<?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>IRCT20140305016852N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-04</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of three methods of treatment in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with and without coronavirus positive test</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of three methods of treatment in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with and without coronavirus positive test (Kovid-19)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47508</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random number table is used to randomize. To use the table of random numbers, first to read the numbers of the table will be determined, then the numbers will be considered for different groups. We touch on one of the numbers and move in one of the predefined directions and assign the numbers to different groups, Blinding description: The study will be blinded in two ways. Patients will be blinded by the type of intervention, and the researcher who has to enter the data in the relevant checklist will be blinded by the type of intervention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Coronavirus disease  (covid-19).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, untreated COVID-19 patients are treated with routine treatments and 50,000 units of vitamin D daily for one week. Intervention 2: Intervention group: In this group, untreated COVID-19 patients are treated with routine and vitamin C-containing treatments containing 500 mg daily for one week. Intervention 3: Control group: The control group includes patients who are under routine care only.</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:
Clinical information (including therapeutic outcomes), laboratory and demographic of Coronavirus patients 2019 under treatment with routine and vitamin D and C

When:
About 5 to 10 months after the start of the study

To whom:
Public

Conditions:
Careful study information can be provided to qualified researchers interested in treating patients.

Where to obtain:
Corresponding author

How to obtain:
Competent and enthusiastic researchers can receive data documentation from the responsible author after presenting the work by presenting their academic information and identification.

Comments:
The clinical trial, titled "Comparison of three therapies in patients with super-acute respiratory syndrome (SARS-COV-2) with and without positive coronavirus testing (Covid-19)", has not been previously reported elsewhere. Not sent elsewhere. We are very happy to have registered our clinical trial on the IRCT website (www.irct.ir). thank you. Wishing you good health and happy moments</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Shirzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of medicine-Campus of the University of Medical Sciences-above the memory of the shohadaye gomnam-shohadaye hasteii Boulevard-Sabzevar</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33787-95196</zip>
        <telephone>+98 51 4401 1300</telephone>
        <email>dreshirzad@yahoo.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayyeh Nayyeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Torbat Heydariyeh University of Medical Sciences, Razi St., North Ferdowsi St.</address>
        <city>Torbat-Heydariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33787-95196</zip>
        <telephone>+98 51 5222 6013</telephone>
        <email>s.nayyeri86@yahoo.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient was admitted to the acute respiratory center
Consent to participate in the study
Age 15 to above
Do not take vitamin C and D supplements
No gout
Lack of kidney and liver disease
No pregnancy or lactation
No treatment with anti convulsants</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient has lung cancer
Patients undergoing chemotherapy and radiotherapy
If the patient dies
If the patient has a decreased level of consciousness
If the patient does not want to continue working on the plan</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B97.29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other coronavirus as the cause of diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, untreated COVID-19 patients are treated with routine treatments and 50,000 units of vitamin D daily for one week.</i_keyword>
      <i_keyword>Intervention group: In this group, untreated COVID-19 patients are treated with routine and vitamin C-containing treatments containing 500 mg daily for one week.</i_keyword>
      <i_keyword>Control group: The control group includes patients who are under routine care only.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Complete recovery of clinical symptoms of 2019 disease. Timepoint: About a week after starting treatment. Method of measurement: Clinical and laboratory questionnaire.</prim_outcome>
      <prim_outcome>Normalization of chest symptoms in CT scan. Timepoint: About 7 to 14 days after starting treatment. Method of measurement: CT scan result.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improving and normalizing the level of laboratory symptoms. Timepoint: At least 1 to 2 weeks after starting treatment. Method of measurement: Laboratory techniques.</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>Sabzevar 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 sabzevar University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology-Campus of the University of Medical Sciences-above the memory of the shohadaye gomnam-shohadaye hasteii Boulevard-Sabzevar Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
