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VALOR DoD: eVusheld Assessment reaL wORld Effectiveness in DoD Health System

Sponsor
AstraZeneca (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05569408
Collaborator
(none)
6,000
Enrollment
12.2
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 treated in DoD Health system.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
6000 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 in the United States Department of Defense Healthcare System
Anticipated Study Start Date :
Oct 10, 2022
Anticipated Primary Completion Date :
Oct 15, 2023
Anticipated Study Completion Date :
Oct 15, 2023

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. COVID-19 Hospitalisation [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 [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 Outcome Measures

    1. Documented SARS-CoV-2 infection [Up to 6 and 12 months]

      To assess the effectiveness of EVUSHELD as PrEP against SARS-CoV-2 infection

    2. Medically attended COVID-19 [Up to 6 and 12 months]

      To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19

    3. COVID-19 hospitalisation [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 [Up 6 and 12 months]

      To assess the effectiveness of EVUSHELD as PrEP against ICU admission

    5. COVID-19 related mortality [Up to 6 and 12 months]

      To assess the effectiveness of EVUSHELD as PrEP against COVID-19-related mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Receipt of Evusheld under the FDA EUA for Evusheld

    2. Eligibility for Evusheld use under the EUA. -

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT05569408
    Other Study ID Numbers:
    • D8850R00016
    First Posted:
    Oct 6, 2022
    Last Update Posted:
    Oct 6, 2022
    Last Verified:
    Oct 1, 2022
    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
    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 Oct 6, 2022