Ozone Therapy in the Prevention of COVID-19 Infection
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|ClinicalTrials.gov Identifier: NCT04400006|
Recruitment Status : Completed
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
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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.
|Condition or disease|
|Corona Virus Infection|
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 Type :||Observational|
|Actual Enrollment :||71 participants|
|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|
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Sampling Method:||Non-Probability Sample|
- 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)
- To received ozone therapy locally or fewer than ten sessions
- not want to participate
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
|Kardelen Gencer Atalay|
|Istanbul, Turkey, 34899|
|Principal Investigator:||Kardelen Gencer||Marmara University|
|Responsible Party:||Kardelen Gencer Atalay, Principal Investigator, Marmara University|
|Other Study ID Numbers:||
|First Posted:||May 22, 2020 Key Record Dates|
|Last Update Posted:||May 22, 2020|
|Last Verified:||May 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
RNA Virus Infections