Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 98
- 试验地点
- 11
- 主要终点
- Duration of received supplemental oxygen therapy
研究概览
简要总结
Randomized open label clinical trial carried out at study centers in Sweden, including Karolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and Västmanlands Hospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligible for inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µg twice daily or to standard of care. Primary outcome is duration of received supplemental oxygen therapy. Key secondary outcome is a composite outcome of death and received invasive mechanical ventilation within 30 days.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Medical treatment
Treatment with ciclesonide
干预措施: Ciclesonide Inhalation Aerosol (Drug)
结局指标
主要结局
Duration of received supplemental oxygen therapy
时间窗: 30 days after study inclusion
Time (in days) of received supplemental oxygen therapy (defined as being alive and discharged from hospital to home or at least 48 h of not receiving oxygen therapy during hospitalization).
次要结局
- Remaining dyspnea symptoms(30-35 days and 5-7 months after inclusion)
- Invasive mechanical ventilation or all-cause death (key secondary outcome)(30 days after study inclusion)
- Need for intensive care(30 days after study inclusion)
- Proportion of discharged from the hospital to their home or a nursery home(30 days after study inclusion)
- Invasive mechanical ventilation(30 days after study inclusion)
- All cause death(30 days after study inclusion)
研究者
Ola Blennow, MD, PhD
Principal Investigator
St Goran's Hospital