<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/NCT04458948</url>
  </required_header>
  <id_info>
    <org_study_id>20-156</org_study_id>
    <nct_id>NCT04458948</nct_id>
  </id_info>
  <brief_title>Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients</brief_title>
  <official_title>Open Label Non-comparative Trial of the Combination of Hydroxychloroquine and Azithromycin in the Treatment of Hospitalized Patients With Moderate or Severe COVID-19 Infection</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>
    <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>
      This research is designed as an open-label,non-comparative prospective trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objects of this research are as follows:&#xD;
&#xD;
      (1) To measure the duration of viral shedding in respiratory secretions of patients with&#xD;
      moderate or severe COVID-19 infection treated with the combination of Hydroxychloroquine and&#xD;
      azithromycin. (2) Evaluate the case fatality rate, the clinical response and length of stay&#xD;
      in hospitalized patients with moderate and severe COVID-19 infection. (3) To report the&#xD;
      safety of the drug combination in hospitalized patients with moderate and severe COVID-19&#xD;
      infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The World Health Organization (WHO) paused Hydrochloroquinone from its Solidarity Trial in&#xD;
    order to conduct a safety data review by the Data Safety Monitoring Board of the WHO to&#xD;
    evaluate HCQ in its clinical trials.&#xD;
  </why_stopped>
  <start_date type="Actual">March 24, 2020</start_date>
  <completion_date type="Actual">August 28, 2020</completion_date>
  <primary_completion_date type="Actual">August 28, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants That Had Viral Shedding as Determined by RT-PCR.</measure>
    <time_frame>14 to 28 days.</time_frame>
    <description>To measure the duration of viral shedding in respiratory secretions of patients with moderate to severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Hydroxychloroquine and Azithromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects receive Hydroxychloroquine and Azithromycin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxychloroquine</intervention_name>
    <description>Hydroxychloroquine 400 mg BID, on day 1 and then 200 mg BID day 2 through 7 IV or po for 5 days. If the condition of the patient does not allow for oral therapy, HCQ can be given via a feeding or NG tube. Azithromycin can be given intravenously.</description>
    <arm_group_label>Hydroxychloroquine and Azithromycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <description>Azithromycin 500 mg, IV or po for 5 days</description>
    <arm_group_label>Hydroxychloroquine and Azithromycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults aged &gt;18 years of age with lower respiratory infection with SARSCo2 documented&#xD;
             by a positive RT-PCR in nasopharyngeal sample admitted to the University of New Mexico&#xD;
             Hospital, with an oxygen saturation of less than 94%, on room air, or a respiratory&#xD;
             rate &gt;24 per minute, or HR&gt;125 per minute of a PaO2/FIO2&lt;150.&#xD;
&#xD;
          2. Patient with life expectancy &gt;48 hours.&#xD;
&#xD;
          3. Pregnant women may be included if deemed necessary. There is insufficient information&#xD;
             regarding the safety of hydroxychloroquine and azithromycin during pregnancy.&#xD;
             Consequently, these medications are not recommended when pregnant or planning to&#xD;
             become pregnant. However, investigators may prescribe hydroxychloroquine and&#xD;
             azithromycin if deemed necessary.&#xD;
&#xD;
          4. Azithromycin is excreted in human milk, therefore participants should not breast-feed&#xD;
             whilst taking Azithromycin, because it may cause side effects including diarrhoea and&#xD;
             infection to a baby. It is recommended to discard the milk during treatment and up&#xD;
             until 2 days after discontinuation of treatment. Additionally, hydroxychloroquine&#xD;
             should not be taken whilst breast-feeding. However, investigators may prescribe&#xD;
             hydroxychloroquine and azithromycin if deemed necessary. Page 6 of 23 Version Date:&#xD;
             04.16.2020&#xD;
&#xD;
          5. Adults unable to consent will be included with the consent of their Legally Authorized&#xD;
             Representative (LAR). Assent will be pursued from cognitively impaired participants if&#xD;
             they are able to provide assent. Note that this does not preclude the enrollment of&#xD;
             cognitively impaired participants that cannot provide assent, but would allow those&#xD;
             that can the opportunity to do so.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prisoners&#xD;
&#xD;
          2. Pre-/co-existing medical conditions, including any of the following:&#xD;
&#xD;
             Known allergy to study drugs. Contraindication to treatment with study drugs,&#xD;
             including retinopathy, and QTc prolongation defined by QTc&gt;450 in males and &gt;470 in&#xD;
             females. Unless, it is the opinion of the treating physician(s) that the benefits to&#xD;
             treat with medications outweigh the risks. Known chronic kidney disease, stage 4 or 5&#xD;
             or receiving dialysis. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.&#xD;
&#xD;
          3. Weight &lt;40 kg.&#xD;
&#xD;
          4. Current use of: hydrocholoroquine or cardiac medicines of: flecainade, Tambocor;&#xD;
             amiodarone Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or&#xD;
             Procan,Procanbid, propafenone, Rythmal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</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>August 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <results_first_submitted>May 16, 2023</results_first_submitted>
  <results_first_submitted_qc>August 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 13, 2023</results_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Azithromycin</mesh_term>
