Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT06016556
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2023-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719967', 'term': 'nirmatrelvir and ritonavir drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Index date up to 30 days post index date (maximum up to 15 months); data was retrospectively evaluated over approximately 6 months of this study', 'description': "Analysis population included all eligible participants whose data were included and observed in this study. AEs were reported as per participants' medical records. There was no specific medical dictionary.", 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.', 'otherNumAtRisk': 248, 'deathsNumAtRisk': 248, 'otherNumAffected': 0, 'seriousNumAtRisk': 248, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Drug-Drug Interaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Education Level at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'title': 'No formal education', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Primary school', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Secondary school', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Undergraduate university degree', 'measurements': [{'value': '85', 'groupId': 'OG000'}]}, {'title': "Master's degree", 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'PhD or doctorate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': "Education level classification: no formal education, primary school, secondary school, undergraduate university degree, master's degree and Doctor of Philosophy (PhD) or doctorate. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Employment Status at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'title': 'Full-time employment', 'measurements': [{'value': '41', 'groupId': 'OG000'}]}, {'title': 'Part-time employment', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Homemaker', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Retired', 'measurements': [{'value': '42', 'groupId': 'OG000'}]}, {'title': 'Student', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Disabled/too ill to work', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Unemployed', 'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Employment status classification: full-time employment, part-time employment, homemaker, retired, student, disabled/too ill to work, and unemployed. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Height at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.62', 'spread': '0.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies number of participants who had non-missing values and were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Weight at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.13', 'spread': '18.81', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies number of participants who had non-missing values and evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Body Mass Index (BMI) at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.25', 'spread': '6.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'BMI was calculated based on the reported weight and height in the unit of kilograms over squared meters (kg/m\\^2). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies number of participants who had non-missing values and evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Smoking Status at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'title': 'Current smoker', 'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '0.10'}]}, {'title': 'Former smoker', 'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '0.10'}]}, {'title': 'Never smoker', 'measurements': [{'value': '207', 'groupId': 'OG000', 'lowerLimit': '0.10'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Smoking status classification: current smoker, former smoker and never smoker. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had at Least 1 Pre-existing Comorbidity at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had at Least 1 Concomitant Medication for Comorbidities at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With COVID-19 Infection During the Last 6 Months Prior to Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 6 months prior to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Duration Between Last COVID-19 Infection and Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.34', 'spread': '2.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 6 months prior to index date up to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Duration (in months) between COVID-19 infection in last 6 months prior to index date and index date was reported in this outcome measure. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had Previously Received at Least 1 Dose of Any COVID-19 Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000', 'lowerLimit': '2.06'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'title': 'Protein-Serum Institute of India', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '2.06'}]}]}, {'title': 'RNA-Moderna', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'RNA-Pfizer/BioNTech', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}]}]}, {'title': 'Viral Vector-Oxford/AstraZeneca', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'One participant could have received more than one type of vaccine. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Duration Between Previous COVID-19 Vaccination Date and Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.16', 'spread': '8.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of first COVID-19 vaccination to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Duration (in months) between vaccination date and index date was calculated as (index date - date of first covid-19 vaccination date)/30.42. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '84', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Dose of Nirmatrelvir/Ritonavir Received at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'title': '300 mg (2*150)/100 mg', 'measurements': [{'value': '229', 'groupId': 'OG000'}]}, {'title': 'Other (150 mg/100 mg)', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Classification: 1) Nirmatrelvir at a dose of 300 milligrams (mg), as 2 split doses of 150 mg and Ritonavir at a dose of 100 mg; 2) Other: Nirmatrelvir at a dose of 150 mg, and Ritonavir at a dose of 100 mg. