<?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>IRCT20160126026217N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-08</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of the effects of prone position on  cardiac and respiratory status in patients with Coronavirus</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the effects of prone position on respiratory status, hemodynamics, hospital stay and transfer to intensive care unit in patients with Covid-19: A randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48403</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The patients by block randomization assigned in intervention and control groups. Classification is done using a random number table. Classes by age(below 50 years/ older 50 years) and gender (male/female). It should be noted that the volume of each block is 4 cases, thus creating 6 different combinations of 4 blocks and randomly selecting the blocks. Blocking and allocation sequences for concealment will be done by the non-involved researcher.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, participants will be in the prone position for 90 minutes for the first time. After evaluating the initial outcomes, the participant will be asked to be in the prone position for 6 to 8 hours until the clearance time, and then the secondary outcomes will be evaluated. Intervention 2: Control group: In this group, participants will be in their usual position for 90 minutes for the first time, after evaluating the initial outcomes, the participant will be asked to be in his usual positions until the time of discharge, and then the secondary outcomes will be evaluated.</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 Given that the results are currently unclear, I have not yet made a decision to publish</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sajad Yarahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lorestan university medical sciences, km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahriz village</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381251698</zip>
        <telephone>+98 66 3324 3143</telephone>
        <email>s.yarahmadi000@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sajad Yarahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lorestan university medical sciences, km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahriz village</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381251698</zip>
        <telephone>+98 66 3324 3143</telephone>
        <email>s.yarahmadi000@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with COVID-19  based on standard diagnosed test and had at least one respiratory symptom
Age between 18 and 65 years
Willing to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Do not use mechanical ventilation devices
Absence of respiratory diseases such as asthma  and COPD
Not suffering from hypertension
No history of heart failure
No history of orthopedic and spinal problems
No history of neurological diseases
Lack of anemia
Lack of treatment-induced pulmonary complications such as barometer and chest tube installation
No history of thoracic surgery in the last 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>RA01.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Covid-19</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, participants will be in the prone position for 90 minutes for the first time. After evaluating the initial outcomes, the participant will be asked to be in the prone position for 6 to 8 hours until the clearance time, and then the secondary outcomes will be evaluated.</i_keyword>
      <i_keyword>Control group: In this group, participants will be in their usual position for 90 minutes for the first time, after evaluating the initial outcomes, the participant will be asked to be in his usual positions until the time of discharge, and then the secondary outcomes will be evaluated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean blood pressure. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Digital sphygmomanometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Pulse oximeter device.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Pulse oximeter device.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Count the number of breaths per minute.</prim_outcome>
      <prim_outcome>Breath shortness. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Visual analog scale for breath shortness.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hospital stay. Timepoint: Patient discharge time. Method of measurement: Count the number of days a patient is hospitalized.</sec_outcome>
      <sec_outcome>Percentage of patients transferred to the intensive care unit. Timepoint: At the end of the study. Method of measurement: Percentage of the number of patients who will be transferred to the intensive care unit.</sec_outcome>
      <sec_outcome>Mortality rate of patients. Timepoint: At the end of the study. Method of measurement: The number of patients who die by the end of the study.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-06</approval_date>
        <contact_name>Ethics committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Lorestan University of Medical Sciences, Anooshirvan Rezaei Square Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
