Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Time to deterioration
研究概览
简要总结
The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
详细描述
Nitric Oxide (NO) is a small endogenously produced molecule recognized to play a critical role in the function of several body systems including the vasodilatation of smooth muscle, neurotransmission, regulation of wound healing and inhibition of pathogens. In-vitro studies have shown that NO inhibits the replication cycle of the severe acute respiratory syndrome coronavirus (SARS CoV) in vitro. The suggested mechanisms of actions of NO on SARS are an effect on the fusion between the S protein and its cognate receptor, ACE2, and reduction in viral RNA production in the early steps of viral replication. The primary aim of this feasibility study is to investigate the safety of intermittent NO, delivered via inhalation, in hospitalized patients with COVID-19. The primary endpoint in the study will be time to deterioration of respiratory symptoms determined by escalation to either non-invasive ventilation (NIV), high-flow nasal cannula (HFNC), or intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment within 24 hours of hospital admission of patients diagnosed with COVID-19
- •Patients with oxygen saturation less than 93 % on room air
- •Shortness of breath, with symptom onset within the previous 8 days.
- •Female subjects of childbearing potential should take adequate measures to avoid pregnancy
- •Signed informed consent by the subject
排除标准
- •Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy
- •Diagnosis of acute respiratory distress syndrome
- •Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
- •Patients receiving drugs that have contraindications with NO.
- •Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
- •Patients with active pulmonary malignancy or lung transplant
- •Patients with a history of frequent epistaxis or significant hemoptysis
结局指标
主要结局
Time to deterioration
时间窗: 14 Days
Time to deterioration measured by need for NIV, HFNC or intubation
次要结局
- Time to NIV(14 Days)
- Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%(14 days)
- Time to HFNC(14 Days)
- Time to intubation(14 days)