COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease
Conditions
Keywords
Evusheld, tixagevimab and cilgavimab, Pre-exposure prophylaxis, COVID-19, SARS-CoV-2, Effectiveness
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 EUA-eligible patient population treated in DoD Health system.
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 EUA-eligible patient population in the DoD health system.
Interventions
DRUGEVUSHELD
Tixagevimab (AZD8895) and cilgavimab (AZD1061)
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Receipt of Evusheld under the FDA EUA for Evusheld 2. Eligibility for Evusheld use under the EUA. -
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Hospitalisation | up to 6 months | To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalizations up to 6 months following its initial administration |
| All-cause mortality | up to 6 months | To compare all-cause mortality up to 6 months following the initial dose of EVUSHELD, among subjects who did and did not receive EVUSHELD as PrEP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 hospitalisation | Up 12 months | To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation at 12 month |
| Documented SARS-CoV-2 infection | Up to 6 and 12 months | To assess the effectiveness of EVUSHELD as PrEP against SARS-CoV-2 infection |
| COVID-19 related mortality | Up to 6 and 12 months | To assess the effectiveness of EVUSHELD as PrEP against COVID-19-related mortality |
| COVID-19 Intensive Care Unit (ICU) admisssion | Up 6 and 12 months | To assess the effectiveness of EVUSHELD as PrEP against ICU admission |
| Medically attended COVID-19 | Up to 6 and 12 months | To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19 |
Countries
United States
Outcome results
None listed