eVusheld Assessment reaL wORld Effectiveness at UPMC | NCT05667116

Studies
eVusheld Assessment reaL wORld Effectiveness at UPMC

NCT05667116

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Nov 12, 2024Actual

Enrollment

4,232Actual

Phase

Not provided

Conditions

SARS-CoV-2, COVID-19

Interventions

EVUSHELD

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2023Actual

Primary Completion Date

Jul 24, 2023Actual

Completion Date

Jul 24, 2023Actual

First Submitted Date

Dec 19, 2022

First Submission Date that Met QC Criteria

Dec 19, 2022

First Posted Date

Dec 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2024

Last Update Posted Date

Nov 12, 2024Actual

Name	Class
University of Pittsburgh	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,232Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
EVUSHELD	Drug	EVUSHELD (AZD 7442, Tixagévimab/Cilgavimab)	EVUSHELD arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Donald M Yealy, MD	University of Pittsburgh	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Pittsburgh	Pennsylvania	15213	United States

Label	URL
Redacted\_CSR Synopsis\_D8850R00001	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

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

https://astrazenecagroup-dt.pharmacm.com/DT/Home

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections