COVID-19
Conditions
Keywords
COVID-19 patients, Paxlovid use, Bahrain
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.
Interventions
Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)
OTHERControls
Patients who do not receive Nirmatrevir/ritonavir (Paxlovid)
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
Secondary
| Measure | 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 | 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 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 |
| 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 |
Countries
Bahrain
Participant flow
Recruitment details
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 \[(I-Seha electronic health records (EHR)\].
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2,005 |
| 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. | 1,006 |
| Total | 3,011 |
Baseline characteristics
| Characteristic | Treated With Paxlovid | Not Treated With Paxlovid | Total |
|---|---|---|---|
| Age, Customized Age 12-17 Years | 2 Participants | 0 Participants | 2 Participants |
| Age, Customized Age 18-29 Years | 457 Participants | 204 Participants | 661 Participants |
| Age, Customized Age 30-49 Years | 453 Participants | 208 Participants | 661 Participants |
| Age, Customized Age 50-64 Years | 485 Participants | 201 Participants | 686 Participants |
| Age, Customized Age 65-74 Years | 459 Participants | 189 Participants | 648 Participants |
| Age, Customized Age Greater than equal to 75 Years | 149 Participants | 204 Participants | 353 Participants |
| Race/Ethnicity, Customized Ethnicity Arab | 1,668 Participants | 916 Participants | 2584 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 291 Participants | 79 Participants | 370 Participants |
| Race/Ethnicity, Customized Ethnicity Black/African/Caribbean | 8 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized Ethnicity Mixed/Multiple Ethnic Groups | 16 Participants | 3 Participants | 19 Participants |
| Race/Ethnicity, Customized Ethnicity Persian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity White | 21 Participants | 5 Participants | 26 Participants |
| Sex: Female, Male Female | 1,005 Participants | 489 Participants | 1494 Participants |
| Sex: Female, Male Male | 1000 Participants | 517 Participants | 1517 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,005 | 0 / 1,006 |
| other Total, other adverse events | 1,427 / 2,005 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2,005 | 0 / 0 |
Outcome results
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.
Time frame: Baseline; from available retrospective data evaluated during 2 months of this study
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treated With Paxlovid | Body Mass Index (BMI) | 29 Kilogram over meter square (Kg/m^2) |
| Not Treated With Paxlovid | Body Mass Index (BMI) | 29 Kilogram over meter square (Kg/m^2) |
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.
Time frame: Baseline; from available retrospective data evaluated during 2 months of this study
Population: 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
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.
Time frame: Baseline; from available retrospective data evaluated during 2 months of this study
Population: 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
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.
Time frame: Baseline; from available retrospective data evaluated during 2 months of this study
Population: 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
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.
Time frame: Baseline; from available retrospective data evaluated during 2 months of this study
Population: 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.
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.
Time frame: Baseline; from available retrospective data evaluated during 2 months of this study
Population: 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.
Primary
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
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated With Paxlovid | Number of Participants Who Used Antibiotics | For any cause | 530 Participants |
| Treated With Paxlovid | Number of Participants Who Used Antibiotics | For COVID-19 | 118 Participants |
| Not Treated With Paxlovid | Number of Participants Who Used Antibiotics | For any cause | 320 Participants |
| Not Treated With Paxlovid | Number of Participants Who Used Antibiotics | For COVID-19 | 103 Participants |
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.
Time frame: Baseline; from available retrospective data evaluated during 2 months of this study
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated With Paxlovid | Number of Participants With at Least 1 Pre-existing Comorbidities | 1709 Participants |
| Not Treated With Paxlovid | Number of Participants With at Least 1 Pre-existing Comorbidities | 920 Participants |
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.
Time frame: Baseline; from available retrospective data evaluated during 2 months of this study
Population: 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.
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated With Paxlovid | Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause | 6 Days | 1 Participants |
| Treated With Paxlovid | Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause | 3 Days | 0 Participants |
| Treated With Paxlovid | Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause | Missing | 2 Participants |
| Not Treated With Paxlovid | Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause | 3 Days | 1 Participants |
| Not Treated With Paxlovid | Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause | 6 Days | 0 Participants |
| Not Treated With Paxlovid | Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause | Missing | 0 Participants |
Secondary
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
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated With Paxlovid | Number of Participants Who Used Invasive Mechanical Ventilation (IMV) | 0 Participants |
| Not Treated With Paxlovid | Number of Participants Who Used Invasive Mechanical Ventilation (IMV) | 1 Participants |
Secondary
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
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated With Paxlovid | Number of Participants With Emergency Room (ER) Visits for Any Cause | 298 Participants |
| Not Treated With Paxlovid | Number of Participants With Emergency Room (ER) Visits for Any Cause | 155 Participants |
Secondary
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
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated With Paxlovid | Number of Participants With Hospitalization for Any Cause | 137 Participants |
| Not Treated With Paxlovid | Number of Participants With Hospitalization for Any Cause | 123 Participants |
Secondary
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
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated With Paxlovid | Number of Participants With Intensive Care Unit (ICU) Admission for Any Cause | 3 Participants |
| Not Treated With Paxlovid | Number of Participants With Intensive Care Unit (ICU) Admission for Any Cause | 1 Participants |
Secondary
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
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated With Paxlovid | Number of Participants With Supplemental Oxygen Usage | 21 Participants |
| Not Treated With Paxlovid | Number of Participants With Supplemental Oxygen Usage | 11 Participants |
Secondary
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
Population: 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.
Secondary
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
Population: 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.