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Ozone Therapy in the Prevention of COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400006
Recruitment Status : Completed
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Kardelen Gencer Atalay, Marmara University

Study Description
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Brief Summary:

Coronavirus has already infected 4,673,809 people and killed 312,646 people worldwide, and no specific treatment or a vaccine against it has yet proven to be effective. Ozone therapy has become o promising tool for both prevention and treatment of COVID-19 infection by various possible mechanisms. The oxidative stress created by ozone in the body to stimulate the peripheral phagocytic cells, activate the antioxidant system, and restore the immune system is thought to be effective for the prevention of COVID-19 infection.

In recent years, ozone therapy has become a popular alternative method for chronic pain management of various diseases such as fibromyalgia, knee osteoarthritis, and rheumatic diseases. As a result of this, there were many individuals who had received ozone therapy before the outbreak of COVID-19. This study aimed to investigate the preventive effect of ozone therapy against COVID-19 infection in these individuals.


Condition or disease
Corona Virus Infection

Detailed Description:

The inclusion criteria were determined to be completed at least ten sessions of ozone therapy applied by the method of major autohemotherapy in the last six months from the time the first COVID-19 case of Turkey reported (Mar 11, 2020). Individuals who received ozone therapy locally or fewer than ten sessions, who did not want to participate were excluded.

The major autohemotherapy procedure to all the participants was applied as follows: 100mL of blood was drawn by a vacuum from the antecubital vein into a sterile glass bottle in which 12 mL of 3.13% sodium citrate solution as an anticoagulant (MediPac®, Germany). A corresponding volume (100mL) of gas with an ozone concentration of 10-20 µg/mL was immediately added and continuously mixed by a gentle rotating movement to avoid foaming to the blood in the bottle. Ozone was produced by a Blue-S medical ozone generator (Turkozone®, Turkey). Reinfusion was accomplished in about 15-20 minutes, and the whole procedure was carried out in approximately 30 minutes and was repeated two or three times a week.

Study Design
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Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effectiveness of Ozone Therapy in the Prevention of COVID-19 Infection
Actual Study Start Date : May 6, 2020
Actual Primary Completion Date : May 16, 2020
Actual Study Completion Date : May 17, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The survey that was taken by telephone calls [ Time Frame: Day 0 ]
    It involved questions about age, gender, height, weight, occupation, comorbidities, and concurrent medications, in addition to a detailed query for COVID-19 infection


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Individuals who completed at least ten sessions of ozone therapy applied by the method of major autohemotherapy* in the last six months from the time the first COVID-19 case of Turkey reported (Mar 11, 2020).
Criteria

Inclusion Criteria:

  • To be completed at least ten sessions of ozone therapy applied by the method of major autohemotherapy in the last six months from the time the first COVID-19 case of Turkey reported (Mar 11, 2020)

Exclusion Criteria:

  • To received ozone therapy locally or fewer than ten sessions
  • not want to participate
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04400006


Locations
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Turkey
Kardelen Gencer Atalay
Istanbul, Turkey, 34899
Sponsors and Collaborators
Marmara University
Investigators
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Principal Investigator: Kardelen Gencer Marmara University
More Information
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Responsible Party: Kardelen Gencer Atalay, Principal Investigator, Marmara University
ClinicalTrials.gov Identifier: NCT04400006    
Other Study ID Numbers: 2761
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kardelen Gencer Atalay, Marmara University:
Coronavirus
Ozone
Preventive Medicine
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Coronavirus Infections
Disease Attributes
Pathologic Processes
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections