A Phase I Study of Inhaled GM-CSF in the Treatment of Respiratory Virus-associated Severe Pneumonia
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Incidence of Treatment-Emergent Adverse Events of Inhaled Sargramostim in Adult Patients with Severe Respiratory Viral Pneumonia
研究概览
简要总结
This study will investigate the safety and efficacy of the administration of inhaled GM-CSF to patients with respiratory virus-associated pneumonia.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aerosolized Sargramostim
A self-controlled, open-label study to evaluate safety of Sargramostim administered by nebulization
干预措施: Sargramostim 0.04 mcg/kg/dose (Drug)
Aerosolized Sargramostim
A self-controlled, open-label study to evaluate safety of Sargramostim administered by nebulization
干预措施: Sargramostim 0.2mcg/kg/dose (Drug)
Aerosolized Sargramostim
A self-controlled, open-label study to evaluate safety of Sargramostim administered by nebulization
干预措施: Sargramostim 1 mcg/kg/dose (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events of Inhaled Sargramostim in Adult Patients with Severe Respiratory Viral Pneumonia
时间窗: 1 year
The occurrence of any treatment-emergent Adverse Events (AE's) or Serious Adverse Events (SAE's) will be recorded over the course of the trial.
次要结局
未报告次要终点