<?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>IRCT20210427051100N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>selenium in covid_19</public_title>
      <acronym></acronym>
      <scientific_title>The effect of selenium supplementation on inflammatory markers and blood cells in patients with Covid 19 double-blind randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55898</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Due to the fact that the sample size of these studies is 40 people, to maintain the balance between the two groups, the block randomization method will be used so that 10 four-person blocks including 2 people in the intervention group and 2 others in the placebo group will be formed and distinguished. The placement of individuals in each block will be using a table of random numbers so that in the table of random numbers from top to bottom even numbers will be assigned to the intervention group and odd numbers to the placebo group, Blinding description: The subjects will be assigned to two groups receiving selenium supplementation and placebo group. The subjects in the intervention group, in addition to their usual treatments, will take 1 capsule of 200 micrograms daily for 2 weeks, and the placebo group will have 1 capsule of placebo daily, which is completely similar in appearance, color, smell and shape to selenium capsules. . The placebo capsule will contain maltodextrin. Supplements and placebos will be provided to patients by a third party who is not directly involved in the research process. Therefore, all patients and researchers will be unaware of the existing grouping. To assess patient admission, a checklist will be prepared and provided to the patient and they will be asked to record their daily intake.</study_design>
      <phase>3</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: includes 20 patients with COVID-19 who, in addition to their usual treatments, will take 1 capsule of 200 micrograms of selenium daily for 2 weeks (14 days) after meals. Intervention 2: Intervention group: Control group: includes 20 patients with COVID-19 who, in addition to their usual treatments, will take 1 placebo tablet (maltodextrin) daily for 2 weeks (14 days) after meals. Placebo capsules are very similar in appearance, color, smell and shape to selenium capsules.</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 information can be shared two months after the results are published

When:
Two months after the publication of the results

To whom:
Physicians, nurses, and infectious disease specialists

Conditions:
To evaluate other complementary therapies and compare its effect with existing treatment related to COVID-19 disease

Where to obtain:
Send an email to mortezakhamoushi@gmail.com

How to obtain:
Two months after the results are published, send a written request to mortezakhamoushi@gmail.com. In this case, and finally within one month after receiving the email, the request will be answered.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirhossein hemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Dietetics, University of Medical Sciences and Health Services, Tehran, Keshavarz Blvd., Naderi St., Hojjatdoost Alley, No. 44</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3439123900</zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>amirhemati2000@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hossein Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Dietetics, University of Medical Sciences and Health Services, Tehran, Keshavarz Blvd., Naderi St., Hojjatdoost Alley, No. 44</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3439123900</zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>h-imani@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Detection of COVID-19 based on PCR tests
Being 20 to 60 years old
Willingness to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Breastfeeding and pregnancy
Advanced respiratory distress syndrome leading to intubation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1 COVI</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>U07.1 COVICOVID-19 , virus identified</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: Intervention group: includes 20 patients with COVID-19 who, in addition to their usual treatments, will take 1 capsule of 200 micrograms of selenium daily for 2 weeks (14 days) after meals.</i_keyword>
      <i_keyword>Intervention group: Control group: includes 20 patients with COVID-19 who, in addition to their usual treatments, will take 1 placebo tablet (maltodextrin) daily for 2 weeks (14 days) after meals. Placebo capsules are very similar in appearance, color, smell and shape to selenium capsules.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum levels of reactive protein-C. Timepoint: The first day and the last day of the intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Serum levels of interleukin-6. Timepoint: The first day and the last day of the intervention. Method of measurement: Using blood sampling, the amount of serum IL6 in pc / dl by the kit.</prim_outcome>
      <prim_outcome>Blood leukocyte count. Timepoint: The first day and the last day of the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Complete number of lymphocytes. Timepoint: The first day and the last day of the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Complete number of neutrophils. Timepoint: The first day and the last day of the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Lactate Dehydrogenase. Timepoint: The first day and the last day of the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Ferritin. Timepoint: The first day and the last day of the intervention. Method of measurement: blood test.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-17</approval_date>
        <contact_name>Ethics Committee in Medical School Research - Tehran University of Medical Sciences</contact_name>
        <contact_address>Central Headquarters of Tehran University of Medical Sciences, Corner of Ghods, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
