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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06016556 | Registry Identifier | ClinicalTrials.gov |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID) | Adult COVID-19 patients' HCRU within the 30-day period following nirmatrelvir, ritonavir prescription. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nirmatrelvir, ritonavir | Drug | single cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Classified According to Education Level at Index Date | 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Classified According to Employment Status at Index Date | 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Height at 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Weight at 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Body Mass Index (BMI) at Index Date | 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 | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Hospitalized During the 30-day Post-Index Period | 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). | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal Specialist Hospital & research center - Jeddah | Jeddah | 21499 | Saudi Arabia | |||
| King Abdulaziz Medical City |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42156669 | Derived | Alraddadi BM, Almaghrabi RS, Bosaeed M, Kamal M, Hassanien A, Hammam H, Zanotti G, Ikizler BK, d'Hellencourt FL, Spinardi JR, Wang L, Kyaw MH. Patient Characteristics and Healthcare Resource Use among Patients With COVID-19 Receiving Treatment with Nirmatrelvir/Ritonavir (PAXLOVID) in the Kingdom of Saudi Arabia. Pulm Ther. 2026 May 19. doi: 10.1007/s41030-026-00360-3. Online ahead of print. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis population included all eligible participants whose data were included and observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Classified According to Education Level at Index Date | 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). | 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. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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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
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug-Drug Interaction | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 17, 2023 | Apr 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 16, 2024 | Apr 7, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
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| At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Classified According to Smoking Status at Index Date | 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Had at Least 1 Pre-existing Comorbidity at 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Had at Least 1 Concomitant Medication for Comorbidities at 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants With COVID-19 Infection During the Last 6 Months Prior to 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). | During 6 months prior to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
| Duration Between Last COVID-19 Infection and Index Date | 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). | 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 |
| Number of Participants Who Had Previously Received at Least 1 Dose of Any COVID-19 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). | Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously | 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). | Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
| Duration Between Previous COVID-19 Vaccination Date and Index Date | 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). | 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 |
| Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken | 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). | Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Classified According to Dose of Nirmatrelvir/Ritonavir Received at Index Date | 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Classified According to Frequency of Dosing of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date | 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Classified According to Dispensed Type of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date | 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date | 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Were Hospitalized at Index Date | 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). | Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Were Hospitalized Due to COVID-19 at Index Date | 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). | Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
| Length of Hospitalization Stay Due to COVID-19 at Index Date | 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). | From day of hospitalization till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants With Intensive Care Unit (ICU) Admission at Index Date | 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). | Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
| Length of ICU Stay Due to COVID-19 at Index Date | 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). | From day of ICU admission till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Were on Supplemental Oxygen Use at Index Date | 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Were on Vasopressor Use at Index Date | 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants With Intubation at Index Date | 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants With Outpatient Visits at 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Had Emergency Room (ER) Visits Due to COVID-19 at 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). | At index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Were Hospitalized Due to COVID-19 During the 30-day Post-Index Period | 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). | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
| Length of Hospitalization Stay Due to COVID-19 During the 30-day Post-Index Period | 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). | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants With ICU Admission During the 30-day Post-Index Period | 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). | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
| Length of ICU Stay Due to COVID-19 During the 30-day Post-Index Period | 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). | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Were on Supplemental Oxygen Use During the 30-day Post-Index Period | 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). | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Were on Vasopressor Use During the 30-day Post-Index Period | 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). | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants With Intubation During the 30-day Post-Index Period | 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). | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Had Outpatient Visits During the 30-day Post-Index Period | 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). | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Who Had ER Visits Due to COVID-19 During the 30-day Post-Index Period | 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). | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
| Number of Participants Classified According to COVID-19 Polymerase Chain Reaction (PCR) and Antigen Test Results During the 30-day Post-Index Period | 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). | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
| Time to Negative COVID-19 Test During the 30-day Post-Index Period | 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. | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
| Riyadh |
| 11426 |
| Saudi Arabia |
| King Faisal Specialist Hospital and Research Center | Riyadh | Saudi Arabia |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Primary | Number of Participants Classified According to Employment Status at Index Date | 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). | 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. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Height at 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). | 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. | Posted | Mean | Standard Deviation | Meters | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Weight at 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). | 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. | Posted | Mean | Standard Deviation | Kilograms | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Body Mass Index (BMI) at Index Date | 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). | 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. | Posted | Mean | Standard Deviation | Kg/m^2 | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants Classified According to Smoking Status at Index Date | 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). | 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. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants Who Had at Least 1 Pre-existing Comorbidity at 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants Who Had at Least 1 Concomitant Medication for Comorbidities at 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). | 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. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants With COVID-19 Infection During the Last 6 Months Prior to 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). | 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. | Posted | Count of Participants | Participants | During 6 months prior to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Duration Between Last COVID-19 Infection and Index Date | 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). | 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. | Posted | Mean | Standard Deviation | Months | 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 |
