Indirect Endovenous Systemic Ozone for New Coronavirus Disease (COVID19) in Non-intubated Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Clinical Trial to Evaluate Efficacy and Safety of Systemic Indirect Endovenous Ozone Therapy (SIEVOT) as Adjuvant Treatment in COVID19 Non-intubated Patients

Conditions
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COVID

Intervention / Treatment
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* Other: Systemic indirect endovenous ozone therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID19 virus detected in oro/nasopharynx mild ill according WHO numeric scale mild ill according Berlin criteria non intubated patients signed informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Control group with WHO recommended treatment. Treatment group with WHO recommended treatment + systemic ozone therapy.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL<br>Base WHO recommended treatment. | |
| Experimental: TREATMENT<br>Base WHO recommended treatment + Systemic indirect endovenous ozone therapy | Other: Systemic indirect endovenous ozone therapy<br>* 200 mL at 40 mcg/mL of medical ozone / oxygen in 200 mL of patients blood mixed in an homologated device for the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID19 clinical scale | World Health Organization (WHO) recommended COVID19 clinical scale | through study completion, an average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of died patients | Dead patients during the trial | through study completion, an average of 3 weeks | 
| Oro/nasopharynx virus | 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) | Thorax imaging according scale. Higher punctuation is worse. | through study completion, an average of 3 weeks | 
| Days in hospital | Days in hospital | through study completion, an average of 3 weeks | 
| Venous gas blood analysis | Venous gas blood analysis | through study completion, an average of 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ozone therapy, COVID19