DRKS00021626尚未招募2 期
A Randomized, Controlled, Open Label, Multicentre Clinical Trial to explore Safety and Efficacy of Hyperbaric Oxygen for preventingICU admission, Morbidity and Mortality in Adult Patients With COVID-19 - COVID-19-HBO
Karolinska Institutet, Departement Physiology und Pharmacology0 个研究点目标入组 200 人开始时间: 2020年5月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •1) Aged 18-90 years
- •2) PaO2/FiO2 (PFI) below 200 mmHg (26.7 kPa)
- •3) Suspected or verified SARS-CoV-2 infection
- •4) At least two risk factors for increased morbidity/mortality
- •Age above 50 years
- •Hypertension
- •Cardiovascular disease
- •Diabetes or pre-diabetes
- •Active or cured cancer
- •Asthma/COPD
- •D-Dimer > 1.0
- •Auto-immune disease
- •5) Documented informed consent according to ICH-GCP and national regulations
排除标准
- •1) ARDS/pneumonia caused by other viral infections (positive for other virus)
- •2) ARDS/pneumonia caused by other non-viral infections or trauma
- •3) Known pregnancy or positive pregnancy test in women of childbearing age
- •4) Patients with previous lung fibrosis more than 10%
- •5) CT- or Spirometry-verified severe COPD with Emphysema
- •6) Contraindication for HBO according to local guidelines
- •7) Not likely to need ICU admission < 7 days of Screening (Subjective criteria that may exclude any patients that fullfill the other inclusion criteria but where the treating physician suspect a spontaneous recovery)
- •8) Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
研究者
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