<?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>IRCT20111121008146N39</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-02</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the Effect of Intravenous Laser and Comparison of Laser Treatment Effect with Red and Blue Wavelengths in the Treatment of Patients with Covid-19</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the Effect of Intravenous Laser and Comparison of Laser Treatment Effect with Red and Blue Wavelengths in the Treatment of Patients with Covid-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52052</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The data analyst was blinded to the grouping of the data. Grouping based on the definition of codes such as A, B, C or 1, 2, and 3 will be provided to the data analyst, and the analyst does not know how to assign these codes to which treatment group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19 (Coronavirus Disease 2019).</hc_freetext>
      <i_freetext>Intervention 1: Two case groups: The treatment procedure with a low-power gallium arsenide 660 nm laser diode with an output dose of 2 joules per square centimeter, continuous for 7 minutes 5 sessions daily under intravenous laser. The same dose of laser with equal time of the first group with low power laser diode laser with a wavelength of 450 nm is prescribed to patients in the case of blue laser. Intervention 2: Control group: Patients will receive the current standard of care for COVID-19.</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 is potentially shareable after unidentified individuals

When:
Access period starts 6 months after the results are published

To whom:
Researchers and doctors

Conditions:
Email the corresponding author and earn permission

Where to obtain:
Email the corresponding author

How to obtain:
Email the corresponding author, the authors' meeting, send the data at your discretion

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Barati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934370</zip>
        <telephone>+98 21 2271 8021</telephone>
        <email>dr.baaraati@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Barati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohadaye Tajrish Hospital, Tajrish, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21 2274 9221</telephone>
        <email>laser.cntr@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Fever
Cough
Pneumonitis
Positive PCR test
Lung involvement&gt;50%
Taking any medication within the past month
age between 30-80 year</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Lactation
Cardiovascular disease
Hyper- and hypothyroidism
Photosensitivity
A history of seizure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Two case groups: The treatment procedure with a low-power gallium arsenide 660 nm laser diode with an output dose of 2 joules per square centimeter, continuous for 7 minutes 5 sessions daily under intravenous laser. The same dose of laser with equal time of the first group with low power laser diode laser with a wavelength of 450 nm is prescribed to patients in the case of blue laser</i_keyword>
      <i_keyword>Control group: Patients will receive the current standard of care for COVID-19</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lung involvement on CT-scan. Timepoint: Before the intervention and after the last session of intravenous laser therapy. Method of measurement: CT-scanner.</prim_outcome>
      <prim_outcome>IL-6 serum levels. Timepoint: Before the intervention and after the last session of intravenous laser therapy. Method of measurement: IL-6 ELISA kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fever. Timepoint: Before the intervention and after the last session of intravenous laser therapy. Method of measurement: Thermometer.</sec_outcome>
      <sec_outcome>Oxygen saturation level. Timepoint: Before the intervention and after the last session of intravenous laser therapy. Method of measurement: Pulse oxymeter.</sec_outcome>
      <sec_outcome>PO2 (partial pressure of oxygen). Timepoint: Before the intervention and after the last session of intravenous laser therapy. Method of measurement: ABG (arterial-blood gas) test.</sec_outcome>
      <sec_outcome>PCO2 (partial pressure of carbon dioxide). Timepoint: Before the intervention and after the last session of intravenous laser therapy. Method of measurement: ABG (arterial-blood gas) test.</sec_outcome>
      <sec_outcome>Respiratory rate per minute. Timepoint: Before the intervention and after the last session of intravenous laser therapy. Method of measurement: Counting the number of breaths in one minute.</sec_outcome>
      <sec_outcome>WBC count. Timepoint: Before the intervention and after the last session of intravenous laser therapy. Method of measurement: Patients' blood samples.</sec_outcome>
      <sec_outcome>Platelet count. Timepoint: Before the intervention and after the last session of intravenous laser therapy. Method of measurement: Patients' blood samples.</sec_outcome>
      <sec_outcome>ESR (erthrocyte sedimentation rate). Timepoint: Before the intervention and after the last session of intravenous laser therapy. Method of measurement: Patients' blood samples.</sec_outcome>
      <sec_outcome>CRP (C-reactive protein). Timepoint: Before the intervention and after the last session of intravenous laser therapy. Method of measurement: Patients' blood samples.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-09</approval_date>
        <contact_name>Shahid Beheshti university of medical sciences</contact_name>
        <contact_address>Daneshjo Blvd, Velenjak, Tehran, Iran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