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| Primary | Number of Participants Who Had Previously Received at Least 1 Dose of Any COVID-19 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). | 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. | Posted | Count of Participants | Participants | Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously | 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). | 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. | Posted | Count of Participants | Participants | Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
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|
| Primary | Duration Between Previous COVID-19 Vaccination Date and Index Date | 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). | 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. | Posted | Mean | Standard Deviation | Months | 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 |
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| Primary | Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken | 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). | 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. | Posted | Count of Participants | Participants | Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
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|
| Primary | Number of Participants Classified According to Dose of Nirmatrelvir/Ritonavir Received at Index Date | 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants Classified According to Frequency of Dosing of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date | 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants Classified According to Dispensed Type of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date | 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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|
| Primary | Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date | 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). | 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. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants Who Were Hospitalized at Index Date | 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants Who Were Hospitalized Due to COVID-19 at Index Date | 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). | 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. | Posted | Count of Participants | Participants | Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Length of Hospitalization Stay Due to COVID-19 at Index Date | 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). | 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. | Posted | Mean | Standard Deviation | Days | From day of hospitalization till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants With Intensive Care Unit (ICU) Admission at Index Date | 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Length of ICU Stay Due to COVID-19 at Index Date | 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). | 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. | Posted | Mean | Standard Deviation | Days | From day of ICU admission till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants Who Were on Supplemental Oxygen Use at Index Date | 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants Who Were on Vasopressor Use at Index Date | 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). | 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. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants With Intubation at Index Date | 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). | 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. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants With Outpatient Visits at 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Primary | Number of Participants Who Had Emergency Room (ER) Visits Due to COVID-19 at 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). | 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. | Posted | Count of Participants | Participants | At index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Number of Participants Who Were Hospitalized During the 30-day Post-Index Period | 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Number of Participants Who Were Hospitalized Due to COVID-19 During the 30-day Post-Index Period | 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). | 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. | Posted | Count of Participants | Participants | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Length of Hospitalization Stay Due to COVID-19 During the 30-day Post-Index Period | 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). | 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. | Posted | Mean | Standard Deviation | Days | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Number of Participants With ICU Admission During the 30-day Post-Index Period | 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Length of ICU Stay Due to COVID-19 During the 30-day Post-Index Period | 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). | 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. | Posted | Mean | Standard Deviation | Days | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Number of Participants Who Were on Supplemental Oxygen Use During the 30-day Post-Index Period | 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Number of Participants Who Were on Vasopressor Use During the 30-day Post-Index Period | 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). | 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. | Posted | Count of Participants | Participants | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Number of Participants With Intubation During the 30-day Post-Index Period | 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). | 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. | Posted | Count of Participants | Participants | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Number of Participants Who Had Outpatient Visits During the 30-day Post-Index Period | 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Number of Participants Who Had ER Visits Due to COVID-19 During the 30-day Post-Index Period | 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). | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Number of Participants Classified According to COVID-19 Polymerase Chain Reaction (PCR) and Antigen Test Results During the 30-day Post-Index Period | 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). | 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. | Posted | Count of Participants | Participants | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
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| Secondary | Time to Negative COVID-19 Test During the 30-day Post-Index Period | 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. | 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. | Posted | Mean | Standard Deviation | Days | 30-day post index date; retrospective data was evaluated during approximately 6 months of this study |
|
|
|
| 0 |
| 248 |
| 2 |
| 248 |
| 0 |
| 248 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Retired |
|
| Student |
|
| Disabled/too ill to work |
|
| Unemployed |
|
| Title | Measurements |
|---|---|
|
| Viral Vector-Oxford/AstraZeneca |
|
| 4 |
|
| Title | Measurements |
|---|---|
|
| Antibiotic: Vancomycin |
|
| Antibiotic: Meropenem |
|
| Antibiotic: Ceftazidime |
|
| Antibiotic: Amoxicillin |
|
| Antibiotic: Ciprofloxacin |
|
| Antibiotic: Doxycycline |
|
| Antibiotic: Levofloxacin |
|
| Antibiotic: Piperacillin/Tazobactam |
|
| Antiviral: Remdesivir |
|
| Antiviral: Acyclovir |
|
| Antiviral: Oseltamivir |
|
| Steroid: Dexamethasone |
|
| Steroid: Hydrocortisone |
|
| Steroid: Methylprednisolone Sodium Succinate |
|
| Steroid: Prednisolone/ Prednisone |
|
| Steroid: Seretide |
|
| Monoclonal antibody: Tocilizumab |
|
| Antipyretics: Acetaminophen |
|
| Antifungals: Noxafil |
|
| Antifungals: Fluconazole |
|
| Other medications: Esomeprazole |
|
| Other medications: Azathioprine |
|
| Other medications: Cyclosporin |
|
| Other medications: Omeprazole |
|
| PCR-Positive |
|