eVusheld Assessment reaL wORld Effectiveness in the VA Health System

An Observational Study to Assess the Real-World Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations Receiving Care in VA Health System in the United States

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05663957

Acronym

VALOR-VA

Enrollment

5814

Registered

2022-12-23

Start date

2023-01-04

Completion date

2023-09-01

Last updated

2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2, COVID-19

Keywords

EVUSHELD, tixagevimab and cilgavimab, Pre-exposure prophylaxis, COVID-19, SARS-CoV-2, Effectiveness

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

Interventions

DRUGEvusheld

EVUSHELD users

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Hospitalization due to COVID-19	up to 6 months	Hospital record of patient admission
All-cause mortality	Up to 6 months	All-cause deaths

Secondary

Measure	Time frame	Description
COVID-19 hospitalisation	up to 12 months	Hospitalisation due to COVID-19
Documented SARS-COV-2 infection	up to 6 and 12 months	Any positive SARS-CoV-2 diagnostic test (eg, PCR, nucleic acid amplification, antigen) OR medical encounter resulting in a diagnosis code for COVID-19b OR medical encounter resulting in a code for isolation due to COVID-19
COVID-19-related mortality	up to 6 and 12 months	Death due to COVID-19
COVID-19 Intensive Care Unit (ICU) admisssion	up to 6 and 12 months	ICU admission due to COVID-19
Medically attended COVID-19	up to 6 and 12 months	COVID-19 or SARS-CoV-2 infection leading to consultation of a healthcare professional

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026