eVusheld Assessment reaL wORld Effectiveness at UPMC
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 University of Pittsburgh Medical Center (UPMC) Health System.
Condition
- SARS-CoV-2, COVID-19
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 assess 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 | 3,000 Individuals given EVUSHELD for pre-exposure prophylaxis |
|
| Concurrent Control arm | 3,000 individuals eligible for EVUSHELD pre-exposure prophylaxis but did not receive Evusheld |
|
Recruiting Locations
More Details
- NCT ID
- NCT05667116
- 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 UPMC health system