eVusheld Assessment reaL wORld Effectiveness in the VA Health System (VALOR-VA)

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2, COVID-19
• Intervention / Treatment: Drug: Evusheld

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 Type: Observational
• Enrollment (Actual): 5814

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84148-0001
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All EUA-eligible immunocompromised patient population in the Department of Veterans Affairs Health System.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EVUSHELD arm; Individuals given EVUSHELD for prophylaxis	Drug: Evusheld; EVUSHELD users
Concurrent Control arm; Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: VA Informatics and Computing Infrastructure (VINCI)
• Investigators: Principal Investigator: Scott L DuVall, PhD, VA Informatics and Computing Infrastructure (VINCI)

Publications and helpful links

Helpful Links

• Redacted CSR Synopsis D8850R00014

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Effectiveness; Pre-exposure prophylaxis; tixagevimab and cilgavimab; EVUSHELD
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Cilgavimab and tixagevimab drug combination
• Other Study ID Numbers: D8850R00014 (Other Identifier: AstraZeneca)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

URL:

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No