NCT05667116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2023

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

December 19, 2022

Last Update Submit

November 8, 2024

Conditions

SARS-CoV-2, COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • COVID-19 hospitalisation

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

    6 months

  • All-cause mortality

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

    6 months

Secondary Outcomes (5)

  • SARS-CoV-2 infection

    6 & 12 months

  • Medically attended COVID-19

    6 & 12 months

  • Medically attended acute COVID-19

    6 & 12 months

  • COVID-19 hospitalisation

    12 months

  • COVID-19 intensive care unit (ICU) admission

    6 & 12 months

Study Arms (2)

EVUSHELD arm

3,000 Individuals given EVUSHELD for pre-exposure prophylaxis

Drug: EVUSHELD

Concurrent Control arm

3,000 individuals eligible for EVUSHELD pre-exposure prophylaxis but did not receive Evusheld

Interventions

EVUSHELDDRUG

EVUSHELD (AZD 7442, Tixagévimab/Cilgavimab)

EVUSHELD arm

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

cilgavimab and tixagevimab drug combination

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Donald M Yealy, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 19, 2022

First Posted

December 28, 2022

Study Start

January 9, 2023

Primary Completion

July 24, 2023

Study Completion

July 24, 2023

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

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.

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.
More information

Locations

US(1)