eVusheld Assessment reaL wORld Effectiveness in DoD Health System

Not yet recruiting

• Conditions: COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease
• Interventions: Drug: EVUSHELD

• Registration Number: NCT05569408
• Lead Sponsor: AstraZeneca

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 treated in DoD 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 DoD health system.

Study Timeline

• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Study Start: 2023-09-30
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Concurrent Control Arms	EVUSHELD	Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD
EVUSHELD Arm	EVUSHELD	Individuals given EVUSHELD for prophylaxis

Primary Outcome Measures

Name	Time	Method
All-cause mortality	up to 6 months	To compare all-cause mortality up to 6 months following the initial dose of EVUSHELD, among subjects who did and did not receive EVUSHELD as PrEP
COVID-19 Hospitalisation	up to 6 months	To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalizations up to 6 months following its initial administration

Secondary Outcome Measures

Name	Time	Method
Medically attended COVID-19	Up to 6 and 12 months	To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19
COVID-19 hospitalisation	Up 12 months	To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation at 12 month
COVID-19 Intensive Care Unit (ICU) admisssion	Up 6 and 12 months	To assess the effectiveness of EVUSHELD as PrEP against ICU admission
COVID-19 related mortality	Up to 6 and 12 months	To assess the effectiveness of EVUSHELD as PrEP against COVID-19-related mortality
Documented SARS-CoV-2 infection	Up to 6 and 12 months	To assess the effectiveness of EVUSHELD as PrEP against SARS-CoV-2 infection

Trial Locations

Locations (1)

Research Site; 🇺🇸 Bethesda, Maryland, United States