METHOD FOR ASSESSING THE SEVERITY OF SARS

Abstract

The present invention relates to a method for assessing the severity of Severe Acute Respiratory Syndrome (SARS) in a patient; said method being based on a severity score consisting of at least: a) a respiratory system score, b) a score determined by the level of pancreatic stone protein/regenerating protein (PSP/reg) in a body fluid sample from said patient. The invention may be used in a healthcare unit for sorting patients to decide the treatment priority

Claims

1. A method for assessing the severity of Severe Acute Respiratory Syndrome (SARS) in a patient, said method being based on a severity score composed of at least: a) a respiratory system score, b) a score determined by the level of pancreatic stone protein/regenerating protein (PSP/reg) in a body fluid sample from said patient.

2. The method of claim 1 for assessing the severity of SARS-CoV-2 (Covid-19).

3. The method of claim 1 comprising the following steps: a) Providing a body fluid sample from said patient; b) Determining the level of pancreatic stone protein/regenerating protein (PSP/reg) in said sample; c) Determining the PSP/reg score; d) Determining the respiratory score; e) Determining the severity score by adding the PSP/reg and respiratory score.

4. The method of claim 1 wherein the severity score also includes another biomarker score.

5. The method of claim 4 wherein said biomarker is C-Reactive Protein (CRP).

6. The method of claim 1 wherein the body fluid sample is a serum, plasma, whole blood sample, saliva, urine, sputum, cerebrospinal fluid, tear fluid, sweat, milk, or extracts from solid tissue or from fecal matter.

7. The method of claim 1 wherein the respiratory score is obtained by assessing how the patient has difficulties to breath, needs oxygen support or mechanical ventilation (invasive and non-invasive).

8. The method of claim 1 wherein a severity score of less than 1 is indicating a low risk of clinical complications and/or deteriorations.

9. The method of claim 1 wherein a severity score greater than 3 is indicative of high risk of developing severe viral sepsis (severe cytokine storm), bacterial sepsis, multiple organ failures and/or death.

10. The method of claim 1 wherein the level of PSP/reg is determined by ELISA, RIA, EIA, mass spectrometry, microarray analysis or any fluidic assay methods.

11. Use of the severity score as defined in claim 1 for patient triage, sorting, orientation, positioning and/or stratification in a healthcare unit.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0030] The invention is explained in a more precise way in the present chapter, with the support of the following figures:

[0031] FIG. 1 shows how the severity score of Covid-19 patients is determined. The severity score called Covid-19 sequential organ failure assessment (cSOFA) is composed of the sum of the respiratory score (RESP.sub.SCORE) and the PSP score (PSP.sub.SCORE). The RESP.sub.SCORE is established by the practitioner as indicated in the table and directly linked to the PaO.sub.2/FiO.sub.2 measurement also known as the respiratory dysfunction component of the SOFA score. The PSP.sub.SCORE is derived from the measured PSP/reg level as indicated in the table.

RESP.sub.SCORE+PSP.sub.SCORE=cSOFA (Covid-19 sequential organ failure assessment)

[0032] FIG. 2a shows the correlation between the cSOFA score and the generally known SOFA score. Each point represents an averaged cSOFA-SOFA comparison over the ICU stay for each patient. 96 patients at ICU have been included in this analysis. The white area represents a maximum of 2 classes difference between cSOFA and SOFA scores. The light grey area represents a maximum of 3 classes difference between cSOFA and SOFA scores, and the dark grey area represents a 4-classes or more difference between cSOFA and SOFA scores. FIG. 2b illustrates the distribution of patients included in the analysis, showing cSOFA and SOFA scores class differences.

[0033] FIG. 3 shows how the cSOFA is interpreted according its level for the positioning of the patient clinical severity and his orientation. A cSOFA score equal to zero indicates a low risk of clinical deterioration, thus the orientation of sending the patient home should be considered. A cSOFA score between 1 and 3 indicates a medium risk of clinical deterioration, thus hospitalization should be considered. A cSOFA score above 3 indicates a high risk of clinical deterioration, thus transferring the patient to intermediate care unit or intensive care unit should be considered.

[0034] FIG. 4 shows a decision tree for triage and orientation of patients according to the cSOFA score level as illustrated in FIG. 3.

[0035] As defined in those illustrated examples that refer to SARS-CoV-2, the severity score is called Covid-19 sequential organ failure assessment (cSOFA) and is composed of the sum of the respiratory score (RESP.sub.SCORE) and the PSP score (PSP.sub.SCORE). The RESP.sub.SCORE is identical to the respiratory dysfunction component of the SOFA score. It may be established by the practitioner's appreciation as shown in FIG. 1 and/or, if available, directly derived from the PaO.sub.2/FiO.sub.2 measurement according the scoring system of the SOFA score. The PSP.sub.SCORE is established based on the measured patient level of pancreatic stone protein/regenerating protein PSP/reg in body fluids according to the table set forth in FIG. 1.

[0036] Body fluids useful for determination of PSP/reg levels are e.g. whole blood, serum, plasma, urine, sputum, cerebrospinal fluid, tear fluid, saliva, sweat, milk, or extracts from solid tissue or from fecal matter.

[0037] Any known method may be used for the determination of the level of PSP/reg in body fluids. Methods considered are e.g. ELISA, RIA, EIA, mass spectrometry, or microarray analysis and any fluidic assay methods.

[0038] The obtained cSOFA score from 0 to 10 correlates well to the well-established SOFA score from 0 to 10 for Covid-19 patients as shown in FIG. 2. The SOFA score is an expression of the extent of organ dysfunction at a given time and is widely used today to assess organ failure, sepsis and septic shock. This score is complex and based on multiple clinical parameters and is therefore cumbersome to establish, reason why it is mainly used in intensive care units. The cSOFA score is based on only two parameters that can quickly be measured and calculated. It can be determined easily by any healthcare professional and therefore it is an alternative for the SOFA score. In particular, as the SOFA score is usually used in intensive care settings, the cSOFA score becomes a solution in all other settings (emergency department, general ward, primary care, testing centers, etc.) where the SOFA score is currently not readily available or calculated. In consequence, the use of the cSOFA score in these other settings allows to determine clinical complication, deterioration, triage and orientation of Covid-19 patients.

[0039] As described in FIG. 3 a cSOFA score equal to zero indicates a low risk of clinical deterioration, thus the orientation of sending the patient home should be considered. A cSOFA score between 1 and 3 indicates a medium risk of clinical deterioration, thus hospitalization should be considered. A cSOFA score above 3 indicates a high risk of clinical deterioration including risk of multiple organ failures, bacterial sepsis and severe viral sepsis (severe cytokine storm), thus transferring the patient to intermediate care unit or intensive care unit should be considered.

[0040] Based on the described classification of the cSOFA score (see FIG. 3) a decision tree for the triage, sorting and orientation of Covid-19 patients is established as shown in FIG. 4. At the emergency department, primary care settings or triage centers the cSOFA score is established once at admission for the purpose of triage and the identification of clinical severity. During hospitalization the cSOFA score is established at least on a daily manner for the same purpose.

[0041] The invention is not limited to the assessment of SARS-CoV-2 but may also be advantageously used with patients infected by any type of SARS.