<?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>IRCT20200329046892N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-02</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Trifluoperazine Effectiveness in Treatment of Coronavirus</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Trifluoperazine Effectiveness in Treatment Process, Survival rate and Cure rate of COVID-19 Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47300</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 70 COVID-19 patients divide to 2 groups each comprising 35 patients, case and control naming A and B, respectively. Randomized blocking will conduct as numbers 1-70 allocate consequently to research units. Then a table will draw including 6 rows named Block, each block having 4 segments filled with A and B. In next stage, the numbers will placed next to each other. The subjects would received A package if they had the numbers placed in A segment. About the subjects being opposite to B segments, B package would allocate to them. Concealment is done via sealed package, Blinding description: Treatment group would be determined just after randomization. Subjects and physicians corresponding to patients' health would n't be blinded. Radiologists, main researchers, outcome assessor and statistician would be blinded to treatment group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Recommended standard care for COVID-19 patients + Trifluoperazine, 2 mg tablet PO (manufactured by Sobhandarou, Iran) q12hr for 21 days. Intervention 2: Control group: Recommended standard care for COVID-19 patients.</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:
Data about outcomes

When:
Summer 2020

To whom:
researchers

Conditions:
requested by authenticated scientific centers and universities

Where to obtain:
Dr. Nematollah Ahangar
School of Medicine

How to obtain:
Official request signed by highest executive is mandatory. Moreover, acceptable reasons should be noted.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nematollah Ahangar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, Guilan University Complex, 7th Km Tehran road</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613769</zip>
        <telephone>+98 13 3369 0099</telephone>
        <email>n.ahangar@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nematollah Ahangar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, Guilan University Complex, 7th Km Tehran road</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613769</zip>
        <telephone>+98 13 3369 0099</telephone>
        <email>n.ahangar@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>َAll of the patients admitted to Razi hospital of Rasht and diagnosed for COVID-19 in April-March 2020
18 years old and more
ّFever (oral temperature more than 37.8)
At least one of the following criteria
Respiratory rate 24 and more per minute
At rest SPO2 fewer than 94
PCR positive
Pulmonary involvement in CT or chest X-ray</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Those who aren't willing to participate in the study based on personal satisfaction
concomitant use of an anti-psychotic drug
History of epileptic disorders
Parkinson's Disease
Dementia
Symptomatic hepatic dysfunction
Allergic reaction to Phenothiazines
History of pheochromocytoma
Any major drug-interaction between routine-taken drugs with trifluoperazine
Pregnancy and breastfeeding
Previous COVID-19 treatment
Multi-organ failure evidences
Need to mechanical ventilation on entrance to the study
eGFR&lt; 50 mL/min</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J00-J99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>بیماری های تنفسی</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: Recommended standard care for COVID-19 patients + Trifluoperazine, 2 mg tablet PO (manufactured by Sobhandarou, Iran) q12hr for 21 days</i_keyword>
      <i_keyword>Control group: Recommended standard care for COVID-19 patients</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to clinical improvment: normalization of body temperature to 37.2 and lower. Timepoint: Daily. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Time to clinical improvment: normalization of respiratory rate to 24 and fewer. Timepoint: Daily. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Time to clinical improvment: Oxygen saturation of 94% and more. Timepoint: Daily. Method of measurement: Palse oximeter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Need to ventilator. Timepoint: Daily. Method of measurement: Clinical assessment.</sec_outcome>
      <sec_outcome>Radiologic changes. Timepoint: 21st day or anytime based on clinical team diagnosis. Method of measurement: Chest imaging.</sec_outcome>
      <sec_outcome>Serious adverse drug reactions. Timepoint: anytime. Method of measurement: clinical evaluation.</sec_outcome>
      <sec_outcome>Morbidity. Timepoint: anytime. Method of measurement: clinical evaluation.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-19</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>School of Medicine, Guilan University Complex, 7th Km Tehran Road Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
