<?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>IRCT20220517054899N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-13</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Plasmapheresis on hypoxia in patients suffering from COVID-19</public_title>
      <acronym>BPS</acronym>
      <scientific_title>The effect ofPlasmapheresis on hypoxia in patients suffering from COVID-19: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64354</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization based on the table of random numbers. A set of numbers without a specific pattern and order and in a completely random manner are in the form of a table. The direction of reading the numbers in this table will be from top to bottom and right to left. Even numbers will be considered for the intervention group and odd numbers for the control group.</study_design>
      <phase>3</phase>
      <hc_freetext>Corona virus (Covid-19).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group, in addition to the standard treatment of Covid-19, (dexamethasone at a dose of 6 mg per day and remedSivir at a dose of 200 mg on the first day and then 100 mg daily for 7 days) will undergo the intervention (plasmapheresis). Each time plasmapheresis is performed, 40 ml per kg of body weight of the patient's plasma is replaced with 5% human albumin and 0.9% normal saline, and for each patient, if the clinical symptoms do not improve, plasmapheresis will be performed up to 3 times. Intervention 2: Control group: In this group, patients received the standard treatment of Covid-19 according to the national protocol (Hedhexamethasone 6 mg daily and Ramdesiver 200 mg on the first day and 100 mg daily for 7 days).</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:
-

When:
-

To whom:
-

Conditions:
-

Where to obtain:
-

How to obtain:
-

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vajehallah Raeesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 28, West, Ghafari Ave., Zakariyay Razi Blvd.Birjand university of medical sciences</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717964151</zip>
        <telephone>+98 56 3162 2430</telephone>
        <email>vajehraeesi@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vajehallah Raeesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 28, Ghafari Ave., Zakariyay Razi Blvd. Birjand university of medical sciences</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717964151</zip>
        <telephone>+98 56 3162 2430</telephone>
        <email>vajehraeesi@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of Covid-19 based on  taking a sample from the pharynx  and PCR laboratory confirmation
Lung involvement more than 50%
SPO2 levels below 80% without oxygen or below 88% with oxygen or IL above 10 or ferritin above 1500
Patients who have not responded to other Covid-19 treatments
Age over 18 years and consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of albumin sensitivity
Heparin allergy who cannot receive heparin as an anticoagulant during plasmapheresis
Patients with hypocalcemia (citrate used in the plasmapheresis process exacerbates hypocalcemia)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Pneumonia </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>J12.81</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: Patients in the intervention group, in addition to the standard treatment of Covid-19, (dexamethasone at a dose of 6 mg per day and remedSivir at a dose of 200 mg on the first day and then 100 mg daily for 7 days) will undergo the intervention (plasmapheresis). Each time plasmapheresis is performed, 40 ml per kg of body weight of the patient's plasma is replaced with 5% human albumin and 0.9% normal saline, and for each patient, if the clinical symptoms do not improve, plasmapheresis will be performed up to 3 times.</i_keyword>
      <i_keyword>Control group: In this group, patients received the standard treatment of Covid-19 according to the national protocol (Hedhexamethasone 6 mg daily and Ramdesiver 200 mg on the first day and 100 mg daily for 7 days).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of blood oxygen saturation (SPO2). Timepoint: On days zero (before the intervention), days one, three, five and seven after the intervention. Method of measurement: Pulse oximeter Bitmos Gmbh made in Germany.</prim_outcome>
      <prim_outcome>Arterial blood oxygen pressure in the analysis of blood gases Pao2. Timepoint: On days zero (before the intervention), days one, three, five and seven after the intervention. Method of measurement: Blood sample to measure blood gases.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of hospitalization of the patient. Timepoint: End of hospitalization or death of the patient. Method of measurement: By day.</sec_outcome>
      <sec_outcome>C-reactive protein (CRP) Factor. Timepoint: On days zero (before the intervention), days one, three, five and seven after the intervention. Method of measurement: Blood Test Prestige 24i machine made in Japan.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-27</approval_date>
        <contact_name>Ethics committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>No. 28, Ghafari Ave., zakariyay razi Blvd وbirjand University of Medical Sciences birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
