A Phase II Study of IL-6 Receptor Antagonist Tocilizumab to Prevent Respiratory Failure and Death in Patients With Severe COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Progression of Respiratory Failure or Death
研究概览
简要总结
The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.
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
- •Patient or designated proxy willing and able to provide informed consent prior to enrollment in the study.
- •COVID-19 PCR positive on nasopharyngeal swab
- •Aged >/= 18 years old
- •Patient hospitalized with newly diagnosed documented severe COVID-19 infection: with respiratory rate >/= 30 breaths/min OR peripheral capillary oxygen saturation (SpO2) < 93% on room air for nonintubated pts.
- •Fever of 38.5 C or suspected respiratory infection
- •IL-6 level >/= 80 pcg/ml
- •Cohort #1 - non intubated Cohort #2 - intubated
- •Women of childbearing potential must have a negative serum or urine pregnancy test
- •Patients receiving ongoing steroid therapy are eligible
- •Patients will be allowed to receive concurrent or sequential treatment with remdesivir
排除标准
- •Patients with uncontrolled systemic fungal and bacterial infections
- •Patients with latent tuberculosis
- •Patients with known hypersensitivity to tocilizumab or any component of the formulation
- •Concurrent initiation of steroid therapy is not allowed
- •Patients with uncrontroled malignant disease, with a life expectancy of 3 months or less
研究组 & 干预措施
Intubation/Mechanical Ventilation
Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation
干预措施: Tocilizumab (Drug)
Respiratory Support
In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Progression of Respiratory Failure or Death
时间窗: 14 days
The primary endpoint for this cohort is progression of respiratory failure (binary yes/no while hospitalized). Progression of respiratory failure will be defined as a sustained increase in oxygen requirement (FiO2) or need for intubation/mechanical ventilation.
次要结局
未报告次要终点