eVusheld Assessment reaL wORld Effectiveness in DoD 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 treated in DoD 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 DoD 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 in the United States Department of Defense Healthcare System

Conditions
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COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease

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 for 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>* Tixagevimab (AZD8895) and cilgavimab (AZD1061)<br>* Other names: AZD7442;|
| Concurrent Control Arms<br>Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD | Drug: EVUSHELD<br>* Tixagevimab (AZD8895) and cilgavimab (AZD1061)<br>* Other names: AZD7442;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Hospitalisation | To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalizations up to 6 months following its initial administration | up to 6 months | 
| All-cause mortality | To compare all-cause mortality up to 6 months following the initial dose of EVUSHELD, among subjects who did and did not receive EVUSHELD as PrEP | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documented SARS-CoV-2 infection | To assess the effectiveness of EVUSHELD as PrEP against SARS-CoV-2 infection | Up to 6 and 12 months | 
| Medically attended COVID-19 | To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19 | Up to 6 and 12 months | 
| COVID-19 hospitalisation | To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation at 12 month | Up 12 months | 
| COVID-19 Intensive Care Unit (ICU) admisssion | To assess the effectiveness of EVUSHELD as PrEP against ICU admission | Up 6 and 12 months | 
| COVID-19 related mortality | To assess the effectiveness of EVUSHELD as PrEP against COVID-19-related mortality | 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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Evusheld, tixagevimab and cilgavimab, Pre-exposure prophylaxis, COVID-19, SARS-CoV-2, Effectiveness