EUCTR2021-001665-20-HU进行中（未招募）1 期
Prospective, randomized, controlled, double-blinded study on the efficacy of nebulized 4.2% sodium-bicarbonate in COVID-19 pneumonia
Semmelweis University Department of Oralbiology0 个研究点目标入组 200 人开始时间: 2021年3月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- antigen or PCR test verified COVID-19 pneumonia
- •- age: 18-64 yrs
- •- informed consent
- •- CT-verified bilateral GGO > 50% (CORADS 6)
- •- invasive ventillation within 48hrs
- •- PaO2/FiO2 <200 (at PEEP > 5 H2O cm)
- •- serum prokalcitonin < 0.5 ng/ml
- •- serum ferritin > 500 ng/ml
- •- 20 < BMI <45
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- hypernatremia
- •- metabolic alkalosis
- •- relevant concomitant disease (excluding well-controlled hypertension)
- •- renal failure: se creatinin > 200 µM (on adequate volume tehrapy)
- •- liver failure (se bilirubin > 34 µM)
- •- hematologic disease
- •- chronic immune and/or hemopoetic disease
- •- bacterial infection (evaluated as serum prokalcitonin szint > 0.5 ng/ml, purulent sputum, unilateral pulmonary consolidation)
研究者
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