Evusheld DBR: An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Evusheld administered group
|
Drug: Evusheld
Administration of Evusheld 600 mg
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
Other Outcome Measures
- Medically attended COVID-19 in subgroups [Up to 180 days after the date of first administration of Evusheld]
Event rate of medically attended COVID-19 by each sub groups (e.g. age, comorbidity) up to 180 days after the date of first administration of Evusheld will be described.
- COVID-19 hospitalization in subgroups [Up to 180 days after the date of first administration of Evusheld]
Event rate of COVID-19 hospitalization by each sub groups (e.g. age, comorbidity) up to 180 days after the date of first administration of Evusheld will be described.
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D8850R00032