<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04400006</url>
  </required_header>
  <id_info>
    <org_study_id>2761</org_study_id>
    <nct_id>NCT04400006</nct_id>
  </id_info>
  <brief_title>Ozone Therapy in the Prevention of COVID-19 Infection</brief_title>
  <official_title>The Effectiveness of Ozone Therapy in the Prevention of COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronavirus has already infected 4,673,809 people and killed 312,646 people worldwide, and no&#xD;
      specific treatment or a vaccine against it has yet proven to be effective. Ozone therapy has&#xD;
      become o promising tool for both prevention and treatment of COVID-19 infection by various&#xD;
      possible mechanisms. The oxidative stress created by ozone in the body to stimulate the&#xD;
      peripheral phagocytic cells, activate the antioxidant system, and restore the immune system&#xD;
      is thought to be effective for the prevention of COVID-19 infection.&#xD;
&#xD;
      In recent years, ozone therapy has become a popular alternative method for chronic pain&#xD;
      management of various diseases such as fibromyalgia, knee osteoarthritis, and rheumatic&#xD;
      diseases. As a result of this, there were many individuals who had received ozone therapy&#xD;
      before the outbreak of COVID-19. This study aimed to investigate the preventive effect of&#xD;
      ozone therapy against COVID-19 infection in these individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The inclusion criteria were determined to be completed at least ten sessions of ozone therapy&#xD;
      applied by the method of major autohemotherapy in the last six months from the time the first&#xD;
      COVID-19 case of Turkey reported (Mar 11, 2020). Individuals who received ozone therapy&#xD;
      locally or fewer than ten sessions, who did not want to participate were excluded.&#xD;
&#xD;
      The major autohemotherapy procedure to all the participants was applied as follows: 100mL of&#xD;
      blood was drawn by a vacuum from the antecubital vein into a sterile glass bottle in which 12&#xD;
      mL of 3.13% sodium citrate solution as an anticoagulant (MediPac®, Germany). A corresponding&#xD;
      volume (100mL) of gas with an ozone concentration of 10-20 µg/mL was immediately added and&#xD;
      continuously mixed by a gentle rotating movement to avoid foaming to the blood in the bottle.&#xD;
      Ozone was produced by a Blue-S medical ozone generator (Turkozone®, Turkey). Reinfusion was&#xD;
      accomplished in about 15-20 minutes, and the whole procedure was carried out in approximately&#xD;
      30 minutes and was repeated two or three times a week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 6, 2020</start_date>
  <completion_date type="Actual">May 17, 2020</completion_date>
  <primary_completion_date type="Actual">May 16, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The survey that was taken by telephone calls</measure>
    <time_frame>Day 0</time_frame>
    <description>It involved questions about age, gender, height, weight, occupation, comorbidities, and concurrent medications, in addition to a detailed query for COVID-19 infection</description>
  </primary_outcome>
  <enrollment type="Actual">71</enrollment>
  <condition>Corona Virus Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who completed at least ten sessions of ozone therapy applied by the method of&#xD;
        major autohemotherapy* in the last six months from the time the first COVID-19 case of&#xD;
        Turkey reported (Mar 11, 2020).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be completed at least ten sessions of ozone therapy applied by the method of major&#xD;
             autohemotherapy in the last six months from the time the first COVID-19 case of Turkey&#xD;
             reported (Mar 11, 2020)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To received ozone therapy locally or fewer than ten sessions&#xD;
&#xD;
          -  not want to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Kardelen Gencer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marmara University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kardelen Gencer Atalay</name>
      <address>
        <city>Istanbul</city>
        <zip>34899</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Marmara University</investigator_affiliation>
    <investigator_full_name>Kardelen Gencer Atalay</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Coronavirus</keyword>
  <keyword>Ozone</keyword>
  <keyword>Preventive Medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04400006
org study id: 2761
nct id: NCT04400006
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: The survey that was taken by telephone calls
time frame: Day 0
description: It involved questions about age, gender, height, weight, occupation, comorbidities, and concurrent medications, in addition to a detailed query for COVID-19 infection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
last name: Kardelen Gencer
role: Principal Investigator
affiliation: Marmara University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Marmara University
investigator full name: Kardelen Gencer Atalay
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Coronavirus Infections