Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Physical and mental component scores of the 36-item Short Form Survey (SF-36)
研究概览
简要总结
The goal of this clinical try is to investigate the effect of hyperbaric oxygen therapy (HBOT) on symptoms, quality of life and absence of work through sickness in patients with post-COVID on short- and mid-term, as well as to identify biochemical mechanisms of action.
The main questions it aims to answer are:
- What is the clinical relevance of improvements of symptoms and quality of life after treatment with HBOT for post-COVID?
- What are the changes in absence from work after treatment with HBOT?
- What is the cost-effectiveness of treatment with HBOT?
- What are possible mechanisms of action of HBOT?
Participants will undergo 40 sessions of HBOT. Researchers will compare HBOT with standard care alone (control group). In case of a positive outcome, patients in the control group can cross-over to the HBOT group after 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cognitive and/or physical symptoms ≥ 12 months after acute COVID-19 infection
- •Symptoms include post-exertional malaise (PEM) and/or dysautonomia as assessed by questionnaires and/or NASA LEAN test
- •Symptoms affect day-to-day life (based on SF-36 'role limitations due to physical functioning' score of ≤ 50 at baseline).
- •Current treatment regimen is stable for at least 1 months before inclusion
排除标准
- •Unfit for hyperbaric treatment
- •Previous diagnosis of ME/CFS
- •Unable to provide informed consent
研究组 & 干预措施
Hyperbaric Oxygen therapy
40 sessions of HBOT at 2.4 ATM
干预措施: Hyperbaric oxygen (Drug)
结局指标
主要结局
Physical and mental component scores of the 36-item Short Form Survey (SF-36)
时间窗: Week 20 (i.e. 3-months after end of HBOT)
Range 0-100, with higher scores indicating higher quality of life
次要结局
- Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns(Worn continuously until week 34)
- Biochemical parameters(Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment))
- Absence from work(Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment).)
- Euroqol-5D (EQ-5D)(Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment).)
- Cost-effectiveness(Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment).)
研究者
Merel Hellemons
Dr.
Erasmus Medical Center