eVusheld Assessment reaL wORld Effectiveness in the VA Health System

AstraZeneca5,814 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

5,814

Conditions

SARS-CoV-2, COVID-19

Interventions

EvusheldDRUG

EVUSHELD users

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Receipt of EVUSHELD under the FDA EUA for EVUSHELD 2. Eligibility to access EVUSHELD use under the EUA. Exclusion Criteria: * None

Locations (1)

Research Site

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Hospitalization due to COVID-19

Hospital record of patient admission

Time frame: up to 6 months

All-cause mortality

All-cause deaths

Time frame: Up to 6 months

Secondary Outcomes

Documented SARS-COV-2 infection

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

Time frame: up to 6 and 12 months

Medically attended COVID-19

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

Time frame: up to 6 and 12 months

COVID-19 hospitalisation

Hospitalisation due to COVID-19

Time frame: up to 12 months

COVID-19 Intensive Care Unit (ICU) admisssion

ICU admission due to COVID-19

Time frame: up to 6 and 12 months

COVID-19-related mortality

Death due to COVID-19

Time frame: up to 6 and 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.