<?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>IRCT20191228045924N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-22</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of Methylene Blue for treatment of COVID-19 outpatients referred to pulmonary clinic.</public_title>
      <acronym></acronym>
      <scientific_title>Application of Methylene Blue Along with Complementary Materials for Treatment of COVID-19 Outpatients with Less Than 8 Days from First Day of Clinical Symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>240</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60065</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple randomization, randomization unit: individual, randomization tool: by using the website of randomization: https://www.random.org/lists/
Simple randomization is done by random numbers generated by the randomization site,  according to the list produced, individuals will be randomly assigned to the intervention (methylene blue) or control groups, Blinding description: In this single blind, the evaluator, who is a health care professional (nurse) and is responsible for collecting data (symptoms and hospitalization and mortality) from patients after using the drug, is not aware that  each patient belongs to control group or intervention group.</study_design>
      <phase>4</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to the standard treatment, Covid-19 outpatients are received orally methylene blue along with complementary materials two times per day in interval time 12 hours. The drug is used for 7 days until 14 days. Drug is prepared by Omid Rajabi pharmaceutical company. Methylene Blue (1 mg/Kg), Vitamin C, Glucose or sugar, Vitamine B1, B2, B3, Calcium Phosphate, Citrate Potassium, Carbonate Sodium, Glycine Amino Acid, Ginger, Lecithin, Ascorbyl Palmitate, Magnesium Stearate will be prepared as powder (in one sacchet) and it will used orally after dissolving in water. Intervention 2: Control group: Patients will received just the standard treatment.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ِDr. Daryoush Hamidi Alamdari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iman Reza Hospital, Daneshgah Ave</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913316</zip>
        <telephone>+98 51 3882 8574</telephone>
        <email>hamidiad@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Daryoush Hamidi Alamdari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, Faculty of Medicine</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913316</zip>
        <telephone>+98 51 3882 8574</telephone>
        <email>hamidiad@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Outpatient COVID-19 patients who confirmed by PCR or HRCT referred to pulmonary clinic
SPO2 is between 70-96 after taking off the mask</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Severe impairment  of liver and heart
Renal insufficiency including severe renal impairment
G6PD enzyme deficiency</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>COVID-19, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>U07.1</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: In addition to the standard treatment, Covid-19 outpatients are received orally methylene blue along with complementary materials two times per day in interval time 12 hours. The drug is used for 7 days until 14 days. Drug is prepared by Omid Rajabi pharmaceutical company. Methylene Blue (1 mg/Kg), Vitamin C, Glucose or sugar, Vitamine B1, B2, B3, Calcium Phosphate, Citrate Potassium, Carbonate Sodium, Glycine Amino Acid, Ginger, Lecithin, Ascorbyl Palmitate, Magnesium Stearate will be prepared as powder (in one sacchet) and it will used orally after dissolving in water.</i_keyword>
      <i_keyword>Control group: Patients will received just the standard treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxygen pressure saturation. Timepoint: Interval time:  the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue. Method of measurement: Pulse oximeter.</prim_outcome>
      <prim_outcome>Respiratory Rate. Timepoint: Interval time:  the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue. Method of measurement: Physical exam.</prim_outcome>
      <prim_outcome>Headache. Timepoint: Interval time:  the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue. Method of measurement: Physical exam.</prim_outcome>
      <prim_outcome>Cough. Timepoint: Interval time:  the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue. Method of measurement: Physical exam.</prim_outcome>
      <prim_outcome>Shivery. Timepoint: Interval time:  the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue. Method of measurement: Physical exam.</prim_outcome>
      <prim_outcome>Chest pain. Timepoint: Interval time:  the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue. Method of measurement: Physical exam.</prim_outcome>
      <prim_outcome>Vomiting. Timepoint: Interval time:  the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue. Method of measurement: Physical exam.</prim_outcome>
      <prim_outcome>Diarrhea. Timepoint: Interval time:  the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue. Method of measurement: Physical exam.</prim_outcome>
      <prim_outcome>Fever. Timepoint: Interval time:  the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue. Method of measurement: Physical exam.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hospital stay time. Timepoint: After 15 days. Method of measurement: Number of days.</sec_outcome>
      <sec_outcome>Mortality rate. Timepoint: After 30 days. Method of measurement: Review of medical records.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-06</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad University of Medical Sciences, Daneshgah Ave Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
