eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services (VALOR C19 IL)

AstraZeneca

Status

Completed

Conditions

COVID-19

SARS-CoV-2

Treatments

Drug: EVUSHELD

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05712096

D8850R00002

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,000 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Individuals who meet all criteria below will be included. The eligibility criteria aligns with the guidelines of the Israeli Ministry of Health

Inclusion criteria:

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.

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)