eVusheld Assessment reaL wORld Effectiveness at UPMC (VALOR-C19 UPMC)

AstraZeneca

Status: Completed

Conditions: SARS-CoV-2, COVID-19

Treatments: Drug: EVUSHELD

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05667116

D8850R00001

Details and patient eligibility

About

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.

Full 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

Enrollment: 4,232 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Receipt of EVUSHELD under the FDA EUA for EVUSHELD
2. Eligibility for assess Evusheld use under the EUA. -

Exclusion criteria

• None

Trial design

4,232 participants in 2 patient groups

EVUSHELD arm

Description:

3,000 Individuals given EVUSHELD for pre-exposure prophylaxis

Treatment:

Drug: EVUSHELD

Concurrent Control arm

Description:

3,000 individuals eligible for EVUSHELD pre-exposure prophylaxis but did not receive Evusheld