Ozone Plasma on Lung Function and Inflammatory Parameters in Pulmonary Sequelae Associated With Coronavirus 19 Infection
Effect of Inhalation Administration of Ozone Plasma on Lung Function and Inflammatory Parameters in Patients With Pulmonary Sequelae Associated With Coronavirus 19 Infection (SARS-COV-2)
The risk for the development of complications from COVID-19 occurs mainly in patients over 65 years of age, with obesity, arterial hypertension, chronic lung diseases and immunosuppression states. Since the persistence of radiological imaging correlates with physiological deterioration, these patients are likely to be at increased risk of parenchymal lung disease.
It is known that the administration of Ozone, in any of the three phases of COVID-19 infection, is useful in the management of acute disease, both for its viricidal and anti-inflammatory activity, however, in the convalescence stage when the persistence of sequelae that can severely affect the quality of life of patients is identified.
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Jalisco
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Guadalajara、Jalisco、墨西哥、44340
- Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
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Guadalajara、Jalisco、墨西哥、44340
- Fernando Grover Paez
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men and women
- 25-80 years
- Individuals without active disease with previous confirmed diagnosis of COVID-19 infection with negative nasopharyngeal PCR test
- With characteristic chest radiographic images compatible with lung infection, particularly interstitial pneumonitis with previous unburied glass patches, cobblestone or areas of consolidation (during active disease)
- Sign a letter of consent under information
Exclusion Criteria:
- Patients taking the following medicines: Ivermectin, azithromycin, corticosteroids, colchicine, chlorine dioxide, oral anticoagulants such as acenocoumarin, apixaban, rivaroxaban; bronchodilators such as β2-agonists such as salbutamol and derivatives, as well as inhaled anticholinergics of the ipratropium bromide type and derivatives.
- Patients who present medical difficulty or contraindication to perform the 6 km walk test in band
- Patients with a history of community-acquired pneumonia, pulmonary neoplasms, heart, renal, or hepatic failure
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Ozone plasma
Patients will be provided with an ion-laden cold atmospheric plasma administration equipment from the company Fulgur Vitae Model 9000, they will also be given the necessary indications for the use of the equipment, which they must use for 5 minutes three consecutive times a day, every 6 hours, for two weeks.
They will also be provided with an atmospheric oxygen meter, with the indication to keep the ppb below 0.07.
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Patients will be provided with an ion-laden cold atmospheric plasma administration equipment from the company Fulgur Vitae Model 9000, they will also be given the necessary indications, as well as recommendations on the use of the equipment, which they must use for 5 minutes three consecutive times a day, every 6 hours, for two weeks.
They will also be provided with an atmospheric oxygen meter, with the indication to keep the ppb below 0.07.
You must record in your diary the start time, end and eventualities (in case of presenting them).
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Lung Function
大体时间:14 days
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Respiratory parameters by pulmonary function tests (spirometry, TLCo) and performing the 6 min walk test in endless band with pre- and post-walk oximetry measurements at the beginning and end of the study.
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14 days
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Inflammatory parameters
大体时间:14 days
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Inflammatory parameters by C reactive protein (CPR), Tumoral Necrosis Factor alfa (TNFa) and Interleukin 6 (IL-6) measurements at the beginning and end of the study.
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14 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blood Biometrics
大体时间:14 days
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Blood Biometrics at the beginning and end of the study.
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14 days
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Oxygen saturation
大体时间:14 days
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Oxygen saturation at the beginning and end of the study.
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14 days
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Ferritin
大体时间:14 days
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Ferritin at the beginning and end of the study.
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14 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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