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

NCT06156982 | Completed

• 1 other identifier: D8850R00032
• Study Type: observational
• Target: 397
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; PrEP

Outcome Measures

Primary Outcomes (1)

• Demographics and clinical characteristics of patients received Evusheld as PrEP

  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.

  Up to 360 days before the date of first administration of Evusheld

Secondary Outcomes (4)

• Medically attended COVID-19

  Up to 180 days after the date of first administration of Evusheld

• COVID-19 hospitalization

  Up to 180 days after the date of first administration of Evusheld

• In-hospital mortality due to COVID-19

  Up to 180 days after the date of first administration of Evusheld

• All cause mortality

  Up to 180 days after the date of first administration of Evusheld

Other Outcomes (2)

• Medically attended COVID-19 in subgroups

  Up to 180 days after the date of first administration of Evusheld

• COVID-19 hospitalization in subgroups

  Up to 180 days after the date of first administration of Evusheld

Study Arms (1)

Evusheld administered group

Drug: Evusheld

Interventions

Evusheld DRUG

Administration of Evusheld 600 mg

Evusheld administered group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who have a record of administration of EVUSHELD in the database and meet the inclusion criteria and do not meet the exclusion criteria will be included in the study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Osaka, Japan

Location

Related Links

• redacted CSR Synopsis

MeSH Terms

Conditions

COVID-19

Interventions

cilgavimab and tixagevimab drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: December 5, 2023
• Study Start: December 6, 2023
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

JP (1)