eVusheld Assessment reaL wORld Effectiveness in the VA Health System (VALOR-VA)

AstraZeneca

Status: Completed

Conditions: SARS-CoV-2, COVID-19

Treatments: Drug: Evusheld

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05663957

D8850R00014 (Other Identifier)

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 Department of Veterans Affairs (VA) 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 the VA Health System.

Enrollment: 5,814 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 to access EVUSHELD use under the EUA.

Exclusion criteria

• None

Trial design

5,814 participants in 2 patient groups

EVUSHELD arm

Description:

Individuals given EVUSHELD for prophylaxis

Treatment:

Drug: Evusheld

Concurrent Control arm

Description:

Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD