<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/NCT04445311</url>
  </required_header>
  <id_info>
    <org_study_id>ZU-IRB#6151/31-5-2020</org_study_id>
    <nct_id>NCT04445311</nct_id>
  </id_info>
  <brief_title>Ivermectin in Treatment of COVID-19</brief_title>
  <official_title>Use of Ivermectin as a Therapeutic Option for Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      confirmed cases with COVID-19 will receive ivermectin as a therapeutic option as well as&#xD;
      standard of care treatment and will be compared to those that will receive only standard of&#xD;
      care ttt&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 31, 2020</start_date>
  <completion_date type="Anticipated">August 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 30, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time to be symptoms free</measure>
    <time_frame>within 21 days after enrollment</time_frame>
    <description>duration from day 1 symptoms till 3 days without symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospitalization</measure>
    <time_frame>within 21 days after enrollement</time_frame>
    <description>need hospital admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation</measure>
    <time_frame>within 21 days after enrollement</time_frame>
    <description>need mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of stay</measure>
    <time_frame>within one month days after enrollement</time_frame>
    <description>days spent in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>within one month days after enrollement</time_frame>
    <description>survived or died</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Ivermectin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group that will receive ivermectin plus standard of care ttt</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>group that will receive standard of care ttt</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin</intervention_name>
    <description>3 successive days ttt of ivermectin started within 48 hours of symptoms</description>
    <arm_group_label>Ivermectin group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        COVID-19 patients during period of the study more than 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        refuse to participate pregnancy or lactation hypersensitivity to ivermectin receive any&#xD;
        drug with interaction with ivermectin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Waheed Shouman, MD</last_name>
    <phone>+201114812048</phone>
    <email>shouman66@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Waheed Shouman</name>
      <address>
        <city>Zagazig</city>
        <state>Sharkia</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Waheed Shouman, MD</last_name>
      <phone>+201114812048</phone>
      <email>shouman66@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Waheed Shouman</investigator_full_name>
    <investigator_title>professor of chest diseases</investigator_title>
  </responsible_party>
  <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/NCT04445311
org study id: ZU-IRB#6151/31-5-2020
nct id: NCT04445311
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
confirmed cases with COVID-19 will receive ivermectin as a therapeutic option as well as
      standard of care treatment and will be compared to those that will receive only standard of
      care ttt
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: time to be symptoms free
time frame: within 21 days after enrollment
description: duration from day 1 symptoms till 3 days without symptoms
measure: hospitalization
time frame: within 21 days after enrollement
description: need hospital admission
measure: Mechanical ventilation
time frame: within 21 days after enrollement
description: need mechanical ventilation
measure: length of stay
time frame: within one month days after enrollement
description: days spent in hospital
measure: mortality
time frame: within one month days after enrollement
description: survived or died
arm group label: Ivermectin group
arm group type: Experimental
description: group that will receive ivermectin plus standard of care ttt
arm group label: Control group
arm group type: No Intervention
description: group that will receive standard of care ttt
intervention type: Drug
intervention name: Ivermectin
description: 3 successive days ttt of ivermectin started within 48 hours of symptoms
arm group label: Ivermectin group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Waheed Shouman, MD
phone: +201114812048
email: shouman66@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Waheed Shouman
investigator title: professor of chest diseases
mesh term: Ivermectin