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Frequency of Dosing of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'title': 'Twice a day', 'measurements': [{'value': '245', 'groupId': 'OG000'}]}, {'title': 'Once', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Once a day on Day 1, then 150mg/100mg once daily on Days 2-5', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Classification: 1) Nirmatrelvir at a dose of 300 mg, as 2 split doses of 150 mg and Ritonavir at a dose of 100 mg; 2) Other: Nirmatrelvir at a dose of 150 mg, and Ritonavir at a dose of 100 mg. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Dispensed Type of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'title': 'Box', 'measurements': [{'value': '236', 'groupId': 'OG000'}]}, {'title': 'Tablets', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Blister', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Classification of dispensed type: blister, box, tablets. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'title': 'Antibiotic: Ceftriaxone', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Antibiotic: Azithromycin', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Antibiotic: Cefepime', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Antibiotic: Vancomycin', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Antibiotic: Meropenem', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Antibiotic: Ceftazidime', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Antibiotic: Amoxicillin', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Antibiotic: Ciprofloxacin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Antibiotic: Doxycycline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Antibiotic: Levofloxacin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Antibiotic: Piperacillin/Tazobactam', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Antiviral: Remdesivir', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Antiviral: Acyclovir', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Antiviral: Oseltamivir', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Steroid: Dexamethasone', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Steroid: Hydrocortisone', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Steroid: Methylprednisolone Sodium Succinate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Steroid: Prednisolone/ Prednisone', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Steroid: Seretide', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Monoclonal antibody: Tocilizumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Antipyretics: Acetaminophen', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Antifungals: Noxafil', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Antifungals: Fluconazole', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other medications: Esomeprazole', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Other medications: Azathioprine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Other medications: Cyclosporin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other medications: Omeprazole', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Number of participants classified according to medications (apart from Nirmatrelvir/Ritonavir \\[PAXLOVIDTM\\]) used to treat COVID-19 infection at index date were reported in this outcome measure. A participant may receive more than one medication to treat COVID-19 infection. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Were Hospitalized at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM) while they were hospitalized (related or non-related to COVID-19). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Were Hospitalized Due to COVID-19 at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM) while they were hospitalized (related to COVID-19). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Length of Hospitalization Stay Due to COVID-19 at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.64', 'spread': '6.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day of hospitalization till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Length of hospitalization stay was measured in days from day of hospitalization (related to COVID-19) till index date. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Intensive Care Unit (ICU) Admission at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '6.69'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were admitted to ICU while they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Length of ICU Stay Due to COVID-19 at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.83', 'spread': '11.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day of ICU admission till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Length of ICU stay was measured in days from day of ICU admission till index date. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Were on Supplemental Oxygen Use at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '6.69'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were on supplemental oxygen use when they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Were on Vasopressor Use at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '6.69'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were on vasopressor use when they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Intubation at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '6.69'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were intubated when they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Outpatient Visits at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '6.69'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had Emergency Room (ER) Visits Due to COVID-19 at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000', 'lowerLimit': '6.69'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Hospitalized During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '6.69'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Hospitalized Due to COVID-19 During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '6.69'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Length of Hospitalization Stay Due to COVID-19 During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.00', 'spread': '26.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With ICU Admission During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '26.87'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Length of ICU Stay Due to COVID-19 During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.00', 'spread': '7.