Clinical trial

An Observational Study to Assess the Real-world Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations in the United States Department of Defense Healthcare System

Name

D8850R00016

Description

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.

Trial arms

Trial start

2023-09-30

Estimated PCD

2024-01-05

Trial end

2024-01-05

Status

Not yet recruiting

Treatment

EVUSHELD

Tixagevimab (AZD8895) and cilgavimab (AZD1061)

Arms:

Concurrent Control Arms, EVUSHELD Arm

Other names:

AZD7442

Size

6000

Primary endpoint

COVID-19 Hospitalisation

up to 6 months

All-cause mortality

up to 6 months

Eligibility criteria

Inclusion Criteria: 1. Receipt of Evusheld under the FDA EUA for Evusheld 2. Eligibility for Evusheld use under the EUA. - Exclusion Criteria: * None

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 6000, 'type': 'ESTIMATED'}}

Updated at

2023-09-22

1 organization

1 product

1 indication

Product

EVUSHELD

Indication

COVID-19

Organization

AstraZeneca