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
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84148-0001
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Receipt of EVUSHELD under the FDA EUA for EVUSHELD
- 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
EVUSHELD arm
Individuals given EVUSHELD for prophylaxis
|
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
Time Frame: up to 6 months
|
Hospital record of patient admission
|
up to 6 months
|
|
All-cause mortality
Time Frame: Up to 6 months
|
All-cause deaths
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
up to 6 and 12 months
|
|
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
|
up to 6 and 12 months
|
|
COVID-19 hospitalisation
Time Frame: up to 12 months
|
Hospitalisation due to COVID-19
|
up to 12 months
|
|
COVID-19 Intensive Care Unit (ICU) admisssion
Time Frame: up to 6 and 12 months
|
ICU admission due to COVID-19
|
up to 6 and 12 months
|
|
COVID-19-related mortality
Time Frame: up to 6 and 12 months
|
Death due to COVID-19
|
up to 6 and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott L DuVall, PhD, VA Informatics and Computing Infrastructure (VINCI)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
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
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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