eVusheld Assessment reaL wORld Effectiveness in the VA He... | NCT05663957

Studies
eVusheld Assessment reaL wORld Effectiveness in the VA Health System

NCT05663957

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Sep 3, 2024Actual

Enrollment

5,814Actual

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

ID	Type	Description	Link
D8850R00014	Other Identifier	AstraZeneca

Status Module

Record Verification Date

Aug 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 4, 2023Actual

Primary Completion Date

Sep 1, 2023Actual

Completion Date

Sep 1, 2023Actual

First Submitted Date

Sep 22, 2022

First Submission Date that Met QC Criteria

Dec 15, 2022

First Posted Date

Dec 23, 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

Aug 30, 2024

Last Update Posted Date

Sep 3, 2024Actual

Name	Class
VA Informatics and Computing Infrastructure (VINCI)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

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 Department of Veterans Affairs (VA) 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 the VA 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

5,814Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EVUSHELD arm		Individuals given EVUSHELD for prophylaxis	Drug: Evusheld
Concurrent Control arm		Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evusheld	Drug	EVUSHELD users	EVUSHELD arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Documented SARS-COV-2 infection	Any positive SARS-CoV-2 diagnostic test (eg, PCR, nucleic acid amplification, antigen) OR medical encounter resulting in a diagnosis code for COVID-19b OR medical encounter resulting in a code for isolation due to COVID-19	up to 6 and 12 months
Medically attended COVID-19

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Receipt of EVUSHELD under the FDA EUA for EVUSHELD
Eligibility to access 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 EUA-eligible immunocompromised patient population in the Department of Veterans Affairs Health System.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott L DuVall, PhD	VA Informatics and Computing Infrastructure (VINCI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Salt Lake City	Utah	84148-0001	United States

Label	URL
Redacted CSR Synopsis D8850R00014	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:

URL

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

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