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

An observational study of COVID-19, run by Pfizer at 1 site in Bahrain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: nirmatrelvir, ritonavir
How many people: 3,011 participants
Where: 1 siteBahrain
Study dates: 13 Mar 2024to 14 May 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

There are no exclusion criteria for this study.

Trial locations and contacts

1 site in 1 country.

Bahrain1 site

Pfizer Gulf FZ
Busaiteen

Other trials in Bahrain

About this study

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.

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
Being tested: nirmatrelvir, ritonavir, Controls
Keywords: COVID-19 patients, Paxlovid use, Bahrain
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nirmatrelvir, ritonavirDrug
Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)
ControlsOther
Patients who do not receive Nirmatrevir/ritonavir (Paxlovid)

Study groups in NCT06291831
Study group	Role	What they receive
Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)		Adult COVID-19 patients' Healthcare Resource Utilization (HRU) within the 30-day period following nirmatrelvir, ritonavir prescription. Receives: Drug: nirmatrelvir, ritonavir
Controls		Adults COVID-19 patient HRU within 30 days period following nirmatrelvir/ritonavir prescription Receives: Other: Controls

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; from available retrospective data evaluated during 2 months of this study
Number of Participants Who Used Antibiotics
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
Number of Participants With Vasopressor Use
Measured: 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)
Measured: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 202414 May 2024

First posted4 Mar 2024
Study start13 Mar 2024
Primary completion14 May 2024
Study completion14 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 3,011 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06291831
Sponsor's protocol ID: C4671050
Other IDs: NCT06291831
Status last verified: Aug 2025
First submitted: 29 Feb 2024
Last updated: 19 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

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.
PubMed 41051660

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT06291831
Acronym / sponsor ID: C4671050
Conditions: COVID-19
Keywords: COVID-19 patients, Paxlovid use, Bahrain
Study type: Observational
Recruitment status: Completed
Enrolment: 3,011 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 13 Mar 2024 (actual)
Primary completion: 14 May 2024 (actual)
Study completion: 14 May 2024 (actual)
First posted: 4 Mar 2024 (actual)
Results: Posted 19 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)	–	Drug: nirmatrelvir, ritonavirAdult COVID-19 patients' Healthcare Resource Utilization (HRU) within the 30-day period following nirmatrelvir, ritonavir prescription.
Controls	–	Other: ControlsAdults COVID-19 patient HRU within 30 days period following nirmatrelvir/ritonavir prescription

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

There are no exclusion criteria for this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nirmatrelvir, ritonavirPatients receiving Nirmatrelvir; Ritonavir (PAXLOVID)	Drug	Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)
ControlsPatients who do not receive Nirmatrevir/ritonavir (Paxlovid)	Other	Controls

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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

8 secondary outcomes

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
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
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
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
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
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
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
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

Results and safety

Results posted to the registry on 19 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treated With Paxlovid	2,005	2,005
Not Treated With Paxlovid	1,006	1,006

Primary outcome: Number of Participants Classified Based on Education

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

Population analysed: I-Seha EHR was used to retrieve the data in this study for evaluation of its objectives. Education information required for this outcome measure was not available in I-Seha EHR. Hence, there was no data that could be analyzed for this outcome measure.

Primary outcome: Number of Participants Classified Based on Employment Status

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

Population analysed: I-Seha EHR was used to retrieve the data in this study for evaluation of its objectives. Employment status information required for this outcome measure was not available in I-Seha EHR. Hence, there was no data that could be analyzed for this outcome measure.

Primary outcome: Height

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

Population analysed: I-Seha EHR was used to retrieve the data in this study for evaluation of its objectives. Height information required for this outcome measure was not available in I-Seha EHR. Hence, there was no data that could be analyzed for this outcome measure.

Primary outcome: Weight

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

Population analysed: I-Seha EHR was used to retrieve the data in this study for evaluation of its objectives. Weight information required for this outcome measure was not available in I-Seha EHR. Hence, there was no data that could be analyzed for this outcome measure.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality for both the reporting groups: up to 24 months following COVID-19 diagnosis and adverse events only for "Treated with Paxlovid" group: at Day 5 post Paxlovid course completion; from available retrospective data evaluated during 2 months of this study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treated With Paxlovid	0 of 2,005 (0%)	1,427 of 2,005 (71.2%)	0 of 2,005
Not Treated With Paxlovid	0 of 0	0 of 0	0 of 1,006

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41051660Murad 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Pfizer at 1 site in Bahrain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bahrain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Classified Based on Education (time frame: Baseline; from available retrospective data evaluated during 2 months of this study). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06291831, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.