eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services

COVID-19 Clinical Trial

— VALOR C19 IL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712096
• Other study ID #: D8850R00002
• Status: Completed
• Start date: March 9, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Drug:
• EVUSHELD
EVUSHELD (AZD 7442, Tixagévimab/Cilgavimab)

Locations

Country	Name	City	State
Israel	Research Site	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	All-cause mortality	All-cause deaths reported in the patient's record	up to 6 months
Secondary	Documented SARS-CoV-2 Infection, COVID-19 related mortality, Severe COVID-19	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	6 months and 12 months
Secondary	COVID-19 mortality	Any record indicating death due to COVID-19 or record of death certificate mentioning SARS-CoV-2 as cause of death.	6 months and 12 months
Secondary	COVID-19-related healthcare resource utilization (HCRU)	Any record of COVID-19 hospitalisation, ICU admission, mechanical ventilation and prescriptions of therapies for COVID-19	6 months
Secondary	COVID-19-related healthcare resource utilization	Any record of hospital admission including hospital lenght of stay, ICU, mechanical ventilation, prescription/dispensations of antiviral drugs used for COVID-19 drugs	6 months
Secondary	SAEs/AESIs	Any record of Serious Adverse Events (SAEs) or Adverse Events of Special Interests (AESIs) up to 6 months following initiation of Evusheld	6 months
Secondary	Adverse events (AEs)	Any record of Adverse events up to 12 months following initiation of Evusheld	12 months