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

NCT ID: NCT06291831

Last Updated: 2025-08-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3011 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-13

Study Completion Date

2024-05-14

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

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

nirmatrelvir, ritonavir

Intervention Type DRUG

Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

Controls

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

Controls

Intervention Type OTHER

Patients who do not receive Nirmatrevir/ritonavir (Paxlovid)

Interventions

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nirmatrelvir, ritonavir

Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

Intervention Type DRUG

Controls

Patients who do not receive Nirmatrevir/ritonavir (Paxlovid)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Gulf FZ

Busaiteen, , Bahrain

Site Status

Countries

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Bahrain

References

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Murad MM, Atkin SL, Wasif PW, Behzad AA, Husain AMJA, d'Hellencourt FL, Joury J, Aziz MA, Haridy H, Spinardi J, Wang L, Boland F, Kyaw MH, Al-Qahtani M. A Retrospective Observational Study on COVID-19 Patients Receiving Treatment with Nirmatrelvir/Ritonavir (PAXLOVID). Pulm Ther. 2025 Oct 6. doi: 10.1007/s41030-025-00316-z. Online ahead of print.

Reference Type DERIVED
PMID: 41051660 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4671050

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Other Identifiers

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NCT06291831

Identifier Type: REGISTRY

Identifier Source: secondary_id

C4671050

Identifier Type: -

Identifier Source: org_study_id

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