Tocilizumab (RoActemra) as Early Treatment of Patients Affected by SARS-CoV2 (COVID-19) Infection With Severe Multifocal Interstitial Pneumonia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- arrest in deterioration of pulmonary function
研究概览
简要总结
In a Phase 2 Simon's Optimal Two-Stages Design intravenous tocilizumab will be administered as single 8mg/Kg dose in patients affected by severe multifocal interstitial pneumonia correlated to SARS-CoV2 infection. Aim of the study is to test the hypothesis that an anti-IL6 treatment can be effective in calming the virus-induced cytokine storm, blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing naso-tracheal intubation and/or death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Radiologist will be blinded for sequence
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SARS-CoV2 Infection diagnosed by rt-PCR
- •CT-scan confirmed multifocal interstitial pneumonia
- •Need of oxygen therapy to maintain SO2>93%
- •Worsening of lung involvement, defined as (one of the following criteria):
- •Worsening of oxygen saturation >3 percentage points or decrease in PaO2 >10%, with stable FiO2 in the last 24h
- •Need of increase FiO2 in order to maintain a stable SO2 or new onset need of mechanical ventilation in the last 24h
- •Increase in number and/or extension of pulmonary areas of consolidation
排除标准
- •Age <18 ys and >90 ys
- •Severe heart failure
- •Bacterial Infection
- •Haematological neoplasm
- •Neutrophil count below 1000/mcl
- •Platelet count below 50000/mcl
- •ALT> x5UNL
- •Inability to give informed consent
研究组 & 干预措施
tocilizumab
干预措施: Tocilizumab (Drug)
结局指标
主要结局
arrest in deterioration of pulmonary function
时间窗: 7days
rate of patients with no need in increase of FiO2 to maintain stable SO2 and no need of intubation
improving in pulmonary function
时间窗: 7 days
rate of patients with change of oxygen saturation \>3 percentage points or \>10% or decrease in FiO2 need or reduction in pulmonary consolidations \>30% at HR CT-scan
次要结局
- need of oro-tracheal intubation(+7 days)
- death(14days)
研究者
Armando Gabrielli
Full Professor Internal Medicine
Università Politecnica delle Marche