Clinical Study to Evaluate the Efficacy and Safety od BZ371B in Patients With Acute Respiratory Distress System (ARDS) in Mechanical Ventilation, Due to Respiratory Infections
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- P/F ratio
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability and efficacy of BZ371B in intubated patients with severe Acute Respiratory Distress Syndrome.
详细描述
Acute respiratory distress syndrome (ARDS) is a severe medical condition that is triggered by an alveolar capillary membrane damage resulted from several causes. Among these causes, respiratory viral infections such as SARS-CoV-2 can be responsible for the development of the disease. ARDS presents a high mortality rate, which may range from 33-52%. The main difficulty for the treatment of this disease is dealing with hypoxia.
Nitric Oxide inhalation therapy has proven to increase oxygenation and Ventilation/Perfusion by it's vasodilation property. However, there are several limitations for it's use, such as the need of a specialized equipment, systemic side effects, etc. The use of others vasodilation medications are not indicated due to their systemic systemic exposure and non-selective vasodilation.
BZ371B is a small peptide that acts as a NO synthase (NOS) enhancer, inducing local NO production, and is capable to present local vasodilation effect increasing blood flow regulation, by a new and innovative mechanism of action.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Men or Women
- •In Mechanical Ventilation
- •Diagnosed with Acute Respiratory Dystress Syndrome characterized by: acute beginning (less than one week from the beggining of the disease); bilateral opacity in the Torax X-Ray (not explained by stroke, atelectasis or nodules); respiratory failure not derived from cardiac failure and water overload.
- •P/F lower or equal to 150 mmHg with FiO2 higher or equal to 70% and PEEP higher or or equal to 88 mmHg
- •ALready executed first pronation, followed by supine position. One hour after returning from supine position.
排除标准
- •Presence of pulmonary thromboembolism
- •Presence of secondary bacterial pneumonia
- •Severe Asthma
- •Pregnant or lactanting women
研究组 & 干预措施
Treated Group
Intubated patients treated with inhaled BZ371B will receive a dose of 12 mg of BZ371B divided in two different nebulizations per day, for three cosnecutive days
干预措施: Inhaled BZ371B (Drug)
结局指标
主要结局
P/F ratio
时间窗: 4 days
PaO2 divided by FiO2 measurement
Shunt ratio
时间窗: 4 days
Shunt ratio measurement
Ventilation-Perfusion (V/Q) ratio
时间窗: 4 days
V/Q measurement
Systemic blood pressure (SBP)
时间窗: 4 days
SBP measurement
Cardiac Function
时间窗: 4 days
Heart Rate (HR) and Ejection Fraction measurement
Adverse Effect
时间窗: 4 days
Adverse effect evaluation of compound use and application
次要结局
- Pulmonary arterial pressure (PAP)(4 days)
- Pulmonary vascular resistence(4 days)