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

Completed

Conditions: COVID-19

Interventions: Other: Controls
Drug: nirmatrelvir, ritonavir

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: 3011

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.

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
Number of Participants Classified Based on Education	Baseline; from available retrospective data evaluated during 2 months of this study	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Number of Participants Classified Based on Employment Status	Baseline; from available retrospective data evaluated during 2 months of this study	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Height	Baseline; from available retrospective data evaluated during 2 months of this study	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Weight	Baseline; from available retrospective data evaluated during 2 months of this study	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Body Mass Index (BMI)	Baseline; from available retrospective data evaluated during 2 months of this study	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Number of Participants Classified Based on Smoking Status	Baseline; from available retrospective data evaluated during 2 months of this study	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Number of Participants With at Least 1 Pre-existing Comorbidities	Baseline; from available retrospective data evaluated during 2 months of this study	Pre-existing comorbidities included: asthma, emphysema, chronic obstructive pulmonary disease (COPD), hypertension, diabetes, obesity, cerebrovascular disease, neurological disease, chronic kidney disease, chronic liver disease, malignancy. Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Number of Participants Who Took at Least 1 Concomitant Medications for Pre-existing Comorbidities	Baseline; from available retrospective data evaluated during 2 months of this study	Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Number of Participants Who Used Antibiotics	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Vasopressor Use	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants With Hospitalization for Any Cause	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants With Intensive Care Unit (ICU) Admission for Any Cause	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants With Yes/no Questionnaire on Outpatient Visits	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants With Emergency Room (ER) Visits for Any Cause	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants With Supplemental Oxygen Usage	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants Who Used Invasive Mechanical Ventilation (IMV)	Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study