NCT05687877

Completed

Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS)

AstraZeneca Source

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Other study identifiers

Sponsor study identifier

D8850C00019

Study Type

observational

Actual enrollment (reported)

366

Locations

1 country

Sites

18

Timeline

Study Start

January 6, 2023

Actual (reported)

Primary Completion

January 20, 2025

Actual (reported)

Study Completion

January 20, 2025

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 366 participants
Study completion date: January 20, 2025
Actual (reported)
Listed locations: 1 countries · 18 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 16, 2022
Actual (reported)
Study Start
January 6, 2023
Actual (reported)
First Posted
January 18, 2023
Actual (reported)
Primary Completion
January 20, 2025
Actual (reported)
Study Completion
January 20, 2025
Actual (reported)

Last Updated: January 8, 2026
Status Verified: December 2025
Last Update Submitted: January 7, 2026

Conditions

SARS-CoV-2 Infection

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

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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.

Sponsors & Collaborators

AstraZeneca
Industrylead

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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

Toshimitsu Tokimoto
AstraZeneca KK
STUDY DIRECTOR

Enrollment

366 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT04896541

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Phase 1Completed

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Safety Immunogenicity Study of MT-2766 in Japanese Adults（COVID-19）

Phase 1/2Terminated

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Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study

Phase 1Completed

NCT04815031

Drug Use Investigation of COMIRNATY Intramuscular Injection

Completed

NCT05263908

A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19

Completed

NCT05697705

Effectiveness of the Oxford-AstraZeneca COVID-19 Vaccine as a 2nd Booster, the REFORCO-Brazil Study

Completed

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.

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

Primary Completion

January 20, 2025

Actual (reported)

Study Completion

January 20, 2025

Actual (reported)

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.

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05687877
Data provider: ClinicalTrials.gov
Source updated: 2026-01-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:47 UTC

Locations

JP(18)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations