An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan

NCT ID: NCT06156982

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 397 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-06
• Study Completion Date: 2024-01-09

Brief Summary

This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.

All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.

Detailed Description

This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.

All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Evusheld administered group

Evusheld

Intervention Type: DRUG

Administration of Evusheld 600 mg

Interventions

Evusheld

Administration of Evusheld 600 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Immunocompromised patients who were administrated EVUSHELD as PrEP and have administration date of EVUSHELD
• patients aged ≥ 12 years at the index date

Exclusion Criteria

• Patients who have no medical visit records at any time in the 12 months preceding the index date

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Osaka, , Japan

Countries

Japan

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8850R00032&attachmentIdentifier=00128184-f255-4339-9f5d-83ab1a5ad54f&fileName=D8850R00032_Evusheld_DBR_Study_report_synopsis_ver1.0.pdf&versionIdentifier=

redacted CSR Synopsis

Other Identifiers

D8850R00032

Identifier Type: -

Identifier Source: org_study_id