<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/NCT04435808</url>
  </required_header>
  <id_info>
    <org_study_id>20-206</org_study_id>
    <nct_id>NCT04435808</nct_id>
  </id_info>
  <brief_title>Efficacy of Hydroxychloroquine Prophylaxis for Health Care Workers at High Risk for COVID-19</brief_title>
  <official_title>Off Label Study to Evaluate the Efficacy of Hydroxychloroquine as Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Health Care Workers at High Risk of Occupational Exposure to SARS-CoV-2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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 HCW Prophylaxis (HCWP) Study, single, open and off label intervention study. Up to 350&#xD;
      participants will be assigned to group that takes HCQ or group that opts to not take study&#xD;
      medication. Participants will be UNM HEALTH SYSTEM HCW at high risk for occupational exposure&#xD;
      to SARSCoV- 2. Study timepoints will include Day 1 screening/enrollment, 30 day, 60 day, and&#xD;
      90 day assessments. Questionnaires will be collected in all timepoints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open and off label use, interventional, single site study. The HCWP Study&#xD;
      eligibility are HCWs at high risk for SARS-CoV-2 exposure (eg MD/DO, NP, RN, and respiratory&#xD;
      therapists in ED, Pediatric ED, Urgent Care, Pediatric Urgent Care and on Covid-19 units) at&#xD;
      UNM HEALTH SYSTEM meeting all inclusion criteria. Total number of participants: 350 (Group A&#xD;
      and B) Group A: up to 275 (HCW who choose to be provided HCQ). Will receive a 600 mg loading&#xD;
      dose followed by 200 mg daily (tablets).&#xD;
&#xD;
      Group B: up to 75 (HCW who choose not to be provided HCQ)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Stopped for futility by DSMB&#xD;
  </why_stopped>
  <start_date type="Actual">April 14, 2020</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SARS-CoV-2 Infection</measure>
    <time_frame>3 months</time_frame>
    <description>Number of health care workers who become infected with SARS-CoV-2 as detected by PCR</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Hydroxychloroquine Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A: up to 275 health care workers who choose to take hydroxychloroquine. Will receive a 600 mg loading dose, followed by 200 mg daily (tablets).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group B: Up to 75 health care workers who choose not to take hydroxychloroquine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxychloroquine</intervention_name>
    <description>Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Subjects will recieve 600 mg loading dose, followed by 200 mg daily (tablets).&#xD;
Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily</description>
    <arm_group_label>Hydroxychloroquine Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men or women ≥18 years of age who are UNM HEALTH SYSTEM health care workers and are&#xD;
             asymptomatic for known presenting symptoms of SARS-CoV-2:&#xD;
&#xD;
          2. UNMHS HCWs include: MD/DO, NP, RN, and respiratory therapists working in ED, Pediatric&#xD;
             ED, Urgent Care, Pediatric Urgent Care or on Covid-19 units. Study PI's will consider&#xD;
             study enrollment of HCWs from other settings, for example certain outpatient clinics&#xD;
             or inpatient units.&#xD;
&#xD;
          3. Are not positive for SARS-CoV-2 testing&#xD;
&#xD;
          4. Willing and able to comply with survey completion, scheduled visits, treatment plan,&#xD;
             and other study procedures&#xD;
&#xD;
          5. Willing and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known hypersensitivity to HCQ or other 4-aminoquinoline compounds&#xD;
&#xD;
          2. Currently hospitalized&#xD;
&#xD;
          3. Symptomatic with subjective fever, cough, or sore throat&#xD;
&#xD;
          4. Current medications exclude concomitant use of HCQ, for example anti-arrhythmic&#xD;
             agents, digoxin, cyclosporin, cimetidine, or tamoxifen.&#xD;
&#xD;
          5. Concomitant use of other anti-malarial treatment or chemoprophylaxis&#xD;
&#xD;
          6. History of retinopathy of any etiology&#xD;
&#xD;
          7. Psoriasis&#xD;
&#xD;
          8. Porphyria&#xD;
&#xD;
          9. Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes&#xD;
             &lt;1500) or thrombocytopenia (&lt;100K)&#xD;
&#xD;
         10. Known liver disease&#xD;
&#xD;
         11. Known long QT syndrome&#xD;
&#xD;
         12. Use of any investigational or non-registered drug or vaccine within 30 days preceding&#xD;
             the first dose of the study drugs or planned use during the study period. There may be&#xD;
             some exceptions to requiring a 30-day washout that will be evaluated by the&#xD;
             Co-Investigators on a case by case basis.&#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>
  <location>
    <facility>
      <name>University of New Mexico Health Sciences Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <results_first_submitted>August 10, 2020</results_first_submitted>
  <results_first_submitted_qc>November 12, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 16, 2020</results_first_posted>
  <last_update_submitted>February 10, 2022</last_update_submitted>
  <last_update_submitted_qc>February 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Walter Dehority</investigator_full_name>
    <investigator_title>Associate Professor: Pediatrics Infectious Disease</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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>June 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT04435808/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT04435808/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Hydroxychloroquine Arm</title>
          <description>Group A: 0 health care workers who chose to take hydroxychloroquine&#xD;
Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria.&#xD;
Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily</description>
        </group>
        <group group_id="P2">
          <title>No Intervention Arm</title>
          <description>Group B: 1 health care worker who chose not to take hydroxychloroquine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0">Study stopped prior to any data collection for this lone participant</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study stopped by DSMB</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>DSMB stopped the study</population>
      <group_list>
        <group group_id="B1">
          <title>Hydroxychloroquine Arm</title>
          <description>Group A: 0 health care workers who choose to take hydroxychloroquine&#xD;
Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria.&#xD;
Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily</description>
        </group>
        <group group_id="B2">
          <title>No Intervention Arm</title>
          <description>Group B: 1 health care workers who chose not to take hydroxychloroquine</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="0"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="0"/>
                    <count group_id="B2" value="1"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <count group_id="B2" value="1"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="1"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>SARS-CoV-2 Infection</title>
        <description>Number of health care workers who become infected with SARS-CoV-2 as detected by PCR</description>
        <time_frame>3 months</time_frame>
        <population>DSMB stopped trial early prior to any data collection.</population>
        <group_list>
          <group group_id="O1">
            <title>Hydroxychloroquine Arm</title>
            <description>Group A: 0 health care workers who chose to take hydroxychloroquine&#xD;
Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria.&#xD;
Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily</description>
          </group>
          <group group_id="O2">
            <title>No Intervention Arm</title>
            <description>Group B: 1 health care worker who chose not to take hydroxychloroquine</description>
          </group>
        </group_list>
        <measure>
          <title>SARS-CoV-2 Infection</title>
          <description>Number of health care workers who become infected with SARS-CoV-2 as detected by PCR</description>
          <population>DSMB stopped trial early prior to any data collection.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Not collected</time_frame>
      <desc>Not collected</desc>
      <group_list>
        <group group_id="E1">
          <title>Hydroxychloroquine Arm</title>
          <description>Group A: 0 health care workers who chose to take hydroxychloroquine&#xD;
Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria.&#xD;
Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily</description>
        </group>
        <group group_id="E2">
          <title>No Intervention Arm</title>
          <description>Group B: 0 health care worker who chose not to take hydroxychloroquine</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Walter Dehority</name_or_title>
      <organization>The University of New Mexico School of Medicine</organization>
      <phone>5052725535</phone>
      <email>wdehority@salud.unm.edu</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/NCT04435808
org study id: 20-206
nct id: NCT04435808
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The HCW Prophylaxis (HCWP) Study, single, open and off label intervention study. Up to 350
      participants will be assigned to group that takes HCQ or group that opts to not take study
      medication. Participants will be UNM HEALTH SYSTEM HCW at high risk for occupational exposure
      to SARSCoV- 2. Study timepoints will include Day 1 screening/enrollment, 30 day, 60 day, and
      90 day assessments. Questionnaires will be collected in all timepoints.
This is an open and off label use, interventional, single site study. The HCWP Study
      eligibility are HCWs at high risk for SARS-CoV-2 exposure (eg MD/DO, NP, RN, and respiratory
      therapists in ED, Pediatric ED, Urgent Care, Pediatric Urgent Care and on Covid-19 units) at
      UNM HEALTH SYSTEM meeting all inclusion criteria. Total number of participants: 350 (Group A
      and B) Group A: up to 275 (HCW who choose to be provided HCQ). Will receive a 600 mg loading
      dose followed by 200 mg daily (tablets).

      Group B: up to 75 (HCW who choose not to be provided HCQ)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: SARS-CoV-2 Infection
time frame: 3 months
description: Number of health care workers who become infected with SARS-CoV-2 as detected by PCR
arm group label: Hydroxychloroquine Arm
arm group type: Experimental
description: Group A: up to 275 health care workers who choose to take hydroxychloroquine. Will receive a 600 mg loading dose, followed by 200 mg daily (tablets).
arm group label: No Intervention Arm
arm group type: No Intervention
description: Group B: Up to 75 health care workers who choose not to take hydroxychloroquine.
intervention type: Drug
intervention name: Hydroxychloroquine
description: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Subjects will recieve 600 mg loading dose, followed by 200 mg daily (tablets).
Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily
arm group label: Hydroxychloroquine Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Walter Dehority
investigator title: Associate Professor: Pediatrics Infectious Disease
mesh term: COVID-19
mesh term: Hydroxychloroquine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 