<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/NCT04422561</url>
  </required_header>
  <id_info>
    <org_study_id>ZU-IRB#6150/31-5-2020</org_study_id>
    <nct_id>NCT04422561</nct_id>
  </id_info>
  <brief_title>Prophylactic Ivermectin in COVID-19 Contacts</brief_title>
  <official_title>Use of Ivermectin as a Prophylactic Option in Asymptomatic Family Close Contact for Patient 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>
      asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic&#xD;
      ivermectin and will be followed up for 14 days for any symptoms &amp; diagnosis of COVID -19&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2020</start_date>
  <completion_date type="Actual">July 27, 2020</completion_date>
  <primary_completion_date type="Actual">July 14, 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>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)</measure>
    <time_frame>within 14 days after enrollement</time_frame>
    <description>history taking and clinical examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of COVID</measure>
    <time_frame>within 14 days after enrollement</time_frame>
    <description>by swab</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">340</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Ivermectin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Contacts who will receive prophylactic ivermectin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Contacts who will be only observed without prophylaxis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin Tablets</intervention_name>
    <description>two doses 72 hours apart</description>
    <arm_group_label>Ivermectin group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        family contact of confirmed COVID-19 case&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuse to participate and receive the drug pregnancy or lactation known&#xD;
             hypersensitivity to ivermectin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <state>Sharkia</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <results_first_submitted>August 23, 2020</results_first_submitted>
  <results_first_submitted_qc>August 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 27, 2020</results_first_posted>
  <last_update_submitted>August 23, 2020</last_update_submitted>
  <last_update_submitted_qc>August 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 31, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT04422561/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ivermectin Group</title>
          <description>Contacts who will receive prophylactic ivermectin&#xD;
Ivermectin Tablets:&#xD;
40-60 kg (15mg/day) 60-80kg (18mg/day) &gt;80kg (24mg/day)</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Contacts who will be only observed without prophylaxis</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="228"/>
                <participants group_id="P2" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="203"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ivermectin Group</title>
          <description>Contacts who will receive prophylactic ivermectin&#xD;
Ivermectin Tablets:&#xD;
40-60 kg (15mg/day) 60-80kg (18mg/day) &gt;80kg (24mg/day)</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Contacts who will be only observed without prophylaxis</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="203"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="304"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="203"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="304"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.75" spread="14.93"/>
                    <measurement group_id="B2" value="37.69" spread="16.95"/>
                    <measurement group_id="B3" value="38.72" spread="15.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="203"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="304"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)</title>
        <description>history taking and clinical examination</description>
        <time_frame>within 14 days after enrollement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ivermectin Group</title>
            <description>Contacts who will receive prophylactic ivermectin&#xD;
Ivermectin Tablets:&#xD;
40-60 kg (15mg/day) 60-80kg (18mg/day) &gt;80kg (24mg/day)</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Contacts who will be only observed without prophylaxis</description>
          </group>
        </group_list>
        <measure>
          <title>Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)</title>
          <description>history taking and clinical examination</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="203"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Development of COVID</title>
        <description>by swab</description>
        <time_frame>within 14 days after enrollement</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ivermectin Group</title>
          <description>Contacts who will receive prophylactic ivermectin&#xD;
Ivermectin Tablets:&#xD;
40-60 kg (15mg/day) 60-80kg (18mg/day) &gt;80kg (24mg/day)</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Contacts who will be only observed without prophylaxis</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="203"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="203"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="203"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>heart burn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="203"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>tingling/numbness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>sleepiness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Waheed Shouman</name_or_title>
      <organization>Zagazig University</organization>
      <phone>+201114812048</phone>
      <email>shouman66@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04422561
org study id: ZU-IRB#6150/31-5-2020
nct id: NCT04422561
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic
      ivermectin and will be followed up for 14 days for any symptoms & diagnosis of COVID -19
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)
time frame: within 14 days after enrollement
description: history taking and clinical examination
measure: Development of COVID
time frame: within 14 days after enrollement
description: by swab
arm group label: Ivermectin group
arm group type: Experimental
description: Contacts who will receive prophylactic ivermectin
arm group label: Control group
arm group type: No Intervention
description: Contacts who will be only observed without prophylaxis
intervention type: Drug
intervention name: Ivermectin Tablets
description: two doses 72 hours apart
arm group label: Ivermectin group
criteria: 
gender: All
minimum age: 16 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
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
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 