eVusheld Assessment reaL wORld effectiveness in DoD Health System - VALOR DoD
Study identifier:D8850R00016
ClinicalTrials.gov identifier:NCT05569408
EudraCT identifier:N/A
CTIS identifier:N/A
Will Be Recruiting
Official Title
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
Medical condition
COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease
Phase
Phase 4
Healthy volunteers
No
Study drug
EVUSHELD
Sex
All
Estimated Enrollment
6000
Study type
Observational
Age
12 Years - n/a
Date
Study Start Date: 30 Sept 2023
Estimated Primary Completion Date: 05 Jan 2024
Estimated Study Completion Date: 05 Jan 2024
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Aug 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| EVUSHELD Arm Individuals given EVUSHELD for prophylaxis | Drug: EVUSHELD Tixagevimab (AZD8895) and cilgavimab (AZD1061) Other Name: AZD7442 |
| Concurrent Control Arms Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD | Drug: EVUSHELD Tixagevimab (AZD8895) and cilgavimab (AZD1061) Other Name: AZD7442 |
