eVusheld Assessment reaL wORld Effectiveness at UPMC
- Registration Number
- NCT05667116
- Lead Sponsor
- AstraZeneca
- 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 in the University of Pittsburgh Medical Center (UPMC) 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 UPMC health system
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4232
- Receipt of EVUSHELD under the FDA EUA for EVUSHELD
- Eligibility for assess Evusheld use under the EUA. -
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EVUSHELD arm EVUSHELD 3,000 Individuals given EVUSHELD for pre-exposure prophylaxis
- Primary Outcome Measures
Name Time Method All-cause mortality 6 months To assess the effectiveness of EVUSHELD as PrEP against all-cause mortality
COVID-19 hospitalisation 6 months To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation
- Secondary Outcome Measures
Name Time Method COVID-19 hospitalisation 12 months To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation
COVID-19 intensive care unit (ICU) admission 6 & 12 months To assess the effectiveness of EVUSHELD as PrEP against COVID-19 intensive care unit (ICU) admission
SARS-CoV-2 infection 6 & 12 months To assess the effectiveness of EVUSHELD as PrEP against documented SARS-CoV-2 infection
Medically attended COVID-19 6 & 12 months To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19
Medically attended acute COVID-19 6 & 12 months To assess the effectiveness of EVUSHELD as PrEP against medically attended acute COVID-19
Trial Locations
- Locations (1)
Research Site
🇺🇸Pittsburgh, Pennsylvania, United States