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Completed

NCT Number: NCT06291831

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Gulf FZ

Busaiteen, Bahrain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nirmatrelvir, ritonavir

Drug

Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

Controls

Other

Patients who do not receive Nirmatrevir/ritonavir (Paxlovid)

Primary outcomes

  1. Number of Participants Classified Based on Education

    Time frame: 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.

  2. Number of Participants Classified Based on Employment Status

    Time frame: 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.

  3. Height

    Time frame: 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.

  4. Weight

    Time frame: 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.

  5. Body Mass Index (BMI)

    Time frame: 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.

  6. Number of Participants Classified Based on Smoking Status

    Time frame: 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.

  7. Number of Participants With at Least 1 Pre-existing Comorbidities

    Time frame: 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.

  8. Number of Participants Who Took at Least 1 Concomitant Medications for Pre-existing Comorbidities

    Time frame: 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.

  9. Number of Participants Who Used Antibiotics

    Time frame: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

Secondary outcomes

  1. Number of Participants With Hospitalization for Any Cause

    Time frame: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

  2. Number of Participants With Intensive Care Unit (ICU) Admission for Any Cause

    Time frame: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

  3. Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause

    Time frame: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

  4. Number of Participants With Yes/no Questionnaire on Outpatient Visits

    Time frame: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

  5. Number of Participants With Emergency Room (ER) Visits for Any Cause

    Time frame: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

  6. Number of Participants With Supplemental Oxygen Usage

    Time frame: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

  7. Number of Participants With Vasopressor Use

    Time frame: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

  8. Number of Participants Who Used Invasive Mechanical Ventilation (IMV)

    Time frame: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2024
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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