<?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>IRCT20200404046932N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-30</date_registration>
      <primary_sponsor>Hakiman e Shargh Research Co.</primary_sponsor>
      <public_title>Preventive effect of FLUVAR® on COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of FLUVAR® in respiratory dosage form on the prevention of COVID-19 respiratory infection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>1000</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58878</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Blinding description: The researcher is unaware of which drug is delivered to which volunteer. The formulator of the two drugs is unaware of the recipients of the drugs and the dispenser of the drugs is unaware of the grouping and content of the drugs. The collector of results and the analyzer of data are also unaware of the type of drug groups.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID-19 Prophylaxis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Three puffs of FLOVAR® spray on each side, equivalent to a total of 500µl of medicine, once a week and receiving an additional dose of medicine in case of contact with a person suspected of having Covid 19 or disease carrier. Intervention 2: Intervention group 2: Three puffs of COLDAMARIS® spray on each side, equivalent to a total of 500µl of medicine, once a week and receiving an additional dose of medicine in case of contact with a person suspected of having Covid 19 or disease carrier. Intervention 3: Control group: Without medicine.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Protection of participants' confidential medical information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Safaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy, Isfahan Medical University</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 7087</telephone>
        <email>leila_safaeian@pharm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sayyed Ali Alavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Technology Park, Isfahan Science &amp; Technology Town, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8415683111</zip>
        <telephone>+98 31 3667 1780</telephone>
        <email>Sayyedalialavi@gmail.com</email>
        <affiliation>Hakiman e Shargh Research Co.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 years and older
Informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of moderate or severe asthma
Participating in another clinical trial for COVID-19</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus not identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Three puffs of FLOVAR® spray on each side, equivalent to a total of 500µl of medicine, once a week and receiving an additional dose of medicine in case of contact with a person suspected of having Covid 19 or disease carrier</i_keyword>
      <i_keyword>Intervention group 2: Three puffs of COLDAMARIS® spray on each side, equivalent to a total of 500µl of medicine, once a week and receiving an additional dose of medicine in case of contact with a person suspected of having Covid 19 or disease carrier</i_keyword>
      <i_keyword>Control group: Without medicine</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rate of COVID-19 infection. Timepoint: Time Frame: 14-20 months after admission to the study. Method of measurement: Acquisition of COVID-19 infection as confirmed by positive PCR swab taken 3-5 days after symptom onset.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration and intensity of COVID-19 symptoms of infected participants. Timepoint: Two weeks after onset of disease symptoms. Method of measurement: Questionnaire of symptoms, duration and intensity of disease.</sec_outcome>
      <sec_outcome>Side effects of intervention. Timepoint: Duration of Study. Method of measurement: Questionnaire of side effects.</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>Hakiman e Shargh Research Co.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-05</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee of Isfahan University of Medical Sciences, Hezarjarib Blvd, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
