<?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>IRCT20251112067972N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-04-23</date_registration>
      <primary_sponsor>vice chancellor for research and technology</primary_sponsor>
      <public_title>The effect of colchicine in patients with covid 19</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of colchicine in the incidence of pulmonary complications after COVID-19 infection: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-01-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87420</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization will be that by using the table of random numbers created on the online site, the patients will be assigned to 2 groups and the method of allocation will be using envelopes in bed.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID-19 disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, after recovering from the acute phase, they will receive colchicine 0.5 mg twice a day for a period of one month. After the 3-month period, lung CT scan will be performed to investigate post-covid pulmonary complications, and the variables of pulmonary fibrosis, cavitary lesions, bronchitis, bronchiectasis and air trapping lesions will be evaluated and quantitatively compared in terms of the number of involved lobes in both groups. Intervention 2: Control group:  In the control group, after recovering from the acute phase, they will receive placebo twice a day for a period of one month. After the 3-month period, lung CT scan will be performed to investigate post-covid pulmonary complications, and the variables of pulmonary fibrosis, cavitary lesions, bronchitis, bronchiectasis and air trapping lesions will be evaluated and quantitatively compared in terms of the number of involved lobes in both groups.</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>Fateme Alizadeh moosavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vasei hospital; touhid shahr blvd;sabzevar town</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873137</zip>
        <telephone>+98 51 4465 1300</telephone>
        <email>AlizademoosaviF01@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Alizadeh moosavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vasei hospital; touhid shahr blvd;sabzevar town</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873137</zip>
        <telephone>+98 51 4465 1300</telephone>
        <email>AlizademoosaviF01@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have been clinically, radiologically and PCR confirmed to have COVID-19
Age above 18 years
Informed written consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of hypersensitivity to colchicine
Pregnancy or lactation
Patients with severe renal impairment (creatinine clearance [CrCl] &lt; 30 mL/min)
Patients with severe hepatic impairment (AST or ALT &gt; 5 times the upper limit of normal [ULN])
Patients with hematologic dyscrasias, absolute neutrophil count &lt; 1,000/mm³ or platelet count &lt; 50,000/mm³
Patients with a history of severe heart failure
Severe diarrhea, diverticulitis, or bowel perforation
Patients unable to tolerate oral intake
Patient demise
Concomitant use of medications with contraindications to colchicine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1+J12.</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified /Other viral pneumonia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, after recovering from the acute phase, they will receive colchicine 0.5 mg twice a day for a period of one month. After the 3-month period, lung CT scan will be performed to investigate post-covid pulmonary complications, and the variables of pulmonary fibrosis, cavitary lesions, bronchitis, bronchiectasis and air trapping lesions will be evaluated and quantitatively compared in terms of the number of involved lobes in both groups.</i_keyword>
      <i_keyword>Control group:  In the control group, after recovering from the acute phase, they will receive placebo twice a day for a period of one month. After the 3-month period, lung CT scan will be performed to investigate post-covid pulmonary complications, and the variables of pulmonary fibrosis, cavitary lesions, bronchitis, bronchiectasis and air trapping lesions will be evaluated and quantitatively compared in terms of the number of involved lobes in both groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Investigating changes in pulmonary fibrosis in CT scan of patients with covid-19. Timepoint: CT scan evaluation of patients' lungs 3 months later. Method of measurement: Investigation of lesions in lung CT scan.</prim_outcome>
      <prim_outcome>Investigating changes in pulmonary bronchiectasis in CT scan of patients with covid-19. Timepoint: CT scan evaluation of patients' lungs 3 months later. Method of measurement: Investigation of lesions in lung CT scan.</prim_outcome>
      <prim_outcome>Investigating changes in bronchitis in CT scan of patients with covid-19. Timepoint: CT scan evaluation of patients' lungs 3 months later. Method of measurement: Investigation of lesions in lung CT scan.</prim_outcome>
      <prim_outcome>Investigating changes in cavitary lesions and air retention in CT scan of patients with covid-19. Timepoint: CT scan evaluation of patients' lungs 3 months later. Method of measurement: Investigation of lesions in lung CT scan.</prim_outcome>
      <prim_outcome>Investigating changes in air retention in CT scan of patients with covid-19. Timepoint: CT scan evaluation of patients' lungs 3 months later. Method of measurement: Investigation of lesions in lung CT scan.</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>vice chancellor for research and technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-09</approval_date>
        <contact_name>Ethics committee of sabzevar University of Medical Sciences</contact_name>
        <contact_address>Sabzevar, Shohadaye Hasteiee Boulevard, Sabzevar University of Medical Science Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
