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

Pfizer

Status: Completed

Conditions: COVID-19

Treatments: Other: Controls; Drug: nirmatrelvir, ritonavir

Study type: Observational

Funder types: Industry

Identifiers

NCT06291831

C4671050

NCT06291831 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 3,011 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,011 participants in 2 patient groups

Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

Description:

Adult COVID-19 patients' Healthcare Resource Utilization (HRU) within the 30-day period following nirmatrelvir, ritonavir prescription.

Treatment:

Drug: nirmatrelvir, ritonavir

Controls

Description:

Adults COVID-19 patient HRU within 30 days period following nirmatrelvir/ritonavir prescription

Treatment:

Other: Controls