eVusheld Assessment reaL wORld Effectiveness in the VA Health System

Completed

• Conditions: SARS-CoV-2, COVID-19
• Interventions: Drug: Evusheld

• Registration Number: NCT05663957
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-23
• Study Start: 2023-01-04
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5814

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EVUSHELD arm	Evusheld	Individuals given EVUSHELD for prophylaxis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Medically attended COVID-19	up to 6 and 12 months	COVID-19 or SARS-CoV-2 infection leading to consultation of a healthcare professional
COVID-19 hospitalisation	up to 12 months	Hospitalisation due to COVID-19
COVID-19 Intensive Care Unit (ICU) admisssion	up to 6 and 12 months	ICU admission due to COVID-19
COVID-19-related mortality	up to 6 and 12 months	Death due to COVID-19

Trial Locations

Locations (1)

Research Site; 🇺🇸 Salt Lake City, Utah, United States