RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hyperbaric Oxygen Therapy for the Treatment of Post COVID Condition (RECLAIM-HBOT)
概览
- 阶段
- 不适用
- 干预措施
- Hyperbaric Oxygen therapy
- 疾病 / 适应症
- 未指定
- 发起方
- University Health Network, Toronto
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Simple reaction time [SRT] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
The RECLAIM study platform will be used to explore whether the use of Hyperbaric Oxygen therapy (HBOT) improves the symptoms of post covid cognitive dysfunction.
Hyperbaric oxygen therapy is a well-established medical treatment. HBOT promotes healing by delivering a high concentration of oxygen into the body. This high level of oxygen has a number of known benefits, such as growth of new blood vessels, as well as regulating immune and inflammation responses. It helps protect the brain and other nervous tissue from inflammation. HBOT may also have antiviral effects.
Collectively, it has the potential to target the underlying mechanisms believed to play a critical role in the development of Long COVID.
Many individuals with Long COVID complain of fatigue, brain fog, muscle aches and other symptoms. There is evidence to suggest that these symptoms may be a problem with the blood vessels, resulting in abnormal delivery of oxygen to tissues. Thus, our group is investigating whether HBOT improves post-COVID cognitive dysfunction.
详细描述
This is a Sub-Protocol to the Core Clinical Study Protocol titled: REcovering from COVID19 Lingering symptoms Adaptive Integrative Medicine (RECLAIM),
研究者
入排标准
入选标准
- •Age ≥18 years;
- •Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15,
- •Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial.
- •Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive test or the date of first symptoms;
- •Lingering symptoms from COVID-19 present at the time of randomization. "Lingering symptoms of Long COVID" must include self-reported cognitive dysfunction symptoms.
- •Female patients of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use effective methods of contraception while on study treatment. Effective methods of contraception must be discussed and approved by the overseeing Investigator.
- •Must be able to provide informed consent and both willing and able to comply with study requirements.
- •A confirmed ability to travel to one of the three sites where HBOT or sham can be administered.
排除标准
- •Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;
- •Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;
- •Contraindications to all of the study interventions;
- •Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted);
- •Currently pregnant or breastfeeding.
- •Pneumothorax
- •Poorly controlled seizure disorder
- •Chronic sinusitis
- •Chronic or acute otitis media
- •Major ear drum trauma.
研究组 & 干预措施
Hyperbaric oxygen therapy
HBOT GROUP will have HBOT with 100% oxygen for 90 min, once daily, five times a week for 8 consecutive weeks. This will be given at a slightly higher pressure than normal air pressure (2 times regular air pressure)
干预措施: Hyperbaric Oxygen therapy
Hyperbaric oxygen sham
CONTROL GROUP will have sham treatment, which will look and feel like HBOT, but will not have high enough oxygen concentration for any therapeutic or health benefit. Sham treatment with 21% oxygen (the amount of oxygen normally present in the air) for 90 min, once daily, five times a week for 8 consecutive weeks. This will be given at standard atmospheric pressure (1.03 ATA). The air pressure will vary slightly to mimic the feeling of HBOT.
干预措施: Hyperbaric Oxygen therapy
结局指标
主要结局
Simple reaction time [SRT] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit
时间窗: Baseline/Start of intervention to two months
On-line survey tool
Verbal paired associates [VPA] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit
时间窗: Baseline/Start of intervention to two months
On-line survey tool
次要结局
- Post-Exertional Malaise(Baseline/start of intervention to 1, 2 months 3 and 6 months)
- Symptoms scale(Baseline/start of intervention weekly to 2 months, then once monthly to 6 months.)
- Symptom Checklist(Baseline/start of intervention to 1, 2 months 3 and 6 months)
- Six Minute Walking Test (6MWT) with oximetry(Baseline/start of intervention and 2 months.)
- SF-36(Baseline/start of intervention to 1, 2 months 3 and 6 months)
- TestMyBrain cognitive testing(Baseline/start of intervention to 1, 2 months 3 and 6 months)
- Post COVID19 functional status scale(Baseline/start of intervention to 1, 2 months 3 and 6 months)
- Reintegration to Normal Living Index (RNLI)(Baseline/start of intervention to 1, 2 months 3 and 6 months)
- The Fatigue Scale(Baseline/start of intervention to 1, 2 months 3 and 6 months)
- Brief Fatigue inventory(Baseline/start of intervention to 1, 2 months 3 and 6 months)
- Mental Health - General Anxiety Assessment Form (GAD-7)(Baseline/start of intervention to 1, 2 months 3 and 6 months)
- Mental Health - Patient Health Questionnaire (PHQ-9)(Baseline/start of intervention to 1, 2 months 3 and 6 months)
- Dyspnea(Baseline/start of intervention to 1, 2 months 3 and 6 months)
- Blood samples(Baseline/start of intervention and 2 months)