一项收录于美国国立医学图书馆的《口服二氧化氯治疗COVID - 19有效性的研究》

本文是对美国国立卫生院临床试验网站上注册并发表的一篇关于《口服二氧化氯治疗COVID - 19有效性的研究》的翻译。

该文章收录在美国国立医学图书馆（NIH U.S.National Library of Medicine）。

进入正文阅读   

题目：口服二氧化氯治疗COVID - 19有效性的研究

Determination of the Effectiveness of Oral Chlorine Dioxide in the Treatment of COVID 19

免责声明

Disclaimer 

本研究的安全性和科学有效性是研究发起者和研究者的责任。列出这项研究并不意味着美国联邦政府对其进行了评估。了解临床研究的风险和潜在的好处，并在参与之前与你的医疗保健医生沟通，并详细阅读我们的免责声明。

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

在美国国立卫生院的临床试验网发布状态，及发布号：NCT04343742

ClinicalTrials.gov， Identifier: NCT04343742

首次发布时间：2020年4月13日

First Posted  : April 13, 2020

最后更新发布时间：2020年5月27日

Last Update Posted  : May 27, 2020

发起人：创世基金会 genesis foundation

信息提供者（责任单位）：Eduardo Insignares Carrione, Genesis Foundation

研究类型：观察性研究

Study Type：Observational

入组人数：20名参与者

Estimated Enrollment : 20 participants

观测模型：单纯病例研究

Observational Model : Case-Only

时间观察法：前瞻性研究

Time Perspective : Prospective

研究课题：《口服二氧化氯治疗COVID-19有效性的研究》

Official Title : Determination of the Effectiveness of Oral Chlorine Dioxide in the Treatment of COVID 19

实际研究开始日期：2020年4月1日

Actual Study Start Date:April 1, 2020

实际初次完成时间：2020年4月7日

Actual Primary Completion Date:April 7, 2020

研究预计完成日期：2020年6月1日

Estimated Study Completion Date:June 1, 2020

摘要（Abstract）

本研究的目的是通过前瞻性病例研究评估口服二氧化氯治疗COVID - 19感染患者的疗效。

The objective of this study is to review, through prospective case research, the efficacy of oral chlorine dioxide in the treatment of patients with COVID 19 infection.

该研究于2020年4月至6月间进行，采用准实验设计的方法对来自两个卫生保健中心的20名COVID-19患者，通过直接干预的方式，对患者用药后的症状表现及COVID-19 转阴结果进行研究，以确定二氧化氯在治疗组的有效性。

The research will be carried out between April and June 2020 with a quasi-experimental design in two health care centers on a sample of twenty (20) patients, through direct intervention, who will measure the changes in the manifest symptoms of infection and negativity. a COVID 19 after administration of the study preparation, to determine the effectiveness of chlorine dioxide in the treated group.

根据该临床试验的结果及对临床症状改善（量表1 - 5分)和COVID-19 转阴结果的评估，我们可以通过观察口服二氧化氯是否对治疗COVID-19有疗效，来判断二氧化氯在本临床试验中的治疗效果是否良好。

Based on the results that are found and on the evaluation of efficacy on the basis of clinical improvement on a scale of 1 to 5, and of the negativization of COVID 19, we can conclude whether the therapeutic efficacy in this investigation is considered good by verifying whether or not there is efficacy of treatment with chlorine dioxide in COVID 19.

鉴于当前新冠大流行中存在的高死亡和发病率，希望通过这项研究，促进寻找新的治疗COVID - 19的方法，并有助于研发新的药物。

With this research, it is hoped to stimulate the search for new therapeutic options in the treatment of COVID 19 and contribute to the development of NEW options in medications, considering the immense number of deaths and morbidity that currently exists in the present pandemic.

关键词：COVID - 19，二氧化氯，治疗

Key words: COVID 19, chlorine dioxide, treatment.

