Comparative LUSZ Therapeutic Study of Antiviral, Antiretroviral, and Immunosuppressive Treatments in Hospitalized COVID-19 Patients With High-Risk Factors, Biomarkers, and Disease Progression.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Mortality rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LUSZ Control group: Corticosteroid Therapy-enhanced Standard Care (CTSC) alone.
The control group receives the standard care treatment with corticosteroid therapy.
干预措施: Corticosteroid Therapy-enhanced Standard Care (CTSC) (Other)
LUSZ Antivirals Group: CTSC + Remdesivir or Lopinavir/Ritonavir.
The Antivirals group receives the standard care treatment with corticosteroid therapy in combination with antiviral (Remdesivir) or antiretroviral (Lopinavir/Ritonavir) medications.
干预措施: Lopinavir / Ritonavir (Drug)
LUSZ Antivirals Group: CTSC + Remdesivir or Lopinavir/Ritonavir.
The Antivirals group receives the standard care treatment with corticosteroid therapy in combination with antiviral (Remdesivir) or antiretroviral (Lopinavir/Ritonavir) medications.
干预措施: Remdesivir (RDV) (Drug)
LUSZ Antivirals Group: CTSC + Remdesivir or Lopinavir/Ritonavir.
The Antivirals group receives the standard care treatment with corticosteroid therapy in combination with antiviral (Remdesivir) or antiretroviral (Lopinavir/Ritonavir) medications.
干预措施: Corticosteroid Therapy-enhanced Standard Care (CTSC) (Other)
LUSZ Immunosuppressive Group: CTSC + IL-6 receptor antagonist (Tocilizumab).
The Immunosuppressive group receives the standard care treatment with corticosteroid therapy in combination with Tocilizumab, an IL-6 receptor antagonist.
干预措施: Tocilizumab (Drug)
LUSZ Immunosuppressive Group: CTSC + IL-6 receptor antagonist (Tocilizumab).
The Immunosuppressive group receives the standard care treatment with corticosteroid therapy in combination with Tocilizumab, an IL-6 receptor antagonist.
干预措施: Corticosteroid Therapy-enhanced Standard Care (CTSC) (Other)
结局指标
主要结局
Mortality rate
时间窗: 28-day mortality rate
The number of deaths recorded in each arm over a specified period
Clinical improvement rate
时间窗: 28-day mortality rate
The proportion of patients showing improvement in clinical symptoms and overall health status in each arm
次要结局
- Disease progression rate(28-day period)
- Adverse events(28-day period)
- Biomarker changes(28-day period)
- Questionnaire about the quality of life(28-day period)
- Time to clinical recovery(28-day period)
- Viral clearance rate(28-day period)
- Healthcare resource utilization(28-day period)
- Length of hospital stay(28-day period)
研究者
Nehman Makdissy
Principal Investigator, Professor
Lebanese University
