eVusheld Assessment reaL wORld effectiveness at UPMC - VALOR-C19 UPMC
Study identifier:D8850R00001
ClinicalTrials.gov identifier:NCT05667116
EudraCT identifier:N/A
CTIS identifier:N/A
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 Receiving Care at UPMC in the United States
Medical condition
SARS-CoV-2, COVID-19
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: 09 Jan 2023
Estimated Primary Completion Date: 15 Jan 2024
Estimated Study Completion Date: 15 Jan 2024
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Feb 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
UPMC
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| EVUSHELD arm 3,000 Individuals given EVUSHELD for pre-exposure prophylaxis | Drug: EVUSHELD EVUSHELD (AZD 7442, Tixagévimab/Cilgavimab) |
| Concurrent Control arm 3,000 individuals eligible for EVUSHELD pre-exposure prophylaxis but did not receive Evusheld | - |
Contacts
Investigators
Principal Investigator
Donald M Yealy
UPMC
