
Number of Participants Classified According to Education Level at Index Date Primary school	1 Participants
Number of Participants Classified According to Education Level at Index Date Secondary school	22 Participants
Number of Participants Classified According to Education Level at Index Date Undergraduate university degree	85 Participants
Number of Participants Classified According to Education Level at Index Date Master's degree	0 Participants
Number of Participants Classified According to Education Level at Index Date PhD or doctorate	0 Participants

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.

Employment status classification: full-time employment, part-time employment, homemaker, retired, student, disabled/too ill to work, and unemployed. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=150 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Classified According to Employment Status at Index Date Full-time employment	41 Participants
Number of Participants Classified According to Employment Status at Index Date Part-time employment	1 Participants
Number of Participants Classified According to Employment Status at Index Date Homemaker	10 Participants
Number of Participants Classified According to Employment Status at Index Date Retired	42 Participants
Number of Participants Classified According to Employment Status at Index Date Student	11 Participants
Number of Participants Classified According to Employment Status at Index Date Disabled/too ill to work	3 Participants
Number of Participants Classified According to Employment Status at Index Date Unemployed	42 Participants

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies number of participants who had non-missing values and were evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=240 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Height at Index Date	1.62 Meters Standard Deviation 0.10

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies number of participants who had non-missing values and evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=242 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Weight at Index Date	74.13 Kilograms Standard Deviation 18.81

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies number of participants who had non-missing values and evaluable for this outcome measure.

BMI was calculated based on the reported weight and height in the unit of kilograms over squared meters (kg/m^2). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=237 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Body Mass Index (BMI) at Index Date	28.25 Kg/m^2 Standard Deviation 6.74

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.

Smoking status classification: current smoker, former smoker and never smoker. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=222 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Classified According to Smoking Status at Index Date Current smoker	8 Participants Interval 0.1 to
Number of Participants Classified According to Smoking Status at Index Date Former smoker	7 Participants Interval 0.1 to
Number of Participants Classified According to Smoking Status at Index Date Never smoker	207 Participants Interval 0.1 to

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Had at Least 1 Pre-existing Comorbidity at Index Date	224 Participants

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=223 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Had at Least 1 Concomitant Medication for Comorbidities at Index Date	186 Participants

PRIMARY outcome

Timeframe: During 6 months prior to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=246 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants With COVID-19 Infection During the Last 6 Months Prior to Index Date	9 Participants

PRIMARY outcome

Timeframe: From 6 months prior to index date up to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Duration (in months) between COVID-19 infection in last 6 months prior to index date and index date was reported in this outcome measure. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=9 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Duration Between Last COVID-19 Infection and Index Date	3.34 Months Standard Deviation 2.06

PRIMARY outcome

Timeframe: Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=233 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Had Previously Received at Least 1 Dose of Any COVID-19 Vaccine	200 Participants Interval 2.06 to

PRIMARY outcome

Timeframe: Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.

One participant could have received more than one type of vaccine. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=147 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously Protein-Serum Institute of India	1 Participants Interval 2.06 to
Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously RNA-Moderna	1 Participants
Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously RNA-Pfizer/BioNTech	143 Participants
Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously Viral Vector-Oxford/AstraZeneca	19 Participants

PRIMARY outcome

Timeframe: From date of first COVID-19 vaccination to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.

Duration (in months) between vaccination date and index date was calculated as (index date - date of first covid-19 vaccination date)/30.42. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=142 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Duration Between Previous COVID-19 Vaccination Date and Index Date	23.16 Months Standard Deviation 8.59

PRIMARY outcome

Timeframe: Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=146 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken 1	10 Participants
Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken 2	45 Participants
Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken 3	84 Participants
Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken 4	7 Participants

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

Classification: 1) Nirmatrelvir at a dose of 300 milligrams (mg), as 2 split doses of 150 mg and Ritonavir at a dose of 100 mg; 2) Other: Nirmatrelvir at a dose of 150 mg, and Ritonavir at a dose of 100 mg. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Classified According to Dose of Nirmatrelvir/Ritonavir Received at Index Date 300 mg (2*150)/100 mg	229 Participants
Number of Participants Classified According to Dose of Nirmatrelvir/Ritonavir Received at Index Date Other (150 mg/100 mg)	19 Participants

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

Classification: 1) Nirmatrelvir at a dose of 300 mg, as 2 split doses of 150 mg and Ritonavir at a dose of 100 mg; 2) Other: Nirmatrelvir at a dose of 150 mg, and Ritonavir at a dose of 100 mg. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Classified According to Frequency of Dosing of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date Twice a day	245 Participants
Number of Participants Classified According to Frequency of Dosing of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date Once	2 Participants
Number of Participants Classified According to Frequency of Dosing of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date Once a day on Day 1, then 150mg/100mg once daily on Days 2-5	1 Participants

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

Classification of dispensed type: blister, box, tablets. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Classified According to Dispensed Type of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date Box	236 Participants
Number of Participants Classified According to Dispensed Type of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date Tablets	11 Participants
Number of Participants Classified According to Dispensed Type of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date Blister	1 Participants

