<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/NCT04425707</url>
  </required_header>
  <id_info>
    <org_study_id>14-2020/3</org_study_id>
    <nct_id>NCT04425707</nct_id>
  </id_info>
  <brief_title>Ivermectin In Treatment of COVID 19 Patients</brief_title>
  <official_title>The Use of Ivermectin In the Treatment of COVID 19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministry of Health and Population, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ministry of Health and Population, Egypt</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>
      as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of&#xD;
      the patients could not acheive viral clearence with the standard module of care teh idea of&#xD;
      introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin&#xD;
      had shown a promising results in vitro studies and in limited in vivo studies. this clinical&#xD;
      trial may open a new hope for COVID 19 patients as a new and cheap line of treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the study will compare the effect of ivermectin in comaprison and addition to the standard&#xD;
      mode of care for the COVID 19 patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 1, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>to evaluate the role of Ivermectin as a line of treatment for COVID 19</measure>
    <time_frame>2 months</time_frame>
    <description>the role of ivermectin in the cure of COVID 19 patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To asses the rate of viral clearance in comparison to other treatment protocols.</measure>
    <time_frame>2 months</time_frame>
    <description>to compare the results of ivermectin with the standard care</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>A ivermectin alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ivermectin will be administarted alone to COVID 19 patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B standard care alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>standard care will be administarted alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C ivermectin added to standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ivermectin will be administarted in adition to standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin</intervention_name>
    <description>use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt</description>
    <arm_group_label>A ivermectin alone</arm_group_label>
    <arm_group_label>B standard care alone</arm_group_label>
    <arm_group_label>C ivermectin added to standard of care</arm_group_label>
    <other_name>hydroxychloroquine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asymptomatic mild cases and moderate cases proven to be infected by COVID 19 by viral&#xD;
             RNA swap&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for the drug: hypersensitivity.&#xD;
&#xD;
          -  Any medications with possible drug interactions.&#xD;
&#xD;
          -  Severe cases.&#xD;
&#xD;
          -  Any malignant condition.&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Breast feeding females.&#xD;
&#xD;
          -  Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to&#xD;
             potential severe drug interaction.&#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>houssam ho masoud, MD</last_name>
    <role>Study Director</role>
    <affiliation>COVID sceintific comittee ministry of health and population</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ehab ah kamal, MD</last_name>
    <phone>01006162663</phone>
    <email>ehabkamal2011@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>noha mo asem, MD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>isolation and referal hospitals for COVID 19 patients</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ehab ah kamal, MD</last_name>
      <phone>01006162663</phone>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Health and Population, Egypt</investigator_affiliation>
    <investigator_full_name>Dr. Ehab kamal</investigator_full_name>
    <investigator_title>general director of fever hospitals</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>Hydroxychloroquine</mesh_term>
    <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/NCT04425707
org study id: 14-2020/3
nct id: NCT04425707
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of
      the patients could not acheive viral clearence with the standard module of care teh idea of
      introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin
      had shown a promising results in vitro studies and in limited in vivo studies. this clinical
      trial may open a new hope for COVID 19 patients as a new and cheap line of treatment
the study will compare the effect of ivermectin in comaprison and addition to the standard
      mode of care for the COVID 19 patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: to evaluate the role of Ivermectin as a line of treatment for COVID 19
time frame: 2 months
description: the role of ivermectin in the cure of COVID 19 patients
measure: To asses the rate of viral clearance in comparison to other treatment protocols.
time frame: 2 months
description: to compare the results of ivermectin with the standard care
arm group label: A ivermectin alone
arm group type: Experimental
description: ivermectin will be administarted alone to COVID 19 patients
arm group label: B standard care alone
arm group type: Experimental
description: standard care will be administarted alone
arm group label: C ivermectin added to standard of care
arm group type: Active Comparator
description: ivermectin will be administarted in adition to standard care
intervention type: Drug
intervention name: Ivermectin
description: use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt
arm group label: A ivermectin alone
arm group label: B standard care alone
arm group label: C ivermectin added to standard of care
other name: hydroxychloroquine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: houssam ho masoud, MD
role: Study Director
affiliation: COVID sceintific comittee ministry of health and population
last name: ehab ah kamal, MD
phone: 01006162663
email: ehabkamal2011@hotmail.com
last name: noha mo asem, MD
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ministry of Health and Population, Egypt
investigator full name: Dr. Ehab kamal
investigator title: general director of fever hospitals
mesh term: COVID-19
mesh term: Hydroxychloroquine
mesh term: Ivermectin