Trials / Completed
CompletedNCT05569408
eVusheld Assessment reaL wORld Effectiveness in DoD Health System
An Observational Study to Assess the Real-world Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations in the United States Department of Defense Healthcare System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,724 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EVUSHELD | Tixagevimab (AZD8895) and cilgavimab (AZD1061) |
Timeline
- Start date
- 2023-08-10
- Primary completion
- 2023-12-22
- Completion
- 2023-12-22
- First posted
- 2022-10-06
- Last updated
- 2024-09-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05569408. Inclusion in this directory is not an endorsement.