Clinical trial NCT06156982: An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan
Official title: An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
PrEP
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-12-05
Enrollment: 397
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have a record of administration of EVUSHELD in the database and meet the inclusion criteria and do not meet the exclusion criteria will be included in the study.

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.

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

Primary outcomes:
measure: Demographics and clinical characteristics of patients received Evusheld as PrEP
timeFrame: Up to 360 days before the date of first administration of Evusheld
Secondary outcomes:
measure: Medically attended COVID-19
timeFrame: Up to 180 days after the date of first administration of Evusheld
measure: COVID-19 hospitalization
timeFrame: Up to 180 days after the date of first administration of Evusheld
measure: In-hospital mortality due to COVID-19
timeFrame: Up to 180 days after the date of first administration of Evusheld
measure: All cause mortality
timeFrame: Up to 180 days after the date of first administration of Evusheld
Other outcomes:
measure: Medically attended COVID-19 in subgroups
timeFrame: Up to 180 days after the date of first administration of Evusheld
measure: COVID-19 hospitalization in subgroups
timeFrame: Up to 180 days after the date of first administration of Evusheld
Locations:
city: Osaka
country: Japan
facility: Research Site
Study officials:
References: