<?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>IRCT20200329046892N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-29</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Effect of ivermectin in COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Study of Ivermectin Effectiveness in treatment process, survival and cure rate of COVID-19 patients: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55216</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: It is a block randomization type and the block with size of 4. 
Randomization tool: sealedenvelope.com.
60 patients will be assigned in 15 blocks of 4. In intervention group (A) they will receive Ivermectin 12 mg/day (Four 3 mg Tablets)  orally for 2 days + standard care for 10 days and in control group (B) they will receive (Four 3 mg Placebo tablets) orally for 2 days + standard care for 10 days. Concealment is done using the sealed envelope method, Blinding description: In this study, participants (patients) and medical staff are kept blind to the specificity of study groups (Double-blinded). For this purpose, an independent person from the research team and an Infectious Diseases specialist prescribes the assigned codes to each patient. Efforts will be made to make the drug and placebo by one company to ensure the similarity. Study drugs will be placed in similar packages, and patients will receive pre-arranged interventions in the order in which they enter the study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: COVID-19. Condition 2: COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Ivermectin (Alborz-Daru) 12 mg/day (Four 3 mg Tablets) orally for 2 days + standard care for 10 days or hospital discharge (whichever comes first). Intervention 2: Control group: Four 3 mg Tablets orally for 2 days + standard care for 10 days or hospital discharge (whichever comes first).</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:
Data about primary outcome

When:
2 months after results published

To whom:
Researchers

Conditions:
Requested by authenticated scientific centers and universities

Where to obtain:
Dr. Nematollah Ahangar School of Medicine Email: n.ahangar@gums.ac.ir

How to obtain:
Official request signed by highest executive is mandatory. Moreover, acceptable reasons should be noted

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nematollah Ahangar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, Guilan University Complex, 7th Km Tehran road</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613769</zip>
        <telephone>+98 13 3369 0099</telephone>
        <email>n.ahangar@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nematollah Ahangar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, Guilan University Complex, 7th Km Tehran road</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613769</zip>
        <telephone>+98 13 3369 0099</telephone>
        <email>n.ahangar@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All Covid-19 patients admitted to the coronavirus ward of Razi Hospital in Rasht for period of April to July 2021
Age greater than or equal to 18 years
Patients admitted with the following criteria: fever (oral temperature greater than 37.2 ° C), dry cough, severe tiredness or dyspnea
At least one of the following criteria : positive PCR OR lung involvement on chest X-ray / CT scan</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of informed consent
Lack of patient cooperation
Having pulmonary embolism or intravascular thrombosis
Any major drug interaction between routine patient's drugs  with any of the study drugs
Pregnancy and lactation
Simultaneous presence in other research study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
      <hc_code>U07.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>virus identified</hc_keyword>
      <hc_keyword>virus not identified; Clinically-epidemiologically diagnosed COVID-19; Probable COVID-19; Suspected COVID-19</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Ivermectin (Alborz-Daru) 12 mg/day (Four 3 mg Tablets) orally for 2 days + standard care for 10 days or hospital discharge (whichever comes first)</i_keyword>
      <i_keyword>Control group: Four 3 mg Tablets orally for 2 days + standard care for 10 days or hospital discharge (whichever comes first)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The time required to improve clinical symptoms within 10 days of treatment start. Timepoint: Daily from the first day of intervention. Method of measurement: Physical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body temperature. Timepoint: Daily from the first day of intervention. Method of measurement: Thermometer.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Daily from the first day of intervention. Method of measurement: Pulse oxymeter.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Daily from the first day of intervention. Method of measurement: Barometer.</sec_outcome>
      <sec_outcome>Respiration rate. Timepoint: Daily from the first day of intervention. Method of measurement: Count.</sec_outcome>
      <sec_outcome>SPO2. Timepoint: Daily from the first day of intervention. Method of measurement: Pulse-oxy mete.</sec_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: Daily from the first day of intervention. Method of measurement: Record in the patient file.</sec_outcome>
      <sec_outcome>Mortality. Timepoint: Daily from the first day of intervention. Method of measurement: Record in the patient file.</sec_outcome>
      <sec_outcome>Creatine phosphokinase. Timepoint: Before intervention, Day 5 and Day 10. Method of measurement: International Federation of Clinical Chemistry (IFCC).</sec_outcome>
      <sec_outcome>C reactive protein. Timepoint: Before intervention, Day 5 and Day 10. Method of measurement: Turbidometry.</sec_outcome>
      <sec_outcome>Erythrocyte sedimentation rate. Timepoint: Before intervention, Day 5 and Day 10. Method of measurement: Westergren method.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-03</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>School of Medicine, Guilan University Complex, 7th Km Tehran Road Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
