Double Blind Randomized Phase 2 Placebo Controlled Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Mortality at 28 days
研究概览
简要总结
This Phase 2 Randomized Placebo Controlled Trial will determine if administering nebulized Dornase Alpha (rhDNase) to COVID-19 patients with respiratory failure is safe and will reduce 28-day mortality.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or Female age 18 or older
- •On high flow oxygen =/> 6 liters nasal cannula (or)
- •On mechanical ventilation
- •Clinical diagnosis of COVID-19 & positive PCR test (or)
- •Clinical diagnosis of COVID-19 & negative PCR test with clinical symptoms of COVID-19 and pathognomonic lesions on a chest CT scan
排除标准
- •Known allergy to Pulmozyme
- •Less than 18 years of age
- •Grave condition with anticipated death within 48 hours; at the discretion of treating physician.
- •Enrollment in another clinical trial receiving investigatory drugs
研究组 & 干预措施
Treatment Arm
Patient will receive 2.5mg Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) aerosolized treatment once every 24 hours for five (5) consecutive days; a total of five (5) doses.
干预措施: Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) (Drug)
Placebo Arm 0.9% sodium chloride
Patient will receive 2.5ml of Sodium Chloride 0.9% aerosolized treatment once every 24 hours for five (5) consecutive days; a total of five (5) doses.
干预措施: 0.9%sodium chloride (Drug)
结局指标
主要结局
Mortality at 28 days
时间窗: 28 days after enrollment
All Cause Mortality at 28 days
Systemic Therapeutic Response
时间窗: 5 days after enrollment
To assess the effect of Pulmozyme® on the severity of respiratory failure, systemic inflammatory response, and multi-organ failure.
次要结局
- Respiratory Response(28 days)
- Legnth of ICU Stay(28 days)
- Legnth of Hospital Stay(28 days)
- Pulmonary Function(5 days)
研究者
Jon Simmons
Chief, Division of Trauma & Acute Care Surgery
University of South Alabama