<?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>IRCT20220228054146N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-02</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Effects of vitamin C on covid-19 patients</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of intravenous of vitamin C therapeutic effects on laboratory findings in covid-19 patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62225</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups of vitamin C treatment (intervention group) and the control group using Block Randomization Method. Initially, 6 blocks are prepared with the AAABBB combination and all possible modes of this combination are listed. A specific code is then assigned to each combination. Then, according to the sample size and the volume of the blocks, 14 blocks are selected ,using randomization method .All this process is done, using Random Allocation Software under the supervision of an epidemiologist, Blinding description: All participants in this study are divided into two groups, receiving vitamin C (intervention group) and the control group, but expect for health staff, no patient knows that the placebo was injected or vitamin C. So only patients in this study are blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Injection of vitamin C (Caspian Company) in amount of 1.5 gr for each patient in the intervention group is performed as an intravenous infusion using normal saline serum(500 cc) in 4 hours ,at the moment of entering the ward. Intervention 2: Control group: Injection of placebo in amount of 1.5 gr for each patient in the control group is performed as an intravenous infusion using normal saline serum(500 cc) in 4 hours ,at the moment of entering the ward.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Malek</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahad Blvd, Rahnamayi Blvd, Modiriat street, Emdad Alley, Gavam Apartment, First Floo</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5713613481</zip>
        <telephone>+98 44 3224 8760</telephone>
        <email>drreza881370@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Malek</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahad Blvd, Rahnamayi Blvd, Modiriat street, Emdad Alley, Gavam Apartment, First Floo</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5713613481</zip>
        <telephone>+98 44 3224 8760</telephone>
        <email>Drreza881370@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adults (age 18 years or older)
SPO2&lt;92%
Being treated in the ward
Positive PCR test
Involvement of Chest-CT-Scan</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a history of allergy to vitamin C
Patients with dyspnea caused by cardiogenic pulmonary edema
Pregnant women
Lactating women
Patients with a previous history of end-stage pulmonary disease, end-stage malignant tumor, diabetic ketoacidosis, severe kidney
Active kidney stone disease</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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Injection of vitamin C (Caspian Company) in amount of 1.5 gr for each patient in the intervention group is performed as an intravenous infusion using normal saline serum(500 cc) in 4 hours ,at the moment of entering the ward.</i_keyword>
      <i_keyword>Control group: Injection of placebo in amount of 1.5 gr for each patient in the control group is performed as an intravenous infusion using normal saline serum(500 cc) in 4 hours ,at the moment of entering the ward.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>White Blood Cell including neutrophil and lymphocyte. Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with X1000/mm3.</prim_outcome>
      <prim_outcome>Inflammatory factor(Erythrocyte Sedimentation Rate)/ESR. Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with mm/h.</prim_outcome>
      <prim_outcome>Inflammatory factor (C-Reactive Protein)/CRP. Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with Diagnostic Kit Unite /liter.</prim_outcome>
      <prim_outcome>Alkaline Phosphatase(Enzyme in liver and bones)/ALK-P. Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with Diagnostic Kit Unite /liter.</prim_outcome>
      <prim_outcome>Aspartate aminotransferase(Liver enzyme)/AST. Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with Diagnostic Kit Unite /liter.</prim_outcome>
      <prim_outcome>Alanine aminotransferase(Liver enzyme)/ALT. Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with Diagnostic Kit Unite /liter.</prim_outcome>
      <prim_outcome>Lactate dehydrogenase(Enzyme in heart and Red blood cell)/LDH. Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with Diagnostic Kit Unite /liter.</prim_outcome>
      <prim_outcome>Blood coagulation factor(D-dimer). Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with Diagnostic Kit Unite /liter.</prim_outcome>
      <prim_outcome>Blood coagulation factor(Prothrombin Time)/PT. Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with Diagnostic Kit Unite /liter.</prim_outcome>
      <prim_outcome>Blood coagulation factor(Partial Thromboplastin Time)/PTT. Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with Diagnostic Kit Unite /liter.</prim_outcome>
      <prim_outcome>Blood coagulation factor(International Normalized Ratio)/INR. Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with Diagnostic Kit Unite /liter.</prim_outcome>
      <prim_outcome>Inflammatory factor(Ferritin). Timepoint: Before the intervention and 5 days after. Method of measurement: Measure with blood test and scale with Diagnostic Kit Unite /liter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: Day of arrival until discharge from the hospital. Method of measurement: Patient record.</sec_outcome>
      <sec_outcome>Death. Timepoint: Day of arrival until discharge from the hospital or death. Method of measurement: Patient record.</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>Reza Malek</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-10</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Resalet Blvd ,Urganse Alley, Urmia University of Medical Sciences Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
