Skip to main content
OpenTrials
Completed

NCT Number: NCT05663957

eVusheld Assessment reaL wORld Effectiveness in the VA Health System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

SARS-CoV-2, COVID-19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Salt Lake City, Utah, 84148-0001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Receipt of EVUSHELD under the FDA EUA for EVUSHELD
  • Eligibility to access EVUSHELD use under the EUA.

Exclusion criteria

  • None

Treatment and study plan

EVUSHELD

Drug

EVUSHELD users

Primary outcomes

  1. Hospitalization due to COVID-19

    Time frame: up to 6 months

    Hospital record of patient admission

  2. All-cause mortality

    Time frame: Up to 6 months

    All-cause deaths

Secondary outcomes

  1. Documented SARS-COV-2 infection

    Time frame: 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

  2. Medically attended COVID-19

    Time frame: up to 6 and 12 months

    COVID-19 or SARS-CoV-2 infection leading to consultation of a healthcare professional

  3. COVID-19 hospitalisation

    Time frame: up to 12 months

    Hospitalisation due to COVID-19

  4. COVID-19 Intensive Care Unit (ICU) admisssion

    Time frame: up to 6 and 12 months

    ICU admission due to COVID-19

  5. COVID-19-related mortality

    Time frame: up to 6 and 12 months

    Death due to COVID-19

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • VA Informatics and Computing Infrastructure (VINCI)

Registry information

Official study title

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

Acronym: VALOR-VA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2022
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.