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Completed

NCT Number: NCT06016556

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Faisal Specialist Hospital & research center - Jeddah, Jeddah, Saudi Arabia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed COVID-19 infection during the study observation period
  • Nirmatrelvir, ritonavir written prescription

Exclusion criteria

  • None

Treatment and study plan

nirmatrelvir, ritonavir

Drug

single cohort

Other names: Paxlovid

Primary outcomes

  1. Number of Participants Classified According to Education Level at Index Date

    Time frame: 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).

  2. Number of Participants Classified According to Employment Status at Index Date

    Time frame: 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).

  3. Height at Index Date

    Time frame: 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).

  4. Weight at Index Date

    Time frame: 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).

  5. Body Mass Index (BMI) at Index Date

    Time frame: 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).

  6. Number of Participants Classified According to Smoking Status at Index Date

    Time frame: 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).

  7. Number of Participants Who Had at Least 1 Pre-existing Comorbidity at Index Date

    Time frame: 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).

  8. Number of Participants Who Had at Least 1 Concomitant Medication for Comorbidities at Index Date

    Time frame: 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).

  9. Number of Participants With COVID-19 Infection During the Last 6 Months Prior to Index Date

    Time frame: 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).

  10. Duration Between Last COVID-19 Infection and Index Date

    Time frame: 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).

  11. Number of Participants Who Had Previously Received at Least 1 Dose of Any COVID-19 Vaccine

    Time frame: 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).

  12. Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously

    Time frame: 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).

  13. Duration Between Previous COVID-19 Vaccination Date and Index Date

    Time frame: 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).

  14. Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken

    Time frame: 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).

  15. Number of Participants Classified According to Dose of Nirmatrelvir/Ritonavir Received at Index Date

    Time frame: 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).

  16. Number of Participants Classified According to Frequency of Dosing of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date

    Time frame: 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).

  17. Number of Participants Classified According to Dispensed Type of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date

    Time frame: 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).

  18. Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date

    Time frame: 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).

  19. Number of Participants Who Were Hospitalized at Index Date

    Time frame: 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).

  20. Number of Participants Who Were Hospitalized Due to COVID-19 at Index Date

    Time frame: 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).

  21. Length of Hospitalization Stay Due to COVID-19 at Index Date

    Time frame: 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).

  22. Number of Participants With Intensive Care Unit (ICU) Admission at Index Date

    Time frame: 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).

  23. Length of ICU Stay Due to COVID-19 at Index Date

    Time frame: 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).

  24. Number of Participants Who Were on Supplemental Oxygen Use at Index Date

    Time frame: 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).

  25. Number of Participants Who Were on Vasopressor Use at Index Date

    Time frame: 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).

  26. Number of Participants With Intubation at Index Date

    Time frame: 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).

  27. Number of Participants With Outpatient Visits at Index Date

    Time frame: 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).

  28. Number of Participants Who Had Emergency Room (ER) Visits Due to COVID-19 at Index Date

    Time frame: 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 outcomes

  1. Number of Participants Who Were Hospitalized During the 30-day Post-Index Period

    Time frame: 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).

  2. Number of Participants Who Were Hospitalized Due to COVID-19 During the 30-day Post-Index Period

    Time frame: 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).

  3. Length of Hospitalization Stay Due to COVID-19 During the 30-day Post-Index Period

    Time frame: 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).

  4. Number of Participants With ICU Admission During the 30-day Post-Index Period

    Time frame: 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).

  5. Length of ICU Stay Due to COVID-19 During the 30-day Post-Index Period

    Time frame: 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).

  6. Number of Participants Who Were on Supplemental Oxygen Use During the 30-day Post-Index Period

    Time frame: 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).

  7. Number of Participants Who Were on Vasopressor Use During the 30-day Post-Index Period

    Time frame: 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).

  8. Number of Participants With Intubation During the 30-day Post-Index Period

    Time frame: 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).

  9. Number of Participants Who Had Outpatient Visits During the 30-day Post-Index Period

    Time frame: 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).

  10. Number of Participants Who Had ER Visits Due to COVID-19 During the 30-day Post-Index Period

    Time frame: 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).

  11. Number of Participants Classified According to COVID-19 Polymerase Chain Reaction (PCR) and Antigen Test Results During the 30-day Post-Index Period

    Time frame: 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).

  12. Time to Negative COVID-19 Test During the 30-day Post-Index Period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics and Healthcare Resource Use (HCRU) Among COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir (PAXLOVID TM) in the Kingdom of Saudi Arabia (KSA).

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2023
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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