Study identifier:D8850R00014
ClinicalTrials.gov identifier:NCT05663957
EudraCT identifier:N/A
CTIS identifier:N/A
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
SARS-CoV-2, COVID-19
Phase 4
No
Evusheld
All
5814
Observational
12 Years - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
VA Informatics and Computing Infrastructure (VINCI)
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.
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.
Location
Location
Salt Lake City, UT, United States, 84148-0001
Arms | Assigned Interventions |
---|---|
EVUSHELD arm Individuals given EVUSHELD for prophylaxis | Drug: Evusheld EVUSHELD users |
Concurrent Control arm Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD | - |
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