ACTRN12620000588998撤回2 期
The safety and efficacy of STC3141 in patient with COVID-19 ARDS require intensive care
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Subjects entering the ICU and presenting with confirmed or suspected COVID-19-related ARDS will be enrolled in the trial.
- •1. Aged 18 to 80 years (inclusive at the time of consent)
- •2. Subjects are diagnosed with moderate to severe ARDS that has been present for less than 3 days
- •3. Meet Berlin Definition
- •1)Must have a partial pressure of arterial O2 (PaO2)/ fraction of inspired O2 (FiO2) less than or equal to 200 mmHg on invasive or non-invasive ventilation with the level of positive end-expiratory pressure (PEEP) or continuous positive pressure (CPAP) greater than or equal to 5cmH2O.
- •2)Bilateral opacities not fully explained by effusion, lobar or lung collapse, or nodules by chest X-ray or CT
- •3)Respiratory failure not fully explained by heart failure or fluid overload
- •In the opinion of the treating clinicians, likely to survive beyond the day after tomorrow.
- •4. Subjects who are consented
排除标准
- •1. Subjects who have <55 ml/min/BSA
- •2. Subjects who require ECMO
- •3. Subjects who require a therapeutic dose of heparin or who are receiving oral
- •anticoagulants, or received warfarin, factor Xa inhibitors within last 24 hours
- •4. Subjects who have Absolute Neutrophil Count (ANC) <1000/mL;
- •6. Subjects who have activated Partial Thromboplastin Time (aPTT) >55 s;
- •7. Severe anaemia (haemoglobin;
- •8. Bleeding in the past 24 hours requiring blood transfusion;
- •9. Subjects who have the following chronic organ dysfunction or immunosuppression
研究者
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