eVusheld Assessment reaL wORld Effectiveness in DoD Health System
Purpose
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.
Condition
- COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Receipt of Evusheld under the FDA EUA for Evusheld 2. Eligibility for Evusheld use under the EUA. -
Exclusion Criteria
- None
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
EVUSHELD Arm | Individuals given EVUSHELD for prophylaxis |
|
Concurrent Control Arms | Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD |
|
Recruiting Locations
More Details
- NCT ID
- NCT05569408
- Status
- Completed
- Sponsor
- AstraZeneca
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.