<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/NCT04414241</url>
  </required_header>
  <id_info>
    <org_study_id>202087</org_study_id>
    <secondary_id>20923</secondary_id>
    <nct_id>NCT04414241</nct_id>
  </id_info>
  <brief_title>Hydroxychloroquine to Prevent SARS-CoV-2 Infection/COVID-19</brief_title>
  <official_title>Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Peruana Cayetano Heredia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Peruana Cayetano Heredia</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether hydroxychloroquine is an effective&#xD;
      prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants&#xD;
      will be randomized into two parallel groups. The first arm will evaluate the use of&#xD;
      hydroxychloroquine every-other-day plus standard measures of protection for the prevention of&#xD;
      SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the&#xD;
      prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant&#xD;
      will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of&#xD;
      COVID-19 symptoms for 8 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">November 23, 2020</completion_date>
  <primary_completion_date type="Actual">November 23, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Proportion of participants with grade 3 or more adverse events</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events</measure>
    <time_frame>Eight weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>Hydroxychloroquine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydroxychloroquine prophylaxis plus standard measures of personal protection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard measures of personal protection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxychloroquine</intervention_name>
    <description>A loading dose of 600mg of hydroxychloroquine orally on the first day, followed by 400mg of hydroxychloroquine orally every-other-day and use of standard measures of personal protection provided from the hospital for 8 weeks.</description>
    <arm_group_label>Hydroxychloroquine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthcare workers in service during the COVID-19 outbreak including medical, nurse,&#xD;
             technical, and auxiliary staff.&#xD;
&#xD;
          2. Negative rapid serologic and molecular testing for SARS-CoV-2.&#xD;
&#xD;
          3. Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell,&#xD;
             and taste.&#xD;
&#xD;
          2. Prior (last 30 days), current or planned use (during study period) of&#xD;
             hydroxychloroquine, chloroquine sulfate, or azithromycin.&#xD;
&#xD;
          3. Known cardiac disease or a history of prolonged QT syndrome.&#xD;
&#xD;
          4. Known allergy or intolerance to hydroxychloroquine and/or chloroquine sulfate.&#xD;
&#xD;
          5. Use of concomitant medications that are contraindicated with the use of&#xD;
             hydroxychloroquine.&#xD;
&#xD;
          6. Other reported medical conditions, such as glucose-6-phosphate dehydrogenase&#xD;
             deficiency, hepatic or renal insufficiency, or visual acuity or field disturbances,&#xD;
             that make study participation not in the individual's best interest.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alejandro Llanos, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Peruana Cayetano Heredia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eduardo Gotuzzo, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidad Peruana Cayetano Heredia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Max Grogl, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>U.S. Naval Medical Research Unit Six</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patricia García, MD, MPH, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidad Peruana Cayetano Heredia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manuel Espinoza, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto de Nacional de Salud</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Médico Naval &quot;Cirujano Mayor Santiago Távara&quot;</name>
      <address>
        <city>Callao</city>
        <zip>07006</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Arzobispo Loayza</name>
      <address>
        <city>Lima</city>
        <zip>15082</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Cayetano Heredia</name>
      <address>
        <city>Lima</city>
        <zip>15102</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Peru</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2 infection</keyword>
  <keyword>Hydroxychloroquine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <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>
  </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/NCT04414241
org study id: 202087
secondary id: 20923
nct id: NCT04414241
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to determine whether hydroxychloroquine is an effective
      prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants
      will be randomized into two parallel groups. The first arm will evaluate the use of
      hydroxychloroquine every-other-day plus standard measures of protection for the prevention of
      SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the
      prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant
      will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of
      COVID-19 symptoms for 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2
time frame: Eight weeks
measure: Safety: Proportion of participants with grade 3 or more adverse events
time frame: Eight weeks
measure: Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events
time frame: Eight weeks
arm group label: Hydroxychloroquine
arm group type: Experimental
description: Hydroxychloroquine prophylaxis plus standard measures of personal protection.
arm group label: Control
arm group type: No Intervention
description: Standard measures of personal protection.
intervention type: Drug
intervention name: Hydroxychloroquine
description: A loading dose of 600mg of hydroxychloroquine orally on the first day, followed by 400mg of hydroxychloroquine orally every-other-day and use of standard measures of personal protection provided from the hospital for 8 weeks.
arm group label: Hydroxychloroquine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alejandro Llanos, MD, PhD
role: Principal Investigator
affiliation: Universidad Peruana Cayetano Heredia
last name: Eduardo Gotuzzo, MD
role: Study Chair
affiliation: Universidad Peruana Cayetano Heredia
last name: Max Grogl, PhD
role: Study Chair
affiliation: U.S. Naval Medical Research Unit Six
last name: Patricia García, MD, MPH, PhD
role: Study Chair
affiliation: Universidad Peruana Cayetano Heredia
last name: Manuel Espinoza, MD
role: Study Chair
affiliation: Instituto de Nacional de Salud
facility: 
facility: 
facility: 
country: Peru
responsible party type: Sponsor
mesh term: Infections
mesh term: COVID-19
mesh term: Hydroxychloroquine
sharing ipd: No