An Clinic Trial of Recombinant Human Interferon Alpha Nasal Drops to Prevent Coronavirus Disease 2019 in Medical Staff in Epidemic Area
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 2,944
- 试验地点
- 1
- 主要终点
- new-onset COVID-19
研究概览
简要总结
The investigators plan to carry out an experimental study on the preventive effect of recombinant human interferon alpha nasal drops on the infection of 2019 new coronavirus in medical staff.
详细描述
The investigators plan to carry out an experimental study enrolling more than 2000 medical staff and divide participants into low-risk group and high-risk group according to whether they can directly exposed to 2019-nCOV infected patients. In the low-risk group, participants will be given recombinant human interferon alpha-1b nasal drops (2-3 drops/nostril/ time, 4 times/ day), and in the high-risk group will be given preventive intervention with interferon nasal drops and thymosin-α (thymosin was injected subcutaneously once / week), and the intervention time is 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Formally serving medical staff in Taihe Hospital;
排除标准
- •pregnant women;
- •severe chronic diseases who are unable to participate in daily routine work;
- •fever (temperature≥37.3 ° ) and / or respiratory symptoms.
研究组 & 干预措施
low-risk group
medical staff work in non-isolated general wards or laboratories, not directly contact with COVID-19 patients.
干预措施: recombinant human interferon Alpha-1b (Drug)
high-risk group
doctors and nurses work in isolated ward, directly contact with COVID-19 patients.
干预措施: recombinant human interferon Alpha-1b (Drug)
high-risk group
doctors and nurses work in isolated ward, directly contact with COVID-19 patients.
干预措施: thymosin alpha 1 (Drug)
结局指标
主要结局
new-onset COVID-19
时间窗: From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.
new-onset coronavirus disease-2019
次要结局
- Number of Participants with coronavirus related symptoms(during 28-day intervention.)
- Number of Participants with adverse effect(during 28-day intervention.)
研究者
Zhongji Meng
Chief of Infectious disease department, Principal Investigator, Clinical Professor
Shanghai Jiao Tong University School of Medicine