NCT05569408

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,724

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

October 4, 2022

Last Update Submit

September 9, 2024

Conditions

COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease

Keywords

Evusheldtixagevimab and cilgavimabPre-exposure prophylaxisCOVID-19SARS-CoV-2Effectiveness

Outcome Measures

Primary Outcomes (2)

  • COVID-19 Hospitalisation

    To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalizations up to 6 months following its initial administration

    up to 6 months

  • All-cause mortality

    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

    up to 6 months

Secondary Outcomes (5)

  • Documented SARS-CoV-2 infection

    Up to 6 and 12 months

  • Medically attended COVID-19

    Up to 6 and 12 months

  • COVID-19 hospitalisation

    Up 12 months

  • COVID-19 Intensive Care Unit (ICU) admisssion

    Up 6 and 12 months

  • COVID-19 related mortality

    Up to 6 and 12 months

Study Arms (2)

EVUSHELD Arm

Individuals given EVUSHELD for prophylaxis

Drug: EVUSHELD

Concurrent Control Arms

Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD

Drug: EVUSHELD

Interventions

EVUSHELDDRUG

Tixagevimab (AZD8895) and cilgavimab (AZD1061)

Also known as: AZD7442
Concurrent Control ArmsEVUSHELD 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 EUA-eligible patient population in the Department of Defence health system.

You may qualify if:

  • Receipt of Evusheld under the FDA EUA for Evusheld
  • Eligibility for 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

Bethesda, Maryland, 20889, United States

Location

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 Design

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

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 6, 2022

Study Start

August 10, 2023

Primary Completion

December 22, 2023

Study Completion

December 22, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

US(1)