- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04400006
Ozone Therapy in the Prevention of COVID-19 Infection
The Effectiveness of Ozone Therapy in the Prevention of COVID-19 Infection
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34899
- Kardelen Gencer Atalay
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kardelen Gencer, Marmara University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2761
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Corona Virus Infection
-
Ain Shams UniversityMisr International UniversityCompletedCorona Virus Infection | Corona Virus Disease 19 (Covid19) | Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)Egypt
-
Montreal Heart InstituteNational Heart, Lung, and Blood Institute (NHLBI); Bill and Melinda Gates Foundation and other collaboratorsTerminatedCorona Virus InfectionSpain, United States, Canada, Brazil, Greece, South Africa
-
Fundación Instituto de Estudios de Ciencias de...Instituto de Investigación Biomédica de SalamancaTerminated
-
ANRS, Emerging Infectious DiseasesSciences Economiques et Sociales de la Santé & Traitement de l'Information... and other collaboratorsWithdrawn
-
National Institute of Allergy and Infectious Diseases...CompletedCorona Virus InfectionUnited States
-
The Cleveland ClinicCompletedCOVID | Corona Virus InfectionUnited States
-
NeurognosUnknownCOVID | Corona Virus Infection | SARS-CoV2Chile
-
Chronic Obstructive Pulmonary Disease Trial Network...TerminatedVirus Diseases | Corona Virus Infection | Infection ViralDenmark
-
University of Sao PauloMaria Aparecida de Andrade Moreira Machado; Thais Marchini de Oliveira ValarelliNot yet recruitingCorona Virus Infection | Exposure During Pregnancy
-
National Research Center for Cardiac Surgery, KazakhstanNazarbayev University Medical CenterRecruitingCovid19 | Corona Virus InfectionKazakhstan