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were on Supplemental Oxygen Use During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '7.07'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were on Vasopressor Use During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '7.07'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Intubation During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '7.07'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study. Here, "Overall Number of Participants Analyzed" signifies those number of participants who had non-missing values and were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Outpatient Visits During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000', 'lowerLimit': '7.07'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had ER Visits Due to COVID-19 During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '7.07'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Classified According to COVID-19 Polymerase Chain Reaction (PCR) and Antigen Test Results During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'title': 'Antigen-Negative', 'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '7.07'}]}, {'title': 'Antigen-Positive', 'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '7.07'}]}, {'title': 'PCR-Negative', 'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '7.07'}]}, {'title': 'PCR-Positive', 'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '7.07'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Time to Negative COVID-19 Test During the 30-day Post-Index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.09', 'spread': '11.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period). Time to negative COVID-19 test was assessed from index date till participant tested negative for COVID-19 during 30 days post index period.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Eligible participants who were prescribed nirmatrelvir, ritonavir (PAXLOVIDTM) in the Kingdom of Saudi Arabia (KSA) any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period) for corona virus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus (SARSCoV-2)- their data was included in this retrospective observational study.', 'preAssignmentDetails': 'Data was extracted from medical records of the participants and data was evaluated per objectives of this study in approximately 6 months of this study (study start date: 17-Oct-2023 to study completion date: 09-Apr-2024).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Eligible participants who had COVID-19 and were prescribed nirmatrelvir, ritonavir treatment (PAXLOVIDTM) in KSA- their data was studied retrospectively as per objectives of this study. No intervention was administered to the participants under this study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.85', 'spread': '18.73', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Arab', 'measurements': [{'value': '247', 'groupId': 'BG000'}]}, {'title': 'Asian/Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-17', 'size': 493390, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-07T12:43', 'hasProtocol': True}, {'date': '2024-09-16', 'size': 1721605, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-07T12:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2023-08-25', 'resultsFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2023-08-25', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-09', 'studyFirstPostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Classified According to Education Level at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': "Education level classification: no formal education, primary school, secondary school, undergraduate university degree, master's degree and Doctor of Philosophy (PhD) or doctorate. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period)."}, {'measure': 'Number of Participants Classified According to Employment Status at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Employment status classification: full-time employment, part-time employment, homemaker, retired, student, disabled/too ill to work, and unemployed. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Height at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Weight at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Body Mass Index (BMI) at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'BMI was calculated based on the reported weight and height in the unit of kilograms over squared meters (kg/m\\^2). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Classified According to Smoking Status at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Smoking status classification: current smoker, former smoker and never smoker. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Had at Least 1 Pre-existing Comorbidity at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Had at Least 1 Concomitant Medication for Comorbidities at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants With COVID-19 Infection During the Last 6 Months Prior to Index Date', 'timeFrame': 'During 6 months prior to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Duration Between Last COVID-19 Infection and Index Date', 'timeFrame': 'From 6 months prior to index date up to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Duration (in months) between COVID-19 infection in last 6 months prior to index date and index date was reported in this outcome measure. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Had Previously Received at Least 1 Dose of Any COVID-19 Vaccine', 'timeFrame': 'Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously', 'timeFrame': 'Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'One participant could have received more than one type of vaccine. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Duration Between Previous COVID-19 Vaccination Date and Index Date', 'timeFrame': 'From date of first COVID-19 vaccination to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Duration (in months) between vaccination date and index date was calculated as (index date - date of first covid-19 vaccination date)/30.42. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken', 'timeFrame': 'Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Classified According to Dose of Nirmatrelvir/Ritonavir Received at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Classification: 1) Nirmatrelvir at a dose of 300 milligrams (mg), as 2 split doses of 150 mg and Ritonavir at a dose of 100 mg; 2) Other: Nirmatrelvir at a dose of 150 mg, and Ritonavir at a dose of 100 mg. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Classified According to Frequency of Dosing of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Classification: 1) Nirmatrelvir at a dose of 300 mg, as 2 split doses of 150 mg and Ritonavir at a dose of 100 mg; 2) Other: Nirmatrelvir at a dose of 150 mg, and Ritonavir at a dose of 100 mg. