eVusheld Assessment reaL wORld Effectiveness at UPMC (VALOR-C19 UPMC)

November 6, 2023 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

4232

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All EVUSHELD EUA-eligible patient population in the UMPC health system.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 infection
Time Frame: 6 & 12 months
To assess the effectiveness of EVUSHELD as PrEP against documented SARS-CoV-2 infection
6 & 12 months
Medically attended COVID-19
Time Frame: 6 & 12 months
To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19
6 & 12 months
Medically attended acute COVID-19
Time Frame: 6 & 12 months
To assess the effectiveness of EVUSHELD as PrEP against medically attended acute COVID-19
6 & 12 months
COVID-19 hospitalisation
Time Frame: 12 months
To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation
12 months
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
6 & 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

University of Pittsburgh

Investigators

  • Principal Investigator: Donald M Yealy, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Actual)

July 24, 2023

Study Completion (Actual)

July 24, 2023

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8850R00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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