EUCTR2020-001349-37-SE进行中（未招募）1 期
A Randomized, Controlled, Open Label, Multicentre Clinical Trial to explore Safety and Efficacy of Hyperbaric Oxygen for preventing ICU admission, Morbidity and Mortality in Adult Patients With COVID-19 - Safety and Efficacy of Hyperbaric oxygen for ARDS in patients with COVID-19
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- •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
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
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 pregnabest practicency 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
- •9) Prisoner (Exclusion criteria according to IRB at UCSD)
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