Oxygen-Ozone as Adjuvant Treatment in Early Control of Disease Progression in Patients With COVID-19 Associated With Modulation of the Gut Microbial Flora
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Delta in the number of patients requiring orotracheal intubation despite treatment
研究概览
简要总结
Italy was the first European country affected by a severe outbreak of the Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China), with a high morbidity and mortality associated with the disease.
In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease 19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research.
This is an interventional, non-pharmacological, open, randomized, prospective, non-profit study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early control of disease progression in patients with COVID-19.
Contextually, all patients are treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases.
The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based intervention (accompanied by supplementation with probiotics) in containing the progression of COVID-19 and in preventing the need for hospitalization in intensive care units.
详细描述
Several studies analyzed the mechanisms by which ozone therapy could combat viral infections. In particular, 1) the improvement of the release of oxygen in the peripheral tissues, 2) the anti-inflammatory action 3) a virucidal activity have been described.
In view of these properties, a number of international clinical trials on the topic are currently ongoing.
Hospitalization, dietary changes, use of antibiotics and systemic inflammation related to COVID-19 are all variables that contribute to changes in the intestinal and lung microbiota with significant repercussions on the outcomes of the disease. Furthermore, the use of ozone therapy could also lead to a modification of the microbial flora. Probiotic supplementation can help to correct these issues.
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
- Single (Outcomes Assessor)
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
- •Age > 18 years
- •Nasopharyngeal swab positive for COVID-19
- •COVID-19 stages I - II - III (*1)
- •Hospitalization in the Department of Infectious Diseases
排除标准
- •COVID-19 stages IV - V - VI (*1)
- •Hospitalization in Intensive Care Units
- •Pregnancy
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Patients who deny consent to the proposed treatment
- •Inability to provide informed consent
- •Contraindications to performing oxygen-ozone therapy
- •hyperhomocysteinemia
- •favism or thyroiditis
- •coagulopathies
- •neurodegenerative diseases
- •angina (in particular Prinzmetal's angina) or with previous myocardial infarction
- •(*1) Compliant with indications published by:
- •Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI).
- •Care pathway for the patient with COVID-
- •Section 2 - Recommendations for local management of the critically ill patient - Version 2
- •Available on http://www.siaarti.it/SiteAssets/News/COVID19%20-%20documenti%20SIAARTI/Percorso%20COVID-19%20-%20Sezione%202%20-%20Raccomandazioni%20per%20la%20gestione%20locale%20-%20Rev%202.0.pdf
- •Last accessed 20/04/2020
- •Posted on 26.03.2020
- •On page 2 of the previous document :
- •"6 identified stages:
- •sick disease - mild COVID-19 (I stage)
- •light pneumonia - mild COVID-19 (II stage)
- •serious pneumonia - severe COVID-19 (III stage)
- •Acute respiratory distress syndrome (ARDS) - critical COVID-19 (IV stage)
- •sepsis - critical COVID-19 (V stage)
- •septic shock - critical COVID-19 (VI stage)"
研究组 & 干预措施
Standard of care
Azithromycin 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day), plus hydroxychloroquine cp 200 mg, 1 cp x 2 / day.
干预措施: Azithromycin (Drug)
Standard of care
Azithromycin 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day), plus hydroxychloroquine cp 200 mg, 1 cp x 2 / day.
干预措施: hydroxychloroquine (Drug)
Oxygen-ozone and probiotic
Oxygen-ozone therapy, probiotic supplementation plus standard of care
Oxygen-ozone therapy: systemic autohemotherapy (twice a day).
Probiotic supplementation: SivoMixx 200 billion (six sachets twice a day).
干预措施: Oxygen-ozone therapy, probiotic supplementation and Standard of care (Other)
Oxygen-ozone and probiotic
Oxygen-ozone therapy, probiotic supplementation plus standard of care
Oxygen-ozone therapy: systemic autohemotherapy (twice a day).
Probiotic supplementation: SivoMixx 200 billion (six sachets twice a day).
干预措施: SivoMixx (200 billion) (Dietary Supplement)
Oxygen-ozone and probiotic
Oxygen-ozone therapy, probiotic supplementation plus standard of care
Oxygen-ozone therapy: systemic autohemotherapy (twice a day).
Probiotic supplementation: SivoMixx 200 billion (six sachets twice a day).
干预措施: Azithromycin (Drug)
Oxygen-ozone and probiotic
Oxygen-ozone therapy, probiotic supplementation plus standard of care
Oxygen-ozone therapy: systemic autohemotherapy (twice a day).
Probiotic supplementation: SivoMixx 200 billion (six sachets twice a day).
干预措施: hydroxychloroquine (Drug)
结局指标
主要结局
Delta in the number of patients requiring orotracheal intubation despite treatment
时间窗: 21 days
Comparison between the two groups
次要结局
- Delta of crude mortality(21 days)
- Delta of length of stay for patients in hospital(90 days)
- delta in the value of IL-10(21 days)
- delta in the value of Tumor Necrosis Factor (TNF)-alpha(21 days)
- delta in the value of IL-6(21 days)
- delta in the value of zonulin(21 days)
- delta in the value of alpha1-antitrypsin(21 days)
- delta in the value of interleukin (IL)-1(21 days)
- delta in the value of lipopolysaccharide (LPS)(21 days)
- delta in the value of cluster of differentiation (CD)4+ CD38/ Human Leukocyte Antigen-DR isotype (HLA-DR)(21 days)
- delta in the value of CD8+ CD38/ HLA-DR(21 days)
- delta in the value of fecal calprotectin(21 days)
研究者
Roberto Poscia MD, PhD
Medical Doctor
Azienda Policlinico Umberto I