<?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>IRCT20180520039738N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-10</date_registration>
      <primary_sponsor>Saveh University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation and comparison of the effectiveness of standard treatment with stand treatment plus Vitamin A in treatment in covid19 patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of standard treatment with stand treatment plus Vitamin A in treatment in covid19 patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46974</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At the beginning of the study, an evaluator examines the criteria for entering the study of patients, and if there are conditions for entering the study, using the table of random numbers, patients will be assigned to the experimental and control group. And this process will continue until the formation of two equal groups of 70 people, Blinding description: In this study, patients, laboratory technicians,  radiologists, and therapists who will be responsible for prescribing the drug, receiving the sample and completing the questionnaire, as well as the researcher responsible for evaluating the results and statistically analyzing the treatment group will blind patients. Were, and will not know the intervention group. The physicians responsible for prescribing medication will not be blind. vitamin A and placebo were purchased from the same factory and coded by the third person who is not involved in the study. the patients have received the random code by the secretariat who is not involved in the study. the patients with even numbers will receive the capsules from box A and the patients with odd numbers will receive the capsules from box B.
To make a placebo, Since Zahrawi Vitamin A will be used for the experimental group, the control group will also use Zahrawi's placebo drug to make the placebo look and feel similar to the original vitamin A, but the active ingredient will be an ineffective substance.</study_design>
      <phase>3</phase>
      <hc_freetext>Corona virus disease 2019 (COVID-19).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:25000 IU vitamin A per day for ten days, the plus, the standard national treatment for COVID 19. Intervention 2: Control group: the standard national treatment for COVID19 ,and placebo.</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:
By publishing an article

When:
Access started on September 2020

To whom:
Researchers working in academic and scientific institutions

Conditions:
Scientific and therapeutic

Where to obtain:
Mohamad Reza Rohani, 00989122859099, mohamadreza.rohani@yahoo.com

How to obtain:
72 hours after a phone call or email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Rouhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.4, Shahid Shiroodi St. - Alam Al-Huda St., Arak University of Medical Sciences, School of Medicine, Department of Internal Medicine</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٣٨١٩٦٩٣٣٤٥</zip>
        <telephone>+98 86 3368 4615</telephone>
        <email>mohamadreza.rohani@yahoo.com</email>
        <affiliation>Saveh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamadreza Rohani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Shiroodi St. - Alam Al-Huda St., Arak University of Medical Sciences, School of Medicine, Department of Internal Medicine</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٣٨١٩٦٩٣٣٤٥</zip>
        <telephone>+98 86 3368 4615</telephone>
        <email>mohamadreza.rohani@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Covid 19 patients
Age over one year
Age less than 75 years
Tendency to participate in research
Completion of informed written consent</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnant women
lactating women
hepatitis B, C
Autoimmune diseases
Chronic renal failure (CRF)
Liver failure
Congestive heart failure (CHF)
Chronic obstructive pulmonary disease (COPD)</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>Intervention group:25000 IU vitamin A per day for ten days, the plus, the standard national treatment for COVID 19</i_keyword>
      <i_keyword>Control group: the standard national treatment for COVID19 ,and placebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body temperature. Timepoint: before the start of the intervention and 10 days after the supplement Vitamin A. Method of measurement: Measureing body temperature with a thermometer through the mouth.</prim_outcome>
      <prim_outcome>Blood oxygen saturation percentage. Timepoint: Before and ten days after starting treatment. Method of measurement: Pulse oximeter.</prim_outcome>
      <prim_outcome>Cough rate. Timepoint: Before and ten days after starting treatment. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>C-Reactive Protein (CRP) Test rate. Timepoint: Before and ten days after starting treatment. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Complete blood count (CBC) Rate. Timepoint: Before and ten days after starting treatment. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Creat. Rate. Timepoint: Before and ten days after starting treatment. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Lymphocytes Rate. Timepoint: Before and ten days after starting treatment. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Erythrocyte Sedimentation Rate (ESR) rate. Timepoint: Before and ten days after starting treatment. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Number of breaths. Timepoint: Before and ten days after starting treatment. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>The pH of the blood. Timepoint: Before and ten days after starting treatment. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Creatine phosphokinase (CPK) rate. Timepoint: Before and ten days after starting treatment. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Lactate Dehydrogenase (LDH) rate. Timepoint: Before and ten days after starting treatment. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Liver function tests rate. Timepoint: Before and ten days after starting treatment. Method of measurement: Laboratory.</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>Saveh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-03</approval_date>
        <contact_name>Ethics committee of  Saveh University of Medical Sciences</contact_name>
        <contact_address>Yas street, Kaveh industrial city, Saveh Saveh Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