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Classified According to Dispensed Type of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Classification of dispensed type: blister, box, tablets. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Number of participants classified according to medications (apart from Nirmatrelvir/Ritonavir \\[PAXLOVIDTM\\]) used to treat COVID-19 infection at index date were reported in this outcome measure. A participant may receive more than one medication to treat COVID-19 infection. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Were Hospitalized at Index Date', 'timeFrame': 'Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM) while they were hospitalized (related or non-related to COVID-19). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Were Hospitalized Due to COVID-19 at Index Date', 'timeFrame': 'Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM) while they were hospitalized (related to COVID-19). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Length of Hospitalization Stay Due to COVID-19 at Index Date', 'timeFrame': 'From day of hospitalization till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Length of hospitalization stay was measured in days from day of hospitalization (related to COVID-19) till index date. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants With Intensive Care Unit (ICU) Admission at Index Date', 'timeFrame': 'Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were admitted to ICU while they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Length of ICU Stay Due to COVID-19 at Index Date', 'timeFrame': 'From day of ICU admission till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Length of ICU stay was measured in days from day of ICU admission till index date. Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Were on Supplemental Oxygen Use at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were on supplemental oxygen use when they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Were on Vasopressor Use at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were on vasopressor use when they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants With Intubation at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'In this outcome measure those number of participants are reported who were intubated when they were prescribed Nirmatrelvir/Ritonavir (PAXLOVIDTM). Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants With Outpatient Visits at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Had Emergency Room (ER) Visits Due to COVID-19 at Index Date', 'timeFrame': 'At index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Were Hospitalized During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Were Hospitalized Due to COVID-19 During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Length of Hospitalization Stay Due to COVID-19 During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants With ICU Admission During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Length of ICU Stay Due to COVID-19 During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Were on Supplemental Oxygen Use During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Were on Vasopressor Use During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants With Intubation During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Had Outpatient Visits During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Who Had ER Visits Due to COVID-19 During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Number of Participants Classified According to COVID-19 Polymerase Chain Reaction (PCR) and Antigen Test Results During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period).'}, {'measure': 'Time to Negative COVID-19 Test During the 30-day Post-Index Period', 'timeFrame': '30-day post index date; retrospective data was evaluated during approximately 6 months of this study', 'description': 'Index date was defined as the date of nirmatrelvir, ritonavir (PAXLOVIDTM) treatment prescription, which could be any day between 1-Apr-2022 to 30-Jun-2023 (15-month look back period). Time to negative COVID-19 test was assessed from index date till participant tested negative for COVID-19 during 30 days post index period.'}]}, 'conditionsModule': {'keywords': ['Paxlovid', 'Saudi Arabia'], 'conditions': ['Covid-19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4671054', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe the baseline demographic, clinical characteristics, and Healthcare Resource Use (HCRU) of adult (≥18 years) COVID-19 patients who have been prescribed nirmatrelvir, ritonavir treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study will involve collection of pre-defined, structured data retrospectively from medical records (electronic and/or paper if necessary) of patients who meet the study eligibility criteria and who have been prescribed nirmatrelvir, ritonavir treatment within a 15-month lookback period from the date of site initiation (Cohort 1). The lookback period will span from 01 April 2022 to 30 June 2023. Data abstracted from patients' medical records will include patient demographics and clinical characteristics at index date (defined as the date of nirmatrelvir, ritonavir treatment prescribing), in addition to patients' HCRU during the 30-day period post-index date.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed COVID-19 infection during the study observation period\n* Nirmatrelvir, ritonavir written prescription\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06016556', 'briefTitle': 'A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics and Healthcare Resource Use (HCRU) Among COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir (PAXLOVID TM) in the Kingdom of Saudi Arabia (KSA).', 'orgStudyIdInfo': {'id': 'C4671054'}, 'secondaryIdInfos': [{'id': 'NCT06016556', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)', 'description': "Adult COVID-19 patients' HCRU within the 30-day period following nirmatrelvir, ritonavir prescription.", 'interventionNames': ['Drug: nirmatrelvir, ritonavir']}], 'interventions': [{'name': 'nirmatrelvir, ritonavir', 'type': 'DRUG', 'otherNames': ['Paxlovid'], 'description': 'single cohort', 'armGroupLabels': ['Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21499', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital & research center - Jeddah', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '11426', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Abdulaziz Medical City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital and Research Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}