Trials / Unknown
UnknownNCT04359303
Indirect Endovenous Systemic Ozone for New Coronavirus Disease (COVID19) in Non-intubated Patients
Randomized Clinical Trial to Evaluate Efficacy and Safety of Systemic Indirect Endovenous Ozone Therapy (SIEVOT) as Adjuvant Treatment in COVID19 Non-intubated Patients
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Javier Hidalgo Tallón · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2020-11-01
- Completion
- 2020-12-01
- First posted
- 2020-04-24
- Last updated
- 2020-06-23
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04359303. Inclusion in this directory is not an endorsement.