Methods of prognosis and treatment
Inventors
MASTBOIM, Niv Steven • GOTTLIEB, Tanya Michelle • Oved, Kfir • Eden, Eran
Assignees
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Publication Number
US-11921119-B2
Publication Date
2024-03-05
Expiration Date
Abstract
A method of determining a management course for treating a subject showing symptoms of a disease is disclosed. The method comprises measuring the TRAIL protein level in a blood sample of the subject, wherein when the TRAIL level is above a predetermined amount, the subject is treated as a low-risk patient.
Core Innovation
The invention relates to TRAIL (tumor necrosis factor-related apoptosis-inducing ligand) protein based risk stratification and determining a management course for subjects having a diagnosis as having a severe coronaviral infection, including coronavirus infection and coronavirus/COVID-19. A TRAIL protein level is measured in a blood sample, and the measured TRAIL level is used as a basis for selecting a management course.
A predetermined TRAIL threshold is applied to guide the selection of care intensity. When the TRAIL level is above 145 pg/ml, the method determines a management course that includes cessation of mechanical ventilation, cessation of invasive monitoring, cessation of last-resort drug administration, cessation of sedation, transfer out of intensive care, and release from hospital. When the TRAIL level is below 145 pg/ml, the method determines a management course including anti-viral treatment, immunomodulatory treatment, mechanical ventilation, invasive monitoring, last-resort drug administration, sedation, intensive care admission, surgical intervention, and hospital admittance.
The described approach also specifies how the TRAIL level is measured and supported, including measurement in a blood sample and immunochemical and/or electrophoretic determination, with immunoassay platforms such as lateral flow immunoassay, flow cytometry, radioimmunoassay, immunofluorescence, and ELISA. Additional biomarker panel support is described using biomarkers such as IP10, CRP, PCT, and IL-6 to further inform the determination and to provide diagnostic performance criteria.
Claims Coverage
The document includes two independent claims. The independent claim set covers determining a management course by measuring a TRAIL protein level and selecting between specified care actions using a TRAIL threshold of 145 pg/ml, with additional dependents specifying biomarker panels, blood sample fraction/cell context, and TRAIL measurement modalities and endpoints.
TRAIL threshold based management course selection for severe coronaviral infection
A method of determining a management course for a subject who has a diagnosis as having a severe coronaviral infection by measuring tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) protein level in a blood sample and, when the TRAIL level is above 145 pg/ml, selecting a management course including cessation of mechanical ventilation, cessation of invasive monitoring, cessation of last-resort drug administration, cessation of sedation, transfer out of intensive care, and release from hospital.
TRAIL below-threshold management course selection for coronaviral infection
A method of determining a management course for a subject having a coronaviral infection by measuring TRAIL protein level in a blood sample and, when the TRAIL level is below 145 pg/ml, selecting a management course including anti-viral treatment, immunomodulatory treatment, mechanical ventilation, invasive monitoring, last-resort drug administration, sedation, intensive care admission, surgical intervention, and hospital admittance.
Across the independent claims, the main inventive aspect is using measured TRAIL protein levels in a blood sample to determine and select among a predefined group of management course actions, with decision thresholds at 145 pg/ml to distinguish between the selected high-TRAIL and low-TRAIL management courses.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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