Hyperbaric Oxygen for Treatment of Long COVID Syndrome; A Randomized, Placebo-Controlled, Double-Blind, Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- RAND 36 change
研究概览
简要总结
Long COVID Syndrome (Long COVID), Post Acute COVID-19 Syndrome (PACS) or Post COVID-19 Syndrome (PCS) is defined as 'signs and symptoms that develop during or following an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis'. 1 in 10 infected individuals may suffer persistent symptoms, and we are facing an emerging problem that will severely affect individuals, health care systems and society for years to come.
We explore hyperbaric oxygen administered in a randomized placebo-controlled clinical trial as a potential treatment for patients suffering from Long COVID.
The overall hypothesis to be evaluated is that hyperbaric oxygen (HBO2) alleviates symptoms associated with Long COVID.
详细描述
Phase II Clinical Trial
Prospective randomized, placebo-controlled, double blind, phase II, clinical trial, estimated enrolment: 80 subjects Parallel groups Intervention: HBO2: 240 kPa for 90 min, maximum 10 treatments within 6 weeks from randomization
Control: Placebo treatment with 'sham' air breathing at a moderately higher pressure (134 kPa) to simulate hyperbaric chamber treatment, maximum 10 treatments within 6 weeks from randomization
The population will comprise of previously healthy patients (American Society of Anaesthesiologists (ASA) class 1-2 diagnosed with Long COVID (U09.9) by a multidisciplinary team. All patients are assessed with a battery of questionnaires, physical tests, laboratory tests and radiology. After their first assessment, individuals may have further organ specific work up for diagnosis, such as diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS).
Once the patient has been diagnosed with Long COVID, they will be informed and asked to participate in the trial. No study specific procedures will take place before an informed consent form (ICF) has been signed. The patients will be included once they fulfil the inclusion criteria and exhibit none of the exclusion criteria. Some study specific procedures will be performed before inclusion. Eligible subjects will be randomized within two weeks of the planned first treatment. Subjects will be randomized in a 1:1 allocation to HBO2 or placebo (sham treatment). Scheduling of the HBOT will depend on available resources but the first treatment should be given within two weeks after randomization, and a maximum ten treatments should be given within 6 weeks from randomization.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Subjects will be randomized to either active treatment or sham treatment. Assessors will be blinded to treatment group.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-60 years
- •Healthy or mild systemic disease (ASA 1-2) prior to COVID-19
- •Symptoms consistent with Long COVID for at least 12 weeks
- •Diagnosed with Long COVID, PACS, PCS (ICD-10 U09.9)
- •Working or studying prior to COVID-19
- •Documented informed consent according to GCP and national regulations
排除标准
- •Known pregnancy or positive pregnancy test in women of childbearing age
- •ASA 3 or more from other cause than Long COVID
- •Score above 70 in RAND-36 Role Limitation Physical Health (RP) or Physical Functioning (PF)
- •Diagnosed with hypertension prior to COVID-19
- •Contraindication for hyperbaric oxygen treatment according to local guidelines
- •Participation or recent participation in a clinical trial with an investigational product
- •Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
研究组 & 干预措施
Hyperbaric oxygen treatment
HBO2 240 kPa, 90 min, maximum 10 treatments
干预措施: Hyperbaric oxygen (Drug)
Sham treatment
Air 134-120 kPa, 90 min, maximum 10 treatments
干预措施: Sham treatment (Procedure)
结局指标
主要结局
RAND 36 change
时间窗: Baseline and 13 weeks
Mean change from baseline to 13 weeks in RAND 36 domains role limitations due to physical health (RP) and physical functioning (PF). RAND 36 is a self-reporting questionnaire that contains 36 items that measure eight concepts of health in general terms, at present and past four weeks. Numeric values from the survey are coded so that all items are scored from 0 (lowest score) to 100 (highest possible score). Scores then represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the eight scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.
次要结局
- RAND 36 normalization(Baseline and 13 weeks)
- Endothelial dysfunction(Baseline and 13 weeks)
- 6-min walk test(Baseline and 13 weeks)
- 30/60 min chair stand(Baseline and 13 weeks)
- EQ-5D(Baseline and 13 weeks)
研究者
Anders Kjellberg, MD
ICU Consultant, head of hyperbaric medicine
Karolinska University Hospital