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.
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 Type
OBSERVATIONAL
Enrollment
4,000
EVUSHELD (AZD 7442, Tixagévimab/Cilgavimab)
Research Site
Ramat Gan, Israel
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
Time frame: up to 6 months
All-cause mortality
All-cause deaths reported in the patient's record
Time frame: up to 6 months
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
Time frame: 6 months and 12 months
COVID-19 mortality
Any record indicating death due to COVID-19 or record of death certificate mentioning SARS-CoV-2 as cause of death.
Time frame: 6 months and 12 months
COVID-19-related healthcare resource utilization (HCRU)
Any record of COVID-19 hospitalisation, ICU admission, mechanical ventilation and prescriptions of therapies for COVID-19
Time frame: 6 months
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
Time frame: 6 months
SAEs/AESIs
Any record of Serious Adverse Events (SAEs) or Adverse Events of Special Interests (AESIs) up to 6 months following initiation of Evusheld
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Time frame: 6 months
Adverse events (AEs)
Any record of Adverse events up to 12 months following initiation of Evusheld
Time frame: 12 months