Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925140
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2023-06-28
Brief Title:
LUSZ Treatment Efficacy in Hospitalized COVID-19 Patients
Sponsor:
Lebanese University
Organization:
Lebanese University
Study Overview
Official Title:
Comparative LUSZ Therapeutic Study of Antiviral Antiretroviral and Immunosuppressive Treatments in Hospitalized COVID-19 Patients With High-Risk Factors Biomarkers and Disease Progression
Status:
RECRUITING
Status Verified Date:
2024-02
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_AVIST
Brief Summary:
This study aims first to assess the efficacy safety and effectiveness of the LUSZ COVID-19 therapy consisting of a comparative study of three different treatment approaches antiviral antiretroviral and immunosuppressive IL-6 receptor antagonist and second to identify high-risk factors and biomarkers associated with fatal outcomes in hospitalized COVID-19 patients The study seeks to validate a novel predictive scoring model for disease progression and evaluate the impact of these treatments on mortality admission to the intensive care unit ICU and time to recovery
Detailed Description:
The ongoing COVID-19 pandemic has posed significant challenges worldwide necessitating the evaluation of various treatment options to mitigate disease severity and improve patient outcomes This study aims to conduct a comparative therapeutic analysis of antiviral antiretroviral and immunosuppressive treatments in hospitalized COVID-19 patients named here the COVID-19 LUSZ Therapeutic Stduy By assessing the efficacy and effectiveness of these treatment modalities as well as considering high-risk factors biomarkers and disease progression we seek to provide valuable insights into their relative benefits and inform evidence-based therapeutic strategies
Hypothesis
Our hypothesis is that certain antiviral antiretroviral and immunosuppressive treatments can effectively mitigate disease progression and improve clinical outcomes in hospitalized COVID-19 patients with different degrees of illness severity as classified by the WHO Ordinary Severity Scale WOSS adjusted to LUSZ scoring We postulate that the choice of treatment may depend on the presence of high-risk factors and the underlying immune response as reflected by biomarker profiles
Study Design
This study will adopt a prospective comparative design analyzing medical records of hospitalized COVID-19 patients from multiple healthcare facilities and evaluating the disease progression The inclusion criteria will encompass patients diagnosed with COVID-19 and receiving either antiviral antiretroviral or immunosuppressive treatments Patients with comorbidities varying levels of disease severity and different treatment durations will be included to reflect real-world clinical scenarios
Data Collection
Key variables of interest will include patient demographics medical history disease severity at admission laboratory results radiology results treatment regimen treatment duration and clinical outcomes High-risk factors such as advanced age immunocompromised status and comorbidities will be specifically analyzed The pulmonary inflammatory lesion biomarkers including inflammatory markers cytokines and viral load will be assessed at various time points to evaluate treatment response and disease progression
Analysis
Descriptive statistics will be employed to summarize patient characteristics treatment modalities and clinical outcomes Comparative analysis will be performed to assess the efficacy and effectiveness of antiviral antiretroviral and immunosuppressive treatments Statistical methods such as chi-square tests t-tests Kaplan-Meier survival analysis and regression analysis will be utilized to examine associations between treatment regimens and clinical outcomes Subgroup analyses will be conducted to evaluate treatment response based on high-risk factors and biomarker profiles applying the LUSZ score
Targets and Significance
The primary targets of this study are to compare the therapeutic effects of antiviral antiretroviral and immunosuppressive treatments in hospitalized COVID-19 patients and identify potential predictors of treatment response By elucidating the relative benefits and limitations of these treatment modalities we aim to contribute to evidence-based clinical decision-making enhance patient care and optimize resource allocation Additionally this study will provide valuable insights into the interplay between high-risk factors biomarkers and disease progression which can aid in the development of personalized treatment approaches for COVID-19 patients
In conclusion this comparative LUSZ therapeutic study in hospitalized COVID-19 patients will provide valuable evidence regarding the efficacy and effectiveness of the LUSZ COVID-19 therapy By considering high-risk factors biomarkers and disease progression we aim to shed light on the optimal treatment strategies for different patient populations The findings of this study have the potential to inform clinical practice improve patient outcomes and contribute to the ongoing efforts to combat the COVID-19 pandemic
Hypothesis
Our hypothesis is that certain antiviral antiretroviral and immunosuppressive treatments can effectively mitigate disease progression and improve clinical outcomes in hospitalized COVID-19 patients with different degrees of illness severity as classified by the WHO Ordinary Severity Scale WOSS adjusted to LUSZ scoring We postulate that the choice of treatment may depend on the presence of high-risk factors and the underlying immune response as reflected by biomarker profiles
Study Design
This study will adopt a prospective comparative design analyzing medical records of hospitalized COVID-19 patients from multiple healthcare facilities and evaluating the disease progression The inclusion criteria will encompass patients diagnosed with COVID-19 and receiving either antiviral antiretroviral or immunosuppressive treatments Patients with comorbidities varying levels of disease severity and different treatment durations will be included to reflect real-world clinical scenarios
Data Collection
Key variables of interest will include patient demographics medical history disease severity at admission laboratory results radiology results treatment regimen treatment duration and clinical outcomes High-risk factors such as advanced age immunocompromised status and comorbidities will be specifically analyzed The pulmonary inflammatory lesion biomarkers including inflammatory markers cytokines and viral load will be assessed at various time points to evaluate treatment response and disease progression
Analysis
Descriptive statistics will be employed to summarize patient characteristics treatment modalities and clinical outcomes Comparative analysis will be performed to assess the efficacy and effectiveness of antiviral antiretroviral and immunosuppressive treatments Statistical methods such as chi-square tests t-tests Kaplan-Meier survival analysis and regression analysis will be utilized to examine associations between treatment regimens and clinical outcomes Subgroup analyses will be conducted to evaluate treatment response based on high-risk factors and biomarker profiles applying the LUSZ score
Targets and Significance
The primary targets of this study are to compare the therapeutic effects of antiviral antiretroviral and immunosuppressive treatments in hospitalized COVID-19 patients and identify potential predictors of treatment response By elucidating the relative benefits and limitations of these treatment modalities we aim to contribute to evidence-based clinical decision-making enhance patient care and optimize resource allocation Additionally this study will provide valuable insights into the interplay between high-risk factors biomarkers and disease progression which can aid in the development of personalized treatment approaches for COVID-19 patients
In conclusion this comparative LUSZ therapeutic study in hospitalized COVID-19 patients will provide valuable evidence regarding the efficacy and effectiveness of the LUSZ COVID-19 therapy By considering high-risk factors biomarkers and disease progression we aim to shed light on the optimal treatment strategies for different patient populations The findings of this study have the potential to inform clinical practice improve patient outcomes and contribute to the ongoing efforts to combat the COVID-19 pandemic
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?:
True
Is an FDA AA801 Violation?:
None