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An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population treated in DoD Health system.
This a Phase IV observational, secondary data study to assess the effectiveness of Evusheld in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system.
The study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the DoD health system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVUSHELD Arm | Individuals given EVUSHELD for prophylaxis |
| |
| Concurrent Control Arms | Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVUSHELD | Drug | Tixagevimab (AZD8895) and cilgavimab (AZD1061) |
|
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Hospitalisation | To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalizations up to 6 months following its initial administration | up to 6 months |
| All-cause mortality | To compare all-cause mortality up to 6 months following the initial dose of EVUSHELD, among subjects who did and did not receive EVUSHELD as PrEP | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Documented SARS-CoV-2 infection | To assess the effectiveness of EVUSHELD as PrEP against SARS-CoV-2 infection | Up to 6 and 12 months |
| Medically attended COVID-19 | To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19 |
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Inclusion Criteria:
Exclusion Criteria:
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All EUA-eligible patient population in the Department of Defence health system.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bethesda | Maryland | 20889 | United States |
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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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| Up to 6 and 12 months |
| COVID-19 hospitalisation | To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation at 12 month | Up 12 months |
| COVID-19 Intensive Care Unit (ICU) admisssion | To assess the effectiveness of EVUSHELD as PrEP against ICU admission | Up 6 and 12 months |
| COVID-19 related mortality | To assess the effectiveness of EVUSHELD as PrEP against COVID-19-related mortality | Up to 6 and 12 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |