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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 4,000
- Locations
- 1
- Primary Endpoint
- Hospitalisation due to COVID-19
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
EVUSHELD Arm
Individuals given EVUSHELD for pre-exposure prophylaxis
Intervention: EVUSHELD (Drug)
Outcomes
Primary Outcomes
Hospitalisation due to COVID-19
Time Frame: 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
Time Frame: up to 6 months
All-cause deaths reported in the patient's record
Secondary Outcomes
- 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)
- Documented SARS-CoV-2 Infection, COVID-19 related mortality, Severe COVID-19(6 months and 12 months)
- SAEs/AESIs(6 months)
- Adverse events (AEs)(12 months)