A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain.

A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics and Healthcare Resource Use (HRU) Among COVID-19 Patients With or Without Nirmatrelvir/Ritonavir (PAXLOVID™) Treatment in the Kingdom of Bahrain.

The purpose of this study is to collect information on the:

• general information of a group of people such as their age, sex
• clinical information of the patients such as any other illness before having COVID 19.
• the number of COVID-19 patients who meet and follow the most up to date World Health Organization (WHO) recommendations for medication to treat COVID-19 (such as version 14, published 10Nov2023) compared to Kingdom of Bahrain national recommendations
• adult COVID-19 patients' health care resource use and outcomes within the 28-day period In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.

This study will be conducted in the Kingdom of Bahrain. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment and those not treated with nirmatrelvir, ritonavir.

This study will have about 3000 patients treated with Paxlovid™ therapy and 1000 were not. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers.

The study will include patient information of those who:

• had COVID-19 infection during the study period from 16 February 2022 to 30 November 2022.
• are 18 years of age or older. This study will help to inform decision-making on use of Paxlovid at the national level.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: nirmatrelvir, ritonavir; Other: Controls

• Study Type: Observational
• Enrollment (Actual): 3011

Contacts and Locations

Study Locations

• Bahrain
  • Busaiteen, Bahrain
    • Pfizer Gulf FZ

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

This will be a retrospective observational cohort study of patients diagnosed with COVID-19 in the Kingdom of Bahrain. Treated patients are defined as those have been prescribed nirmatrelvir, ritonavir and managed in the outpatient setting (eg, receiving medical treatment without being admitted to a hospital for COVID-19) while control group is those not treated with nirmatrelvir, ritonavir. Data will be from the I-Seha electronic medical records and descriptive analyses will be conducted for these two cohorts and will compare healthcare resource use in patients treated with nirmatrelvir, ritonavir and those not treated with nirmatrelvir, ritonavir.

Description

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:Age 18 years and older Patients with a diagnosis of COVID-19 whose information can be extracted from the I-Seha database

Exclusion Criteria:

There are no exclusion criteria for this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID); Adult COVID-19 patients' Healthcare Resource Utilization (HRU) within the 30-day period following nirmatrelvir, ritonavir prescription.	Drug: nirmatrelvir, ritonavir; Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)
Controls; Adults COVID-19 patient HRU within 30 days period following nirmatrelvir/ritonavir prescription	Other: Controls; Patients who do not receive Nirmatrevir/ritonavir (Paxlovid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Classified Based on Education	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.	Baseline; from available retrospective data evaluated during 2 months of this study
Number of Participants Classified Based on Employment Status	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.	Baseline; from available retrospective data evaluated during 2 months of this study
Height	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.	Baseline; from available retrospective data evaluated during 2 months of this study
Weight	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.	Baseline; from available retrospective data evaluated during 2 months of this study
Body Mass Index (BMI)	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.	Baseline; from available retrospective data evaluated during 2 months of this study
Number of Participants Classified Based on Smoking Status	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.	Baseline; from available retrospective data evaluated during 2 months of this study
Number of Participants With at Least 1 Pre-existing Comorbidities	Pre-existing comorbidities included: asthma, emphysema, chronic obstructive pulmonary disease (COPD), hypertension, diabetes, obesity, cerebrovascular disease, neurological disease, chronic kidney disease, chronic liver disease, malignancy. Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.	Baseline; from available retrospective data evaluated during 2 months of this study
Number of Participants Who Took at Least 1 Concomitant Medications for Pre-existing Comorbidities	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.	Baseline; from available retrospective data evaluated during 2 months of this study
Number of Participants Who Used Antibiotics		Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Hospitalization for Any Cause	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants With Intensive Care Unit (ICU) Admission for Any Cause	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants With Yes/no Questionnaire on Outpatient Visits	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants With Emergency Room (ER) Visits for Any Cause	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants With Supplemental Oxygen Usage	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants With Vasopressor Use	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants Who Used Invasive Mechanical Ventilation (IMV)	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 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): March 13, 2024
• Primary Completion (Actual): May 14, 2024
• Study Completion (Actual): May 14, 2024

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Bahrain; COVID-19 patients; Paxlovid use
• 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: C4671050; NCT06291831 (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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No