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Completed

NCT Number: NCT05667116

eVusheld Assessment reaL wORld Effectiveness at UPMC

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.

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Key information

Conditions

SARS-CoV-2, COVID-19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Pittsburgh, Pennsylvania, 15213, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

EVUSHELD

Drug

EVUSHELD (AZD 7442, Tixagévimab/Cilgavimab)

Primary outcomes

  1. COVID-19 hospitalisation

    Time frame: 6 months

    To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation

  2. All-cause mortality

    Time frame: 6 months

    To assess the effectiveness of EVUSHELD as PrEP against all-cause mortality

Secondary outcomes

  1. SARS-CoV-2 infection

    Time frame: 6 & 12 months

    To assess the effectiveness of EVUSHELD as PrEP against documented SARS-CoV-2 infection

  2. Medically attended COVID-19

    Time frame: 6 & 12 months

    To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19

  3. Medically attended acute COVID-19

    Time frame: 6 & 12 months

    To assess the effectiveness of EVUSHELD as PrEP against medically attended acute COVID-19

  4. COVID-19 hospitalisation

    Time frame: 12 months

    To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation

  5. COVID-19 intensive care unit (ICU) admission

    Time frame: 6 & 12 months

    To assess the effectiveness of EVUSHELD as PrEP against COVID-19 intensive care unit (ICU) admission

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • University of Pittsburgh

Registry information

Official study 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

Acronym: VALOR-C19 UPMC

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 28, 2022
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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