Ozone Therapy in the Prevention of COVID-19 Infection

NCT ID: NCT04400006

Last Updated: 2020-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-06

Study Completion Date

2020-05-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Corona Virus Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Kardelen Gencer Atalay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kardelen Gencer

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

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Kardelen Gencer Atalay

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2761

Identifier Type: -

Identifier Source: org_study_id

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