eVusheld Assessment reaL wORld Effectiveness in the VA Health System

NCT05663957 | Completed FDA Drug

• 1 other identifier: D8850R00014
• Study Type: observational
• Target: 5,814
• Locations: 1 country
• Sites: 1

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 Department of Veterans Affairs (VA) Health System.

Conditions

SARS-CoV-2, COVID-19

Keywords

EVUSHELD; tixagevimab and cilgavimab; Pre-exposure prophylaxis; COVID-19; SARS-CoV-2; Effectiveness

Outcome Measures

Primary Outcomes (2)

• Hospitalization due to COVID-19

  Hospital record of patient admission

  up to 6 months

• All-cause mortality

  All-cause deaths

  Up to 6 months

Secondary Outcomes (5)

• Documented SARS-COV-2 infection

  up to 6 and 12 months

• Medically attended COVID-19

  up to 6 and 12 months

• COVID-19 hospitalisation

  up to 12 months

• COVID-19 Intensive Care Unit (ICU) admisssion

  up to 6 and 12 months

• COVID-19-related mortality

  up to 6 and 12 months

Study Arms (2)

EVUSHELD arm

Individuals given EVUSHELD for prophylaxis

Drug: Evusheld

Concurrent Control arm

Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD

Interventions

Evusheld DRUG

EVUSHELD users

EVUSHELD arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All EUA-eligible immunocompromised patient population in the Department of Veterans Affairs Health System.

You may qualify if:

• Receipt of EVUSHELD under the FDA EUA for EVUSHELD
• Eligibility to access EVUSHELD use under the EUA.

You may not qualify if:

• None

Sponsors & Collaborators

• AstraZeneca: lead
• VA Informatics and Computing Infrastructure (VINCI): collaborator

Study Sites (1)

Research Site

Salt Lake City, Utah, 84148-0001, United States

Location

Related Links

• Redacted CSR Synopsis D8850R00014

MeSH Terms

Conditions

COVID-19

Interventions

cilgavimab and tixagevimab drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Scott L DuVall, PhD

  VA Informatics and Computing Infrastructure (VINCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: December 23, 2022
• Study Start: January 4, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• 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.
• 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. URL:

Locations

US (1)