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

COVID-19 Clinical Trial

— Evusheld DBR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06156982
• Other study ID #: D8850R00032
• Status: Completed
• Start date: December 6, 2023
• Est. completion date: January 9, 2024

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Evusheld
Administration of Evusheld 600 mg

Locations

Country	Name	City	State
Japan	Research Site	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medically attended COVID-19 in subgroups	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
Other	COVID-19 hospitalization in subgroups	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
Primary	Demographics and clinical characteristics of patients received Evusheld as PrEP	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	Medically attended COVID-19	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
Secondary	COVID-19 hospitalization	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
Secondary	In-hospital mortality due to COVID-19	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
Secondary	All cause mortality	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