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Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS)

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05687877
Collaborator
(none)
700
Enrollment
3
Locations
26.8
Anticipated Duration (Months)
233.3
Patients Per Site
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.

    The investigation will be conducted as the addtional pharmacovigilance activitiy specified in the Japan Risk Management Plan (J-RMP) of Evusheld in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    General Drug Use-Result Study of Evusheld Intramuscular Injection Set (Treatment and Prevention of Symptomatic Disease Caused by SARS-CoV-2 Infection)
    Actual Study Start Date :
    Jan 6, 2023
    Anticipated Primary Completion Date :
    Mar 31, 2025
    Anticipated Study Completion Date :
    Mar 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of ADRs [24weeks(6 months)]

      The incidence of ADRs related to Evusheld Safety Specification; anaphylaxis and other serious allergic reactions, cardiovascular events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • For treatment of symptomatic disease caused by SARS-CoV-2 infection; Patients with risk factors for severe SARS-CoV-2 infection who do not require supplemental oxygen.

    • For prevention of symptomatic disease caused by SARS-CoV-2 infection; Individuals for whom SARS-CoV-2 vaccination is not recommended OR those who are considered to have an inadequate response to a COVID-19 vaccine due to immunodeficiencies AND who is not close contacts such as family members or other people living in the same dwelling as patients infected with SARS-CoV-2.

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Aichi Japan
    2 Research Site Nara Japan
    3 Research Site Osaka Japan

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Toshimitsu Tokimoto, AstraZeneca KK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT05687877
    Other Study ID Numbers:
    • D8850C00019
    First Posted:
    Jan 18, 2023
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Additional relevant MeSH terms:
    Infections
    COVID-19

    Study Results

    No Results Posted as of Jan 18, 2023