Trial Outcomes & Findings for A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain. (NCT NCT06291831)
NCT ID: NCT06291831
Last Updated: 2025-08-19
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
3011 participants
Primary outcome timeframe
Baseline; from available retrospective data evaluated during 2 months of this study
Results posted on
2025-08-19
Participant Flow
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 \[(I-Seha electronic health records (EHR)\].
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
2005
|
1006
|
|
Overall Study
COMPLETED
|
2005
|
1006
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain.
Baseline characteristics by cohort
| Measure |
Treated With Paxlovid
n=2005 Participants
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.
|
Not Treated With Paxlovid
n=1006 Participants
Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group.
|
Total
n=3011 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 12-17 Years
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Customized
Age · 18-29 Years
|
457 Participants
n=93 Participants
|
204 Participants
n=4 Participants
|
661 Participants
n=27 Participants
|
|
Age, Customized
Age · 30-49 Years
|
453 Participants
n=93 Participants
|
208 Participants
n=4 Participants
|
661 Participants
n=27 Participants
|
|
Age, Customized
Age · 50-64 Years
|
485 Participants
n=93 Participants
|
201 Participants
n=4 Participants
|
686 Participants
n=27 Participants
|
|
Age, Customized
Age · 65-74 Years
|
459 Participants
n=93 Participants
|
189 Participants
n=4 Participants
|
648 Participants
n=27 Participants
|
|
Age, Customized
Age · Greater than equal to 75 Years
|
149 Participants
n=93 Participants
|
204 Participants
n=4 Participants
|
353 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
1,005 Participants
n=93 Participants
|
489 Participants
n=4 Participants
|
1494 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1000 Participants
n=93 Participants
|
517 Participants
n=4 Participants
|
1517 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Arab
|
1,668 Participants
n=93 Participants
|
916 Participants
n=4 Participants
|
2584 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
291 Participants
n=93 Participants
|
79 Participants
n=4 Participants
|
370 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black/African/Caribbean
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed/Multiple Ethnic Groups
|
16 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Persian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
21 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline; from available retrospective data evaluated during 2 months of this studyPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline; from available retrospective data evaluated during 2 months of this studyPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline; from available retrospective data evaluated during 2 months of this studyPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline; from available retrospective data evaluated during 2 months of this studyPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline; from available retrospective data evaluated during 2 months of this studyPopulation: 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.
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.
Outcome measures
| Measure |
Treated With Paxlovid
n=2005 Participants
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.
|
Not Treated With Paxlovid
n=1006 Participants
Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group.
|
|---|---|---|
|
Body Mass Index (BMI)
|
29 Kilogram over meter square (Kg/m^2)
Interval 25.0 to 33.0
|
29 Kilogram over meter square (Kg/m^2)
Interval 25.0 to 34.0
|
PRIMARY outcome
Timeframe: Baseline; from available retrospective data evaluated during 2 months of this studyPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline; from available retrospective data evaluated during 2 months of this studyPopulation: Analysis population included all eligible participants whose data were included and observed in 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.
Outcome measures
| Measure |
Treated With Paxlovid
n=2005 Participants
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.
|
Not Treated With Paxlovid
n=1006 Participants
Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group.
|
|---|---|---|
|
Number of Participants With at Least 1 Pre-existing Comorbidities
|
1709 Participants
|
920 Participants
|
PRIMARY outcome
Timeframe: Baseline; from available retrospective data evaluated during 2 months of this studyPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this studyPopulation: Analysis population included all eligible participants whose data were included and observed in this study.
Outcome measures
| Measure |
Treated With Paxlovid
n=2005 Participants
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.
|
Not Treated With Paxlovid
n=1006 Participants
Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group.
|
|---|---|---|
|
Number of Participants Who Used Antibiotics
For any cause
|
530 Participants
|
320 Participants
|
|
Number of Participants Who Used Antibiotics
For COVID-19
|
118 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this studyPopulation: Analysis population included all eligible participants whose data were included and observed in this study.
Outcome measures
| Measure |
Treated With Paxlovid
n=2005 Participants
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.
|
Not Treated With Paxlovid
n=1006 Participants
Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group.
|
|---|---|---|
|
Number of Participants With Hospitalization for Any Cause
|
137 Participants
|
123 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this studyPopulation: Analysis population included all eligible participants whose data were included and observed in this study.
Outcome measures
| Measure |
Treated With Paxlovid
n=2005 Participants
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.
|
Not Treated With Paxlovid
n=1006 Participants
Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group.
|
|---|---|---|
|
Number of Participants With Intensive Care Unit (ICU) Admission for Any Cause
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this studyPopulation: 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.
Outcome measures
| Measure |
Treated With Paxlovid
n=3 Participants
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.
|
Not Treated With Paxlovid
n=1 Participants
Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group.
|
|---|---|---|
|
Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause
3 Days
|
0 Participants
|
1 Participants
|
|
Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause
6 Days
|
1 Participants
|
0 Participants
|
|
Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause
Missing
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this studyPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this studyPopulation: Analysis population included all eligible participants whose data were included and observed in this study.
Outcome measures
| Measure |
Treated With Paxlovid
n=2005 Participants
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.
|
Not Treated With Paxlovid
n=1006 Participants
Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group.
|
|---|---|---|
|
Number of Participants With Emergency Room (ER) Visits for Any Cause
|
298 Participants
|
155 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this studyPopulation: Analysis population included all eligible participants whose data were included and observed in this study.
Outcome measures
| Measure |
Treated With Paxlovid
n=2005 Participants
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.
|
Not Treated With Paxlovid
n=1006 Participants
Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group.
|
|---|---|---|
|
Number of Participants With Supplemental Oxygen Usage
|
21 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this studyPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this studyPopulation: Analysis population included all eligible participants whose data were included and observed in this study.
Outcome measures
| Measure |
Treated With Paxlovid
n=2005 Participants
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.
|
Not Treated With Paxlovid
n=1006 Participants
Participants who were diagnosed with COVID-19 and declined offer for treatment with Paxlovid (nirmatrelvir, ritonavir) treatment. This reporting arm served as control group.
|
|---|---|---|
|
Number of Participants Who Used Invasive Mechanical Ventilation (IMV)
|
0 Participants
|
1 Participants
|
Adverse Events
Treated With Paxlovid
Serious events: 0 serious events
Other events: 1427 other events
Deaths: 0 deaths
Not Treated With Paxlovid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treated With Paxlovid
n=2005 participants at risk
Eligible participants who had COVID-19 and were treated with nirmatrelvir, ritonavir treatment (PAXLOVIDTM). Their data was studied retrospectively in this study.
|
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.
|
|---|---|---|
|
General disorders
Impaired sense of taste / Bitterness
|
60.5%
1214/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Impaired sense of smell
|
0.10%
2/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Stomach/Abdominal pain
|
2.3%
47/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Diarrhea
|
18.2%
365/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Nausea/Vomiting
|
2.2%
44/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Muscle aches
|
4.4%
88/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Headache
|
0.75%
15/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Cough
|
0.25%
5/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Tiredness/Fatigue
|
0.20%
4/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Dizziness
|
0.40%
8/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Itching
|
0.35%
7/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Leg
|
0.20%
4/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Skin rash
|
0.15%
3/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Loss of appetite
|
0.20%
4/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Chest Pain/Heaviness
|
0.20%
4/2005 • 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.
|
—
0/0 • 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.
|
|
General disorders
Neck/Back Pain
|
0.35%
7/2005 • 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.
|
—
0/0 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER