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

This is an observational, cohort study that will use secondary data to describe thebaseline demographics and clinical characteristics in patients who received EVUSHELD asPrEP against SARS-CoV-2 infection/COVID-19 in Japan.All patients who have a record of administration of EVUSHELD in the database will beincluded in the study. The index date will be defined as the date of first EVUSHELDadministration in the database (Day 0) and the patients will be followed up to 6 monthsafter the index date (Day 1 to 180). The look back period is defined as the 12-monthperiod prior to index date (Day -360 to -1). The exposure of interest will be defined asthe administration of EVUSHELD for use as PrEP against COVID-19. As the result offeasibility 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.

Completed
COVID-19

Drug: Evusheld

Administration of Evusheld 600 mg

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Japan
Locations

Research Site
Osaka 1853909, Japan

Not Provided

NCT Number
Keywords
Covid-19
SARS-CoV-2
PrEP
MeSH Terms
COVID-19
Cilgavimab and tixagevimab drug combination