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临床试验/EUCTR2021-000764-30-SE
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:
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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

发起方
Karolinska University Hospital

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