NCT04804943招募中不适用
Pilot Clinical Study to Investigate the Efficacy and Safety of NOA-001 for the Treatment of Patients With Acute Respiratory Distress Syndrome.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Ventilator Free Days (VFD, Days alive and ventilator-free)
研究概览
简要总结
The primary object of this clinical study is to investigate the efficacy and the safety of NOA-001 in patients with ARDS (ARDS caused by Non-COVID-19 or COVID-19).
详细描述
(ARDS caused by Non-COVID-19 cohort): The objectives of this clinical study is to investigate the efficacy and safety of NOA-001 in patients with ARDS caused by Non-COVID-19. The number of patients enrolled is 30 (20 patients in the NOA-001 group and 10 patients in the standard therapy group).
(ARDS caused by COVID-19 cohort): The objectives of this clinical study is to investigate the efficacy and the safety of NOA-001 in patients with ARDS caused by COVID-19. The number of patients enrolled is 15 (in the NOA-001 group only).
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At Informed Consent
- •Patients with ARDS confirmed by the Berlin definition based on the following diagnostic criteria (a)-(d):
- •Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS.
- •Patients with respiratory failure not fully explained by cardiac failure or fluid overload; Need objective assessment (e. g., echo-cardiography) to exclude hydrostatic edema if no risk factor present
- •Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on chest X-ray or CT scan
- •Patients with PaO2/ FiO2 ratio ≤ 300 mmHg (PEEP ≥ 5 cmH2O)
- •Patients who are intubated and mechanically ventilated
- •Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation
- •Patients aged ≥ 16 years at informed consent (Signed informed consent form from legally acceptable representative must be available if patient is aged < 20 years)
- •At Enrollment
- •Patients with PaO2/ FiO2 ratio ≥ 50 mmHg and ≤ 200 mmHg (PEEP ≥ 5 cmH2O)
- •Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on CT scan within 48 hours before enrollment
- •Patients who are intubated and mechanically ventilated
- •Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation
排除标准
- •At Informed Consent
- •Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
- •Patients who are treated with ECMO or HFOV
- •Patients with renal dialysis therapy for chronic renal failure
- •Patients with congestive heart failure (NYHA class IV)
- •Patients with acuter left ventricular failure
- •Patients with liver failure (Child-Pugh grade C)
- •Patients who have burns in excess of 15% total body surface area
- •Patients after resuscitation from cardiac arrest
- •Patients with a history of hypersensitivity to the anticoagulants (Heparin or Nafamostat mesylate)
- •Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy within 7 days prior to informed consent
- •Patients with pregnancy or lactating
- •Patients tested positive for COVID-19
- •At Enrollment
- •Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
- •Patients who are treated with ECMO or HFOV after obtaining informed consent prior to enrollment
- •Patients with platelet count ≤ 50,000 /mm3 by the latest blood test
- •Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy between informed consent and enrollment
- •Patients whose life expectancy is ≤ 24 hours after enrollment
- •Patients after resuscitation from cardiac arrest between informed consent and enrollment
- •Patients tested positive for COVID-19 between informed consent and enrollment
- •(ARDS caused by COVID-19 cohort)
- •Inclusion Criteria:
- •At Informed Consent
- •Patients tested positive for COVID-19
- •Patients with ARDS confirmed by the Berlin definition based on the following diagnostic criteria (a)-(d):
- •Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS.
- •Patients with respiratory failure not fully explained by cardiac failure or fluid overload; Need objective assessment (e. g., echo-cardiography) to exclude hydrostatic edema if no risk factor present
- •Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on chest X-ray or CT scan
- •Patients with PaO2/ FiO2 ratio ≤ 300 mmHg (PEEP ≥ 5 cmH2O)
- •Patients who are intubated and mechanically ventilated
- •Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation
- •Patients aged ≥ 16 years at informed consent (Signed informed consent form from legally acceptable representative must be available if patient is aged < 20 years)
- •At Enrollment
- •Patients with PaO2/ FiO2 ratio ≥ 50 mmHg and ≤ 200 mmHg (PEEP ≥ 5 cmH2O)
- •Patients who are intubated and mechanically ventilated
- •Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation
- •Exclusion Criteria:
- •At Informed Consent
- •Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
- •Patients who are treated with ECMO or HFOV
- •Patients with renal dialysis therapy for chronic renal failure
- •Patients with congestive heart failure (NYHA class IV)
- •Patients with acuter left ventricular failure
- •Patients with liver failure (Child-Pugh grade C)
- •Patients who have burns in excess of 15% total body surface area
- •Patients after resuscitation from cardiac arrest
- •Patients with a history of hypersensitivity to the anticoagulants (Heparin or Nafamostat mesylate)
- •Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy within 7 days prior to informed consent
- •Patients with pregnancy or lactating
- 另有 7 项未显示
结局指标
主要结局
Ventilator Free Days (VFD, Days alive and ventilator-free)
时间窗: Day 28
VFD is a composite measure of all-cause mortality and the number of days free of mechanical ventilation (VFD) within 28 days.
次要结局
- All-cause Mortality(Up to Day 28, 60 and 90)
- Mortality in ICU(Up to Day 28)
- Mortality in Hospital(Up to Day 28)
- Changes in PaO2/ FiO2 ratio(Up to Day 28)
研究者
研究点 (1)
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