<?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>IRCT20200921048783N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-06</date_registration>
      <primary_sponsor>Abadan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  GRAPEX in treatment of COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Grapex on the alternations of clinical symptoms and laboratory finding on COVID19.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51199</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization, Blinding description: Patients and researchers are blinded as double blind.</study_design>
      <phase>3</phase>
      <hc_freetext>covid19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Patients receiving standard country protocol drugs with Grapex 200 mg twice  a day until the patient's clinical symptoms improve . Intervention 2: Control group: Patients receiving standard country protocol drugs with placebo twice a day until the patient's clinical symptoms improve .</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:
All data can be shared after the participants in the study are unrecognizable.

When:
The data access period after printing the article

To whom:
The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.

Conditions:
Any analysis can be done with the consent of the main researcher.

Where to obtain:
dr.mojiri@yahoo.com

How to obtain:
The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hoda Mojiri-Forushani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6313833177</zip>
        <telephone>+98 61 5338 4004</telephone>
        <email>dr.mojiri@yahoo.com</email>
        <affiliation>Abadan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hoda Mojjiri-Forushani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abadan School of Medical Sciences, Beginning of the street 30 meters Ave, Zolfaghari street, Abadan city.</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>631911154</zip>
        <telephone>+98 61 5338 4004</telephone>
        <email>dr.mojiri@yahoo.com</email>
        <affiliation>Abadan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients diagnosed with covid19 by positive PCR test.
Patients diagnosed with covid19 by positive CT scan evaluation</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other coronavirus as the cause of diseases classified elsewhere</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:  Patients receiving standard country protocol drugs with Grapex 200 mg twice  a day until the patient's clinical symptoms improve .</i_keyword>
      <i_keyword>Control group: Patients receiving standard country protocol drugs with placebo twice a day until the patient's clinical symptoms improve .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to clinical alternations defined as start of taking medication time to Discharge Time. Timepoint: The beginning of the study ,the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day. Method of measurement: Medical record.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complete Blood Count. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>C-reactive-protein. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>SER. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Creatinine. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Aspartate amino transferase. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Alanine amino transferase. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Prothrombin time. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Partial Thromboplastin time. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Cough. Timepoint: The beginning of the study ,the seventh day, the fourteenth day. Method of measurement: Clinical observation and examination.</sec_outcome>
      <sec_outcome>Level of consciousness. Timepoint: The beginning of the study ,the seventh day, the fourteenth day. Method of measurement: Using the Glasgow Coma scale.</sec_outcome>
      <sec_outcome>Arterial oxygen saturation. Timepoint: The beginning of the study ,the seventh day, the fourteenth day. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Clinical examination.</sec_outcome>
      <sec_outcome>Level of serum  sodium. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Level of  serum potassium. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>BUN. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>INR. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Mortality rate. Timepoint: Daily. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Number of days of hospitalization. Timepoint: Daily. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Alkaline phosphatase. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample.</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>Abadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-25</approval_date>
        <contact_name>Ethics committee of Abadan school of Medical Sciences</contact_name>
        <contact_address>Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city. Abadan Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
