Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Clinical condition
研究概览
简要总结
COVID-19 pandemic has spread all over the world, and hospitalization of the patients with COVİD-19 Pneumonia has become a great burden to the Intensive Care Units. Unfortunately there is still no curative method for the disease yet. Intensive Care Units provide general care for the patients; including oxygen therapy, maintenance of the organ systems (e.g., cardiovascular, renal), nutrition, antibiotic therapy for secondary infections, and etc.
One of the major problems in COVID-19 is macrophage activation syndrome, also known as cytokine storm. It stems from exaggerated inflammatory response, which causes increased cytokine release and results in clinical deterioration of the patients. Many drugs have been used to prevent this exaggerated inflammation, like corticosteroids, interleukin (IL) receptor blockers, plasma exchange, etc.
In this study our aim is to investigate the effectiveness of high dose corticosteroid (methylprednisolone 250 mg for 3 days) and an IL-6 receptor antagonist (tocilizumab) in the treatment of the cytokine storm of the COVID-19 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with COVID-19 Pneumonia treated in the Intensive Care Unit
- •Clinical deterioration during intensive care follow-up
- •First 14 days from the COVID-19 diagnosis
排除标准
- •More than 14 days passed from the COVID-19 diagnosis
- •Clinical and laboratory signs of secondary bacterial infection
研究组 & 干预措施
Pulse methylprednisolone
250 mg methylprednisolone for 3 days
干预措施: Methylprednisolone (Drug)
Tocilizumab
Tocilizumab 400-800 mg for one time
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Clinical condition
时间窗: Next 7 days of the intervention.
Arterial oxygen partial pressure of the patient will be observed.
Blood analysis
时间窗: Next 7 days of the intervention.
Acute phase reactants (C-reactive protein, procalcitonin, ferritin, fibrinogen), will be investigated.
次要结局
- Hospital stay(Until the hospital discharge.)
- Mortality(Not relevant)
研究者
Ruslan Abdullayev
Assist. Prof.
Marmara University