A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Covid-19

Intervention / Treatment
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* Drug: nirmatrelvir, ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed COVID-19 infection during the study observation period Nirmatrelvir, ritonavir written prescription Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)<br>Adult COVID-19 patients' HCRU within the 30-day period following nirmatrelvir, ritonavir prescription. | Drug: nirmatrelvir, ritonavir<br>* single cohort<br>* Other names: Paxlovid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Age |  | Baseline | 
| Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Gender |  | Baseline | 
| Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Ethnicity |  | Baseline | 
| Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Education |  | Baseline | 
| Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Employment status |  | Baseline | 
| Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Height |  | Baseline | 
| Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Weight |  | Baseline | 
| Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Body Mass Index (BMI) |  | Baseline | 
| Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Smoking status |  | Baseline | 
| Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Pre-existing Comorbidities |  | Baseline | 
| Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Concomitant medications for comorbidities at index date |  | Baseline | 
| Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Medications used to treat COVID-19 |  | Baseline | 
| Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Previous COVID-19 infection during the last 6 months |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Participants HRU: Inpatient setting | Days hospitalized, days in Intensive care unit (ICU) admission and length of stay. | Within the 30-day period following nirmatrelvir, ritonavir prescription | 
| Assessment of Participants HRU | Yes/no questionnaire on outpatient visits, ER visits, supplemental oxygen use, vasopressor use, patient intubation. | Within the 30-day period following nirmatrelvir, ritonavir prescription | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paxlovid, Saudi Arabia