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

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).

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.

Study Overview

• Status: Completed
• Conditions: Covid-19
• Intervention / Treatment: Drug: nirmatrelvir, ritonavir

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 21499
    • King Faisal Specialist Hospital & research center - Jeddah
  • Riyadh, Saudi Arabia, 11426
    • King Abdulaziz Medical City
  • Riyadh, Saudi Arabia
    • King Faisal Specialist Hospital and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will involve collection of pre-defined, structured data retrospectively from medical records (electronic and/or paper if necessary) of patients who meet the study eligibility criteria and who have been prescribed nirmatrelvir, ritonavir treatment within a 15-month lookback period from the date of site initiation (Cohort 1). The lookback period will span from 01 April 2022 to 30 June 2023. Data abstracted from patients' medical records will include patient demographics and clinical characteristics at index date (defined as the date of nirmatrelvir, ritonavir treatment prescribing), in addition to patients' HCRU during the 30-day period post-index date.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID); Adult COVID-19 patients' HCRU within the 30-day period following nirmatrelvir, ritonavir prescription.	Drug: nirmatrelvir, ritonavir; single cohort; Other Names: Paxlovid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Classified According to Education Level at Index Date	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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Classified According to Employment Status at Index Date	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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Height at 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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Weight at 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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Body Mass Index (BMI) at Index Date	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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Classified According to Smoking Status at Index Date	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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Had at Least 1 Pre-existing Comorbidity at 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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Had at Least 1 Concomitant Medication for Comorbidities at 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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants With COVID-19 Infection During the Last 6 Months Prior to 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).	During 6 months prior to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
Duration Between Last COVID-19 Infection and Index Date	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).	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
Number of Participants Who Had Previously Received at Least 1 Dose of Any COVID-19 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).	Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously	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).	Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
Duration Between Previous COVID-19 Vaccination Date and Index Date	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).	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
Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken	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).	Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Classified According to Dose of Nirmatrelvir/Ritonavir Received at Index Date	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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Classified According to Frequency of Dosing of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date	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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Classified According to Dispensed Type of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date	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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date	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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Were Hospitalized at Index Date	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).	Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Were Hospitalized Due to COVID-19 at Index Date	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).	Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
Length of Hospitalization Stay Due to COVID-19 at Index Date	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).	From day of hospitalization till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants With Intensive Care Unit (ICU) Admission at Index Date	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).	Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
Length of ICU Stay Due to COVID-19 at Index Date	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).	From day of ICU admission till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Were on Supplemental Oxygen Use at Index Date	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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Were on Vasopressor Use at Index Date	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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants With Intubation at Index Date	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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants With Outpatient Visits at 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).	At index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Had Emergency Room (ER) Visits Due to COVID-19 at 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).	At index date; retrospective data was evaluated during approximately 6 months of this study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Were Hospitalized During the 30-day Post-Index Period	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).	30-day post index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Were Hospitalized Due to COVID-19 During the 30-day Post-Index Period	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).	30-day post index date; retrospective data was evaluated during approximately 6 months of this study
Length of Hospitalization Stay Due to COVID-19 During the 30-day Post-Index Period	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).	30-day post index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants With ICU Admission During the 30-day Post-Index Period	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).	30-day post index date; retrospective data was evaluated during approximately 6 months of this study
Length of ICU Stay Due to COVID-19 During the 30-day Post-Index Period	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).	30-day post index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Were on Supplemental Oxygen Use During the 30-day Post-Index Period	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).	30-day post index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Were on Vasopressor Use During the 30-day Post-Index Period	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).	30-day post index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants With Intubation During the 30-day Post-Index Period	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).	30-day post index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Had Outpatient Visits During the 30-day Post-Index Period	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).	30-day post index date; retrospective data was evaluated during approximately 6 months of this study
Number of Participants Who Had ER Visits Due to COVID-19 During the 30-day Post-Index Period	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).	30-day post index date; retrospective data was evaluated during approximately 6 months of 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	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).	30-day post index date; retrospective data was evaluated during approximately 6 months of this study
Time to Negative COVID-19 Test During the 30-day Post-Index Period	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.	30-day post index date; retrospective data was evaluated during approximately 6 months of this study

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): April 9, 2024
• Study Completion (Actual): April 9, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Paxlovid; Saudi Arabia
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Viral Protease Inhibitors; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Antiviral Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Nirmatrelvir; Nirmatrelvir and ritonavir drug combination; Ritonavir
• Other Study ID Numbers: C4671054; NCT06016556 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.