A Phase I Study of ResCure™ to Treat COVID-19 Infection
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Assess the safety of ResCure™ via oxygen saturation
研究概览
简要总结
This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.
详细描述
In this Phase I open-label interventional study we will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection. Patients being treated will have severe respiratory symptoms that are at or near requiring the patient be placed on a ventilator.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill patients with SARS from COVID-19 infection on respirators OR
- •Patients with SARS from COVID-19 infection prior or after being placed on respirator
- •Male or female patients 18 years of age and older
排除标准
- •Patients less than 18 years of age
结局指标
主要结局
Assess the safety of ResCure™ via oxygen saturation
时间窗: 12 Weeks
Oxygen saturation from baseline to 12 weeks
Assess Tolerability of ResCure™
时间窗: 12 Weeks
Assess Adverse Events and Serious Adverse Events due to ResCure™
Reduction or progression of symptomatic days
时间窗: 12 Weeks
Reduction and/or progression of symptomatic days, reduction of symptom severity
Assess the safety of ResCure™ via pulse
时间窗: 12 Weeks
Pulse from baseline to 12 weeks
The rate of recovery of mild or moderate COVID-19 in patients using ResCure™
时间窗: 12 Weeks
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Assess the safety of ResCure™ via EKG
时间窗: 12 Weeks
EKG from baseline to 12 weeks
次要结局
未报告次要终点