LUSZ Treatment Efficacy in Hospitalized COVID-19 Patients
- Conditions
- COVID-19Hospitalized COVID-19 Patients
- Interventions
- Other: Corticosteroid Therapy-enhanced Standard Care (CTSC)
- Registration Number
- NCT05925140
- Lead Sponsor
- Lebanese University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LUSZ Antivirals Group: CTSC + Remdesivir or Lopinavir/Ritonavir. Remdesivir (RDV) The Antivirals group receives the standard care treatment with corticosteroid therapy in combination with antiviral (Remdesivir) or antiretroviral (Lopinavir/Ritonavir) medications. LUSZ Antivirals Group: CTSC + Remdesivir or Lopinavir/Ritonavir. Lopinavir / Ritonavir The Antivirals group receives the standard care treatment with corticosteroid therapy in combination with antiviral (Remdesivir) or antiretroviral (Lopinavir/Ritonavir) medications. LUSZ Control group: Corticosteroid Therapy-enhanced Standard Care (CTSC) alone. Corticosteroid Therapy-enhanced Standard Care (CTSC) The control group receives the standard care treatment with corticosteroid therapy. LUSZ Antivirals Group: CTSC + Remdesivir or Lopinavir/Ritonavir. Corticosteroid Therapy-enhanced Standard Care (CTSC) The Antivirals group receives the standard care treatment with corticosteroid therapy in combination with antiviral (Remdesivir) or antiretroviral (Lopinavir/Ritonavir) medications. LUSZ Immunosuppressive Group: CTSC + IL-6 receptor antagonist (Tocilizumab). Corticosteroid Therapy-enhanced Standard Care (CTSC) The Immunosuppressive group receives the standard care treatment with corticosteroid therapy in combination with Tocilizumab, an IL-6 receptor antagonist. LUSZ Immunosuppressive Group: CTSC + IL-6 receptor antagonist (Tocilizumab). Tocilizumab The Immunosuppressive group receives the standard care treatment with corticosteroid therapy in combination with Tocilizumab, an IL-6 receptor antagonist.
- Primary Outcome Measures
Name Time Method Mortality rate 28-day mortality rate The number of deaths recorded in each arm over a specified period
Clinical improvement rate 28-day mortality rate The proportion of patients showing improvement in clinical symptoms and overall health status in each arm
- Secondary Outcome Measures
Name Time Method Disease progression rate 28-day period The rate at which patients experience disease progression, such as the development of severe respiratory distress or organ failure, within a 28-day period.
Adverse events 28-day period The occurrence of any adverse events or side effects related to the treatments in each arm, including drug-related complications or complications associated with immunosuppression, within a 28-day period.
Biomarker changes 28-day period Evaluation of changes in specific biomarkers associated with disease severity, inflammation, immune response, or organ dysfunction in each treatment arm within a 28-day period.
Questionnaire about the quality of life 28-day period Assessment of patients' quality of life measures, including physical functioning, psychological well-being, and social aspects, using standardized questionnaires within a 28-day period.
Time to clinical recovery 28-day period The duration taken for patients to achieve clinical recovery, such as resolution of fever, improvement in respiratory symptoms, and normalization of laboratory markers within 28-day period.
Viral clearance rate 28-day period The rate at which patients in each treatment arm achieve clearance of the SARS-CoV-2 virus from respiratory samples, indicating a reduction in viral replication, within a 28-day period.
Healthcare resource utilization 28-day period Examination of the utilization of healthcare resources, such as the need for intensive care, mechanical ventilation, or other supportive interventions, in each treatment arm within a 28-day period.
Length of hospital stay 28-day period The number of days patients spend in the hospital from admission to discharge or until a predefined endpoint within a 28-day period.
Trial Locations
- Locations (2)
Lebanese University
🇱🇧Tripoli, Lebanon
SZUMC
🇱🇧Zgharta, North, Lebanon