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

Study Complete

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

Study drug

EVUSHELD

Sex

All

Actual Enrollment

4232

Study type

Observational

Age

12 Years - n/a

Date

Study Start Date: 09 Jan 2023

Primary Completion Date: 24 Jul 2023

Study Completion Date: 24 Jul 2023

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Oct 2023 by AstraZeneca

Collaborators

UPMC

Inclusion and exclusion criteria

No locations available

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	-

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Donald M Yealy