Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCT06291831 | Registry Identifier | ClinicalTrials.gov |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to collect information on the:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID) | Adult COVID-19 patients' Healthcare Resource Utilization (HRU) within the 30-day period following nirmatrelvir, ritonavir prescription. |
| |
| Controls | Adults COVID-19 patient HRU within 30 days period following nirmatrelvir/ritonavir prescription |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nirmatrelvir, ritonavir | Drug | Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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.
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Gulf FZ | Busaiteen | Bahrain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41051660 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Available retrospective data was evaluated per objectives of this study in 2 months of this study (study start date: 13-Mar-2024 to study completion date: 14-May-2024).
Data of eligible participants diagnosed with corona virus disease 2019 (COVID-19) in the Kingdom of Bahrain who were offered Paxlovid (nirmatrelvir, ritonavir) treatment between 16 February 2022 to 30 November 2022 (9.5 months) was included in this retrospective observational study. Data was retrieved from Kingdom of Bahrain national health information system [(I-Seha electronic health records (EHR)].
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treated With Paxlovid | Participants who were diagnosed with COVID-19 and accepted offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment in real world setting. No intervention was administered under this study. |
| FG001 | Not Treated With Paxlovid | Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treated With Paxlovid | Participants who were diagnosed with COVID-19 and accepted offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment in real world setting. No intervention was administered under this study. |
| BG001 | Not Treated With Paxlovid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Baseline; from available retrospective data evaluated during 2 months of this study |
|
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
Adverse events were passively reported only for those participants who were treated with Paxlovid. Adverse events were not monitored or assessed for participants not treated with Paxlovid. Adverse events were reported as per records from I-Seha EHR. There was no specific medical dictionary.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treated With Paxlovid | Eligible participants who had COVID-19 and were treated with nirmatrelvir, ritonavir treatment (PAXLOVIDTM). Their data was studied retrospectively in this study. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impaired sense of taste / Bitterness | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2023 | Apr 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2023 | Apr 7, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Controls | Other | Patients who do not receive Nirmatrevir/ritonavir (Paxlovid) |
|
| 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 |
| 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 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 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 |
Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Not Treated With Paxlovid | Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group. |
|
| Primary | 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. | 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. | Posted | Baseline; from available retrospective data evaluated during 2 months of this study |
|
|
| Primary | 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. | 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. | Posted | Baseline; from available retrospective data evaluated during 2 months of this study |
|
|
| Primary | 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. | 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. | Posted | Baseline; from available retrospective data evaluated during 2 months of this study |
|
|
| Primary | 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. | Analysis population included all eligible participants whose data were included and observed in this study. BMI was extracted from records and method how it was collected originally was not known. | Posted | Median | Inter-Quartile Range | Kilogram over meter square (Kg/m^2) | Baseline; from available retrospective data evaluated during 2 months of this study |
|
|
|
| Primary | 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. | I-Seha EHR was used to retrieve the data in this study for evaluation of its objectives. Smoking 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. | Posted | Baseline; from available retrospective data evaluated during 2 months of this study |
|
|
| Primary | 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. | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | Baseline; from available retrospective data evaluated during 2 months of this study |
|
|
|
| Primary | 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. | I-Seha EHR was used to retrieve the data in this study for evaluation of its objectives. Concomitant medications for pre-existing comorbidities 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. | Posted | Baseline; from available retrospective data evaluated during 2 months of this study |
|
|
| Primary | Number of Participants Who Used Antibiotics | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study |
|
|
|
| Secondary | Number of Participants With Hospitalization for Any Cause | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study |
|
|
|
| Secondary | Number of Participants With Intensive Care Unit (ICU) Admission for Any Cause | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study |
|
|
|
| Secondary | Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause | Analysis population included all eligible participants whose data were included and observed in this study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study |
|
|
|
| Secondary | Number of Participants With Yes/no Questionnaire on Outpatient Visits | I-Seha EHR was used to retrieve the data in this study for evaluation of its objectives. Participants with yes/no questionnaire on outpatient visits 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. | Posted | Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study |
|
|
| Secondary | Number of Participants With Emergency Room (ER) Visits for Any Cause | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study |
|
|
|
| Secondary | Number of Participants With Supplemental Oxygen Usage | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study |
|
|
|
| Secondary | Number of Participants With Vasopressor Use | I-Seha EHR was used to retrieve the data in this study for evaluation of its objectives. Participants with vasopressor use 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. | Posted | Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study |
|
|
| Secondary | Number of Participants Who Used Invasive Mechanical Ventilation (IMV) | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study |
|
|
|
| 0 |
| 2,005 |
| 0 |
| 2,005 |
| 1,427 |
| 2,005 |
| EG001 | Not Treated With Paxlovid | Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group. | 0 | 1,006 | 0 | 0 | 0 | 0 |
| Impaired sense of smell | General disorders | Non-systematic Assessment |
|
| Stomach/Abdominal pain | General disorders | Non-systematic Assessment |
|
| Diarrhea | General disorders | Non-systematic Assessment |
|
| Nausea/Vomiting | General disorders | Non-systematic Assessment |
|
| Muscle aches | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Cough | General disorders | Non-systematic Assessment |
|
| Tiredness/Fatigue | General disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Itching | General disorders | Non-systematic Assessment |
|
| Leg | General disorders | Non-systematic Assessment |
|
| Skin rash | General disorders | Non-systematic Assessment |
|
| Loss of appetite | General disorders | Non-systematic Assessment |
|
| Chest Pain/Heaviness | General disorders | Non-systematic Assessment |
|
| Neck/Back Pain | General disorders | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Missing |
|