eVusheld Assessment reaL wORld Effectiveness at UPMC

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 University of Pittsburgh Medical Center (UPMC) 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 UPMC 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 at UPMC 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 for assess 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>3,000 Individuals given EVUSHELD for pre-exposure prophylaxis | Drug: EVUSHELD<br>* EVUSHELD (AZD 7442, Tixagévimab/Cilgavimab)<br>|
| Concurrent Control arm<br>3,000 individuals eligible for EVUSHELD pre-exposure prophylaxis but did not receive Evusheld | |

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 hospitalisation | 6 months | 
| All-cause mortality | To assess the effectiveness of EVUSHELD as PrEP against all-cause mortality | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 infection | To assess the effectiveness of EVUSHELD as PrEP against documented SARS-CoV-2 infection | 6 & 12 months | 
| Medically attended COVID-19 | To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19 | 6 & 12 months | 
| Medically attended acute COVID-19 | To assess the effectiveness of EVUSHELD as PrEP against medically attended acute COVID-19 | 6 & 12 months | 
| COVID-19 hospitalisation | To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation | 12 months | 
| COVID-19 intensive care unit (ICU) admission | To assess the effectiveness of EVUSHELD as PrEP against COVID-19 intensive care unit (ICU) admission | 6 & 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EVUSHELD, AZD7442, SARS-CoV-2, COVID-19, Immunocompromise