<?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>IRCT20110423006257N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-03</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Thalidomide effects in COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>A clinical trial to evaluate the therapeutic effects of thalidomide in patients with COVID-19 infection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53279</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced block randomization is used as a randomization method. Patients are divided into two groups using the above method. Therefore, six four-part combinations of intervention groups A and B are as follows : AABB, ABAB, ABBA, BBAA, BABA, BAAB.
Then we assign them from the number one to six and with the table of random numbers from the right side of the selected number, move in order and select each of the numbers 1 to 6 of the above combination that appears, and the people who agree to participate in Study, fall into study groups. The allocation concealment will also be maintained in this method and the order of the quadruple compounds will also be completely hidden, Blinding description: In this study, the patients are randomly assigned to different groups and physicians. The physicians, patients , nurses, primary investigators, and also researchers who collect clinical data and researchers who evaluate the treatment response will be blinded to the patient groups and treatment protocol.</study_design>
      <phase>3</phase>
      <hc_freetext>Covid 19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, in addition to the standard drugs recommended in the protocol of the Ministry of Health and supportive measures for patients, thalidomide (Lipomed-Swiss), in a dose of 100 mg, will be administered orally for 14 days (every night). Intervention 2: Control group: In this group, standard and recommended drugs are prescribed for patients in the protocol of the Ministry of Health and supportive measures, and they receive placebo drug, both in color and shape with the main drug, for 14 days (every night).</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Abdollatif Moini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran Internal Medicin Department of Amir-al-momenin Haspital</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 1222 5202</telephone>
        <email>dr.moini@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Abdollatif Moini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran Internal Medicin Department of Amir-al-momenin Haspital</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 1222 5202</telephone>
        <email>dr.moini@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Duration of the symptoms less than 10 days
Lymphocyte count less than 1000 per microliter
Quantitative CRP more than 1.5 times normal
Positive pcr test of covid 19
O2 sat less than 93%
Respiratory rate less than 24
Chest CT scan findings compatible with COVID-19 Pneumonia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of chronic disease
Pregnant women, lactating women , sexually active premenopausal women
Loss of consciousness
Liver enzymes more than 5 times normal</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Covid 19</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 this group, in addition to the standard drugs recommended in the protocol of the Ministry of Health and supportive measures for patients, thalidomide (Lipomed-Swiss), in a dose of 100 mg, will be administered orally for 14 days (every night).</i_keyword>
      <i_keyword>Control group: In this group, standard and recommended drugs are prescribed for patients in the protocol of the Ministry of Health and supportive measures, and they receive placebo drug, both in color and shape with the main drug, for 14 days (every night).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Radiological changes of the lung. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Pulmonary computed topography scan.</prim_outcome>
      <prim_outcome>Death rate. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Length of hospitalization. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Blood oxygen saturation. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Pulseoxymeter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complete blood count. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Paraclinical.</sec_outcome>
      <sec_outcome>Erythrocyte sedimentation rate. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Paraclinical.</sec_outcome>
      <sec_outcome>Interleukin 6. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Paraclinical.</sec_outcome>
      <sec_outcome>Creatine phosphokinase. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Paraclinical.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-03</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Payambar-e-azam Complex,  Sardasht Town Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
