The Use of Tocilizumab in the Management of Patients Who Have Severe COVID-19 With Suspected Pulmonary Hyperinflammation
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Survival
研究概览
简要总结
Title: The use of Tocilizumab in the management of patients who have severe COVID-19 with suspected pulmonary hyperinflammation.
This is a study designed to assess the therapeutic value of intravenous tocilizumab administered as single 8mg/Kg dose in patients affected by SARS-CoV2 infection with a pulmonary manifestation causing hypoxia. Aim of the study is to test the hypothesis that anti-IL6 treatment can be effective in reducing the virus-induced cytokine storm, blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing tracheal intubation and/or death.
This drug will be administered to those patients entering the ICU with severe acute respiratory failure COVID-19 disease. The endpoints are death and duration of hospitalization. The patients will be assessed with surrogate markers determining the level of the cytokine storm.
详细描述
Study design This is a multicenter, two arms, 2:1 (treatment: control) open-label randomized control study with a drug approved for another indication in Israel. All the patients enrolled will be treated with tocilizumab or not. One-month mortality rate is the primary endpoint. One arm will be the study drug anti-IL6R (Tocilizumab (Actmera)) 8 mg/kg given IV during one hour once. The placebo will be a 100 ml saline IV infusion administered along one hour.
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
- None
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
- •Age 18 and older
- •Informed consent for participation in the study
- •Virological diagnosis of Sars-CoV2 infection (PCR)
- •Acute respiratory failure
- •Radiographic pneumonia, defined as any/ changing new lung infiltrate
- •Patient breathing spontaneously, required more than 50% oxygen and MEWS score >
- •If intubated, intubated less than 24 hours with PaO2/Fio2 ratio ≤ 200 and PEEP ≥ 5 cm H2O.
排除标准
- •Known hypersensitivity to tocilizumab or its excipients
- •Patient with a life expectancy of less than 6 months.
- •Known active infections or other clinical condition that contra-indicate tocilizumab and cannot be treated or solved according to the judgement of the clinician.
- •Neutrophils <500 / mmc
- •Platelets <40.000 / mmc
研究组 & 干预措施
Tocilizumab treatment group
Treatment: intravenous administration of monoclonal anti body anti- IL6R. The dose is 8 mg/kg up to total dose of 800 mg.
干预措施: Tocilizumab (Drug)
Placebo group
Placebo. intravenous administration of 100 ml of normal saline.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Survival
时间窗: One-month
One-month mortality rate .
次要结局
未报告次要终点