<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/NCT04403555</url>
  </required_header>
  <id_info>
    <org_study_id>tanta covid treatment</org_study_id>
    <nct_id>NCT04403555</nct_id>
  </id_info>
  <brief_title>Ivermectin as a Novel Therapy in COVID-19 Treatment</brief_title>
  <official_title>The Efficacy of Ivermectin in COVID-19 Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta 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>
      Efficacy of Ivermectin in COVID-19 treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical Study Evaluating the Efficacy of Ivermectin in COVID-19 treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 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>The number of patients with mortality</measure>
    <time_frame>1 month</time_frame>
    <description>Improvement of survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>1 month</time_frame>
    <description>Effect on the length of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The need for mechanical ventilation</measure>
    <time_frame>1 month</time_frame>
    <description>Need for mechanical ventilation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Ivermectin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ivermectin plus standard of care treatment Dose 2 tablets 12mg per day for 3 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin</intervention_name>
    <description>Ivermectin treatment</description>
    <arm_group_label>Ivermectin</arm_group_label>
    <other_name>iverzine, ivermectin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All Adult Patients aging from 20 to 65 years-old with COVID-19 confirmed by pharyngeal&#xD;
             swab PCR.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or contraindication to the drugs used in the study.&#xD;
&#xD;
          -  Pregnant and lactating mothers.&#xD;
&#xD;
          -  Patients with cardiac problems.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>sherief Abd-Elsalam, Ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>ass. Prof. Tropical Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sherief Abd-Elsalam</name>
      <address>
        <city>Tanta</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Sherief Abd-Elsalam</investigator_full_name>
    <investigator_title>Ass. Prof. Tropical Medicine</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ivermectin</mesh_term>
  </intervention_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/NCT04403555
org study id: tanta covid treatment
nct id: NCT04403555
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Efficacy of Ivermectin in COVID-19 treatment
Clinical Study Evaluating the Efficacy of Ivermectin in COVID-19 treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The number of patients with mortality
time frame: 1 month
description: Improvement of survival
measure: Length of hospital stay
time frame: 1 month
description: Effect on the length of hospital stay
measure: The need for mechanical ventilation
time frame: 1 month
description: Need for mechanical ventilation
arm group label: Ivermectin
arm group type: Experimental
description: Ivermectin plus standard of care treatment Dose 2 tablets 12mg per day for 3 days
arm group label: Standard of care
arm group type: No Intervention
description: Standard of care treatment
intervention type: Drug
intervention name: Ivermectin
description: Ivermectin treatment
arm group label: Ivermectin
other name: iverzine, ivermectin
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: sherief Abd-Elsalam, Ass. Prof.
role: Principal Investigator
affiliation: ass. Prof. Tropical Medicine
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Sherief Abd-Elsalam
investigator title: Ass. Prof. Tropical Medicine
mesh term: Ivermectin
sharing ipd: No