A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia
- Registration Number
- NCT06016556
- Lead Sponsor
- Pfizer
- Brief Summary
The aim of this study is to describe the baseline demographic, clinical characteristics, and Healthcare Resource Use (HCRU) of adult (≥18 years) COVID-19 patients who have been prescribed nirmatrelvir, ritonavir treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 248
- Confirmed COVID-19 infection during the study observation period
- Nirmatrelvir, ritonavir written prescription
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID) nirmatrelvir, ritonavir Adult COVID-19 patients' HCRU within the 30-day period following nirmatrelvir, ritonavir prescription.
- Primary Outcome Measures
Name Time Method Number of Participants Classified According to Education Level at Index Date At index date; retrospective data was evaluated during approximately 6 months of this study 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).
Number of Participants Classified According to Employment Status at Index Date At index date; retrospective data was evaluated during approximately 6 months of this study 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).
Height at Index Date At index date; retrospective data was evaluated during approximately 6 months of 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).
Weight at Index Date At index date; retrospective data was evaluated during approximately 6 months of 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).
Body Mass Index (BMI) at Index Date At index date; retrospective data was evaluated during approximately 6 months of this study 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).
Number of Participants Classified According to Smoking Status at Index Date At index date; retrospective data was evaluated during approximately 6 months of this study 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).
Number of Participants Who Had at Least 1 Pre-existing Comorbidity at Index Date At index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Who Had at Least 1 Concomitant Medication for Comorbidities at Index Date At index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants With COVID-19 Infection During the Last 6 Months Prior to Index Date During 6 months prior to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of 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).
Duration Between Last COVID-19 Infection and Index Date 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 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).
Number of Participants Who Had Previously Received at Least 1 Dose of Any COVID-19 Vaccine Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study 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).
Duration Between Previous COVID-19 Vaccination Date and Index Date 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 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).
Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Classified According to Dose of Nirmatrelvir/Ritonavir Received at Index Date At index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Classified According to Frequency of Dosing of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date At index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Classified According to Dispensed Type of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date At index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date At index date; retrospective data was evaluated during approximately 6 months of this study 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).
Number of Participants Who Were Hospitalized at Index Date Information obtained at index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Who Were Hospitalized Due to COVID-19 at Index Date Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study 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).
Length of Hospitalization Stay Due to COVID-19 at Index Date From day of hospitalization till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study 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).
Number of Participants With Intensive Care Unit (ICU) Admission at Index Date Information obtained at index date; retrospective data was evaluated during approximately 6 months of 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).
Length of ICU Stay Due to COVID-19 at Index Date From day of ICU admission till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study 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).
Number of Participants Who Were on Supplemental Oxygen Use at Index Date At index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Who Were on Vasopressor Use at Index Date At index date; retrospective data was evaluated during approximately 6 months of this study 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).
Number of Participants With Intubation at Index Date At index date; retrospective data was evaluated during approximately 6 months of this study 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).
Number of Participants With Outpatient Visits at Index Date At index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Who Had Emergency Room (ER) Visits Due to COVID-19 at Index Date At index date; retrospective data was evaluated during approximately 6 months of 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).
- Secondary Outcome Measures
Name Time Method Number of Participants Classified According to COVID-19 Polymerase Chain Reaction (PCR) and Antigen Test Results During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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).
Time to Negative COVID-19 Test During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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). Time to negative COVID-19 test was assessed from index date till participant tested negative for COVID-19 during 30 days post index period.
Number of Participants Who Were Hospitalized During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Who Were Hospitalized Due to COVID-19 During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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).
Length of Hospitalization Stay Due to COVID-19 During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants With ICU Admission During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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).
Length of ICU Stay Due to COVID-19 During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Who Were on Supplemental Oxygen Use During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Who Were on Vasopressor Use During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants With Intubation During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Who Had Outpatient Visits During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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).
Number of Participants Who Had ER Visits Due to COVID-19 During the 30-day Post-Index Period 30-day post index date; retrospective data was evaluated during approximately 6 months of 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).
Trial Locations
- Locations (7)
Saudi Arabia
🇸🇦Riyadh, Saudi Arabia
King Faisal Specialist Hospital & research center - Jeddah
🇸🇦Jeddah, Saudi Arabia
King Abdulaziz Medical City
🇸🇦Riyadh, Saudi Arabia
King Faisal Specialist Hospital and Research Center
🇸🇦Riyadh, Saudi Arabia
King Faisal Specialist Hospital & research center - Jeddah
🇸🇦Jeddah, Saudi Arabia
King Abdulaziz Medical City
🇸🇦Riyadh, Saudi Arabia
King Faisal Specialist Hospital and Research Center
🇸🇦Riyadh, Saudi Arabia