eVusheld Assessment reaL wORld Effectiveness at UPMC

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05667116

Acronym

VALOR-C19 UPMC

Enrollment

4232

Registered

2022-12-28

Start date

2023-01-09

Completion date

2023-07-24

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2, COVID-19

Keywords

EVUSHELD, AZD7442, SARS-CoV-2, COVID-19, Immunocompromise

Brief 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 in the University of Pittsburgh Medical Center (UPMC) 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 UPMC health system

Interventions

DRUGEVUSHELD

EVUSHELD (AZD 7442, Tixagévimab/Cilgavimab)

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Receipt of EVUSHELD under the FDA EUA for EVUSHELD 2. Eligibility for assess Evusheld use under the EUA. -

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
COVID-19 hospitalisation	6 months	To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation
All-cause mortality	6 months	To assess the effectiveness of EVUSHELD as PrEP against all-cause mortality

Secondary

Measure	Time frame	Description
Medically attended acute COVID-19	6 & 12 months	To assess the effectiveness of EVUSHELD as PrEP against medically attended acute COVID-19
SARS-CoV-2 infection	6 & 12 months	To assess the effectiveness of EVUSHELD as PrEP against documented SARS-CoV-2 infection
COVID-19 intensive care unit (ICU) admission	6 & 12 months	To assess the effectiveness of EVUSHELD as PrEP against COVID-19 intensive care unit (ICU) admission
COVID-19 hospitalisation	12 months	To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation
Medically attended COVID-19	6 & 12 months	To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026