<?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>IRCT20190418043307N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-17</date_registration>
      <primary_sponsor>Deputy Dean of Research and Technology, Ilam university of medical science</primary_sponsor>
      <public_title>Effect of selenium on covid-19 disease</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of selenium on recovery of hospitalized patients with COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47209</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The first phase involves the screening process of potential patients by the researcher to identify the eligibility to participate based on the study inclusion and exclusion criteria. The research assistant will contact eligible participants for enrollment. Those patients who agree to take part in the study will be provided with the information sheet and written consent form before baseline assessment at enrolment. 100 Patients with Covid-19 will be randomized sequentially at the time they provided a baseline assessment. Randomization will be generated by permuted block randomization with allocation concealment. Participants will be divided into intervention or control groups. The control group will receive only the standard protocol treatment, but the intervention group will receive the selenium for 2 weeks in addition to the standard protocol treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to the standard protocol treatment, patients in the intervention group will receive 200 micrograms selenium daily for at least 2 weeks. Routine blood tests, the need for hospitalization, and the mortality rate will be measured as the study outcomes. Intervention 2: Control group: Participants in the control group will receive the standard protocol treatment. standard protocol treatment consists of 400 mg Hydroxychloroquine twice daily on day one, followed by 200 mg twice per day.</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 I haven't decided on that yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Modares Avenue</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931854919</zip>
        <telephone>+98 84 3222 3721</telephone>
        <email>nazari-a@medilam.ac.ir</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Modares Avenue</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931854919</zip>
        <telephone>+98 84 3222 3721</telephone>
        <email>nazari-a@medilam.ac.ir</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of COVID-19 by RT-PCR test
Respiratory rate above 30 bar per minute
Percentage of peripheral blood oxygen saturation less than 90%
Relative oxygen depletion ratio to arterial oxygen saturation less than 300 mm Hg
Interloquin six blood levels higher Abnormally
age over 18 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>chronic kidney disease
acute kidney failure
Pregnancy or lactation
History of drug allergy
Pneumonia  caused by  H influenza, viral infections, bacterial infections, fungi; and other noninfectious types of pneumonia
Chronic liver disease
history of latent or active tuberculosis
patients with acquired immunodeficiency syndrome</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus 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: In addition to the standard protocol treatment, patients in the intervention group will receive 200 micrograms selenium daily for at least 2 weeks. Routine blood tests, the need for hospitalization, and the mortality rate will be measured as the study outcomes.</i_keyword>
      <i_keyword>Control group: Participants in the control group will receive the standard protocol treatment. standard protocol treatment consists of 400 mg Hydroxychloroquine twice daily on day one, followed by 200 mg twice per day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ferritin changes. Timepoint: Daily. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Platelet. Timepoint: Daily. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>CRP. Timepoint: Daily. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>WBC changes. Timepoint: Daily. Method of measurement: Laboratory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reduced mortality. Timepoint: Day 1 to 14. Method of measurement: Record the time of death.</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>Deputy Dean of Research and Technology, Ilam university of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-14</approval_date>
        <contact_name>Ethics committee of Ilam University of Medical Sciences</contact_name>
        <contact_address>modares Ave Ilam Ilam Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
