<?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>IRCT20080901001165N52</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-05</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the efficacy of high dose of glucocorticoid in patients with moderate to severe pneumonia related to COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the efficacy of high dose of glucocorticoid in patients with moderate to severe pneumonia related to COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47641</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method is used to randomized the patients.
In this method, the number of people assigned to each group is usually almost equal. Blocks are formed based on the considered variables and within each block, half of the people are involved and half are considered as witnesses. The main goal in this method is to balance the number of participants in each group.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At Day 1: Amp. Methylprednisolone 500mg IV infusion over 1 hour. At Day 2 and 3, Amp. Methylprednisolone 250mg IV infusion over 1 hour. At Day 4 and 5, Amp. Methylprednisolone100mg IV infusion over 1 hour. Then, Tab. Prednisolone 25mg, per oral, daily, until the day of discharge, then Tab. Prednisolone will gradually taper off over during 1 month. All patients will receive routine treatment according to the latest national guideline. Intervention 2: Control group: Includes patients who will not receive high-dose of glucocorticoids during hospitalization. All patients will receive routine treatment according to the latest national guideline.</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 The release schedule is not clear yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8245 5393</telephone>
        <email>ahmadzarei1373@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yunes Panahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8245 5393</telephone>
        <email>Yunespanahi@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
The patient has written consciously and freely consent to participate in the study;
The patient has moderate to severe Corona-Virus associated pneumonia;
In the first 48 hours of hospitalization, the patient did not show an improving trend;
In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital;</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of hypersensitivity reaction to glucocorticoids;
Recent hospitalization and treatment history due to COVID-19;
Receive antiviral drugs before including into this study, such as: Hydroxychloroquine, Kaletra, Ribavirin, Oseltamivir;
Receiving Methylprednisolone pulse before including into this study;
Uncontrolled severe chronic illnesses, including heart failure, kidney failure, liver failure, active cancer (history of chemotherapy within recent month), diabetes;
Receiving immunosuppressing /immunomodulating agents, such as systemic glucocorticoids.
Pregnancy;
Lactation.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: At Day 1: Amp. Methylprednisolone 500mg IV infusion over 1 hour. At Day 2 and 3, Amp. Methylprednisolone 250mg IV infusion over 1 hour. At Day 4 and 5, Amp. Methylprednisolone100mg IV infusion over 1 hour. Then, Tab. Prednisolone 25mg, per oral, daily, until the day of discharge, then Tab. Prednisolone will gradually taper off over during 1 month. All patients will receive routine treatment according to the latest national guideline.</i_keyword>
      <i_keyword>Control group: Includes patients who will not receive high-dose of glucocorticoids during hospitalization. All patients will receive routine treatment according to the latest national guideline.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Need to receive ICU service (occurrence of shock, resistant hypoxemia despite receiving oxygen via reservoir oxygen mask, GCS score drops below 12). Timepoint: The patient is monitored every 6 hours, but the results are recorded daily in the checklist. Method of measurement: Physical assessment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mortality rate. Timepoint: 30 days after including the study. Method of measurement: Physical assessment.</sec_outcome>
      <sec_outcome>Length of hospitalization. Timepoint: The first day and the end of hospitalization. Method of measurement: The hospital record review.</sec_outcome>
      <sec_outcome>Radiologic response. Timepoint: At the admission, before the discharge. Method of measurement: CT-SCAN.</sec_outcome>
      <sec_outcome>Laboratory changes. Timepoint: Daily. Method of measurement: Blood sample, laboratory analysis.</sec_outcome>
      <sec_outcome>Fever. Timepoint: Daily. Method of measurement: Thermometer.</sec_outcome>
      <sec_outcome>Respiratory distress. Timepoint: Daily. Method of measurement: Clinical assessment.</sec_outcome>
      <sec_outcome>Oxygen saturation without receiving oxygen supplement. Timepoint: It will be measured every 6 hours, but will be recorded daily. Method of measurement: Pulse-oxymetery device.</sec_outcome>
      <sec_outcome>The amount of oxygen received. Timepoint: It will be measured every 6 hours, but will be recorded daily. Method of measurement: The volume of oxygen consumed through the oxygen mask /Ventilation Volume  via Mechanical Ventilation Machine or BiPAP.</sec_outcome>
      <sec_outcome>Discharge without the need of ICU service. Timepoint: At discharge time. Method of measurement: Physical assessment.</sec_outcome>
      <sec_outcome>Pulmonary function changes. Timepoint: 6 week later after discharge. Method of measurement: Spirometry.</sec_outcome>
      <sec_outcome>Rate of readmission. Timepoint: until 2 months after discharge. Method of measurement: The hospital record review.</sec_outcome>
      <sec_outcome>Side effects. Timepoint: Daily during hospitalization,  weekly after discharge. Method of measurement: During hospitalization by clinical evaluation, after discharge by telephone follow-up.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-19</approval_date>
        <contact_name>Ethics committee of Baqiyatallah University of Medical Science</contact_name>
        <contact_address>Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
