Proof of Concept Safety Trial for S-Nitrosylation Therapy to Improve Oxygenation Status in Severe Covid-19 Patients Receiving Supplemental Oxygen Support
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Progression to use of ECMO
研究概览
简要总结
The primary objective of this study is to provide expanded access of S-nitrosylation therapy for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.
详细描述
Randomized controlled trial for safety of a 6-hour escalating dose of S-nitrosylation therapy or placebo to ventilated patients. This will be a single-site study conducted within the UH-CMC medical ICU designated COVID-19 quarantine areas.
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
The investigational product will be prepared and dispensed by designated unblinded site personnel at the pharmacy; the investigational product label will indicate the study number but will not indicate the treatment assignment. Any site personnel involved in the administration and assessment of the investigational product will be blinded to subject treatment assignments throughout the study.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SNO
12 patients in the S-nitrosylation arm will receive SNO (six-hour treatment with a sequential increasing dose regimen of 20 ppm x 2 hr, 40 ppm x 2 hr, 80 ppm x 2 hr).
干预措施: SNO (Drug)
Placebo
12 patients in the placebo arm will receive nitrogen gas (six-hour treatment).
干预措施: Nitrogen gas (Drug)
结局指标
主要结局
Progression to use of ECMO
时间窗: 30 days
Use of ECMO required.
Treatment Emergent Adverse Events
时间窗: 30 days
Adverse events related to SNO therapy.
Frequency of Intubation
时间窗: 30 days
Number of intubations required.
次要结局
- Discontinuation of Oxygen Therapy(30 days)
- All-Cause Mortality(30, 60 days)
- Clinical Status(30 days)
- Time to Clinical Status Improvement(30 days)
- Respiratory Clinical Status(30 days)
- Duration of Hospitalization(30 days)
- Time to Discontinuation of Oxygen Therapy(30 days)
研究者
James Reynolds
Principal Investigator
University Hospitals Cleveland Medical Center