<?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>IRCT20211012052735N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-05</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Methylene Blue in treatment of Coronavirus Patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the Effects of Methylene Blue on Coronavirus Patients treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59256</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple randomization
randomization unit: individualized
randomization tool: through the randomization website https://random.org/lists/. Simple randomization will be achieved through numbers randomly generated by the website, in a way that according to the  generated list, the target individuals will be randomly divided into two groups of control and treatment (by Methylene blue), Blinding description: Patients, Researchers, Health personnel, data collectors, and those evaluating the outcome will be blinded throughout this study.</study_design>
      <phase>1-2</phase>
      <hc_freetext>coronavirus infection.</hc_freetext>
      <i_freetext>Intervention 1: In this clinical trial study, 60 patients with Covid-19 admitted to Hajar Hospital in Shahrekord with positive PCR test and O2-Saturation equal to 85 and less are selected and randomly divided into two groups of 30. Control and Intervention. Treated group: O2-Saturation equal to 85 and less. All the 30 patients will be matched in terms of age and gender. Prior to the study, all patients will be tested for biochemical factors such as CRP, methemoglobin, ferritin, serum creatinine, SGOT, SGPT, and LDH, Ddimer, CRP, and O2-Saturation levels will be measured daily. For patients in the treatment group, methylene blue (at the time of hospitalization) with a concentration of 34 mg / kg is given for 4 days, orally, along with the conventional treatments (routine treatment), Remdesiver and corticosteroids. At the end of four days, patients are assessed for improvement in indicators (general condition, O2-Saturation level, and biochemical factors) compared to the control group. Intervention 2: In this clinical trial study, 60 patients with Covid 19 admitted to Hajar Hospital in Shahrekord with positive PCR test and O2-Saturation equal to 85 and less are selected and randomly divided into two groups of 30. Control group:O2-Saturation equal to 85 and less.  The 30 patients in both groups will be matched in terms of age and gender. Prior to the study, all patients will be tested for biochemical factors such as CRP, methemoglobin, ferritin, serum creatinine, SGOT, SGPT, and LDH, Ddimer, CRP, and O2-Saturation levels are measured daily. The control group will  only receive the usual treatment (routine treatment) of Remdesiver and corticosteroids with placebo. At the end of four days, patients are assessed for improvement in indicators (general condition, O2-Saturation level, and biochemical factors).</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 will be shared

When:
6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Provide other scientific research

Where to obtain:
Dr Akbar Soleimani

How to obtain:
By E-mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Akbar Soleimani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rahmatyeh</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8813833435</zip>
        <telephone>+98 35 3333 1471</telephone>
        <email>j_saffari@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Akbar Soleimani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rahmatyeh</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8813833435</zip>
        <telephone>+98 38 3333 1471</telephone>
        <email>j_saffari@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients are to be free of any underlying disorders.
Patients are to be free of any kidney (creatinine test), liver (liver and LFT tests), and heart damages.
The age of inclusion in the study is to be between 20-50 years
Nasopharyngeal RT-PCR test sample is to be positive
Diagnosed with lung damages through CT scan
Have no history of viral infections with hepatitis and AIDS
Have not had received recombinant treatments
Have not had G6PD enzyme defect
O2Saturation of patients is to be less or equal to 85</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant women and women who are planning to become pregnant
Breastfeeding women
People with a history of allergies to methylene blue
People with a BMI above 30
People with kidney, heart, lung disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus infection, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this clinical trial study, 60 patients with Covid-19 admitted to Hajar Hospital in Shahrekord with positive PCR test and O2-Saturation equal to 85 and less are selected and randomly divided into two groups of 30. Control and Intervention. Treated group: O2-Saturation equal to 85 and less. All the 30 patients will be matched in terms of age and gender. Prior to the study, all patients will be tested for biochemical factors such as CRP, methemoglobin, ferritin, serum creatinine, SGOT, SGPT, and LDH, Ddimer, CRP, and O2-Saturation levels will be measured daily. For patients in the treatment group, methylene blue (at the time of hospitalization) with a concentration of 34 mg / kg is given for 4 days, orally, along with the conventional treatments (routine treatment), Remdesiver and corticosteroids. At the end of four days, patients are assessed for improvement in indicators (general condition, O2-Saturation level, and biochemical factors) compared to the control group.</i_keyword>
      <i_keyword>In this clinical trial study, 60 patients with Covid 19 admitted to Hajar Hospital in Shahrekord with positive PCR test and O2-Saturation equal to 85 and less are selected and randomly divided into two groups of 30. Control group:O2-Saturation equal to 85 and less.  The 30 patients in both groups will be matched in terms of age and gender. Prior to the study, all patients will be tested for biochemical factors such as CRP, methemoglobin, ferritin, serum creatinine, SGOT, SGPT, and LDH, Ddimer, CRP, and O2-Saturation levels are measured daily. The control group will  only receive the usual treatment (routine treatment) of Remdesiver and corticosteroids with placebo. At the end of four days, patients are assessed for improvement in indicators (general condition, O2-Saturation level, and biochemical factors).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood O2 saturation. Timepoint: daily. Method of measurement: saturation %.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-14</approval_date>
        <contact_name>IR.SKUMS.REC.1400.111</contact_name>
        <contact_address>Rahmatyeh Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
