Randomized Clinical Trial to Evaluate Efficacy and Safety of Systemic Indirect Endovenous Ozone Therapy (SIEVOT) as Adjuvant Treatment in COVID19 Non-intubated Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- COVID19 clinical scale
研究概览
简要总结
Systemic medical ozone has proved to help in several viral diseases, chronic obstructive pulmonary disease and chronic inflammation process. The investigators are sure that its application to COVID-19 patients, as an adjuvant therapy, will improve the health status of these individuals.
详细描述
Due to the extreme world situation caused by COVID19 pandemic, the investigators consider unethical not to try any treatment option with a justified rationale.
The investigators have explained that medical ozone therapy has a clear scientific basement thanks to all preclinical and clinical investigation already published. It can be classified as chemical stressor that produces a modulation in the redox balance and immunity. Moreover, it is easy and safe to administer with insignificant side effects.
The efficacy in viral diseases has been proved in publications together the modulation of interleukin 6 and other proinflammatory cytokines that could potentially help in COVID19 patients. The improve of exchange of gases and microcirculation will surely contribute to enhance this patients' health status.
As explained above, the investigators propose to carry out a randomized control trial to evaluate the safety and efficacy of systemic ozone (indirect endovenous) in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
With a randomization table, nurses will treat the patients in treatment groups. Each patient will be in individual rooms.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID19 virus detected in oro/nasopharynx
- •mild ill according WHO numeric scale
- •mild ill according Berlin criteria
- •non intubated patients
- •signed informed consent
排除标准
- •patients treated with systemic ozone in the last 6 months
- •patients treated before with systemic ozone and referring any side effect
- •glucose-6-phosphate-dehydrogenase deficit
- •other severe concomitant disease apart from COVID19
- •psychiatric disease specified in axis I of l Diagnostic and Statistical Manual of Mental Disorders, 5 edition, but major depression
- •patients not capable of understanding the study methods and targets
- •pregnant woman
结局指标
主要结局
COVID19 clinical scale
时间窗: through study completion, an average of 3 weeks
World Health Organization (WHO) recommended COVID19 clinical scale
次要结局
- Number of died patients(through study completion, an average of 3 weeks)
- Oro/nasopharynx virus(through study completion, an average of 3 weeks)
- Thorax imaging (0=none; 1=unilateral; 2=bilateral; 3=ground-glass opacification; 4=consolidation)(through study completion, an average of 3 weeks)
- Days in hospital(through study completion, an average of 3 weeks)
- Venous gas blood analysis(through study completion, an average of 3 weeks)
研究者
Javier Hidalgo Tallón
Lecturer
Universidad Católica San Antonio de Murcia