研究人群

Study Population

本实验的研究人群包含一组医疗和卫生机构的COVID-19阳性感染者。他们均来自位于哥伦比亚波哥大市和西班牙马德里市(多中心)的不同医疗护理中心和医院。

The population to which the study was directed consisted of a group of patients of medical and health profession with active infection with COVID-19, from various medical care centers, hospitals, in the city of Bogotá, Colombia and Madrid, Spain (multicenter .)

患者的选择是基于医生/患者自愿参与本研究，即他们提出自愿作为本实验研究的对象。另外，所有研究对象在同一时间内纳入本研究（simultaneity）。

The selection of the patients was made based on the self-proposal of the doctors / patients as candidates for research, which refers to the fact that they proposed themselves as cases.

Similarly, simultaneity was applied, which means that the patients were obtained in the same period of time in which the cases arose.

纳入标准

Inclusion Criteria 

一、Covid - 19阳性患者

二、有Covid - 19的一些典型症状，例如，发热、吞咽痛、呼吸窘迫。

三、年龄18-80岁

to. Covid 19 positives

b. Some of the characteristic symptoms of covid 19: fever, odynophagia, respiratory distress.

c. Age between 18 years and 80 years

排除标准

Criteria Exclusion 

一、新冠阴性

二、伴随肾衰竭IV / VI者

三、充血性心力衰竭

四、正在服用抗凝血剂患者，尤其是华法林钠者。

to. Covid 19 negatives

b. Kidney failure IV / VI.

c. Congestive heart failure.

d. Patients taking anticoagulants, particularly warfarin sodium

干预措施/治疗方法，及给药剂量和服用方法

Intervention/treatment , dosage and route of administration.

二氧化氯 3000 ppm，150 毫升/瓶.

Drug: chlorine dioxide 3000 ppm，Bottle x 150 cc.

每个病人都将收一瓶3000ppm的二氧化氯制剂（150 毫升/瓶）及一份详细说明如何准备和服用稀释剂的书面指导。

Each patient will receive the 3,000 ppm chlorine dioxide base preparation with written and precise instructions on how to prepare and take the dilutions.

每天将10ml 3000ppm二氧化氯加入1升水中，每小时饮用一部分，直到全部喝完(8 – 12次喝完)。口服1个月。

10 ml of 3000 ppm chlorine dioxide are added to 1 liter of water, per day. One part is taken every hour, until the content of the bottle is finished (8 to 12 shots).

The medication will be taken orally for one month.

保存注意事项

Precautions for preservation

原液和稀释液都要放到冰箱里冷藏保存。

Both the original dioxide bottle and the preparation for the day should be kept refrigerated.

研究药物分配方法 

Assignment of study medication 

每位患者将按入院顺序收到一个连续的患者编号（编号是临床试验开始前计算机生成的列表），患者按照编号领取药物。参与实验人员会收到3000 ppm的二氧化氯原液及一份指导配制和服用二氧化氯稀释液的详细说明。

Each patient will receive, in order of admission to the study, a consecutive patient number and the corresponding study medication. The assignment of this medication was made before the start of the study, using a computer generated list. Patients will receive the 3,000 ppm chlorine dioxide base preparation with written and precise instructions on how to prepare and take the dilutions.

主要疗效标准 

Main efficacy criteria

依据视觉模拟评分，10个评定级别：1=最低分，10=最优。

新冠COVID 19阴性。

Assessment according to 'visual analog scale' (VAS), 10-point scale (1 = poor VAS; 10 = optimal) evaluation by patients.

Negativization of COVID 19 in the patient.

耐受标准

Tolerance criteria 

不良反应，如症状学、临床和实验室检查在研究开始的7天、15天和30天后出现。

Adverse reactions Semiological, clinical and laboratory explorations are expected at the beginning of the study treatment (or baseline) as well as after 7, 15 and 30 days.

二氧化氯对新冠作用机制的建议

Base proposals for mechanisms of action in COVID 19

二氧化氯在极短的时间内，通过选择性氧化过程清除病毒。主要使病毒壳蛋白质变性，使其遗传物质氧化，从而使其遗传复制无效。

Chlorine dioxide removes viruses through the selective oxidation process in a very short time. It does this by denaturing the capsid proteins, and subsequently oxidizes the genetic material of the virus, disabling it.

