NCT04383002已完成1 期
Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted With COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate
研究概览
简要总结
Novel therapies are desperately needed for treatment of COVID-19 patients. At present, there are no proven interventions to prevent progression of the disease or to rapidly treat patients with COVID-19 related respiratory failure. Data on the original coronavirus -SARS pneumonia suggested that high dose (>160ppm) inhaled Nitric Oxide could have beneficial effects also on COVID-19, due to the genomic similarities between these two coronaviruses (1-3). This study will test whether high dose inhaled nitric oxide is safe and can reverse virus burden and respiratory failure in patients on mechanical ventilation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed infection with COVID-19 positive RT-PCR tracheal aspirate prior to treatment
- •Use of mechanical ventilation with or without ECMO
- •Male or female ages > 18 years
- •< 14 days from symptom initiation to study enrolment and < 7 days from intubation to study enrolment
排除标准
- •Patients on other interventional clinical trials
- •Subjects diagnosed with congestive or unstable heart disease including heart failure, left ventricular dysfunction (LVEF < 40 %) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
- •Subjects diagnosed with immunodeficiency
- •Hematology: patients with clinically significant anemia e.g. Hemoglobin < 100 and thrombocytopenia e.g. Platelets < 75
- •Subjects with clinically significant history of, or active bleeding including active pulmonary or gastrointestinal bleeding
- •Hepatic Function: Patients with abnormal liver function defined as any two of the following ALT >3x ULN, AST >3x ULN, Total bilirubin < 1.5 X ULN
- •Patient receiving drugs that have a contraindication with NO e.g. use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening as relevant to the proposed study population
- •Subjects with a known hypersensitivity to methylene blue, subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Known or suspected thalassemia, sickle cell disease, or other conditions associated with poor oxygen carrying capacity
研究组 & 干预措施
Inhaled Nitric Oxide
Experimental
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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