An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 397
- Locations
- 1
- Primary Endpoint
- Demographics and clinical characteristics of patients received Evusheld as PrEP
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Evusheld administered group
Intervention: Evusheld (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- COVID-19 hospitalization(Up to 180 days after the date of first administration of Evusheld)
- All cause mortality(Up to 180 days after the date of first administration of Evusheld)
- Medically attended COVID-19(Up to 180 days after the date of first administration of Evusheld)
- In-hospital mortality due to COVID-19(Up to 180 days after the date of first administration of Evusheld)