二氧化氯最大的优势是对几乎任何病毒亚种作用，且病毒对该氧化性没有抗药性。我们不要忘记二氧化氯已经用于废水处理近百年，且没产生过任何抗药性。

The great advantage of chlorine dioxide is that it works for any viral subspecies and there are no possible resistances to this type of oxidation.

Let's not forget that this substance has been used for 100 years in wastewater without generating any type of resistance.

已经有科学研究表明，二氧化氯对冠状病毒（SARS-CoV-2 coronaviruses）有效，包括人冠状病毒，动物如狗冠状病毒有效，比较常见的是犬齿冠状病毒、猫肠道冠状病毒(FECV)、猫传染性腹膜炎病毒(FIPV)。主要使病毒壳蛋白氧化变性。

There is already scientific evidence that chlorine dioxide is effective in SARS-CoV-2 coronaviruses, It has also been shown to be effective in human coronavirus and in animals such as dogs, known as canine respiratory coronavirus, or in cats, including feline enteric coronavirus (FECV) and the better known virus of feline infectious peritonitis (FIPV), since it denatures the capsids by oxidation inactivating the virus in a short time .

主要研究结果

Primary Outcome Measures

COVID -19核酸检测转阴后7天无复阳

通过RT-PCR扩增新冠病毒基因

negative testing of covid19 [ Time Frame: 7 DAYS ]

amplification of coronavirus genes by RT-PCR

研究合作和支持方：创世基金会 

Sponsors and Collaborators : Genesis Foundation

研究者

Investigators

Study Chair:yohanny andrade, researcherGenesis Foundation

Study Chair:oswaldo leyva, researcherGenesis Foundation

招募医院

Recruiting Hospital

哥伦比亚昆迪纳马卡省波哥大市 弗兰克医院

Colombia Hospital FhsjRecruiting

Bogota, Cundinamarca, Colombia

哥伦比亚昆迪纳马卡省波哥大市 圣卡洛斯医院

San Carlos HospitalRecruiting

Bogota, Cundinamarca, Colombia

声明：本译文仅以信息介绍为目的，不代表译者立场。

本译文是对来源于美国国立卫生院临床试验网站注册的一项临床研究的翻译（文章来源：https://clinicaltrials.gov/ct2/show/NCT04343742），该课题为：口服二氧化氯治疗COVID-19有效性的研究（Determination of the Effectiveness of Oral Chlorine Dioxide in the Treatment of COVID 19）。

1. 此项在ClinicalTrials.gov注册的临床试验计划不代表试验药物二氧化氯获得美国FDA药物注册，也不意味着美国联邦政府对其进行了评估。在中国，二氧化氯同样是未获得药监注册，严禁用于治疗疾病。

2. 计划显示预计研究完成日期为2020年6月1日，但目前没有发布研究结果。

3. 此项研究表明，有机构在尝试对二氧化氯能否对新冠感染有治疗作用进行观察，但是否实施或实施结果未予公示。

4. 该实验是计划招募部分COVID-19患者和部分主动感染COVID-19的医疗工作者，采用口服二氧化氯溶液进行疗效观察。

5. 二氧化氯用于人体，尚需在所在国完成药物临床前的相关研究并获得临床研究许可，目前在FDA网站上未检索到二氧化氯作为药物的相关注册信息。

6. 如果进入药物临床研究阶段，并且该项研究能顺利完成并得出有效的结论，将是一个令人鼓舞的结果。但是这也不代表二氧化氯能够顺利获得FDA药物注册应用于人体，仅仅是为二氧化氯临床应用的研发提供了一个依据，而众所周知新药研发上市是一个极其漫长的过程。

7. 此项研究表达了一个信息，有机构尝试进行二氧化氯治疗COVID-19有效性的研究，并制定了临床试验方案，但能否实施或实施进展未予公示。