Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS)

SARS-CoV-2 Infection Clinical Trial

Official title:

General Drug Use-Result Study of Evusheld Intramuscular Injection Set (Treatment and Prevention of Symptomatic Disease Caused by SARS-CoV-2 Infection)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687877
• Other study ID #: D8850C00019
• Status: Recruiting
• Start date: January 6, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV-2 Infection

Locations

Country	Name	City	State
Japan	Research Site	Aichi
Japan	Research Site	Aichi
Japan	Research Site	Chiba
Japan	Research Site	Fukuoka
Japan	Research Site	Fukuoka
Japan	Research Site	Fukushima
Japan	Research Site	Gifu
Japan	Research Site	Hiroshima
Japan	Research Site	Hokkaido
Japan	Research Site	Hyogo
Japan	Research Site	Ibaraki
Japan	Research Site	Ishikawa
Japan	Research Site	Iwate
Japan	Research Site	Kagoshima
Japan	Research Site	Kagoshima
Japan	Research Site	Kanagawa
Japan	Research Site	Kumamoto
Japan	Research Site	Kyoto
Japan	Research Site	Kyoto
Japan	Research Site	Mie
Japan	Research Site	Nagasaki
Japan	Research Site	Nara
Japan	Research Site	Nara
Japan	Research Site	Niigata
Japan	Research Site	Oita
Japan	Research Site	Okayama
Japan	Research Site	Okayama
Japan	Research Site	Osaka
Japan	Research Site	Osaka
Japan	Research Site	Osaka
Japan	Research Site	Tokyo
Japan	Research Site	Tokyo
Japan	Research Site	Tokyo
Japan	Research Site	Tottori
Japan	Research Site	Yamanashi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ADRs	The incidence of ADRs related to Evusheld Safety Specification; anaphylaxis and other serious allergic reactions, cardiovascular events	24weeks(6 months)