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

June 21, 2020 updated by: Javier Hidalgo Tallón

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46013
        • SEOT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL
Base WHO recommended treatment.
Experimental: TREATMENT
Base WHO recommended treatment + Systemic indirect endovenous ozone therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID19 clinical scale
Time Frame: through study completion, an average of 3 weeks
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
Time Frame: through study completion, an average of 3 weeks
Dead patients during the trial
through study completion, an average of 3 weeks
Oro/nasopharynx virus
Time Frame: through study completion, an average of 3 weeks
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)
Time Frame: through study completion, an average of 3 weeks
Thorax imaging according scale. Higher punctuation is worse.
through study completion, an average of 3 weeks
Days in hospital
Time Frame: through study completion, an average of 3 weeks
Days in hospital
through study completion, an average of 3 weeks
Venous gas blood analysis
Time Frame: through study completion, an average of 3 weeks
Venous gas blood analysis
through study completion, an average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javier Hidalgo Tallón

Collaborators

Sociedad Española de Ozonoterapia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 21, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.Inv. Ozono-COVID19 Ver.1.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

According to hospitals' statements and data protection agreements

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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