An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan
- Registration Number
- NCT06156982
- Lead Sponsor
- AstraZeneca
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 397
- Immunocompromised patients who were administrated EVUSHELD as PrEP and have administration date of EVUSHELD
- patients aged ≥ 12 years at the index date
- Patients who have no medical visit records at any time in the 12 months preceding the index date
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Evusheld administered group Evusheld -
- Primary Outcome Measures
Name Time Method Demographics and clinical characteristics of patients received Evusheld as PrEP 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 Outcome Measures
Name Time Method COVID-19 hospitalization 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
All cause mortality 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
Medically attended COVID-19 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
In-hospital mortality due to COVID-19 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
Trial Locations
- Locations (1)
Research Site
🇯🇵Osaka, Japan