<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20191125045492N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-18</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Ozone therapy in treatment of COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Ozone therapy with conventional therapy in improving patient outcomes in Covid-19 patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47149</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the individuals will be randomly allocated into two groups (Treatment and Control) by using the block randomization method. The procedure of randomization will be carried out by using the SPSS software and the block size will be 4. Allocation concealment will be carried out.</study_design>
      <phase>2-3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  In addition to the conventional treatments for Covid-19, patients will undergo a cycle of Ozone Major Autohemotherapy. In this method, a specific volume of patient's blood is drawn (100 to 200 cc in mild to moderate cases and 200 cc in severe cases). Then, a corresponding volume (100 to 200cc) of the oxygen-ozone gas mixture is added to the blood (initially with an ozone concentration of 35 micrograms/ml and gradually increasing it up to 45micrograms/ml in mild to moderate cases and up to 50micrograms/ml in severe cases). After mixing the blood with the gas mixture for at least 5 minutes with gentle rotating movements, the blood is reinfused to the patient. Mild to moderate cases will be treated daily for 4 days. Severe cases will be treated twice daily for at least 7 days. Intervention 2: Control group: Patients of this group, will just get the conventional treatments for COVID-19.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Sarrafzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sarrafzadeh house, No. 21, in front of Mellat park, Ahmadzade avenue, Ansari boulevard</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4153786864</zip>
        <telephone>+98 13 3324 7683</telephone>
        <email>ali_sarrafzadeh@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Sarrafzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sarrafzadeh house, No. 21, in front of Mellat park, Ahmadzade avenue, Ansari boulevard</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4153786864</zip>
        <telephone>+98 13 3324 7683</telephone>
        <email>ali_sarrafzadeh@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have been diagnosed with COVID-19</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with hypersensitivity to ozone
Patients with abnormal thyroid function tests
Patients with abnormal coagulation tests
Patients with G6PD deficiency
Pregnant or lactating women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus not identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  In addition to the conventional treatments for Covid-19, patients will undergo a cycle of Ozone Major Autohemotherapy. In this method, a specific volume of patient's blood is drawn (100 to 200 cc in mild to moderate cases and 200 cc in severe cases). Then, a corresponding volume (100 to 200cc) of the oxygen-ozone gas mixture is added to the blood (initially with an ozone concentration of 35 micrograms/ml and gradually increasing it up to 45micrograms/ml in mild to moderate cases and up to 50micrograms/ml in severe cases). After mixing the blood with the gas mixture for at least 5 minutes with gentle rotating movements, the blood is reinfused to the patient. Mild to moderate cases will be treated daily for 4 days. Severe cases will be treated twice daily for at least 7 days.</i_keyword>
      <i_keyword>Control group: Patients of this group, will just get the conventional treatments for COVID-19.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quantitative CRP. Timepoint: Before and after the intervention. Method of measurement: Lab kit.</prim_outcome>
      <prim_outcome>Oxygen Saturation. Timepoint: Before and after the intervention. Method of measurement: Pulse Oximetry.</prim_outcome>
      <prim_outcome>Body's temperature. Timepoint: Before and after the intervention. Method of measurement: Thermometer.</prim_outcome>
      <prim_outcome>Dyspnea. Timepoint: Before and after the intervention. Method of measurement: Subjective assessment of the patient and physical examination.</prim_outcome>
      <prim_outcome>Cough. Timepoint: Before and after the intervention. Method of measurement: subjective assessment of the patient.</prim_outcome>
      <prim_outcome>Diarrhea. Timepoint: before and after the intervention. Method of measurement: subjective assessment of the patient.</prim_outcome>
      <prim_outcome>Headache. Timepoint: Before and after the intervention. Method of measurement: Subjective assessment of the patient.</prim_outcome>
      <prim_outcome>Chills. Timepoint: Before and after the intervention. Method of measurement: Subjective assessment of the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-05</approval_date>
        <contact_name>Ethics committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>No. 2, South Sheikh Bahaei Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
