A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain.
- Registration Number
- NCT06291831
- Lead Sponsor
- Pfizer
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3000
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
There are no exclusion criteria for this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Controls Controls Adults COVID-19 patient HRU within 30 days period following nirmatrelvir/ritonavir prescription Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID) nirmatrelvir, ritonavir Adult COVID-19 patients' Healthcare Resource Utilization (HRU) within the 30-day period following nirmatrelvir, ritonavir prescription.
- Primary Outcome Measures
Name Time Method Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Pre-existing Comorbidities Baseline Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Concomitant medications for comorbidities at index date Baseline Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Medications used to treat COVID-19 Baseline Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Gender Baseline Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Height Baseline Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Smoking status Baseline Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Age Baseline Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Ethnicity Baseline Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Education Baseline Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Weight Baseline Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Body Mass Index (BMI) Baseline Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Employment status Baseline
- Secondary Outcome Measures
Name Time Method Assessment of all Participants HRU: Inpatient setting Within the 30-day period following nirmatrelvir, ritonavir prescription (During index period between 16 Feb 2022 and 30 Nov 2022) Days hospitalized, days in Intensive care unit (ICU) admission and length of stay.
Assessment of all Participants HRU Within the 30-day period following nirmatrelvir, ritonavir prescription (During index period between 16 Feb 2022 and 30 Nov 2022) Yes/no questionnaire on outpatient visits, ER visits, supplemental oxygen use, vasopressor use, patient intubation.
Trial Locations
- Locations (1)
Pfizer Gulf FZ
🇧đź‡Busaiteen, Bahrain