<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/NCT04405843</url>
  </required_header>
  <id_info>
    <org_study_id>ScDi823</org_study_id>
    <secondary_id>IVE-PA</secondary_id>
    <nct_id>NCT04405843</nct_id>
  </id_info>
  <brief_title>Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)</brief_title>
  <acronym>EPIC</acronym>
  <official_title>Randomized, Placebo Controlled, Double Blind Clinical Trial to Evaluate the Efficacy of Molecule D11AX22 in Adults Patients From Valle Del Cauca, Colombia With Early Stages of SARS COV2 / COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro de Estudios en Infectogía Pediatrica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro de Estudios en Infectogía Pediatrica</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>
      Double blind, placebo controlled, randomized clinical trial to evaluate the efficacy of&#xD;
      ivermectin in preventing progression of disease in adult patients with early stages of&#xD;
      COVID-19&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Actual">December 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 21, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to event</measure>
    <time_frame>21 days</time_frame>
    <description>Time until resolution of symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical condition on day 2</measure>
    <time_frame>On day 2 (± 1 day) after randomization</time_frame>
    <description>Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical condition on day 5</measure>
    <time_frame>On day 5 (± 1 day) after randomization</time_frame>
    <description>Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical condition on day 8</measure>
    <time_frame>On day 8 (± 1 day) after randomization</time_frame>
    <description>Clinical condition in an ordinal scale of 7 points, on day 8. Higher scores indicate worse outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical condition on day 11</measure>
    <time_frame>On day 11 (± 1 day) after randomization</time_frame>
    <description>Clinical condition in an ordinal scale of 7 points, on day 11. Higher scores indicate worse outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical condition on day 15</measure>
    <time_frame>On day 15 (± 1 day) after randomization</time_frame>
    <description>Clinical condition in an ordinal scale of 7 points, on day 15. Higher scores indicate worse outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical condition on day 21</measure>
    <time_frame>On day 21 (± 1 day) after randomization</time_frame>
    <description>Clinical condition in an ordinal scale of 7 points, on day 21. Higher scores indicate worse outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with additional care</measure>
    <time_frame>21 days</time_frame>
    <description>Proportion of subjects who require hospitalization, use of supplementary oxygen for &gt;24 hours or ICU admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who die</measure>
    <time_frame>From randomization up to 21 days</time_frame>
    <description>Proportion of subjects who die</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of additional care</measure>
    <time_frame>21 days</time_frame>
    <description>Duration of supplementary oxygen, hospitalization, ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>21 days</time_frame>
    <description>Proportion of subjects who develop solicited adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who discontinue intervention</measure>
    <time_frame>21 days</time_frame>
    <description>Proportion of subjects who required discontinuation of the intervention due to adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to event</measure>
    <time_frame>21 days</time_frame>
    <description>Time until deterioration of 2 or more points in an ordinal 7 points scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of fever</measure>
    <time_frame>21 days</time_frame>
    <description>Number of days with fever since randomization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">476</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Ivermectin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ivermectin, 300 micrograms / kg, once daily for 5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin Oral Product</intervention_name>
    <description>Ivermectin oral suspension, 6 mg/mL</description>
    <arm_group_label>Ivermectin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Confirmed SARS-CoV-2 by RT-PCR or antigen detection in a Colombian NIH-approved&#xD;
             laboratory&#xD;
&#xD;
          -  Beginning of symptoms in the past 7 days&#xD;
&#xD;
          -  Mild disease&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preexisting liver disease&#xD;
&#xD;
          -  Hypersensitivity to ivermectin&#xD;
&#xD;
          -  Participants in other clinical trials for therapies against COVID-19&#xD;
&#xD;
          -  Severe pneumonia&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Concomitant use of warfarin, erdafitinib or quinidine&#xD;
&#xD;
          -  Use of ivermectin in the 5 days prior to randomization&#xD;
&#xD;
          -  Inability to obtain a blood sample needed to assess liver transaminases&#xD;
&#xD;
          -  Elevation of transaminases &gt;1.5 times the normal level&#xD;
&#xD;
          -  Participant whose first contact with the study personnel occurs between days 5 and 7&#xD;
             and at that time manifests significant and progressive resolution of COVID-19 related&#xD;
             signs and symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eduardo López-Medina, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Estudios en Infectología Pediátrica</name>
      <address>
        <city>Cali</city>
        <state>Valle</state>
        <zip>12345</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>December 24, 2020</last_update_submitted>
  <last_update_submitted_qc>December 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2020</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ivermectin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </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/NCT04405843
org study id: ScDi823
secondary id: IVE-PA
nct id: NCT04405843
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Double blind, placebo controlled, randomized clinical trial to evaluate the efficacy of
      ivermectin in preventing progression of disease in adult patients with early stages of
      COVID-19
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to event
time frame: 21 days
description: Time until resolution of symptoms
measure: Clinical condition on day 2
time frame: On day 2 (± 1 day) after randomization
description: Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes
measure: Clinical condition on day 5
time frame: On day 5 (± 1 day) after randomization
description: Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes
measure: Clinical condition on day 8
time frame: On day 8 (± 1 day) after randomization
description: Clinical condition in an ordinal scale of 7 points, on day 8. Higher scores indicate worse outcomes
measure: Clinical condition on day 11
time frame: On day 11 (± 1 day) after randomization
description: Clinical condition in an ordinal scale of 7 points, on day 11. Higher scores indicate worse outcomes
measure: Clinical condition on day 15
time frame: On day 15 (± 1 day) after randomization
description: Clinical condition in an ordinal scale of 7 points, on day 15. Higher scores indicate worse outcomes
measure: Clinical condition on day 21
time frame: On day 21 (± 1 day) after randomization
description: Clinical condition in an ordinal scale of 7 points, on day 21. Higher scores indicate worse outcomes
measure: Proportion of subjects with additional care
time frame: 21 days
description: Proportion of subjects who require hospitalization, use of supplementary oxygen for >24 hours or ICU admission
measure: Proportion of subjects who die
time frame: From randomization up to 21 days
description: Proportion of subjects who die
measure: Duration of additional care
time frame: 21 days
description: Duration of supplementary oxygen, hospitalization, ICU stay
measure: Adverse events
time frame: 21 days
description: Proportion of subjects who develop solicited adverse events
measure: Proportion of subjects who discontinue intervention
time frame: 21 days
description: Proportion of subjects who required discontinuation of the intervention due to adverse events
measure: Time to event
time frame: 21 days
description: Time until deterioration of 2 or more points in an ordinal 7 points scale.
measure: Duration of fever
time frame: 21 days
description: Number of days with fever since randomization
arm group label: Ivermectin
arm group type: Experimental
description: Ivermectin, 300 micrograms / kg, once daily for 5 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
intervention type: Drug
intervention name: Ivermectin Oral Product
description: Ivermectin oral suspension, 6 mg/mL
arm group label: Ivermectin
intervention type: Drug
intervention name: Placebo
description: Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eduardo López-Medina, MD MSc
role: Principal Investigator
affiliation: Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--
facility: 
country: Colombia
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Ivermectin
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code