    <mesh_term>Hydroxychloroquine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT04458948/Prot_004.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>April 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT04458948/ICF_005.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Hydroxychloroquine and Azithromycin</title>
          <description>All subjects receive Hydroxychloroquine and Azithromycin.&#xD;
Hydroxychloroquine: Hydroxychloroquine 400 mg BID, on day 1 and then 200 mg BID day 2 through 7 IV or po for 5 days. If the condition of the patient does not allow for oral therapy, HCQ can be given via a feeding or NG tube. Azithromycin can be given intravenously.&#xD;
Azithromycin: Azithromycin 500 mg, IV or po for 5 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Our baseline population is from the state of New Mexico, Navajo nation and other surrounding Pueblo nations. We enrolled 28 patients, about equal males and females, ages from 32 to 85.</population>
      <group_list>
        <group group_id="B1">
          <title>ICU Patients in Our Quarterary Care</title>
          <description>28 individuals admitted with severe COVID-19 pneumonia.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
          </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="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" lower_limit="32" upper_limit="85"/>
                  </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="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </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_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants That Had Viral Shedding as Determined by RT-PCR.</title>
        <description>To measure the duration of viral shedding in respiratory secretions of patients with moderate to severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin.</description>
        <time_frame>14 to 28 days.</time_frame>
        <population>28 patients all had COVID -19 pneumonia.</population>
        <group_list>
          <group group_id="O1">
            <title>Hydroxychloroquine and Azithromycin</title>
            <description>All subjects receive Hydroxychloroquine and Azithromycin.&#xD;
Hydroxychloroquine: Hydroxychloroquine 400 mg BID, on day 1 and then 200 mg BID day 2 through 7 IV or po for 5 days. If the condition of the patient does not allow for oral therapy, HCQ can be given via a feeding or NG tube. Azithromycin can be given intravenously.&#xD;
Azithromycin: Azithromycin 500 mg, IV or po for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Had Viral Shedding as Determined by RT-PCR.</title>
          <description>To measure the duration of viral shedding in respiratory secretions of patients with moderate to severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin.</description>
          <population>28 patients all had COVID -19 pneumonia.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Days 1-5 of admission.</time_frame>
      <desc>Adverse events were not related to drug intervention.</desc>
      <group_list>
        <group group_id="E1">
          <title>Hydroxychloroquine and Azithromycin</title>
          <description>All subjects receive Hydroxychloroquine and Azithromycin.&#xD;
Hydroxychloroquine: Hydroxychloroquine 400 mg BID, on day 1 and then 200 mg BID day 2 through 7 IV or po for 5 days. If the condition of the patient does not allow for oral therapy, HCQ can be given via a feeding or NG tube. Azithromycin can be given intravenously.&#xD;
Azithromycin: Azithromycin 500 mg, IV or po for 5 days</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>Other-</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Clotting to vital organs (lungs, heart, kidney and brain)</sub_title>
                <description>All patients passed at one month. 9 passed during day 1 to 5 of the trial.</description>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="28"/>
              </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="28"/>
              </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>Cristina Beato</name_or_title>
      <organization>UNM HSC</organization>
      <phone>505-272-1734</phone>
      <email>CBeato@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/NCT04458948
org study id: 20-156
nct id: NCT04458948
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This research is designed as an open-label,non-comparative prospective trial.
The objects of this research are as follows:

      (1) To measure the duration of viral shedding in respiratory secretions of patients with
      moderate or severe COVID-19 infection treated with the combination of Hydroxychloroquine and
      azithromycin. (2) Evaluate the case fatality rate, the clinical response and length of stay
      in hospitalized patients with moderate and severe COVID-19 infection. (3) To report the
      safety of the drug combination in hospitalized patients with moderate and severe COVID-19
      infection.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants That Had Viral Shedding as Determined by RT-PCR.
time frame: 14 to 28 days.
description: To measure the duration of viral shedding in respiratory secretions of patients with moderate to severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin.
arm group label: Hydroxychloroquine and Azithromycin
arm group type: Experimental
description: All subjects receive Hydroxychloroquine and Azithromycin.
intervention type: Drug
intervention name: Hydroxychloroquine
description: Hydroxychloroquine 400 mg BID, on day 1 and then 200 mg BID day 2 through 7 IV or po for 5 days. If the condition of the patient does not allow for oral therapy, HCQ can be given via a feeding or NG tube. Azithromycin can be given intravenously.
arm group label: Hydroxychloroquine and Azithromycin
intervention type: Drug
intervention name: Azithromycin
description: Azithromycin 500 mg, IV or po for 5 days
arm group label: Hydroxychloroquine and Azithromycin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Azithromycin
mesh term: Hydroxychloroquine
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 