Indirect Endovenous Systemic Ozone for New Coronavirus Disease (COVID19) in Non-intubated Patients (OzonoCOVID19)
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ClinicalTrials.gov Identifier: NCT04359303 |
Recruitment Status : Unknown
Verified June 2020 by Javier Hidalgo Tallón, Universidad Católica San Antonio de Murcia.
Recruitment status was: Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : June 23, 2020
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Condition or disease | Intervention/treatment | Phase |
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COVID | Other: Systemic indirect endovenous ozone therapy | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Control group with WHO recommended treatment. Treatment group with WHO recommended treatment + systemic ozone therapy. |
Masking: | Double (Participant, Investigator) |
Masking Description: | With a randomization table, nurses will treat the patients in treatment groups. Each patient will be in individual rooms. |
Primary Purpose: | Treatment |
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 |
Estimated Study Start Date : | July 2020 |
Estimated Primary Completion Date : | November 2020 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
No Intervention: CONTROL
Base WHO recommended treatment.
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Experimental: TREATMENT
Base WHO recommended treatment + Systemic indirect endovenous ozone therapy
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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. |
- COVID19 clinical scale [ Time Frame: through study completion, an average of 3 weeks ]World Health Organization (WHO) recommended COVID19 clinical scale
- Number of died patients [ Time Frame: through study completion, an average of 3 weeks ]Dead patients during the trial
- Oro/nasopharynx virus [ Time Frame: through study completion, an average of 3 weeks ]Oro/nasopharynx virus
- Thorax imaging (0=none; 1=unilateral; 2=bilateral; 3=ground-glass opacification; 4=consolidation) [ Time Frame: through study completion, an average of 3 weeks ]Thorax imaging according scale. Higher punctuation is worse.
- Days in hospital [ Time Frame: through study completion, an average of 3 weeks ]Days in hospital
- Venous gas blood analysis [ Time Frame: through study completion, an average of 3 weeks ]Venous gas blood analysis

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359303
Contact: Jose Baeza Noci, MD, PhD | +34963177800 | jose.baeza@uv.es | |
Contact: Francisco J Hidalgo Tallón, MD, PhD | fjht63@gmail.com |
Spain | |
SEOT | |
Valencia, Spain, 46013 | |
Contact: Jose Baeza Noci, MD, PhD +34963177800 jose.baeza@uv.es | |
Contact: Francisco J Hidalgo Tallón, MD, PhD fjht63@gmail.com |
Responsible Party: | Javier Hidalgo Tallón, Lecturer, Universidad Católica San Antonio de Murcia |
ClinicalTrials.gov Identifier: | NCT04359303 |
Other Study ID Numbers: |
P.Inv. Ozono-COVID19 Ver.1.2 |
First Posted: | April 24, 2020 Key Record Dates |
Last Update Posted: | June 23, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | According to hospitals' statements and data protection agreements |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ozone therapy COVID19 |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |