eVusheld Assessment reaL wORld Effectiveness in DoD Health System (VALOR DoD)

September 21, 2023 updated by: AstraZeneca

An Observational Study to Assess the Real-world Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations in the United States Department of Defense Healthcare System

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 treated in DoD Health system.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 DoD health system.

Study Type

Observational

Enrollment (Estimated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 patient population in the Department of Defence health system.

Description

Inclusion Criteria:

  1. Receipt of Evusheld under the FDA EUA for Evusheld
  2. Eligibility for Evusheld use under the EUA. -

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: EVUSHELD
Tixagevimab (AZD8895) and cilgavimab (AZD1061)
Other Names:
  • AZD7442
Concurrent Control Arms
Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD
Drug: EVUSHELD
Tixagevimab (AZD8895) and cilgavimab (AZD1061)
Other Names:
  • AZD7442

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 Hospitalisation
Time Frame: up to 6 months
To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalizations up to 6 months following its initial administration
up to 6 months
All-cause mortality
Time Frame: up to 6 months
To compare all-cause mortality up to 6 months following the initial dose of EVUSHELD, among subjects who did and did not receive EVUSHELD as PrEP
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
To assess the effectiveness of EVUSHELD as PrEP against SARS-CoV-2 infection
Up to 6 and 12 months
Medically attended COVID-19
Time Frame: Up to 6 and 12 months
To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19
Up to 6 and 12 months
COVID-19 hospitalisation
Time Frame: Up 12 months
To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation at 12 month
Up 12 months
COVID-19 Intensive Care Unit (ICU) admisssion
Time Frame: Up 6 and 12 months
To assess the effectiveness of EVUSHELD as PrEP against ICU admission
Up 6 and 12 months
COVID-19 related mortality
Time Frame: Up to 6 and 12 months
To assess the effectiveness of EVUSHELD as PrEP against COVID-19-related mortality
Up to 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2023

Primary Completion (Estimated)

January 5, 2024

Study Completion (Estimated)

January 5, 2024

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8850R00016

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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