Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS)
General Drug Use-Result Study of Evusheld Intramuscular Injection Set (Treatment and Prevention of Symptomatic Disease Caused by SARS-CoV-2 Infection)
1 other identifier
observational
366
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2022
CompletedStudy Start
First participant enrolled
January 6, 2023
CompletedFirst Posted
Study publicly available on registry
January 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2025
CompletedJanuary 8, 2026
December 1, 2025
2 years
December 16, 2022
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of ADRs
The incidence of ADRs related to Evusheld Safety Specification; anaphylaxis and other serious allergic reactions, cardiovascular events
24weeks(6 months)
Eligibility Criteria
Treatment and prevention of symptomatic disease caused by SARS-CoV-2 infection
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Aichi, Japan
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyōgo, Japan
Research Site
Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Kagoshima, Japan
Research Site
Kanagawa, Japan
Research Site
Kyoto, Japan
Research Site
Mie, Japan
Research Site
Nara, Japan
Research Site
Numakunai, Japan
Research Site
Osaka, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Toshimitsu Tokimoto
AstraZeneca KK
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2022
First Posted
January 18, 2023
Study Start
January 6, 2023
Primary Completion
January 20, 2025
Study Completion
January 20, 2025
Last Updated
January 8, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- 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 contact 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, Pleas review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.