<?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>IRCT20081027001411N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-01</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Prednisolone on treatment of COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Study of Prednisolone effects on treatment and clinical symptoms and laboratory signs of Iranian COVID-19 patients: a clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46975</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study will be carried out on 60 hospitalized ‎COVID-19 patients. Patients randomly divided into two groups: control group and treatment group ‎which received 0.5mg/kg prednisolone in three divided doses up to 30 mg per day for 5-7 days. Clinical signs of patient including ‎heart rate, blood pressure ‎ body temperature, O2 saturation, CT scan findings, laboratory tests result ‎‎(CBC, ESR, CRP, Ferritin, Troponin, D-dimer) will be recorded before treatment ‎‎and at day 8 and day 14). In addition, Patients' mortality rates, length of hospitalization, and the need for mechanical ventilation and intubation are recorded in two groups of intervention and control, Randomization description: Block Balanced Randomization Method will be used.
Patients will allocate to two groups with Block Balanced Randomization Method. The size of each random block is 2, and patients will be allocated equally to the two intervention groups, Blinding description: In this study patients don't know which group of patients will use the ‎medicine. Physician and clinicians team know about the drug and group who use the drug.‎.</study_design>
      <phase>2</phase>
      <hc_freetext>COVID-19 disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients hospitalized with COVID-19 disease who in addition to their standard treatment will received 0.5mg/kg prednisolone in three divided doses up to 30 mg per day for 5-7 days. Intervention 2: Control group: Patients hospitalized with COVID-19 disease who are received standard treatment.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmadreza Jamshidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1313514117</zip>
        <telephone>+98 21 8822 0065</telephone>
        <email>jamshida@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Mahmoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1313514117</zip>
        <telephone>+98 21 8822 0065</telephone>
        <email>mahmoudim@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>COVID-19 patient with Acute Respiratory Distress Syndrome (ARDS) and confirmed by positive PCR test for SARS-CoV-2
or confirmed by abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities),
With blood oxygen saturation &lt;93%,
Not responding to stamdard COVID-19 treatment after 48-72h</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A history of type I diabetes, asthma and lung diseases, malignancies, kidney and heart failure, uncontrolled high blood pressure, positive pro-calcitonin and active infection
Taking immunosuppressive drugs and corticosteroids
Pregnant or lactating women
Prescribing antibiotics due to a bacterial infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.2, U07</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients hospitalized with COVID-19 disease who in addition to their standard treatment will received 0.5mg/kg prednisolone in three divided doses up to 30 mg per day for 5-7 days.</i_keyword>
      <i_keyword>Control group: Patients hospitalized with COVID-19 disease who are received standard treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Radiographic features findings. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: CT scan.</prim_outcome>
      <prim_outcome>Mortality rate. Timepoint: Before and after treatment with Prednisolone. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>O2 saturation. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Pulse Oximeter.</prim_outcome>
      <prim_outcome>Need for an oxygen therapy. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Clinical.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>CBC laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.</sec_outcome>
      <sec_outcome>ESR laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.</sec_outcome>
      <sec_outcome>CRP laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.</sec_outcome>
      <sec_outcome>Ferritin laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.</sec_outcome>
      <sec_outcome>D-Dimer laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.</sec_outcome>
      <sec_outcome>Troponin laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.</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>2020-03-27</approval_date>
        <contact_name>Vice-Chancellor in Research Affairs Tehran University of Medical Science</contact_name>
        <contact_address>Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
