<?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>IRCT20220208053970N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-12</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Toscilizumab and Infliximab on Covid 19</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of ACTEMRA (TOCILIZUMAB) and REMICADE (INFLIXIMAB) in patients with Covid19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61962</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, patients with Covid19 are divided into two groups and according to the treating physician, one of the drugs Tocilizumab and Infliximab is injected according to the inclusion criteria.
In this study, patients are aware and satisfied to receive one of these two drugs, but they are blind to which of these drugs, but the doctor and other research team are aware of which drug to receive by which group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>covid19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: This group of patients with Covid19 who have received standard treatments ,receive tocilizumab brand name ACTEMRA and TEMZIVA from ROCHE PHARMA and ARIOGEN PHARMED factories at a dose of 8 mg / kg in one or two doses two days apart. Intervention 2: Intervention group 2: This group of patients with Covid19 who have received standard treatments, receive an infliximab brand name REMICADE from JANSSEN factory at a dose of 5 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:
All data from the study can be shared after being unidentified

When:
Access begins in the winter of 1401

To whom:
The data will be available to researchers and academics

Conditions:
Access will be possible to assist with future studies and scientific reviews

Where to obtain:
Contact Dr. Amir Hossein Koohi to receive data
amirh1391@gmail.com

How to obtain:
After introducing the applicant and stating the purpose of the information request, as well as the commitment not to use it anymore, it can be received via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir hossein Koohi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>121Unit, Ghaem complex, Pars St, Shariati St</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8814658602</zip>
        <telephone>+98 31 3230 5627</telephone>
        <email>st-kouhi.a@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir hossein Koohi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>121Unit, Ghaem complex, Pars St, Shariati St</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8814658602</zip>
        <telephone>+98 31 3230 5627</telephone>
        <email>st-kouhi.a@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with Covid 19 (based on RT-PCR test for SARS-CoV-19 virus or CT scan criteria)
People between the ages of 25 and 70
Symptoms indicate severe disease (more than 50% of lung involvement in CT or oxygen saturation below 90% or respiratory rate greater than 30 per minute)
Elevated CRP, ferritin and other inflammatory markers</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who test positive for PPD, HCV, HBV and have infections other than Covid 19 infection
Pregnancy and pregnancy intention
Mild involvement or in the early stages of Covid 19</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>covid19</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 1: This group of patients with Covid19 who have received standard treatments ,receive tocilizumab brand name ACTEMRA and TEMZIVA from ROCHE PHARMA and ARIOGEN PHARMED factories at a dose of 8 mg / kg in one or two doses two days apart.</i_keyword>
      <i_keyword>Intervention group 2: This group of patients with Covid19 who have received standard treatments, receive an infliximab brand name REMICADE from JANSSEN factory at a dose of 5 mg/kg</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ferritin. Timepoint: Before the intervention and five days after receiving the drug. Method of measurement: Elisa.</prim_outcome>
      <prim_outcome>D-dimer. Timepoint: Before the intervention and five days after receiving the drug. Method of measurement: Bio-Lis.</prim_outcome>
      <prim_outcome>C-Reactive Protein. Timepoint: Before the intervention and five days after receiving the drug. Method of measurement: Bio-Lis.</prim_outcome>
      <prim_outcome>Lactate Dehydrogenase. Timepoint: Before the intervention and five days after receiving the drug. Method of measurement: Bio-Lis.</prim_outcome>
      <prim_outcome>Complete blood count. Timepoint: Before the intervention and five days after receiving the drug. Method of measurement: sysmex.</prim_outcome>
      <prim_outcome>Erythrocyte Sedimentation Rate. Timepoint: Before the intervention and five days after receiving the drug. Method of measurement: Sediman Reader.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-25</approval_date>
        <contact_name>Shahrekord University of Medical Sciences (Research Ethics Committee)</contact_name>
        <contact_address>Hajar Hospital, Parastar Ave shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
