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

NCT06016556 | Completed Results

• 2 other identifiers: C4671054NCT06016556
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid-19

Keywords

Paxlovid; Saudi Arabia

Outcome Measures

Primary Outcomes (28)

• 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 Outcomes (12)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

Adult COVID-19 patients' HCRU within the 30-day period following nirmatrelvir, ritonavir prescription.

Drug: nirmatrelvir, ritonavir

Interventions

nirmatrelvir, ritonavir DRUG

single cohort

Also known as: Paxlovid

Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

King Faisal Specialist Hospital & research center - Jeddah

Jeddah, 21499, Saudi Arabia

Location

King Abdulaziz Medical City

Riyadh, 11426, Saudi Arabia

Location

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

Location

Related Links

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

MeSH Terms

Conditions

COVID-19

Interventions

nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 29, 2023
• Study Start: October 17, 2023
• Primary Completion: April 9, 2024
• Study Completion: April 9, 2024
• Last Updated: June 5, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (3)