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Completed

NCT Number: NCT05569408

eVusheld Assessment reaL wORld Effectiveness in DoD Health 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.

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Key information

Conditions

COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Bethesda, Maryland, 20889, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

EVUSHELD

Drug

Tixagevimab (AZD8895) and cilgavimab (AZD1061)

Other names: AZD7442

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. COVID-19 hospitalisation

    Time frame: Up 12 months

    To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation at 12 month

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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 in the United States Department of Defense Healthcare System

Acronym: VALOR DoD

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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