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
Overview
- Phase
- Not Applicable
- Intervention
- EVUSHELD
- Conditions
- COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease
- Sponsor
- AstraZeneca
- Enrollment
- 6000
- Locations
- 1
- Primary Endpoint
- All-cause mortality
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Receipt of Evusheld under the FDA EUA for Evusheld
- •Eligibility for Evusheld use under the EUA. -
Exclusion Criteria
- Not provided
Arms & Interventions
EVUSHELD Arm
Individuals given EVUSHELD for prophylaxis
Intervention: EVUSHELD
Concurrent Control Arms
Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD
Intervention: EVUSHELD
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: up to 6 months
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
COVID-19 Hospitalisation
Time Frame: up to 6 months
To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalizations up to 6 months following its initial administration
Secondary Outcomes
- Medically attended COVID-19(Up to 6 and 12 months)
- COVID-19 hospitalisation(Up 12 months)
- COVID-19 Intensive Care Unit (ICU) admisssion(Up 6 and 12 months)
- COVID-19 related mortality(Up to 6 and 12 months)
- Documented SARS-CoV-2 infection(Up to 6 and 12 months)