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

January 16, 2024 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

397

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Osaka, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who have a record of administration of EVUSHELD in the database and meet the inclusion criteria and do not meet the exclusion criteria will be included in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Evusheld administered group
Drug: Evusheld
Administration of Evusheld 600 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics and clinical characteristics of patients received Evusheld as PrEP
Time Frame: Up to 360 days before the date of first administration of Evusheld
Proportion of patients by age, gender, and clinical characteristics of interest (i.e. comorbidity, concurrent medication) between 360 days from the date of first administration of Evusheld (index date) to the index date will be described.
Up to 360 days before the date of first administration of Evusheld

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medically attended COVID-19
Time Frame: Up to 180 days after the date of first administration of Evusheld
Event rate and time to event for medically attended COVID-19 up to 180 days after the date of first administration of Evusheld will be described
Up to 180 days after the date of first administration of Evusheld
COVID-19 hospitalization
Time Frame: Up to 180 days after the date of first administration of Evusheld
Event rate and time to event for COVID-19 hospitalization up to 180 days after the date of first administration of Evusheld will be described
Up to 180 days after the date of first administration of Evusheld
In-hospital mortality due to COVID-19
Time Frame: Up to 180 days after the date of first administration of Evusheld
Event rate and time to event for in-hospital mortality due to COVID-19 up to 180 days after the date of first administration of Evusheld will be described
Up to 180 days after the date of first administration of Evusheld
All cause mortality
Time Frame: Up to 180 days after the date of first administration of Evusheld
Event rate and time to event for all cause mortality up to 180 days after the date of first administration of Evusheld will be described
Up to 180 days after the date of first administration of Evusheld

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medically attended COVID-19 in subgroups
Time Frame: Up to 180 days after the date of first administration of Evusheld
Event rate of medically attended COVID-19 by each sub groups (e.g. age, comorbidity) up to 180 days after the date of first administration of Evusheld will be described.
Up to 180 days after the date of first administration of Evusheld
COVID-19 hospitalization in subgroups
Time Frame: Up to 180 days after the date of first administration of Evusheld
Event rate of COVID-19 hospitalization by each sub groups (e.g. age, comorbidity) up to 180 days after the date of first administration of Evusheld will be described.
Up to 180 days after the date of first administration of Evusheld

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Actual)

January 9, 2024

Study Completion (Actual)

January 9, 2024

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8850R00032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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