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.
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.
Study Type
OBSERVATIONAL
Enrollment
4,724
Tixagevimab (AZD8895) and cilgavimab (AZD1061)
Research Site
Bethesda, Maryland, United States
COVID-19 Hospitalisation
To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalizations up to 6 months following its initial administration
Time frame: 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
Time frame: up to 6 months
Documented SARS-CoV-2 infection
To assess the effectiveness of EVUSHELD as PrEP against SARS-CoV-2 infection
Time frame: Up to 6 and 12 months
Medically attended COVID-19
To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19
Time frame: Up to 6 and 12 months
COVID-19 hospitalisation
To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation at 12 month
Time frame: Up 12 months
COVID-19 Intensive Care Unit (ICU) admisssion
To assess the effectiveness of EVUSHELD as PrEP against ICU admission
Time frame: Up 6 and 12 months
COVID-19 related mortality
To assess the effectiveness of EVUSHELD as PrEP against COVID-19-related mortality
Time frame: Up to 6 and 12 months
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