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

AstraZeneca

Status: Completed

Conditions: COVID-19

Treatments: Drug: Evusheld

Study type: Observational

Funder types: Industry

Identifiers

NCT06156982

D8850R00032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 397 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

397 participants in 1 patient group

Evusheld administered group

Treatment:

Drug: Evusheld