Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of VentaProst (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in Respiratory Failure
研究概览
简要总结
The purpose of this study is to investigate whether inhaled epoprostenol given via a breath actuated delivery system will help improve oxygen levels and treatment outcomes in patients with COVID-19 who are on mechanical ventilation.
详细描述
This study will evaluate the potential therapeutic benefit of VentaProst in treating patients with COVID-19 at risk for respiratory and/ or cardiac/circulatory failure. This is a double-blind, placebo controlled study of VentaProst in 10 confirmed COVID-19 patients compared to 10- COVID-19 placebo patients to assess the efficacy and safety of VentaProst given over 10 days at varying doses.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo controlled
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
- •Confirmed COVID-19 positive by RT-PCR test
- •Patients who require invasive mechanical ventilation.
- •Consent or professional consent obtained
排除标准
- •Patients on ECMO support.
- •Patients receiving another inhalation research medication or inhaled nitric oxide.
- •Not expected to survive for 48 hours.
- •Allergy to Epoprostenol and its diluent
研究组 & 干预措施
Study Treatment
Up to 10 days of inhaled epoprostenol delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.
干预措施: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system) (Drug)
Placebo Control
Up to 10 days of inhaled 0.9% sodium chloride solution delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.
干预措施: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system) (Drug)
结局指标
主要结局
Change in Respiratory Failure
时间窗: 10 days post-randomization
Number of participants that were extubated
Change in Cardiac/Circulatory Failure
时间窗: 10 days post-randomization
Number of participants that required ECMO or left ventricular assist device (LVAD)
次要结局
未报告次要终点