Randomized Controlled Trial Of A Delivered Continuously By Nasal Cannula For The Treatment Of Patients With COVID-19 And Mild To Moderate Hypoxemia Requiring Supplemental Oxygen
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
This randomized, controlled trial will assess the efficacy and safety of pulsed iNO in subjects with COVID-19 who are hospitalized and require supplemental oxygen.
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
- Double (Participant, 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
- •Age 18 or above
- •Proven COVID-19 viral infection. Non-confirmed highly suspicious suspects may be enrolled.
- •Presence of radiographic findings compatible with pneumonia/pneumonitis.
- •Patients requiring at least 3 L/m oxygen via nasal canula to maintain O2 above 92%.
- •Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine).
- •Willing and able to comply with treatment schedule and study procedures.
排除标准
- •Patient with severe hypoxemia who are unable to maintain an oxygen saturation (SpO2) > 88% on a maximum supplemental oxygen of 6 L/m by nasal cannula and a non-rebreather facemask.
- •Participating in any other clinical trial for COVID-19
- •Pregnancy, or positive pregnancy test in a pre-dose examination.
- •Open tracheostomy.
- •Clinical contra-indication, as deemed by the PI or their designee.
- •Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as intravenous lidocaine, or topical benzocaine or dapsone at screening.
- •Known history or clinical evidence of heart failure or left ventricular dysfunction (LVEF < 45%).
- •Significant hemoptysis
- •Unable to provide informed consent (proxy consent is acceptable if available)
- •Any of the following conditions at time of possible enrollment: Fulminant Liver Failure, Acute Coronary Syndrome , Renal Failure requiring dialysis, Bacteremia, Shock, Cardiac arrest, Cardiac arrhythmia requiring acute treatment, Delirium / Encephalopathy, Severe Disseminated Intravascular Coagulation, Gastrointestinal hemorrhage, Hypoglycemia, Pneumothorax, Rhabdomyolysis / Myositis, Seizures, or Acute Stroke
研究组 & 干预措施
iNOpulse Treatment Group
Participants in this group will receive iNO delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days.
干预措施: Inhaled nitric oxide (iNO) (Drug)
iNOpulse Treatment Group
Participants in this group will receive iNO delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days.
干预措施: Oxygen gas (Drug)
Placebo Group
Participants in this group will receive nitrogen gas delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days
干预措施: Nitrogen gas (Drug)
Placebo Group
Participants in this group will receive nitrogen gas delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days
干预措施: Oxygen gas (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: Up to 14 days
As assessed per treating physician's discretion.
Incidence of adverse events
时间窗: Up to 6 hours
Incidence of hypoxemia and hypotension as assessed per treating physician's discretion.
Incidence of methemoglobinemia
时间窗: Up to 14 days
Incidence of increase to \> 5% total methemoglobin as assessed by pulse oximetry.
次要结局
- Number of participants with progression of respiratory failure(Up to 14 days)
- Time until resolution of hypoxemia(Up to 14 days)
- Incidence of mortality(Up to 28 days)
- Duration of hospitalization(Up to 28 days)
研究者
Roger Alvarez
Assistant Professor of Clinical Medicine Pulmonary Vascular Diseases
University of Miami