A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Ventilator Free Days
研究概览
简要总结
The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.
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
- •Hospitalized and symptomatic (cough, fevers, SOB, or sputum production)
- •SARS CoV-2 laboratory positive obtained within 14 days of enrollment
排除标准
- 未提供
结局指标
主要结局
Ventilator Free Days
时间窗: Measured from hospital admission day 60 after admission.
Days alive and off mechanical ventilation at day 60. Measured only among patients who receive invasive mechanical ventilation.
Duration of supplemental oxygen use
时间窗: Measured from hospital admission to day 60.
Duration from hospital admission until cessation of supplemental oxygen use. Measured only among patients who do not receive invasive mechanical ventilation.
次要结局
- Systemic inflammation(Measured at day 5 post enrollment.)
- All cause mortality(Measured at day 60 or at hospital discharge, whichever comes first.)