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临床试验/EUCTR2020-005020-11-ES
EUCTR2020-005020-11-ES进行中(未招募)1 期

Randomized multicenter single-blind controlled trial on ozonated blood in COVID-19 severe pneumonia

Políclinica Nuestra Señora del Rosario0 个研究点目标入组 30 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
30

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. Men and women over 18 years of age.
  • 2. Diagnosis of COVID-19 confirmed by positive nasopharyngeal PCR.
  • 3. Lung infiltrate confirmed by imaging test (chest X-ray or CT) + patient with severe pneumonia (failure of > = 1 organ or SpO2 ambient air of <90% or respiratory rate> = 30) with need for oxygen with nasal canula , Venturi mask, non-rebreathing mask, high-flow nasal goggles or non-invasive mechanical ventilation (NIMV).
  • 4. Evolution time of <2 weeks from symptom onset to recruitment.
  • 5. Acceptance to participate in the study and signing of the consent form
  • 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 15
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 15

排除标准

  • 1. Patients who have received treatment with systemic ozone six months before admission to the hospital.
  • 2. Patients who have previously experienced some type of adverse reaction to ozone therapy.
  • 3. Patients who are aware of having a glucose-6-phosphate-dehydrogenase deficiency
  • 4. Patients who are not able to clearly understand the objectives and methodology of the study.
  • 5. Pregnant or lactating patients.
  • 6. Patients who are intubated with invasive mechanical ventilation.
  • 7. Patients with decompensated concomitant pathology and / or associated infectious pathology not related to COVID-19.

研究者

发起方
Políclinica Nuestra Señora del Rosario

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