Clinical trial NCT05712096: eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services
Official title: An Observational Study to Assess the Real-world Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among Immunocompromised Patients in Israel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
COVID-19
Keywords: SARS-CoV-2
COVID-19
Immunocompromised Patients
Pre-exposure Prophylaxis Against COVID-19
Evusheld
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Clalit Health Services
First posted: 2023-02-03
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All EVUSHELD PrEP-eligible patient population in the Clalit Health Services system

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.

Eligibility 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)

Primary outcomes:
measure: Hospitalisation due to COVID-19
timeFrame: up to 6 months
measure: All-cause mortality
timeFrame: up to 6 months
Secondary outcomes:
measure: Documented SARS-CoV-2 Infection, COVID-19 related mortality, Severe COVID-19
timeFrame: 6 months and 12 months
measure: COVID-19 mortality
timeFrame: 6 months and 12 months
measure: COVID-19-related healthcare resource utilization (HCRU)
timeFrame: 6 months
measure: COVID-19-related healthcare resource utilization
timeFrame: 6 months
measure: SAEs/AESIs
timeFrame: 6 months
measure: Adverse events (AEs)
timeFrame: 12 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Research Site
Study officials:
References: