EUCTR2021-000764-30-SE进行中(未招募)1 期
Hyperbaric Oxygen for Treatment of Long COVID syndrome; A Randomized, Placebo-Controlled, Double-Blind, Phase II Clinical Trial - Safety and Efficacy of Hyperbaric Oxygen Therapy for Long COVID Syndrome
Karolinska University Hospital0 个研究点目标入组 80 人开始时间: 2021年5月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 80
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 18–60 years
- •2)Healthy or mild systemic disease prior to COVID-19
- •3)Symptoms consistent with Long COVID for at least 12 weeks
- •4)Diagnosed with Long COVID, PACS, PCS (ICD-10 U09.9)
- •5)Working or studying prior to COVID-19
- •6)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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Known pregnancy or positive pregnancy test in women of childbearing age
- •2)ASA 3 or more from other cause than Long COVID
- •3)Score above 70 in RAND-36 domain Role Limitation Physical Health (RP) or Physical Functioning (PF)
- •4)Diabetes
- •5)Diagnosed with Hypertension prior to COVID-19
- •6)Contraindication for HBO2 treatment according to local guidelines
- •7)Participation or recent participation in a clinical trial with an investigational product
- •8)Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of trialstudy participation
研究者
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