<?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>IRCT20230523058271N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-08</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the efficacy of Pentoxiphyllin in hospitalized diabetic patients with covid19</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficacy of Pentoxiphyllin in hospitalized diabetic patients with covid19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70311</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who meet the inclusion criteria are divided into two groups by a simple randomization method and based on the table of random numbers prepared by the statistics consultant whom out of  the study, and the grouping of each person is in a sealed envelope at the disposal of the relevant doctor and the nursing team. will be placed, Blinding description: In this double-blind study, the researcher and the statistical analyst will not know about the grouping. In this way, only the doctor who prescribed the patient's orders, the nursing team and the patient knew about the medicine received, and the researcher who was responsible for collecting the information and results of the patients would not know about the grouping, and the statistical researcher would also know that each of It will not be known what drugs the groups received.</study_design>
      <phase>3</phase>
      <hc_freetext>covid 19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They are treated with pentoxifylline 400 mg three times a day along with intravenous dexamethasone 4 mg every 12 hours. Intervention 2: Control group: They are treated with intravenous dexamethasone 4 mg every 12 hours.</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:
Only a part of the data, such as the information related to the main outcome or the like, can be shared.

When:
One year after the time of publication

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
The data will be available only to researchers working in academic and scientific institutions

Where to obtain:
The data will only be available to researchers working in academic and scientific institutions through the following email address.

How to obtain:
Only the data related to the main results of the study can be presented to the mentioned people after mentioning the valid reason.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Falahati marvast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy, Shohday gomnam Boulevard, Alam Square, Yazd, Iran</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3837 4597</telephone>
        <email>zs.falahati1988@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Falahati marvast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy, Shohday gomnam Boulevard, Alam Square, Yazd, Iran</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3837 4596</telephone>
        <email>zs.falahati1988@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of covid in the last 24 to 48 hours
Candidate for hospitalization (o2sat&lt;93% or RR&gt;24 or Pao2/Fio2&lt;300)
Covid-19 patients who are candidates for hospitalization with indications for hospitalization according to the country's guidelines, who had pulmonary infiltration in CT scan
Outpatients with pulmonary infiltration on CT scan
Age 18 to 70 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who were treated with Coltera (lupinavir/ritonavir).
Patients with shock or hemodynamic instability
Drug intolerance
Patients with a history of Crohn's or ulcerative colitis, diarrhea or chronic malabsorption
Neuromuscular diseases
GFR less than 30 ml/min
History of cirrhosis, hepatitis and severe liver diseases
Patients receiving chemotherapy for cancer
Pregnancy and breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Post-COVID</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>U09</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: They are treated with pentoxifylline 400 mg three times a day along with intravenous dexamethasone 4 mg every 12 hours.</i_keyword>
      <i_keyword>Control group: They are treated with intravenous dexamethasone 4 mg every 12 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Recovery. Timepoint: It is evaluated during the first 72 hours after hospitalization and the start of the intervention. Method of measurement: It is evaluated in the form of arterial blood oxygen level of at least 93%, cessation of fever for 72 hours and improvement of the general condition through a questionnaire.</prim_outcome>
      <prim_outcome>IL-6. Timepoint: At the start of treatment and after one week from the start of treatment. Method of measurement: kit.</prim_outcome>
      <prim_outcome>CRP. Timepoint: At the start of treatment and after one week from the start of treatment. Method of measurement: kit.</prim_outcome>
      <prim_outcome>ESR. Timepoint: At the start of treatment and after one week from the start of treatment. Method of measurement: KIT.</prim_outcome>
      <prim_outcome>Ferritin. Timepoint: At the start of treatment and after one week from the start of treatment. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Involvement in HRCT. Timepoint: At the start of treatment and after one week from the start of treatment. Method of measurement: Using CT SCAN observation and evaluation by a lung specialist.</prim_outcome>
      <prim_outcome>Hospitalization in ICU. Timepoint: During the course of treatment. Method of measurement: CHECKLIST.</prim_outcome>
      <prim_outcome>Death. Timepoint: During the course of treatment. Method of measurement: CHECKLIST.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Research Vice President of Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-11</approval_date>
        <contact_name>Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Shahid Sadoughi University of Medical Sciences, Shohday gomnam Boulevard, Alam Square, Yazd, Iran yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
