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

Sponsor

AstraZeneca (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05663957

Collaborator

VA Informatics and Computing Infrastructure (VINCI) (Other)

5,782

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2, COVID-19	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 Design

Study Type:

Observational

Anticipated Enrollment :

5782 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official 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

Anticipated Study Start Date :

Dec 16, 2022

Anticipated Primary Completion Date :

Sep 15, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

AstraZeneca
VA Informatics and Computing Infrastructure (VINCI)

Investigators

Principal Investigator: Scott L DuVall, PhD, VA Informatics and Computing Infrastructure (VINCI)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT05663957

Other Study ID Numbers:

D8850R00014
D8850R00014

First Posted:

Dec 23, 2022

Last Update Posted:

Dec 23, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by AstraZeneca

EVUSHELD

tixagevimab and cilgavimab

Pre-exposure prophylaxis

COVID-19

SARS-CoV-2

Effectiveness

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Dec 23, 2022