An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan

Study Overview
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Brief Summary
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This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan. All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.

Detailed Description
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This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan. All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.

Official Title
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An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Evusheld


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Immunocompromised patients who were administrated EVUSHELD as PrEP and have administration date of EVUSHELD patients aged ≥ 12 years at the index date Exclusion Criteria: Patients who have no medical visit records at any time in the 12 months preceding the index date
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 |
| --- | --- |
| Evusheld administered group<br> | Drug: Evusheld<br>* Administration of Evusheld 600 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics and clinical characteristics of patients received Evusheld as PrEP | Proportion of patients by age, gender, and clinical characteristics of interest (i.e. comorbidity, concurrent medication) between 360 days from the date of first administration of Evusheld (index date) to the index date will be described. | Up to 360 days before the date of first administration of Evusheld | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medically attended COVID-19 | Event rate and time to event for medically attended COVID-19 up to 180 days after the date of first administration of Evusheld will be described | Up to 180 days after the date of first administration of Evusheld | 
| COVID-19 hospitalization | Event rate and time to event for COVID-19 hospitalization up to 180 days after the date of first administration of Evusheld will be described | Up to 180 days after the date of first administration of Evusheld | 
| In-hospital mortality due to COVID-19 | Event rate and time to event for in-hospital mortality due to COVID-19 up to 180 days after the date of first administration of Evusheld will be described | Up to 180 days after the date of first administration of Evusheld | 
| All cause mortality | Event rate and time to event for all cause mortality up to 180 days after the date of first administration of Evusheld will be described | Up to 180 days after the date of first administration of Evusheld | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, PrEP