Cytokine Storm Scoring Algorithm for Biomarker-Based Risk Stratification

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Solution Overview

Problem

Current treatments for COVID-19, particularly for patients requiring ICU care, face challenges due to inadequate identification of determinant cytokines driving cytokine storms and a lack of reliable methods to quantify cytokine storm severity, which hinders effective clinical management.

Innovation Solution

The use of biomarkers such as MCP-3, IL-8, IFN-α2, and IFN-γ to identify patients at risk of severe symptoms, allowing for targeted immunomodulation therapies and early intervention to prevent ICU admission and mortality.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If immunomodulatory therapies are administered to COVID-19 patients, then clinical outcomes may be improved by dampening excessive inflammatory response, but the determinant cytokines driving cytokine storm remain inconclusive and treatment targeting is inadequate

Engineering Contradiction:
Improveclinical outcomeVSAvoiddeterminant cytokine identification
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The patent transforms the qualitative assessment of cytokine storm into a quantitative measurement system by developing a scoring algorithm that computes cytokine storm severity based on multiple cytokine parameters (IL-6, IL-10, TNF-α, IP-10, MCP-1, MIP-1α, G-CSF). This enables precise identification of determinant cytokines and their relative contributions to disease severity, resolving the inconclusiveness of previous studies.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces the traditional mechanical approach of individual cytokine measurement with a computational system that integrates multiple cytokine levels through a scoring algorithm. This computational mechanism substitutes for the inadequate visual or qualitative assessment methods, providing objective and reproducible identification of cytokine storm drivers.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If multiple cytokines are measured to assess cytokine storm severity, then more comprehensive evaluation is achieved, but lack of uniform evaluation standard makes clinical management guidance difficult

Engineering Contradiction:
Improvecytokine storm severity assessmentVSAvoidevaluation standard uniformity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent creates a universal evaluation standard that can be applied across different clinical settings and patient populations. The cytokine storm scoring algorithm serves as a multi-functional tool that not only assesses severity but also identifies determinant cytokines, predicts ICU admission risk, and guides treatment decisions, thereby simplifying clinical management despite measuring multiple cytokines.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent merges multiple individual cytokine measurements into a single integrated scoring system. By combining the levels of seven different cytokines into one composite score, the system maintains comprehensive evaluation capability while providing a unified metric that simplifies clinical interpretation and decision-making.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If ICU patients receive current available treatments, then some clinical benefit may be achieved, but mortality remains high due to inadequate identification of high-risk patients and determinant cytokines

Engineering Contradiction:
Improvemortality rateVSAvoidhigh-risk patient identification
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The patent enables preliminary identification of high-risk patients before they deteriorate to critical condition. By measuring cytokine levels early in the disease course and computing the cytokine storm score, clinicians can identify patients at high risk of ICU admission and fatal outcome in advance, allowing for proactive intervention with immunomodulatory therapies before irreversible damage occurs.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent establishes a feedback mechanism where cytokine levels are measured, processed through the scoring algorithm, and the results feed back into clinical decision-making. This feedback loop allows continuous monitoring of cytokine storm severity and adjustment of treatment strategies based on quantitative assessment, improving outcomes by targeting therapy to the right patients at the right time.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS11275091B2SARS-COV-2 infection biomarkers and uses thereof
Publication Date: 2022.03.15 CHILDRENS HOSPITAL MEDICAL CENT CINCINNATI
  • US11275091B2 patent drawing
  • US11275091B2 patent drawing
  • US11275091B2 patent drawing

AI summary

Disclosed herein are methods that employ the use of one or more biomarkers for the treatment of SARS-CoV-2 infected individuals (COVID-19 patients). The methods may employ detection and measurement of one or more cytokines, the measurement of which may be used to treat COVID-19 patients with one or more immunomodulatory therapies.