<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/NCT04429711</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-20-7156-ES-CTIL</org_study_id>
    <nct_id>NCT04429711</nct_id>
  </id_info>
  <brief_title>Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19</brief_title>
  <official_title>Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection and to Decrease Viral Shedding - A Double Blind , Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ivermectin which is an FDA-approved broad spectrum anti-parasitic agent, has also anti-viral&#xD;
      activity. In vitro study have shown its activity against SARS-CoV-2, however its clinical&#xD;
      effect on patients with COVID-19 never been tested.&#xD;
&#xD;
      In this RCT we would like to evaluate the effect of Ivermectin on reduction of viral shedding&#xD;
      among mild to moderate COVID-19 patients, and in shortening the symptom resolution time.&#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">October 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 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>
    <intervention_model_description>Double blind randomized</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Viral clearance at day 6</measure>
    <time_frame>Outcome will be determined till 6 days post intervention</time_frame>
    <description>The primary outcome will be the viral clearance at day 6 in the intervention group compared to placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Viral shedding duration</measure>
    <time_frame>Outcome will be determined till 14 days post intervention</time_frame>
    <description>Secondary outcomes: viral shedding duration (time between first positive PCR to last of two consecutive negative tests)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptoms clearance time</measure>
    <time_frame>Outcome will be determined till 14 days post intervention</time_frame>
    <description>Time between drug treatment and symptoms resolution</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>IVERMECTIN</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PLACEBO</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin Oral Product</intervention_name>
    <description>3mg Capsules, 12-15mg/ day for 3 days</description>
    <arm_group_label>IVERMECTIN</arm_group_label>
    <arm_group_label>PLACEBO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants eligible for inclusion will include non-pregnant adult (&gt;18 years old) with&#xD;
        molecular confirmation of COVID-19. [Participants will be eligible in a period of no longer&#xD;
        than 72 hours after exposure].&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe infection ( defined as need for invasive or non-invasive ventilator support,&#xD;
             ECMO or shock requiring vasopressor support).&#xD;
&#xD;
          -  Weight below 40Kg or above 100Kg&#xD;
&#xD;
          -  Unable to take oral medication&#xD;
&#xD;
          -  Known allergy to the drugs&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Participating in another RCT for treatment of COVID-19.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eli Schwartz, Prof.</last_name>
    <phone>972 3 5308456</phone>
    <email>Eli.schwartz@sheba.health.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Asaf Biber, Dr.</last_name>
    <phone>972 50 7339184</phone>
    <email>Asaf.Biber@sheba.health.gov.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat-Gan</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eli Schwartz, M.D</last_name>
      <phone>+972-35308456</phone>
      <email>Eli.schwartz@sheba.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 14, 2020</last_update_submitted>
  <last_update_submitted_qc>June 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Prof. Eli Schwartz MD, DTMH</investigator_full_name>
    <investigator_title>Prinicipal 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>Ivermectin</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/NCT04429711
org study id: SHEBA-20-7156-ES-CTIL
nct id: NCT04429711
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Ivermectin which is an FDA-approved broad spectrum anti-parasitic agent, has also anti-viral
      activity. In vitro study have shown its activity against SARS-CoV-2, however its clinical
      effect on patients with COVID-19 never been tested.

      In this RCT we would like to evaluate the effect of Ivermectin on reduction of viral shedding
      among mild to moderate COVID-19 patients, and in shortening the symptom resolution time.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blind randomized
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Viral clearance at day 6
time frame: Outcome will be determined till 6 days post intervention
description: The primary outcome will be the viral clearance at day 6 in the intervention group compared to placebo.
measure: Viral shedding duration
time frame: Outcome will be determined till 14 days post intervention
description: Secondary outcomes: viral shedding duration (time between first positive PCR to last of two consecutive negative tests)
measure: Symptoms clearance time
time frame: Outcome will be determined till 14 days post intervention
description: Time between drug treatment and symptoms resolution
arm group label: IVERMECTIN
arm group type: Placebo Comparator
arm group label: PLACEBO
arm group type: Active Comparator
intervention type: Drug
intervention name: Ivermectin Oral Product
description: 3mg Capsules, 12-15mg/ day for 3 days
arm group label: IVERMECTIN
arm group label: PLACEBO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Eli Schwartz, Prof.
phone: 972 3 5308456
email: Eli.schwartz@sheba.health.gov.il
last name: Asaf Biber, Dr.
phone: 972 50 7339184
email: Asaf.Biber@sheba.health.gov.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Prof. Eli Schwartz MD, DTMH
investigator title: Prinicipal Investigator
mesh term: COVID-19
mesh term: Ivermectin