Clinical trial NCT06291831: A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19 patients
Paxlovid use
Bahrain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Age
timeFrame: Baseline
measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Gender
timeFrame: Baseline
measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Ethnicity
timeFrame: Baseline
measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Education
timeFrame: Baseline
measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Employment status
timeFrame: Baseline
measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Height
timeFrame: Baseline
measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Weight
timeFrame: Baseline
measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Body Mass Index (BMI)
timeFrame: Baseline
measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Smoking status
timeFrame: Baseline
measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Pre-existing Comorbidities
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: Baseline
Secondary outcomes:
measure: Assessment of all Participants HRU: Inpatient setting
timeFrame: Within the 30-day period following nirmatrelvir, ritonavir prescription (During index period between 16 Feb 2022 and 30 Nov 2022)
measure: Assessment of all Participants HRU
timeFrame: Within the 30-day period following nirmatrelvir, ritonavir prescription (During index period between 16 Feb 2022 and 30 Nov 2022)
Other outcomes:
Locations:
city: Busaiteen
country: Bahrain
facility: Pfizer Gulf FZ
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: