<?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>IRCT20210426051090N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-12</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>The effect of atorvastatin on Covid 19</public_title>
      <acronym></acronym>
      <scientific_title>The effect of atorvastatin on on inflammatory factors and prognosis outcomes in patients with Covid 19, hospitalized in Hajar Hospital, Shahrekord University of Medical Sciences, 2021</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56387</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients will be done by the responsible researcher using Excel software. Randomization will be done by creating blocks. Blocks will be considered in variable sizes including 4 or 6 or 8 patients. In order to randomly assign patients in the two groups receiving medication and placebo, a specific code including 2 letters and a number will be assigned to each patient. This code will be unique to each patient (for example, code AB1 for patient number one). Only the researcher in charge of the study will know that each code is assigned to the drug or placebo group, Blinding description: The drugs required for the participants in the study will be fully covered at the research site will be available to the participants in the study. Study participants and evaluators of the final outcome of patients will not be aware of the drug or placebo.</study_design>
      <phase>3</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Patients receiving standard diet treatment (according to national protocol) + placebo. Intervention 2: Intervention group: Patients with standard diet treatment + atorvastatin 40 mg made by Mehr Daroo Pharmaceutical Company daily for 14 days.</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:
Only part of the data such as information about the main outcome or the like can be shared.

When:
2021-2022

To whom:
En The data will be available only to researchers working in academic and scientific institutions

Conditions:
I have not decided yet

Where to obtain:
I have not decided yet

How to obtain:
I have not decided yet

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahab Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar aven</address>
        <city>Sahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8816754633</zip>
        <telephone>+98 38 3222 0016</telephone>
        <email>st-moghaddam.sh@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahab Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Aven</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8816754633</zip>
        <telephone>+98 38 3222 0016</telephone>
        <email>st-moghaddam.sh@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with confirmed molecular test of blood oxygen saturation level SpO2 less than 90% in room air
Patients with pulmonary involvement in radiological studies
Do not take statins
The patient is not in a state of shock and sepsis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having advanced heart disease (CHF)
Liver disease (based on primary LFT)
Incidence of statin side effects
Long-term use of corticosteroids
to die
Pulmonary underlying disease</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Patients receiving standard diet treatment (according to national protocol) + placebo.</i_keyword>
      <i_keyword>Intervention group: Patients with standard diet treatment + atorvastatin 40 mg made by Mehr Daroo Pharmaceutical Company daily for 14 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>O2 Saturation. Timepoint: 1 and 7 days after the start of the study. Method of measurement: Pulse oximetry device.</prim_outcome>
      <prim_outcome>FBS. Timepoint: 1 and 7 days after the start of the study. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>IL-6. Timepoint: 1 and 14 days after the start of the study. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Alt، Ast ،Alkp ، Bill total ، Bill direct. Timepoint: 1 and 7 and 14 days after the start of the study. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>BUN, Na, K, Cr. Timepoint: 1 and 7 days after the start of the study. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>PT, PTT, INR. Timepoint: 1 and 7 days after the start of the study. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>TG, Total Cholesterol, LDL, HDL. Timepoint: 1 and 7 days after the start of the study. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>CBC(diff). Timepoint: 1 and 7 days after the start of the study. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>LDH. Timepoint: 1 and 7 and 14 days after the start of the study. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>ESR. Timepoint: 1 and 7 and 14 days after the start of the study. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>CRP. Timepoint: 1 and 7 and 14 days after the start of the study. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Ferritin. Timepoint: 1 and 7 and 14 days after the start of the study. Method of measurement: blood test.</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>2021-05-12</approval_date>
        <contact_name>Shahre-kord University of Medical Sciences</contact_name>
        <contact_address>Parastar Aven 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>
