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

  1. 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

ArmDescriptionAssigned Intervention
EVUSHELD arm 3,000 Individuals given EVUSHELD for pre-exposure prophylaxis
  • Drug: EVUSHELD
    EVUSHELD (AZD 7442, Tixagévimab/Cilgavimab)
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