<?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>IRCT20091012002582N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-18</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of intrapulmonary injection of processed serum derived from covid-19 patients in reduction of pulmonary complications</public_title>
      <acronym>-</acronym>
      <scientific_title>Effect of intratracheal Injection of Processed Autologous Serum Derived from Patients with covid-19 in oxygenation parameters and pulmonary Complications</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47197</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, the blocks (n=4) with different arrangements of A and B will be defined. Considering the different probable arrangement of A and B, blocks will be numbered from 1 to 6.  To enroll initial 4 patients into the study, one of the arrangements will be selected using the random digit table and the patients will be assigned into the A and B groups accordingly. For the next 4 patients, the arrangement pattern will be selected again and the patients will be assigned to the groups and this cycle will be repeated to achieve our intended sample size. Unpredictability of assignment and balancing the number of patients across the two groups during or at the end of the study are main advantages of this method. 
Notably, the patients will be assigned into the study based on the ICU date of admission and no body will be able to assign the patients to the specific group of interest, Blinding description: The aim of double blinding is the avoidance of patients and researchers from being informed about the study intervention, so enrollment of patients in intervention and placebo groups will not be recognized. As the patients will be unconscious and under mechanical ventilation, they actually will not be aware of the group in which they are (intervention /placebo). The informed consent will be obtained from the patient's next of kin and they will thoroughly be informed about the study but they will be blind about the group in which their patient will be included. Also, the researcher who will assess the outcomes will not have any information about study enrollment and only primary investigator will know that. So, blinding will be performed for the researcher who will assess the study outcomes. As he/she will not be a member of treatment team and will be blinded to the study groups.</study_design>
      <phase>2</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After taking blood samples and centrifugation with 5000/min the plasma will be separated and incubated for 8 hours and then this plasma will be injected intratracheally for the patient. This procedure will be performed every 3 days and the maximum number of administration will be 3 times. Intervention 2: Control group:in the same volume for the patients in control group normal saline is intratracheally will be injected.This procedure will be performed every 3 days and the maximum number of administration will be 3 times.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Will be available if needed</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Roshangar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Daneshkade Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 3334 2086</telephone>
        <email>lroshangar@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ata Mahmoodpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Hospital, Daneshkade street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614756</zip>
        <telephone>+98 41 3335 2073</telephone>
        <email>amahmoodpoor@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>intubated covid-19 patients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>transplantation history
malignancy
thoracic surgery
active bacterial infection
autoimmune disease</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After taking blood samples and centrifugation with 5000/min the plasma will be separated and incubated for 8 hours and then this plasma will be injected intratracheally for the patient. This procedure will be performed every 3 days and the maximum number of administration will be 3 times.</i_keyword>
      <i_keyword>Control group:in the same volume for the patients in control group normal saline is intratracheally will be injected.This procedure will be performed every 3 days and the maximum number of administration will be 3 times.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxygenation. Timepoint: During 10 days from intratracheal injection. Method of measurement: Arterial blood gas analysis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change in CO2. Timepoint: During 10 days after intratracheal intubation. Method of measurement: Analysis of arterial blood gases.</sec_outcome>
      <sec_outcome>Respiratory compliance. Timepoint: During 10 days after intratracheal intubation. Method of measurement: Ventilator.</sec_outcome>
      <sec_outcome>Airway resistance. Timepoint: During 10 days after intratracheal intubation. Method of measurement: Ventilator.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-06</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>General ICU, Imam Reza Hospital, Daneshkade Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
