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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evusheld administered group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evusheld | Drug | Administration of Evusheld 600 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 360 days before the date of first administration of Evusheld |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 180 days after the date of first administration of Evusheld |
| COVID-19 hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Medically attended COVID-19 in subgroups | 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. | Up to 180 days after the date of first administration of Evusheld |
| COVID-19 hospitalization in subgroups |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Osaka | Japan |
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| Label | URL |
|---|---|
| redacted CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000714168 | cilgavimab and tixagevimab drug combination |
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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 |
| 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 | 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 | 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. |
| Up to 180 days after the date of first administration of Evusheld |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |