eVusheld Assessment reaL wORld Effectiveness in the VA Health System

Study Overview
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Brief Summary
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An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the Department of Veterans Affairs (VA) Health System.

Detailed Description
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This a Phase IV observational, secondary data study to assess the effectiveness of Evusheld in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system. The study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the VA Health System.

Official Title
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An Observational Study to Assess the Real-World Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations Receiving Care in VA Health System in the United States

Conditions
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SARS-CoV-2, COVID-19

Intervention / Treatment
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* Drug: Evusheld


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receipt of EVUSHELD under the FDA EUA for EVUSHELD Eligibility to access EVUSHELD use under the EUA. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 12 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 |
| --- | --- |
| EVUSHELD arm<br>Individuals given EVUSHELD for prophylaxis | Drug: Evusheld<br>* EVUSHELD users<br>|
| Concurrent Control arm<br>Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization due to COVID-19 | Hospital record of patient admission | up to 6 months | 
| All-cause mortality | All-cause deaths | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documented SARS-COV-2 infection | Any positive SARS-CoV-2 diagnostic test (eg, PCR, nucleic acid amplification, antigen) OR medical encounter resulting in a diagnosis code for COVID-19b OR medical encounter resulting in a code for isolation due to COVID-19 | up to 6 and 12 months | 
| Medically attended COVID-19 | COVID-19 or SARS-CoV-2 infection leading to consultation of a healthcare professional | up to 6 and 12 months | 
| COVID-19 hospitalisation | Hospitalisation due to COVID-19 | up to 12 months | 
| COVID-19 Intensive Care Unit (ICU) admisssion | ICU admission due to COVID-19 | up to 6 and 12 months | 
| COVID-19-related mortality | Death due to COVID-19 | up to 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Pre-exposure prophylaxis, SARS-CoV-2, Effectiveness, EVUSHELD, tixagevimab and cilgavimab