eVusheld Assessment reaL wORld Effectiveness in DoD Health System (VALOR DoD)

AstraZeneca

Status: Completed

Conditions: COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease

Treatments: Drug: EVUSHELD

Study type: Observational

Funder types: Industry

Identifiers

NCT05569408

D8850R00016

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 treated in DoD 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 DoD health system.

Enrollment: 4,724 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 Evusheld use under the EUA. -

Exclusion criteria

• None

Trial design

4,724 participants in 2 patient groups

EVUSHELD Arm

Description:

Individuals given EVUSHELD for prophylaxis

Treatment:

Drug: EVUSHELD

Concurrent Control Arms

Description:

Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD

Treatment:

Drug: EVUSHELD