Clinical Outcome of Anti-IL6 and Corticosteroid Monotherapy vs Combination in COVID-19 Cytokine Release Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 860
- 试验地点
- 1
- 主要终点
- Ventilator-Free Days
研究概览
简要总结
The cytokine storms mediated by over production of proinflammatory cytokines have been observed in a large population of critically ill patients infected with COVID-19. Patients diagnosed with cytokine storms progress to cardiovascular collapse, multiple organ dysfunction and death rapidly. Therefore, early identification, treatment and prevention of the cytokine storms are of crucial importance for the patients. Immuomedulator such as interleukin-6 (IL-6) antagonist, emerged as an alternative treatment for COVID-19 patients with a risk of cytokine storms recently. In this study, we aimed to evaluate the safety and efficacy of anti-IL6 alone vs anti-IL6 corticosteroid combination in patients with COVID-19 pneumonia
详细描述
This study will provide further insight whether anti-IL6 alone provide same efficacy and clinical outcome with reasonable side effects profile compared to anti-IL6 + corticosteroid and might serve as a corticosteroid sparing agents in COVID-19 patient with cytokine storms. Data elements will be retrieved from VIRUS registry which is a prospective, non-interventional, multi-center, multi-national observational cross sectional study
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Critically ill patients
- •COVID-19 PCR positive
- •Presence of clinical and radiological signs of progressive disease, and laboratory evidence indicative of risk for cytokine storm complications.
- •Received anti-IL6 or corticosteroids as part of COVID-19 treatment
排除标准
- •Non COVID-19 related admissions
- •Repeated Admission to ICUs/Hospital
- •Patient did not receive anti-IL6 or corticosteroids
研究组 & 干预措施
Experimental
anti-IL-6 drugs (tocilizumab and siltuximab)
干预措施: Interleukin 6 (IL6) Antagonist (Drug)
Active Comparator 1
Anti-IL-6 drugs (tocilizumab and siltuximab) and corticosteroids combination
干预措施: Interleukin 6 (IL6) Antagonist and corticosteroids (Drug)
Active Comparator 2
corticosteroids alone
干预措施: corticosteroid alone (Drug)
结局指标
主要结局
Ventilator-Free Days
时间窗: Up to Day 28
The median ventilator-free days will be calculated as calendar days with no ventilator support to day 28 . Participants who die before day 28 are assigned zero free days.
次要结局
- Median duration of ventilation(Up to Day 28)
- Median change in the PaO2/FiO2(Up to Day 28)
- Vasopressor-Free days(Up to Day 28)
- Duration of ICU Stay(Up to 28 days)
- Duration of Hospital Stay(Up to 28 days)
- Mortality Rate(Up to Day 28)
- Percentage of participants with adverse events [transaminitis, hyperglycemia](Up to 28 days)
- Concentration of Ferritin, IL6, D dimer, fibrinogen, C-reactive protein (CRP), Lactate dehydrogenase (LDH) and absolute lymphocyte count and their correlation with the effectiveness of the treatment(Up to 28 days)
- Rate of superinfection (bacterial, viral, invasive fungal infections)(Up to 28 days)
- Time to the first COVID 19 test negative(Up to 28 days)