<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/NCT04409522</url>
  </required_header>
  <id_info>
    <org_study_id>IR.BMSU.REC.1399.039</org_study_id>
    <nct_id>NCT04409522</nct_id>
  </id_info>
  <brief_title>Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients</brief_title>
  <official_title>Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohammad Sadegh Bagheri Baghdasht</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>
      The leading cause of death in patients with COVID19 is a severe inflammatory response caused&#xD;
      by a cytokine storm that results in acute respiratory distress syndrome and acute pulmonary&#xD;
      insufficiency, as well as dysfunction of several vital organs. Therefore, preventing the&#xD;
      occurrence of uncontrolled inflammation is the main goal of the ongoing clinical trials.&#xD;
      Chloroquine and tocilizumab, which have the best results, are also prescribed to control&#xD;
      inflammation. But it can be said that treatments are the main source of inflammation.&#xD;
      Inflammasome NLRP3 is one of the mechanisms involved in many severe inflammatory disorders.&#xD;
      Inflammatory activation has already been demonstrated by many viruses. Melatonin, on the&#xD;
      other hand, is a hormone in the body that can inhibit Inflammation NLRP3 in addition to&#xD;
      various anti-inflammatory effects, especially after severe inflammation. Older adults with&#xD;
      lower levels of melatonin and children with maximum levels of melatonin are the risk groups&#xD;
      and low-risk groups for the disease, respectively. In the present study, while measuring&#xD;
      melatonin in patients with COVID19, its effectiveness as a treatment method along with the&#xD;
      common antiviral drug regimen in patients with severe disease will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 12, 2020</start_date>
  <completion_date type="Anticipated">September 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 5, 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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Melatonin</measure>
    <time_frame>up to 10 days</time_frame>
    <description>Immune system modulator. The amount of it is determined by laboratory methods</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inflammatory cytokines</measure>
    <time_frame>up to 10 days</time_frame>
    <description>is a type of signaling molecule (a cytokine) that is secreted from immune cells like helper T cells (Th) and macrophages, and certain other cell types that promote inflammation which is measured by serological or analyzer method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein (CRP)</measure>
    <time_frame>up to 10 days</time_frame>
    <description>C-reactive protein (CRP) is a protein made by the liver that measured by serological or analyzer method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cough</measure>
    <time_frame>up to 10 days</time_frame>
    <description>A sudden, audible expulsion of air from the lungs through a partially closed glottis, preceded by inhalation. It is a protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions that measured by Physical examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation of the blood</measure>
    <time_frame>up to 10 days</time_frame>
    <description>Oxygen saturation of the blood will measure by pulse oximeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ESR</measure>
    <time_frame>up to 10 days</time_frame>
    <description>Red blood cell sedimentation rate will measure by Autoanalyzer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological Treatment Response</measure>
    <time_frame>up to 10 days</time_frame>
    <description>Radiological Treatment Response (CT scan), more than 50% reduction in the affected area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory route</measure>
    <time_frame>up to 10 days</time_frame>
    <description>Cellular pathway active in inflammation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">55</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Test Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group, in addition to receiving the usual treatment of COVID-19, will receive a 9 mg dose of melatonin for seven to ten nights.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will receive the usual treatment of COVID-19</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melatonin</intervention_name>
    <description>Participants in this group, in addition to receiving the usual treatment of COVID-19, will receive a 9 mg dose of melatonin for seven to ten nights.</description>
    <arm_group_label>Test Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>The usual treatment</intervention_name>
    <description>Participants in this group will receive the usual treatment of COVID-19</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Test Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or&#xD;
             positive RT-PCR test for COVID-19&#xD;
&#xD;
          -  Oxygen saturation drop below 93%&#xD;
&#xD;
          -  Systolic blood pressure drop below 100 or blood pressure drop of 30 mm Hg from the&#xD;
             patient's previous normal systolic blood pressure&#xD;
&#xD;
          -  Fever&#xD;
&#xD;
          -  Dry cough&#xD;
&#xD;
          -  Positive PCR for COVID-19&#xD;
&#xD;
          -  Laboratory indices include CRP and ESR indicating COVID-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient dissatisfaction&#xD;
&#xD;
          -  Existence of drug interactions&#xD;
&#xD;
          -  Lack of proper conditions for receiving medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohammad Sadegh Bagheri Baghdasht</last_name>
    <phone>0098 9356318204</phone>
    <email>sadegh.bagheri@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mohammad Sadegh Bagheri Baghdasht</name>
      <address>
        <city>Tehran</city>
        <zip>0</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad Sadegh Bagheri Baghdasht</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>Melatonin</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/NCT04409522
org study id: IR.BMSU.REC.1399.039
nct id: NCT04409522
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The leading cause of death in patients with COVID19 is a severe inflammatory response caused
      by a cytokine storm that results in acute respiratory distress syndrome and acute pulmonary
      insufficiency, as well as dysfunction of several vital organs. Therefore, preventing the
      occurrence of uncontrolled inflammation is the main goal of the ongoing clinical trials.
      Chloroquine and tocilizumab, which have the best results, are also prescribed to control
      inflammation. But it can be said that treatments are the main source of inflammation.
      Inflammasome NLRP3 is one of the mechanisms involved in many severe inflammatory disorders.
      Inflammatory activation has already been demonstrated by many viruses. Melatonin, on the
      other hand, is a hormone in the body that can inhibit Inflammation NLRP3 in addition to
      various anti-inflammatory effects, especially after severe inflammation. Older adults with
      lower levels of melatonin and children with maximum levels of melatonin are the risk groups
      and low-risk groups for the disease, respectively. In the present study, while measuring
      melatonin in patients with COVID19, its effectiveness as a treatment method along with the
      common antiviral drug regimen in patients with severe disease will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Melatonin
time frame: up to 10 days
description: Immune system modulator. The amount of it is determined by laboratory methods
measure: Inflammatory cytokines
time frame: up to 10 days
description: is a type of signaling molecule (a cytokine) that is secreted from immune cells like helper T cells (Th) and macrophages, and certain other cell types that promote inflammation which is measured by serological or analyzer method
measure: C-reactive protein (CRP)
time frame: up to 10 days
description: C-reactive protein (CRP) is a protein made by the liver that measured by serological or analyzer method
measure: Cough
time frame: up to 10 days
description: A sudden, audible expulsion of air from the lungs through a partially closed glottis, preceded by inhalation. It is a protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions that measured by Physical examination.
measure: Oxygen saturation of the blood
time frame: up to 10 days
description: Oxygen saturation of the blood will measure by pulse oximeter
measure: ESR
time frame: up to 10 days
description: Red blood cell sedimentation rate will measure by Autoanalyzer
measure: Radiological Treatment Response
time frame: up to 10 days
description: Radiological Treatment Response (CT scan), more than 50% reduction in the affected area
measure: Inflammatory route
time frame: up to 10 days
description: Cellular pathway active in inflammation
arm group label: Test Group
arm group type: Experimental
description: Participants in this group, in addition to receiving the usual treatment of COVID-19, will receive a 9 mg dose of melatonin for seven to ten nights.
arm group label: Control Group
arm group type: Active Comparator
description: Participants in this group will receive the usual treatment of COVID-19
intervention type: Drug
intervention name: Melatonin
description: Participants in this group, in addition to receiving the usual treatment of COVID-19, will receive a 9 mg dose of melatonin for seven to ten nights.
arm group label: Test Group
intervention type: Drug
intervention name: The usual treatment
description: Participants in this group will receive the usual treatment of COVID-19
arm group label: Control Group
arm group label: Test Group
criteria: 
gender: All
minimum age: 16 Years
maximum age: 100 Years
healthy volunteers: No
last name: Mohammad Sadegh Bagheri Baghdasht
phone: 0098 9356318204
email: sadegh.bagheri@gmail.com
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Baqiyatallah Medical Sciences University
investigator full name: Mohammad Sadegh Bagheri Baghdasht
investigator title: Principal Investigator
mesh term: COVID-19
mesh term: Melatonin