<?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>IRCT20111224008507N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-27</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of Ivermectin in the treatment of coronavirus infection</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Ivermectin in the Treatment of Coronavirus Infection in Patients admitted to Educational Hospitals of Mazandaran in 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49174</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of intervention and control with 33 members using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process, Blinding description: After selecting the samples, none of the participant will be aware of randomization and allocation to groups. The evaluator nurse of data recording is from out of the study and questionnaires will be provided in the form of coding to him/her. So, the present study is double-blinded.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID-19 infection.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In the control group, only standard drugs of the national protocol are used. Intervention 2: Intervention group: In the intervention group, along with the standard drugs of the national protocol, a single dose of 3 mg Ivermectin oral tablet with a dose of 0.2 mg/kg of Tadbir Kala Jam Company will be used according to the following table: weight 15-24, 3 mg; Weight 25-35, 6 mg; Weight 36-50, 9 mg; Weight 51-80, 12 mg and weight over 80, 0.2 mg/kg.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Part of the data is available

When:
Starting in January 2021

To whom:
All people

Conditions:
Nothing

Where to obtain:
Contact Dr. Mohammad Sadegh Rezai. E-mail: drmsrezaii@yahoo.com

How to obtain:
After contact, information is sent within a few days

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Sadegh Rezai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Hospital, Pasdaran boulevard, Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815838477</zip>
        <telephone>+98 11 3334 2334</telephone>
        <email>drmsrezaii@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadsadegh Rezai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Hospital, Pasdaran Boulevard, Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815838477</zip>
        <telephone>+98 11 3334 2334</telephone>
        <email>drmsrezaii@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients hospitalized with suspected Covid-19
Informed consent for inclusion in study
Age above 5 years
Weight above 15 kg</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Liver and kidney disease
Patients with acquired immunodeficiency
Consumption of warfarin and ACEI family drugs (captopril, enalapril, etc.)
Breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus infection, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In the control group, only standard drugs of the national protocol are used.</i_keyword>
      <i_keyword>Intervention group: In the intervention group, along with the standard drugs of the national protocol, a single dose of 3 mg Ivermectin oral tablet with a dose of 0.2 mg/kg of Tadbir Kala Jam Company will be used according to the following table: weight 15-24, 3 mg; Weight 25-35, 6 mg; Weight 36-50, 9 mg; Weight 51-80, 12 mg and weight over 80, 0.2 mg/kg</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical symptoms including fever, chills, sore throat, cough, shortness of breath, decreased appetite, abdominal pain, dizziness, insomnia, itching, joint pain, joint swelling, headache, nausea, vomiting, diarrhea, malaise, conjunctivitis, tachycardia, wheezing, rhonchus, retraction, hypotension, rash, other symptoms. Timepoint: The first, second, third, fourth, fifth, sixth, seventh day. Method of measurement: Observation and record in checklist.</prim_outcome>
      <prim_outcome>Respiratory rate and O2 saturation. Timepoint: The first, second, third, fourth, fifth, sixth, seventh day. Method of measurement: Pulse Oximeter.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-11</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for Research, Moallem square, Sari Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
