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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- ICU admission
研究概览
简要总结
COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure.
We explore a treatment administered in a randomized clinical trial that could prevent ICU admission and reduce mortality.
The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the inflammatory response.
详细描述
Main objective: To evaluate if HBO reduce the number of ICU admissions compared to Best practice for COVID-19
Secondary objectives:
Main secondary objectives:
To evaluate if HBO:
- reduces mortality in severe cases of COVID-19.
- reduces morbidity associated with COVID-19.
- reduce the load on ICU resources in COVID-19.
- mitigate the inflammatory reaction in COVID-19.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •ARDS/pneumonia caused by other viral infections (positive for other virus)
- •ARDS/pneumonia caused by other non-viral infections or trauma
- •Known pregnancy or positive pregnancy test in women of childbearing age
- •Patients with previous lung fibrosis more than 10%
- •CT- or Spirometry-verified severe COPD with Emphysema
- •Contraindication for HBO according to local guidelines
- •Not likely to need ICU admission < 7 days of screening (Subjective criteria that may exclude any patients that fulfil the other inclusion criteria but where the treating physician suspect a spontaneous recovery)
- •Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- •Prisoner (Exclusion criteria according to IRB at UCSD)
研究组 & 干预措施
Hyperbaric oxygen
Hyperbaric oxygen 1,6-2.4 Bar for 30-60 minutes (compression/decompression time, according to local routines) in addition to best practice
干预措施: Hyperbaric oxygen (Drug)
结局指标
主要结局
ICU admission
时间窗: Through study completion 30 days
The proportion of subjects admitted to ICU from day 1 to day 30, based on at least one of the following criteria: i) Rapid progression over hours ii) Lack of improvement on high flow oxygen \>40L/min or non invasive ventilation with fraction of inspired oxygen (FiO2) \> 0.6 iii) Evolving Hypercapnia or increased work of breathing not responding to increased oxygen despite maximum standard of care available outside ICU iv) Hemodynamic instability or multi organ failure with maximum standard of care available outside ICU
次要结局
- 30-day mortality(Through study completion 30 days)
- Time-to-intubation(Through study completion 30 days)
- Time-to-ICU(Through study completion 30 days)
- Inflammatory response(Through study completion 30 days)
- Overall survival(Through study completion 30 days)
研究者
Anders Kjellberg, MD
ICU Consultant/PhD student
Karolinska Institutet