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.
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
397
Administration of Evusheld 600 mg
Research Site
Osaka, Japan
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.
Time frame: Up to 360 days before the date of first administration of Evusheld
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
Time frame: Up to 180 days after the date of first administration of Evusheld
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
Time frame: Up to 180 days after the date of first administration of Evusheld
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
Time frame: Up to 180 days after the date of first administration of Evusheld
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
Time frame: Up to 180 days after the date of first administration of Evusheld
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