<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/NCT04500132</url>
  </required_header>
  <id_info>
    <org_study_id>EC-18-C201</org_study_id>
    <nct_id>NCT04500132</nct_id>
  </id_info>
  <brief_title>To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia</brief_title>
  <official_title>Phase 2, Multi-center, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enzychem Lifesciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Enzychem Lifesciences Corporation</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>
      Prevention of COVID-19 infection to severe pneumonea or ARDS&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Actual">February 15, 2021</completion_date>
  <primary_completion_date type="Actual">February 4, 2021</primary_completion_date>
  <phase>Phase 2</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of transition to ARDS</measure>
    <time_frame>14 days after starting IP administration</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>EC-18 Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EC-18 QD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo EC-18 QD</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EC-18</intervention_name>
    <description>EC-18 QD</description>
    <arm_group_label>EC-18 Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo EC-18</intervention_name>
    <description>Placebo EC-18 QD</description>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Male or female age 19 years or older&#xD;
&#xD;
          -  Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed diagnosis of bacterial pneumonia or viral pneumonia&#xD;
&#xD;
          -  Pregnant or nursing at the time of signing informed consent&#xD;
&#xD;
          -  Known sensitivity to any study medication&#xD;
&#xD;
          -  Unwilling or unable to complete study diary&#xD;
&#xD;
          -  Any other condition or prior therapy that, in the opinion of the Investigator, would&#xD;
             make the subject unsuitable for the study or unable to comply with the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyewon Jeong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chungbuk National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chungbuk National University Hospital</name>
      <address>
        <city>Cheongju-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04500132
org study id: EC-18-C201
nct id: NCT04500132
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prevention of COVID-19 infection to severe pneumonea or ARDS
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Rate of transition to ARDS
time frame: 14 days after starting IP administration
arm group label: EC-18 Arm
arm group type: Experimental
description: EC-18 QD
arm group label: Placebo Arm
arm group type: Placebo Comparator
description: Placebo EC-18 QD
intervention type: Drug
intervention name: EC-18
description: EC-18 QD
arm group label: EC-18 Arm
intervention type: Drug
intervention name: Placebo EC-18
description: Placebo EC-18 QD
arm group label: Placebo Arm
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Hyewon Jeong
role: Principal Investigator
affiliation: Chungbuk National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
sharing ipd: No