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Number of participants classified according to medications (apart from Nirmatrelvir/Ritonavir [PAXLOVIDTM]) used to treat COVID-19 infection at index date were reported in this outcome measure. A participant may receive more than one medication to treat COVID-19 infection. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=94 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antibiotic: Ceftriaxone	13 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antibiotic: Azithromycin	11 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antibiotic: Cefepime	8 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antibiotic: Vancomycin	7 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antibiotic: Meropenem	5 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antibiotic: Ceftazidime	3 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antibiotic: Amoxicillin	2 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antibiotic: Ciprofloxacin	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antibiotic: Doxycycline	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antibiotic: Levofloxacin	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antibiotic: Piperacillin/Tazobactam	11 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antiviral: Remdesivir	39 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antiviral: Acyclovir	2 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antiviral: Oseltamivir	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Steroid: Dexamethasone	16 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Steroid: Hydrocortisone	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Steroid: Methylprednisolone Sodium Succinate	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Steroid: Prednisolone/ Prednisone	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Steroid: Seretide	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Monoclonal antibody: Tocilizumab	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antipyretics: Acetaminophen	3 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antifungals: Noxafil	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Antifungals: Fluconazole	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Other medications: Esomeprazole	2 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Other medications: Azathioprine	2 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Other medications: Cyclosporin	1 Participants
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date Other medications: Omeprazole	1 Participants

PRIMARY outcome

Timeframe: Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

In this outcome measure those number of participants are reported who were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM) while they were hospitalized (related or non-related to COVID-19). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Were Hospitalized at Index Date	120 Participants

PRIMARY outcome

Timeframe: Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

In this outcome measure those number of participants are reported who were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM) while they were hospitalized (related to COVID-19). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=120 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Were Hospitalized Due to COVID-19 at Index Date	72 Participants

PRIMARY outcome

Timeframe: From day of hospitalization till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Length of hospitalization stay was measured in days from day of hospitalization (related to COVID-19) till index date. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=72 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Length of Hospitalization Stay Due to COVID-19 at Index Date	6.64 Days Standard Deviation 6.69

PRIMARY outcome

Timeframe: Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

In this outcome measure those number of participants are reported who were admitted to ICU while they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants With Intensive Care Unit (ICU) Admission at Index Date	17 Participants Interval 6.69 to

PRIMARY outcome

Timeframe: From day of ICU admission till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.

Length of ICU stay was measured in days from day of ICU admission till index date. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=6 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Length of ICU Stay Due to COVID-19 at Index Date	17.83 Days Standard Deviation 11.41

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

In this outcome measure those number of participants are reported who were on supplemental oxygen use when they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Were on Supplemental Oxygen Use at Index Date	14 Participants Interval 6.69 to

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

In this outcome measure those number of participants are reported who were on vasopressor use when they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=120 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Were on Vasopressor Use at Index Date	0 Participants Interval 6.69 to

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

In this outcome measure those number of participants are reported who were intubated when they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=120 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants With Intubation at Index Date	2 Participants Interval 6.69 to

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants With Outpatient Visits at Index Date	32 Participants Interval 6.69 to

PRIMARY outcome

Timeframe: At index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=146 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Had Emergency Room (ER) Visits Due to COVID-19 at Index Date	126 Participants Interval 6.69 to

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Were Hospitalized During the 30-day Post-Index Period	23 Participants Interval 6.69 to

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=23 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Were Hospitalized Due to COVID-19 During the 30-day Post-Index Period	2 Participants Interval 6.69 to

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=2 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Length of Hospitalization Stay Due to COVID-19 During the 30-day Post-Index Period	23.00 Days Standard Deviation 26.87

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants With ICU Admission During the 30-day Post-Index Period	9 Participants Interval 26.87 to

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=2 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Length of ICU Stay Due to COVID-19 During the 30-day Post-Index Period	8.00 Days Standard Deviation 7.07

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Were on Supplemental Oxygen Use During the 30-day Post-Index Period	6 Participants Interval 7.07 to

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=23 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Were on Vasopressor Use During the 30-day Post-Index Period	1 Participants Interval 7.07 to

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=23 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants With Intubation During the 30-day Post-Index Period	2 Participants Interval 7.07 to

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Had Outpatient Visits During the 30-day Post-Index Period	61 Participants Interval 7.07 to

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=248 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Who Had ER Visits Due to COVID-19 During the 30-day Post-Index Period	21 Participants Interval 7.07 to

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).

Outcome measures

Measure	All Participants n=17 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Number of Participants Classified According to COVID-19 Polymerase Chain Reaction (PCR) and Antigen Test Results During the 30-day Post-Index Period Antigen-Positive	1 Participants Interval 7.07 to
Number of Participants Classified According to COVID-19 Polymerase Chain Reaction (PCR) and Antigen Test Results During the 30-day Post-Index Period PCR-Negative	7 Participants Interval 7.07 to
Number of Participants Classified According to COVID-19 Polymerase Chain Reaction (PCR) and Antigen Test Results During the 30-day Post-Index Period PCR-Positive	5 Participants Interval 7.07 to
Number of Participants Classified According to COVID-19 Polymerase Chain Reaction (PCR) and Antigen Test Results During the 30-day Post-Index Period Antigen-Negative	4 Participants Interval 7.07 to

SECONDARY outcome

Timeframe: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period). Time to negative COVID-19 test was assessed from index date till participant tested negative for COVID-19 during 30 days post index period.

Outcome measures

Measure	All Participants n=11 Participants Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
Time to Negative COVID-19 Test During the 30-day Post-Index Period	15.09 Days Standard Deviation 11.13

Adverse Events

All Participants

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=248 participants at risk Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.
General disorders Drug-Drug Interaction	0.81% 2/248 • From Index date up to 30 days post index date (maximum up to 15 months); data was retrospectively evaluated over approximately 6 months of this study Analysis population included all eligible participants whose data were included and observed in this study. AEs were reported as per participants' medical records. There was no specific medical dictionary.

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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 disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER