Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05848427
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2023-05-05
Brief Title:
The LUSZ COVID-19 Severity Index A Prognostic and Predictive Score of Mortality for Hospitalized Patients With Covid-19
Sponsor:
Lebanese University
Organization:
Lebanese University
Study Overview
Official Title:
The LUSZ COVID-19 Severity Index A Prognostic and Predictive Score of Mortality for Hospitalized Patients With Covid-19
Status:
RECRUITING
Status Verified Date:
2024-04
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:
LUSZ_SCORE
Brief Summary:
The coronavirus disease 2019 COVID-19 has spread rapidly and caused a global pandemic as defined by the WHO within a short period of time The prognostic of disease severity is still a challenge and early identification of risk factors to be involved in its progression is of high importance The scoring of variables related to worse outcomes is key for a targeted andor advanced protocol Besides the need for a predictive-wide model is mandatory for hospitalized unvaccinated patients to avoid any delay in the characterization of severe illness and the development of complications The LUSZ COVID-19 Severity Index was developed as a predictive tool based on 100 risk factorsbiomarkers that could effectively identify high-risk patients and prevent mortality
Detailed Description:
The scientific community is in urgent need of reliable biomarkers related to COVID-19 disease progression in order to stratify high-risk patients The rapid disease spread necessitates the immediate categorization of patients into risk groups following diagnosis to ensure optimal resource allocation Novel biomarkers are needed to identify patients who will suffer rapid disease progression to severe complications and death The identification of novel biomarkers is strictly related to the understanding of viral pathogenetic mechanisms as well as cellular and organ damage Effective biomarkers would be helpful for screening clinical management and prevention of serious complications
Indeed previous studies suggested and developed predictive scores CALL Chosen HA2T2 ANDC ABC2-SPH ICOP SEIMC IRS NLP APACHE II GRAM and others that estimate the severity of the disease the risk of needing invasive mechanical ventilation IMV among patients with COVID-19 and the risk of mortality Many scores including so many relevant parameters have been used to predict the status of a patient In addition to comorbidities age etc some hematological parameters including white blood cell WBC lymphopenia c-Reactive Protein CRP and some biochemical parameters such as lactate dehydrogenase LDH creatine kinase CK and troponin were reported to be associated with COVID-19 severity In fact the patients initial laboratory scoring is useful but not sufficient to avoid mortality high neutrophil count 07 103μL lymphopenia 08 103μL elevated CRP 475 mgdL and elevated LDH 593 UL were the most important predictors of mortality Another prognostic marker the lymphocyte-to-CRP ratio LCR was also helpful A rise in the NLR and a decline in LCR correlates with the severity of COVID-19 Specifically a low LCR at presentation was seen to predict ICU admission and the need for invasive ventilation Patients critically ill with COVID-19 had a hyperinflammation the associated biomarkers may be beneficial for risk stratification Many studies found other associations with serum CRP procalcitonin PCT D-dimer and serum ferritin Subsequent studies demonstrate that the inflammatory response plays a critical role in COVID-19 and inflammatory cytokine storm increases the severity of COVID-19 In fact the serum levels of IL-6 can effectively assess disease severity and predict outcomes in patients with COVID-19 So these prognostic models have been introduced to guide treatment and resource management
In this study we aimed to specify high-risk factors and biomarkers of fatal outcomes in hospitalized subjects with coronavirus depending on many variables analysis and also to compare the efficacy of targeted treatments antiviral antiretroviral immunosuppressive antagonist etc in order to help clinicians better choose a therapeutic strategy
The population had been divided into groups according to the WHO Ordinal Clinical Severity Scale on which the LUSZ SCORE was applied The percentage of mortality in and out of the hospital the length of stay in the hospital the pulmonary inflammatory lesions and their distribution the SARS-CoV-2 IgM and IgG variations at admission the inflammatory markers the complete blood count the coagulation factors and enzymes proteins and electrolytes profile glucose and lipid profile and others were measured before and after LUSZ scoring The establishment of this novel predictive scoring model of disease progression may help identify patients with COVID-19 who may subsequently develop a critical illness Thus we can improve the therapeutic effect and reduce the mortality of COVID-19 with more accurate and efficient use of medical resources which helps to deliver proper treatment according to each case
Indeed previous studies suggested and developed predictive scores CALL Chosen HA2T2 ANDC ABC2-SPH ICOP SEIMC IRS NLP APACHE II GRAM and others that estimate the severity of the disease the risk of needing invasive mechanical ventilation IMV among patients with COVID-19 and the risk of mortality Many scores including so many relevant parameters have been used to predict the status of a patient In addition to comorbidities age etc some hematological parameters including white blood cell WBC lymphopenia c-Reactive Protein CRP and some biochemical parameters such as lactate dehydrogenase LDH creatine kinase CK and troponin were reported to be associated with COVID-19 severity In fact the patients initial laboratory scoring is useful but not sufficient to avoid mortality high neutrophil count 07 103μL lymphopenia 08 103μL elevated CRP 475 mgdL and elevated LDH 593 UL were the most important predictors of mortality Another prognostic marker the lymphocyte-to-CRP ratio LCR was also helpful A rise in the NLR and a decline in LCR correlates with the severity of COVID-19 Specifically a low LCR at presentation was seen to predict ICU admission and the need for invasive ventilation Patients critically ill with COVID-19 had a hyperinflammation the associated biomarkers may be beneficial for risk stratification Many studies found other associations with serum CRP procalcitonin PCT D-dimer and serum ferritin Subsequent studies demonstrate that the inflammatory response plays a critical role in COVID-19 and inflammatory cytokine storm increases the severity of COVID-19 In fact the serum levels of IL-6 can effectively assess disease severity and predict outcomes in patients with COVID-19 So these prognostic models have been introduced to guide treatment and resource management
In this study we aimed to specify high-risk factors and biomarkers of fatal outcomes in hospitalized subjects with coronavirus depending on many variables analysis and also to compare the efficacy of targeted treatments antiviral antiretroviral immunosuppressive antagonist etc in order to help clinicians better choose a therapeutic strategy
The population had been divided into groups according to the WHO Ordinal Clinical Severity Scale on which the LUSZ SCORE was applied The percentage of mortality in and out of the hospital the length of stay in the hospital the pulmonary inflammatory lesions and their distribution the SARS-CoV-2 IgM and IgG variations at admission the inflammatory markers the complete blood count the coagulation factors and enzymes proteins and electrolytes profile glucose and lipid profile and others were measured before and after LUSZ scoring The establishment of this novel predictive scoring model of disease progression may help identify patients with COVID-19 who may subsequently develop a critical illness Thus we can improve the therapeutic effect and reduce the mortality of COVID-19 with more accurate and efficient use of medical resources which helps to deliver proper treatment according to each case
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?:
False
Is an FDA AA801 Violation?:
None