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

NCT06291831 | Completed Results

• 2 other identifiers: C4671050NCT06291831
• Study Type: observational
• Target: 3,011
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19 patients; Paxlovid use; Bahrain

Outcome Measures

Primary Outcomes (9)

• Number of Participants Classified Based on Education

  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.

  Baseline; from available retrospective data evaluated during 2 months of this study

• Number of Participants Classified Based on Employment Status

  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.

  Baseline; from available retrospective data evaluated during 2 months of this study

• Height

  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.

  Baseline; from available retrospective data evaluated during 2 months of this study

• Weight

  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.

  Baseline; from available retrospective data evaluated during 2 months of this study

• Body Mass Index (BMI)

  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.

  Baseline; from available retrospective data evaluated during 2 months of this study

• Number of Participants Classified Based on Smoking Status

  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.

  Baseline; from available retrospective data evaluated during 2 months of this study

• Number of Participants With at Least 1 Pre-existing Comorbidities

  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.

  Baseline; from available retrospective data evaluated during 2 months of this study

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

  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.

  Baseline; from available retrospective data evaluated during 2 months of this study

• 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 Outcomes (8)

• 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

Study Arms (2)

Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

Adult COVID-19 patients' Healthcare Resource Utilization (HRU) within the 30-day period following nirmatrelvir, ritonavir prescription.

Drug: nirmatrelvir, ritonavir

Controls

Adults COVID-19 patient HRU within 30 days period following nirmatrelvir/ritonavir prescription

Other: Controls

Interventions

nirmatrelvir, ritonavir DRUG

Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

Controls OTHER

Patients who do not receive Nirmatrevir/ritonavir (Paxlovid)

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Gulf FZ

Busaiteen, Bahrain

Location

Related Publications (1)

• 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 Dec;11(4):645-659. doi: 10.1007/s41030-025-00316-z. Epub 2025 Oct 6.

  PMID: 41051660 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19

Interventions

nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 4, 2024
• Study Start: March 13, 2024
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)