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
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View full resultsBasic Information
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COMPLETED
3011 participants
OBSERVATIONAL
2024-03-13
2024-05-14
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
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
Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)
Controls
Adults COVID-19 patient HRU within 30 days period following nirmatrelvir/ritonavir prescription
Controls
Patients who do not receive Nirmatrevir/ritonavir (Paxlovid)
Interventions
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nirmatrelvir, ritonavir
Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)
Controls
Patients who do not receive Nirmatrevir/ritonavir (Paxlovid)
Eligibility Criteria
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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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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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
Countries
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
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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