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

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

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.

Unknown status
COVID

Other: Systemic indirect endovenous ozone therapy

200 mL at 40 mcg/mL of medical ozone / oxygen in 200 mL of patients blood mixed in an homologated device for the procedure.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

SEOT
Valencia, Spain

Investigator: Jose Baeza Noci, MD, PhD
Contact: +34963177800
jose.baeza@uv.es

Contacts

Jose Baeza Noci, MD, PhD
+34963177800
jose.baeza@uv.es

Francisco J Hidalgo Tallón, MD, PhD
fjht63@gmail.com

Sociedad Española de Ozonoterapia
NCT Number
Keywords
ozone therapy
COVID19
MeSH Terms
COVID-19