Indirect Endovenous Systemic Ozone for New Coronavirus Disease (COVID19) in Non-intubated Patients (OzonoCOVID19)

Javier Hidalgo Tallón

Status and phase

Unknown

Phase 3

Conditions

COVID

Treatments

Other: Systemic indirect endovenous ozone therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04359303

P.Inv. Ozono-COVID19 Ver.1.2

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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