eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services

NCT05712096 | Completed FDA Drug

• 1 other identifier: D8850R00002
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2; COVID-19

Keywords

SARS-CoV-2; COVID-19; Immunocompromised Patients; Pre-exposure Prophylaxis Against COVID-19; Evusheld

Outcome Measures

Primary Outcomes (2)

• Hospitalisation due to COVID-19

  Any record of admission to hospital that was reported to the Israeli MOH as hospitalization due to SARS-CoV-2

  up to 6 months

• All-cause mortality

  All-cause deaths reported in the patient's record

  up to 6 months

Secondary Outcomes (6)

• Documented SARS-CoV-2 Infection, COVID-19 related mortality, Severe COVID-19

  6 months and 12 months

• COVID-19 mortality

  6 months and 12 months

• COVID-19-related healthcare resource utilization (HCRU)

  6 months

• COVID-19-related healthcare resource utilization

  6 months

• SAEs/AESIs

  6 months

Study Arms (2)

EVUSHELD Arm

Individuals given EVUSHELD for pre-exposure prophylaxis

Drug: EVUSHELD

Concurrent Control Arm

Individuals eligible for EVUSHELD pre-exposure prophylaxis but did not receive Evusheld

Interventions

EVUSHELD DRUG

EVUSHELD (AZD 7442, Tixagévimab/Cilgavimab)

EVUSHELD Arm

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 EVUSHELD PrEP-eligible patient population in the Clalit Health Services system

You may qualify if:

• Aged 12 years and older as of the date of receipt of EVUSHELD
• No record of infection or SARS-CoV- hospitalization within last 90 days prior to the index date
• Individuals who are moderate/severe immune compromised due to a medical condition or receipt of immunosuppressive medications or treatments and may mount an adequate immune response to COVID-19 vaccine:
• Hypogammaglobinemia patients regularly treated with immunoglobulins
• Patients treated with B-cell depleting therapy, including for example such anti-CD20 as rituximab, obinatuzumab, ofatumumab, veltuzumab, Y-ibritumomab tiuxetan or ocrelizumab, even without malignant disease, up to six months from treatment.
• Patients that are treated with B-cell depleting therapy (i.e. anti CD20, rituximab, Y-ibritumomab tiuxetan, veltuzumab, ofatumumab, obinatuzumab, ocrelizumab), without a malignant disease
• Bone marrow transplant (up to a year from the BMT) from outside donors, or with GVHD grades 3-4.
• Bone marrow transplant (up to a 6 months after the BMT) from self
• Patients after (CAR) T-cell therapy (chimeric antigen receptor T-cell therapy) up to 6 months from the treatment.
• Lungs transplant recipients
• Solid organ transplant recipients (who has any kind of transplant) or those who received ATG (anti thymocyte globulin) over the last 6 months
• Patients with aggressive lymphoma.
• Multiple Myeloma patients that have active disease, and on treatment at the time of study initiation.
• Individuals who meet the criterion below will be excluded:
• Per the current FDA EUA, individuals currently infected with SARS-CoV-2 are not eligible for EVUSHELD as PrEP. Therefore, in the main analysis, individuals who meet the following criteria will also be excluded.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead
• Clalit Health Services: collaborator

Study Sites (1)

Research Site

Ramat Gan, Israel

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: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 3, 2023
• Study Start: March 9, 2023
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: January 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

IL (1)