<?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>IRCT20200406046968N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-08</date_registration>
      <primary_sponsor>Zist Daru Danesh Company</primary_sponsor>
      <public_title>effect of Interfron-beta1(zifron) on clinical improvement and prognosis of COVID-19 in Tabriz Imam-Reza hospital</public_title>
      <acronym></acronym>
      <scientific_title>effect of Interfron-beta1(zifron) on clinical improvement and prognosis of COVID-19 in Tabriz Imam-Reza hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47152</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done  by permuted (balanced) block randomization method. At the beginning,  we will define quadruple  blocks with group (a) and group (b) arrangements, and then we will select each of the blocks using the table of random numbers, and after each black determination, prepare 4 patients  in the arrangement of(A) and (B) group in the selected block enrolled to the study. Then 4 other patients will be selected through the other block. We will Continue this process to complete patients.</study_design>
      <phase>2</phase>
      <hc_freetext>COVID-19 diseaese.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  30 COVID-19 patients with inclusion criteria  will be treated with  250 micro grams of betafron (Zifron Zist Darou Danesh)  Subcutaneously every other day up to 10 days or 5 dosages in addition to antivirals including hydroxychloroquine 400 mg,bid stat. and Kaletra 2 tablet bid for 10 days. Intervention 2: Control group: 30 COVID-19 patients will be treated only with antivirals including hydroxychloroquine 400 mg,bid stat and Kaletra 2 tablet bid for 10 days.</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:
All data related to the study of the effect of interferon-beta 1 (zifron) on clinical improvement and prognosis of patients with COVID-19 will be shared in Imam Reza (AS) Hospital in Tabriz.

When:
Since the summer of 1399

To whom:
Researchers and all treatment staff

Conditions:
For treatment

Where to obtain:
Dr. Mikaeili haleh

How to obtain:
After finishing the work and getting the result

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mikaeili Haleh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd Floor, Central Building, University Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5157679746</zip>
        <telephone>+98 41 3329 6024</telephone>
        <email>halehmikaeili@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mikaeili Haleh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd Floor, Central Building, University Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5157679746</zip>
        <telephone>+98 41 3329 6024</telephone>
        <email>halehmikaeili@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>respiratory rate&gt; 24 / min
pao2 / Fio2&lt; 300</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
history of Sensitivity to interferon-beta 1 compounds (zifron)
History of advanced liver disease and liver enzymes three times normal
history of severe depression or suicidal thought</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  30 COVID-19 patients with inclusion criteria  will be treated with  250 micro grams of betafron (Zifron Zist Darou Danesh)  Subcutaneously every other day up to 10 days or 5 dosages in addition to antivirals including hydroxychloroquine 400 mg,bid stat. and Kaletra 2 tablet bid for 10 days.</i_keyword>
      <i_keyword>Control group: 30 COVID-19 patients will be treated only with antivirals including hydroxychloroquine 400 mg,bid stat and Kaletra 2 tablet bid for 10 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxygenation. Timepoint: daily. Method of measurement: pulse oximetery.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>P/F ratio. Timepoint: daily. Method of measurement: ABG.</sec_outcome>
      <sec_outcome>Need for mechanical ventilation. Timepoint: daily. Method of measurement: file.</sec_outcome>
      <sec_outcome>In hospital mortality. Timepoint: daily. Method of measurement: file.</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>Zist Daru Danesh Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-13</approval_date>
        <contact_name>Regional Research Ethics Committee (Humanities Studies)</contact_name>
        <contact_address>Tabriz / Golgasht St. / Tabriz University of Medical Sciences Central Building No. 2 / Third Floor Deputy of Research and Technology Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
