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Completed

NCT Number: NCT06156982

An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan

This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.

All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Osaka, Japan

About this study

This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.

All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Immunocompromised patients who were administrated EVUSHELD as PrEP and have administration date of EVUSHELD
  • patients aged ≥ 12 years at the index date

Exclusion criteria

  • Patients who have no medical visit records at any time in the 12 months preceding the index date

Treatment and study plan

EVUSHELD

Drug

Administration of Evusheld 600 mg

Primary outcomes

  1. Demographics and clinical characteristics of patients received Evusheld as PrEP

    Time frame: Up to 360 days before the date of first administration of Evusheld

    Proportion of patients by age, gender, and clinical characteristics of interest (i.e. comorbidity, concurrent medication) between 360 days from the date of first administration of Evusheld (index date) to the index date will be described.

Secondary outcomes

  1. Medically attended COVID-19

    Time frame: Up to 180 days after the date of first administration of Evusheld

    Event rate and time to event for medically attended COVID-19 up to 180 days after the date of first administration of Evusheld will be described

  2. COVID-19 hospitalization

    Time frame: Up to 180 days after the date of first administration of Evusheld

    Event rate and time to event for COVID-19 hospitalization up to 180 days after the date of first administration of Evusheld will be described

  3. In-hospital mortality due to COVID-19

    Time frame: Up to 180 days after the date of first administration of Evusheld

    Event rate and time to event for in-hospital mortality due to COVID-19 up to 180 days after the date of first administration of Evusheld will be described

  4. All cause mortality

    Time frame: Up to 180 days after the date of first administration of Evusheld

    Event rate and time to event for all cause mortality up to 180 days after the date of first administration of Evusheld will be described

Other outcomes

  1. Medically attended COVID-19 in subgroups

    Time frame: Up to 180 days after the date of first administration of Evusheld

    Event rate of medically attended COVID-19 by each sub groups (e.g. age, comorbidity) up to 180 days after the date of first administration of Evusheld will be described.

  2. COVID-19 hospitalization in subgroups

    Time frame: Up to 180 days after the date of first administration of Evusheld

    Event rate of COVID-19 hospitalization by each sub groups (e.g. age, comorbidity) up to 180 days after the date of first administration of Evusheld will be described.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: Evusheld DBR

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2023
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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