eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services

Completed

• Conditions: SARS-CoV-2; COVID-19
• Interventions: Drug: EVUSHELD

• Registration Number: NCT05712096
• 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 EVUSHELD eligible patient population in the Clalit Health Services in Israel.

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 EVUSHELD eligible patient population in the Clalit Health Services in Israel.

Study Timeline

• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-02-03
• Study Start: 2023-03-09
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

Not provided

Exclusion Criteria

• With evidence of COVID 19 (i.e., a positive diagnostic test, or COVID-19 diagnosis code) in the period of 90 days before (pseudo) index date OR
• With evidence of SARS-CoV-2 infection on the (pseudo) index date or anytime within the 6-day period immediately following this date (i.e., index date to index date+6)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EVUSHELD Arm	EVUSHELD	Individuals given EVUSHELD for pre-exposure prophylaxis

Primary Outcome Measures

Name	Time	Method
Hospitalisation due to COVID-19	up to 6 months	Any record of admission to hospital that was reported to the Israeli MOH as hospitalization due to SARS-CoV-2
All-cause mortality	up to 6 months	All-cause deaths reported in the patient's record

Secondary Outcome Measures

Name	Time	Method
COVID-19 mortality	6 months and 12 months	Any record indicating death due to COVID-19 or record of death certificate mentioning SARS-CoV-2 as cause of death.
COVID-19-related healthcare resource utilization (HCRU)	6 months	Any record of COVID-19 hospitalisation, ICU admission, mechanical ventilation and prescriptions of therapies for COVID-19
COVID-19-related healthcare resource utilization	6 months	Any record of hospital admission including hospital lenght of stay, ICU, mechanical ventilation, prescription/dispensations of antiviral drugs used for COVID-19 drugs
Documented SARS-CoV-2 Infection, COVID-19 related mortality, Severe COVID-19	6 months and 12 months	SARS-CoV-2 diagnostic test (eg, PCR, nucleic acid amplification, antigen) OR medical encounter resulting in a diagnosis code for COVID-19b OR medical encounter resulting in a code for isolation due to COVID-19
SAEs/AESIs	6 months	Any record of Serious Adverse Events (SAEs) or Adverse Events of Special Interests (AESIs) up to 6 months following initiation of Evusheld
Adverse events (AEs)	12 months	Any record of Adverse events up to 12 months following initiation of Evusheld

Trial Locations

Locations (1)

Research Site; 🇮🇱 Ramat Gan, Israel