Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712096
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-01-26
Brief Title:
eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
An Observational Study to Assess the Real-world Effectiveness of EVUSHELD TixagevimabCilgavimab as Pre-exposure Prophylaxis Against COVID-19 Among Immunocompromised Patients in Israel
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VALOR C19 IL
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None