NCT04606407已完成不适用
Prospective, Open-label, Randomized, Multi-Center Study for Safety and Efficacy Evaluation of Inhaled Nitric Oxide (NO) Given Intermittently to Adults With Viral Pneumonia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- incidence of Serious Adverse Events
研究概览
简要总结
The purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (male and female) admitted to the hospital for clinical diagnosis of viral pneumonia including COVID-19 patients that have a positive nasal swab.
- •Age 18 to 80 years
- •Female subjects must be willing to use medically acceptable contraception from screening to Day 30 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent).
- •Ability to understand and comply with study requirements.
- •Signed informed consent by subject
排除标准
- •Patients with pneumonia with two or more of the following:
- •WBC of more than 15,000
- •Lobar pneumonia
- •Pleural effusion
- •Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy
- •Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
- •Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction (LVEF <40%) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
- •Use of an investigational drug during the last 30 days prior enrollment
- •Methemoglobin level >3% at screening
- •Patients on chronic (over two weeks of treatment) systemic steroids (any formulation, excluding Dexamethasone or Prednisone) within 30 days prior to enrollment.
- •History of daily, continuous oxygen supplementation
- •Patients with BMI greater than or equal to 40
- •Patients with clinically significant anemia, e.g., Hb <10.0 and/or thrombocytopenia, e.g., Platelets <
- •Smokers who are unwilling to refrain from smoking during hospitalization
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data, e.g., known or suspected thalassemia, sickle cell disease or other diseases associated with poor oxygen carrying capacity.
- •The subject is identified by the investigator as being unable or unwilling to perform study procedures.
结局指标
主要结局
incidence of Serious Adverse Events
时间窗: 30 days
Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)
次要结局
- ICU admission(Baseline to 30 days)
- Oxygen support(Baseline to 30 days)
- fever resolution(Baseline to 30 days)
- Stable room air saturation(Baseline to 30 days)
研究者
研究点 (3)
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