NCT04588441撤回2 期
Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19 (The ARCTIC Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Improved COVID-19 symptoms
研究概览
简要总结
This is a phase II study to test adenosine efficacy for down-regulation of the overwhelming inflammation of COVID-19 in the lungs as reflected by clinical recovery of lung function; resolution of clinically relevant markers of lung function, and resolution of systemic markers of inflammation and coagulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 18 years old) male and female patients with diagnosed COVID-19 respiratory infection, verified by culture/swab RNA. Impending ARDS respiratory collapse with progressive increasing oxygen requirements, and in line with sub-study as defined below.
- •Patients intubated within the prior 24 hours.
- •Hemodynamically stable (not requiring vasopressors or catecholamine agents to support systemic blood pressure; no existing shock defined as BP < 100 mmHg systolic).
- •In-place continuous arterial line for blood sampling.
排除标准
- •Younger than 18 years old.
- •Prisoners
- •Pregnant women.
- •Unable to obtain next of kin consent.
- •End-stage cardiac disease with COVID-
- •Non COVID-related causes of ARDS/respiratory failure, septic shock, or post trauma shock, respiratory failure after blood transfusion or surgery.
- •Unstable asthma or history of frequent/poorly controlled asthmatic attacks.
- •Not expected to live more than 6 months due to underlying condition such as cancer.
研究组 & 干预措施
Adenosine
Experimental
Treatment consists of 9 mg adenosine in 5ml normal saline (NS) administered over 5-10 min via an Aerogen™ nebulizer
干预措施: Adenosine (Drug)
结局指标
主要结局
Improved COVID-19 symptoms
时间窗: Day 50
Improved COVID-19 symptoms measured by alive v. mortality, not hospitalized, or free of respiratory failure.
次要结局
未报告次要终点
研究者
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