<?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>IRCT20200531047619N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-18</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of Tofacitinib in covid-19 patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of Tofacitinib drug (Iranian brand of Rhofanib drug) on clinical and laboratory symptoms in severe and resistant patients with  COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48766</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: 1-The dose of this drug in patients with rheumatoid arthritis is 5 mg twice a day and in patients with covid-19 the same dose is used for 10 days. 2-In this study, 10 patients are used first, and if the effect of the drug is good in improving patients, the number will be higher.</study_design>
      <phase>3</phase>
      <hc_freetext>Coronavirus disease (COVID-19).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group includes severe and ill covid-19 patients who did not respond to routine and existing treatments.In these patients, the Iranian brand of drug tofacitinib or rhofanib is used and this drug is in the form of 5 mg tablets that are used orally twice a day for fourteen days and the manufacturer of this drug is Alvand Nanotechnology Company. Intervention 2: Control group: In this group, severe and ill COVID-19 patients are admitted to the ICU and received all the routine medications used in ill patients.Tofacitinib given in the intervention group is not given to the control group.</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:
In this study, all data can be shared after identifying individuals.

When:
In this study, the data access time is six months after the results are published.

To whom:
The data of this study are available to researchers working in academic and scientific institutions and people working in industry.

Conditions:
There is no limit to the use of this data and the only condition is that this data be used to advance science and help patients.

Where to obtain:
For data, contact Simin Almasi at Firoozgar Hospital or email simin_almasi@yahoo.com.

How to obtain:
About 7 to 10 days after the announcement of the request to obtain the data, this data will be received by the applicant.

Comments:
I have no other explanation</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Simin Almasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Firoozgar hospital, Valadi Street, Valiasr Sq, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1593747811</zip>
        <telephone>+98 21 8214 1600</telephone>
        <email>almasi.s@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Simin Almasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Firoozgar hospital, Valadi Street, Valiasr Sq.Tehran,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1593747811</zip>
        <telephone>+98 21 8214 1600</telephone>
        <email>almasi.s@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Severe illness (respiratory rate above 30 per minute, heart rate above 120 per minute and per cent reduction in peripheral oxygen saturation to less than 93%)
Patients resistant to existing treatments</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Bacterial infection is positive for the patient or procalcitonin is positive
The patient may have hepatitis B or hepatitis C or HIV
The patient has pulmonary embolism or intravascular thrombosis
The patient has active and inactive tuberculosis
The patient has diverticulitis and peptic ulcer
Leukocytes count less than 3500 cells / mm  and hemoglobin less than 9 g / dL and neutrophils less than 1000 cells / mm3</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>An emergency ICD-10 code of ‘U07.1 COVID-19, virus identified’ is assigned to a disease diagnosis of COVID-19 confirmed by laboratory testing,An emergency ICD-10 code of ‘U07.2 COVID-19, virus not identified’ is assigned to a clinical or epidemiological d</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: This group includes severe and ill covid-19 patients who did not respond to routine and existing treatments.In these patients, the Iranian brand of drug tofacitinib or rhofanib is used and this drug is in the form of 5 mg tablets that are used orally twice a day for fourteen days and the manufacturer of this drug is Alvand Nanotechnology Company.</i_keyword>
      <i_keyword>Control group: In this group, severe and ill COVID-19 patients are admitted to the ICU and received all the routine medications used in ill patients.Tofacitinib given in the intervention group is not given to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxygen saturation level. Timepoint: Daily. Method of measurement: Pulse oximetry.</prim_outcome>
      <prim_outcome>Rate of breaths. Timepoint: Daily. Method of measurement: Number per minute.</prim_outcome>
      <prim_outcome>Heart Rate. Timepoint: Daily. Method of measurement: Number per minute.</prim_outcome>
      <prim_outcome>Level of consciousness. Timepoint: Daily. Method of measurement: GCS, Glasgow Coma Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Radiographic changes in lung CT scan. Timepoint: The first and fourteenth day of treatment. Method of measurement: Scoring system for determining the amount of grand glass and interstitial lung involvement (by radiologist)(By Radiologist).</sec_outcome>
      <sec_outcome>Measurement of serum levels of interleukin -1,interleukin- 2, interleukin-6 and TNF-alpha. Timepoint: The first and fourteenth day of treatment. Method of measurement: ELISA test.</sec_outcome>
      <sec_outcome>Serum ferritin. Timepoint: The first and fourteenth day of treatment. Method of measurement: Micro grams per liter.</sec_outcome>
      <sec_outcome>D-dimer serum. Timepoint: The first and fourteenth day of treatment. Method of measurement: Micro grams per milliliter.</sec_outcome>
      <sec_outcome>Hemoglobin. Timepoint: every other day. Method of measurement: gram per deciliter.</sec_outcome>
      <sec_outcome>White blood cells count. Timepoint: every other day. Method of measurement: Micrograms per liter.</sec_outcome>
      <sec_outcome>Platelet count. Timepoint: every other day. Method of measurement: Micro grams per liter.</sec_outcome>
      <sec_outcome>Erythrocyte sedimentation rate. Timepoint: On the first, seventh and fourteenth days of treatment. Method of measurement: Millimeter per hour.</sec_outcome>
      <sec_outcome>Lactate dehydrogenase(LDH). Timepoint: The first and fourteenth day of treatment. Method of measurement: Micro grams per deciliter.</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>Iran University of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-15</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی ایران</contact_name>
        <contact_address>Firoozgar Hospital, Valy-aser Avenue, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
