<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04466280</url>
  </required_header>
  <id_info>
    <org_study_id>IR.BMSU.REC.1399.086</org_study_id>
    <nct_id>NCT04466280</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19</brief_title>
  <official_title>Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19 Disease in Healthcare Providers at Baqiyatallah Hospital in Tehran</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baqiyatallah Medical Sciences University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baqiyatallah Medical Sciences University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      180 people from the medical staff and high-risk people in Baqiyatallah Hospital, who are in&#xD;
      close contact with patients, will enter the study. Participants will be divided into two&#xD;
      intervention groups and one control group. The control group will use the full protective&#xD;
      equipment assigned to the treatment staff. In addition to protective equipment, the first&#xD;
      intervention team will receive a daily diet of 200 mg hydroxychloroquine tablets. The second&#xD;
      intervention team, while observing and using the complete protective equipment, will place a&#xD;
      thin layer of Mucodentol gel in the vestibular area of the mouth daily, every 6 to 8 hours.&#xD;
&#xD;
      At the beginning of the treatment, qualified people will participate in the study while&#xD;
      recording demographic and clinical information, PCR test will be performed, and if they have&#xD;
      negative PCR, they will be in one of the 3 study groups. During the study, if the symptoms of&#xD;
      the disease occur in each of the participants, the test will be taken again. If the test is&#xD;
      positive, the person will withdraw from the study, and the patient's information will be&#xD;
      recorded. Finally, the people present in the study will be tested for PCR, and the results of&#xD;
      the disease and the side effects of the drugs will be compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The financier of this research project died due to covid-19, Therefore, this project was&#xD;
    stopped due to lack of funds&#xD;
  </why_stopped>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Actual">September 21, 2020</completion_date>
  <primary_completion_date type="Actual">September 21, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PCR test</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Laboratory PCR testing can help diagnose the disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Laboratory Treatment Response</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Normal blood cell count and CRP count (normal laboratory range)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>drug reactions Adverse</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Complications in both groups should be evaluated and evaluated during treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allergic drug</measure>
    <time_frame>up to 1 month</time_frame>
    <description>There will be known allergic reactions to the drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological Treatment Response</measure>
    <time_frame>up to 1 month</time_frame>
    <description>CT scans help determine how much the lungs are affected by COVID-19.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group use personal protective equipment in the face of patients with COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, participants, while observing and using complete personal protective equipment, will apply a thin layer of Dentol gel to the vestibular area of the mouth daily, every 6 to 8 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxychloroquine</intervention_name>
    <description>200 mg of hydroxychloroquine daily for participants in the intervention group 1</description>
    <arm_group_label>Intervention Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mucodentol</intervention_name>
    <description>Intervention Group 2 participants will place a thin layer of Dentol gel in the vestibular area of the mouth every 6 to 8 hours.</description>
    <arm_group_label>Intervention Group 2</arm_group_label>
    <other_name>Dentol Gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Personal protective equipment</intervention_name>
    <description>Personal protective equipment such as masks, gloves, protective shields</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Intervention Group 1</arm_group_label>
    <arm_group_label>Intervention Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Negative PCR testing through throat swabs&#xD;
&#xD;
          -  Signing Conscious Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of ocular complications and visual disturbances&#xD;
&#xD;
          -  Sensitivity to plant compounds in the product&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mohammad Sadegh Bagheri Baghdasht</name>
      <address>
        <city>Tehran</city>
        <zip>0</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baqiyatallah Medical Sciences University</investigator_affiliation>
    <investigator_full_name>Mohammad Sadegh Bagheri Baghdasht</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydroxychloroquine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04466280
org study id: IR.BMSU.REC.1399.086
nct id: NCT04466280
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
180 people from the medical staff and high-risk people in Baqiyatallah Hospital, who are in
      close contact with patients, will enter the study. Participants will be divided into two
      intervention groups and one control group. The control group will use the full protective
      equipment assigned to the treatment staff. In addition to protective equipment, the first
      intervention team will receive a daily diet of 200 mg hydroxychloroquine tablets. The second
      intervention team, while observing and using the complete protective equipment, will place a
      thin layer of Mucodentol gel in the vestibular area of the mouth daily, every 6 to 8 hours.

      At the beginning of the treatment, qualified people will participate in the study while
      recording demographic and clinical information, PCR test will be performed, and if they have
      negative PCR, they will be in one of the 3 study groups. During the study, if the symptoms of
      the disease occur in each of the participants, the test will be taken again. If the test is
      positive, the person will withdraw from the study, and the patient's information will be
      recorded. Finally, the people present in the study will be tested for PCR, and the results of
      the disease and the side effects of the drugs will be compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: PCR test
time frame: up to 1 month
description: Laboratory PCR testing can help diagnose the disease
measure: Laboratory Treatment Response
time frame: up to 1 month
description: Normal blood cell count and CRP count (normal laboratory range)
measure: drug reactions Adverse
time frame: up to 1 month
description: Complications in both groups should be evaluated and evaluated during treatment.
measure: Allergic drug
time frame: up to 1 month
description: There will be known allergic reactions to the drugs.
measure: Radiological Treatment Response
time frame: up to 1 month
description: CT scans help determine how much the lungs are affected by COVID-19.
arm group label: Control Group
arm group type: Active Comparator
description: Participants in this group use personal protective equipment in the face of patients with COVID-19
arm group label: Intervention Group 1
arm group type: Experimental
description: In this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment.
arm group label: Intervention Group 2
arm group type: Experimental
description: In this group, participants, while observing and using complete personal protective equipment, will apply a thin layer of Dentol gel to the vestibular area of the mouth daily, every 6 to 8 hours.
intervention type: Drug
intervention name: Hydroxychloroquine
description: 200 mg of hydroxychloroquine daily for participants in the intervention group 1
arm group label: Intervention Group 1
intervention type: Drug
intervention name: Mucodentol
description: Intervention Group 2 participants will place a thin layer of Dentol gel in the vestibular area of the mouth every 6 to 8 hours.
arm group label: Intervention Group 2
other name: Dentol Gel
intervention type: Device
intervention name: Personal protective equipment
description: Personal protective equipment such as masks, gloves, protective shields
arm group label: Control Group
arm group label: Intervention Group 1
arm group label: Intervention Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Baqiyatallah Medical Sciences University
investigator full name: Mohammad Sadegh Bagheri Baghdasht
investigator title: Principal Investigator
mesh term: COVID-19
mesh term: Hydroxychloroquine