eVusheld Assessment reaL wORld Effectiveness in the VA 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 in the Department of Veterans Affairs (VA) Health System.
Condition
- SARS-CoV-2, COVID-19
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Receipt of EVUSHELD under the FDA EUA for EVUSHELD 2. Eligibility to access 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 arm | Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD |
|
Recruiting Locations
More Details
- NCT ID
- NCT05663957
- 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 VA Health System.