<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/NCT04447534</url>
  </required_header>
  <id_info>
    <org_study_id>tanta zinc chloroquine</org_study_id>
    <nct_id>NCT04447534</nct_id>
  </id_info>
  <brief_title>Zinc With Chloroquine/Hydroxychloroquine in Treatment of COVID-19</brief_title>
  <official_title>Does Zinc Supplementation Enhance the Clinical Efficacy of Chloroquine/Hydroxychloroquine in Treatment of COVID-19?</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>No</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>
      we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine&#xD;
      in treatment of COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine&#xD;
      in treatment of COVID-19. As, zinc may be of value in these cases and may be of value in&#xD;
      enhancing chloroquine effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">August 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <phase>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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with improvement or mortality</measure>
    <time_frame>2 weeks</time_frame>
    <description>The number of patients with improvement or mortality.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">191</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Chloroquine or hydroxychloroquine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chloroquine or hydroxychloroquine alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chloroquine or hydroxychloroquine with zinc</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chloroquine or hydroxychloroquine with zinc</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chloroquine or hydroxychloroquine</intervention_name>
    <description>Chloroquine or hydroxychloroquine</description>
    <arm_group_label>Chloroquine or hydroxychloroquine</arm_group_label>
    <arm_group_label>Chloroquine or hydroxychloroquine with zinc</arm_group_label>
    <other_name>alexoquine, chloroquine, hydroquine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>zinc</intervention_name>
    <description>Zinc tablets</description>
    <arm_group_label>Chloroquine or hydroxychloroquine with zinc</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with positive COVID-19.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications or hypersensitivity to chloroquine.&#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>sherief Abd-Elsalam, Ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>ass. Prof. Tropical Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tanta university hospital, Assuit University, Ainshams University</name>
      <address>
        <city>Tanta</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>March 23, 2022</last_update_submitted>
  <last_update_submitted_qc>March 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2022</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>Hydroxychloroquine</mesh_term>
    <mesh_term>Chloroquine</mesh_term>
    <mesh_term>Chloroquine diphosphate</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/NCT04447534
org study id: tanta zinc chloroquine
nct id: NCT04447534
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine
      in treatment of COVID-19.
we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine
      in treatment of COVID-19. As, zinc may be of value in these cases and may be of value in
      enhancing chloroquine effect.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Number of patients with improvement or mortality
time frame: 2 weeks
description: The number of patients with improvement or mortality.
arm group label: Chloroquine or hydroxychloroquine
arm group type: Experimental
description: Chloroquine or hydroxychloroquine alone
arm group label: Chloroquine or hydroxychloroquine with zinc
arm group type: Experimental
description: Chloroquine or hydroxychloroquine with zinc
intervention type: Drug
intervention name: Chloroquine or hydroxychloroquine
description: Chloroquine or hydroxychloroquine
arm group label: Chloroquine or hydroxychloroquine
arm group label: Chloroquine or hydroxychloroquine with zinc
other name: alexoquine, chloroquine, hydroquine
intervention type: Drug
intervention name: zinc
description: Zinc tablets
arm group label: Chloroquine or hydroxychloroquine with zinc
criteria: 
gender: All
minimum age: 18 Years
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: Hydroxychloroquine
mesh term: Chloroquine
mesh term: Chloroquine diphosphate
sharing ipd: No