A Trial of Ozone Auto-hemotherapy in Adults Hospitalized With Covid-19 Pneumonia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 208
- 试验地点
- 11
- 主要终点
- Rate of patients achieving improvement in clinical condition at day 14 after recruitment
研究概览
简要总结
This is a multicenter, randomized, controlled, open-label clinical trial testing the use of ozone auto-hemotherapy in hospitalized patients with Covid-19 pneumonia.
Eligible patients will be randomly assigned to receive either ozone auto-hemotherapy plus standard treatment, or standard treatment alone.
Patients in the ozone auto-hemotherapy group will receive treatment mixing 100-200ml of blood with ozone at a concentration of 40 μg / mL with a gas volume of 200 ml. Treatment will occur every 12h during 5 days. Standard treatment will be the one used in each hospital participating in the trial.
All analyses will be done according to the intention-to-treat principle
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COVID-19 confirmed by positive polymerase chain reaction (PCR) for Severe Acute Respiratory Syndrome (SARS-COV-2) in respiratory tract sample, plus pneumonia confirmed by imaging tests and arterial oxygen saturation (SpO2) <94% with ambient air or a partial pressure of oxygen to fraction of inspired oxygen (pO2/FiO2) ratio <300 mmHg or SpO2/FiO2 ≤
- •Acceptance to participate in the study and signing of the informed consent.
排除标准
- •Patients who have received treatment with any form of ozone therapy 6 months before admission to the hospital.
- •Patients who have previously been treated and have experienced some type of adverse reaction to ozone therapy.
- •Patients aware of having a deficiency of Glucose-6-phosphate dehydrogenase.
- •Patients with clinically decompensated chronic comorbidities, independently of COVID-
- •Patients suffering from any psychiatric disorder specified in axis I of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), other than major depression.
- •Patients who are not able to clearly understand the objectives and methodology of the study.
- •Pregnant or lactating patients.
结局指标
主要结局
Rate of patients achieving improvement in clinical condition at day 14 after recruitment
时间窗: 14 days
Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO)
次要结局
- Time to clinical improvement or hospital discharge(28 days)
- Time to a 2-fold decrease in Lactate Dehydrogenase(14 days)
- Time to a 2-fold decrease in ferritin(14 days)
- Time to a 2-fold decrease in C-protein reactive(14 days)
- Number of ventilator-free days at 28 days(28 days)
- Hospital length of stay(28 days)
- Rate of patients achieving improvement in clinical condition at day 28 after recruitment(28 days)
- Mortality at day 28(28 days)
- Rate of patients achieving improvement in clinical condition at day 7 after recruitment(7 days)
- Time to a 2-fold decrease in Dimer-D(14 days)
- Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio(14 days)
研究者
Marc Vives
MD, PhD
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta