<?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>IRCT20220814055690N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-22</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Effect of ozone therapy in post COVID-19 lung sequels</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the consequences of ozone therapy in hypoxia of oxygen-dependent patients affected by COVID-19 after discharge from the hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>206</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65280</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted (block randomization). Based on this method, the patients are categorized and equal number of participants are entered into the intervention and control groups at consecutive but equal time intervals. In this way, for example, one type of treatment is given to the first block, another type is given to the second, and again the first type is given to the third block and so on.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Post COVID fibrosis/ inflammatory lung disease. Condition 2: COVID-19 disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients referred to ozone therapy centers affiliated to Baqiyatullah University located in Tehran and Najaf Abad, with a history of contracting COVID-19, who have been discharged from hospital with hypoxemia and oxygen dependency, will be included in the study. The therapeutic dose is 35-50 micrograms/mL with a volume of 120-240 cc of blood and its equivalent O2/O3 mixture for 5-20 sessions, based on the inflammatory factors and severity of lung involvement and hypoxia at the time of referral, the exact amount of the dose and the number of sessions is selected. The first sessions will be daily and then alternate in the week. Intervention 2: Control group: This group receives standard treatment including prednisolone or pirfenidone. These patients were admitted to the hospital and referred to the relevant medical centers and received appropriate treatment and were included in the study under the name of control group. Normally, the dose of Pirfenidon for the first week is 267 mg daily, for the second week, 534 mg, and from the third week (maintenance treatment) 801 mg. Maintenance treatment is selected based on the condition and severity of the patient's involvement. Prednisolone is usually 1mg/kg daily, which can be changedbased on the patient.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sina Abbaspour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatollah University,Sheikh Bahayi Ave, Mollasadra Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5493153491</zip>
        <telephone>+98 13 4277 3001</telephone>
        <email>Sina.abbaspour75@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Morteza Izadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatollah University,Sheikh Bahayi Ave, Mollasadra Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8804 0060</telephone>
        <email>morteza_izadi@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Filling out the informed consent form
Post COVID-19 oxygen dependent patients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hypersensitivity to ozone
Albumin less than 3.4
Platelets less than 60,000
Bleeding and coagulation disorders
Uncontrolled hyperthyroidism</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R91</hc_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abnormal findings on diagnostic imaging of lung</hc_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients referred to ozone therapy centers affiliated to Baqiyatullah University located in Tehran and Najaf Abad, with a history of contracting COVID-19, who have been discharged from hospital with hypoxemia and oxygen dependency, will be included in the study. The therapeutic dose is 35-50 micrograms/mL with a volume of 120-240 cc of blood and its equivalent O2/O3 mixture for 5-20 sessions, based on the inflammatory factors and severity of lung involvement and hypoxia at the time of referral, the exact amount of the dose and the number of sessions is selected. The first sessions will be daily and then alternate in the week.</i_keyword>
      <i_keyword>Control group: This group receives standard treatment including prednisolone or pirfenidone. These patients were admitted to the hospital and referred to the relevant medical centers and received appropriate treatment and were included in the study under the name of control group. Normally, the dose of Pirfenidon for the first week is 267 mg daily, for the second week, 534 mg, and from the third week (maintenance treatment) 801 mg. Maintenance treatment is selected based on the condition and severity of the patient's involvement. Prednisolone is usually 1mg/kg daily, which can be changedbased on the patient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of improvement of pulmonary involvement in CT scan reports of patients. Timepoint: At the beginning of the study and 6 months after the received treatment. Method of measurement: CT scan report of patients.</prim_outcome>
      <prim_outcome>Spirometry diagram. Timepoint: At the beginning of the study and 6 months after the received treatment. Method of measurement: Interpretation of spirometry.</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>2024-02-05</approval_date>
        <contact_name>Ethics Committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Baqiyatallah hospital, Sheikh Bahayi Ave., Mollasadra Ave.,  Vanak square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
