<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/NCT04494646</url>
  </required_header>
  <id_info>
    <org_study_id>20-00591</org_study_id>
    <nct_id>NCT04494646</nct_id>
  </id_info>
  <brief_title>BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)</brief_title>
  <official_title>BARCONA: A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Reata Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multi-center, double-blind, placebo-controlled, randomized Phase 2 trial will study the&#xD;
      safety, tolerability, and efficacy of bardoxolone methyl in patients hospitalized with&#xD;
      confirmed COVID-19. The trial will include approximately 40 patients and is designed to&#xD;
      provide an early interim analysis of safety. Patients will be randomized using permuted block&#xD;
      randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20&#xD;
      mg) or matching placebo and treatment will be administered for the duration of&#xD;
      hospitalization (until recovery), with a maximum treatment duration of 29 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following randomization on Day 1, patients will be assessed while hospitalized on Days 3, 5,&#xD;
      8, 11, 15, 22, and 29. Assessments will include clinical status assessments, vital sign&#xD;
      measurements, clinical chemistry collection, and adverse event collection. Patients that&#xD;
      recover prior to Day 29 will complete an end-of-treatment visit. Patients will have an&#xD;
      in-person follow-up on Day 29, regardless of treatment adherence and recovery status prior to&#xD;
      Day 29, and a safety follow-up 60 days after randomization for clinical status assessments,&#xD;
      vital sign measurements, clinical chemistry collection, and adverse event collection.&#xD;
      Follow-up in-person visits are preferred but recognizing quarantine and other factors may&#xD;
      limit the subject's ability to return to the site for the visit. In this case, the visit may&#xD;
      be performed by phone. An independent Data and Safety Monitoring Board will advise the study&#xD;
      leadership on safety aspects and overall progress of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2020</start_date>
  <completion_date type="Actual">January 8, 2021</completion_date>
  <primary_completion_date type="Actual">January 8, 2021</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>All patients, investigators, site personnel, laboratories, and study personnel with direct involvement in the conduct of the study or their designees will be blinded to treatment assignments. To prevent potential bias, appropriate measures will be taken to ensure the blind is maintained for the patients and personnel mentioned previously. To maintain the blind, investigators will distribute blinded study drug treatment to patients as directed by the IWRS system. Investigators and patients will not be blinded to dose level, but will be blinded to treatment assignment (i.e., bardoxolone methyl vs. placebo).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Serious Adverse Events</measure>
    <time_frame>Day 29</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Bardoxolone Methyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bardoxolone Methyl</intervention_name>
    <description>Once-daily administration of bardoxolone methyl (20mg)</description>
    <arm_group_label>Bardoxolone Methyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Once-daily administration of matching placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Laboratory-confirmed COVID-19 infection as determined by polymerase chain reaction&#xD;
             (PCR)&#xD;
&#xD;
          2. Hospitalized patients that meets one of the following conditions:&#xD;
&#xD;
               1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.); OR&#xD;
&#xD;
               2. At rest, blood oxygen saturation ≤ 94%; OR&#xD;
&#xD;
               3. Require supplemental oxygen; OR&#xD;
&#xD;
               4. Requiring non-invasive ventilation; OR&#xD;
&#xD;
               5. Requiring invasive mechanical ventilation for up to 2 days.&#xD;
&#xD;
          3. Age ≥ 18 years. Enrollment of patients ≥70 years of age may be limited (e.g., comprise&#xD;
             no more than 10% of all randomized patients), pending safety review by the DSMB and&#xD;
             executive committee&#xD;
&#xD;
          4. Participant or legally authorized representative is willing to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Intubated and on invasive mechanical ventilation for three or more days at the time of&#xD;
             randomization&#xD;
&#xD;
          2. Known left ventricular ejection fraction (LVEF) &lt;40% or prior hospitalization for&#xD;
             heart failure&#xD;
&#xD;
          3. Cardiac arrest&#xD;
&#xD;
          4. Shock&#xD;
&#xD;
          5. Known uncontrolled bacterial, fungal, or non-COVID viral infection&#xD;
&#xD;
          6. eGFR &lt;30 ml/min/1.73 m² or requiring dialysis&#xD;
&#xD;
          7. ALT or AST &gt; 5X ULN&#xD;
&#xD;
          8. History of cirrhosis, chronic active hepatitis or severe hepatic disease&#xD;
&#xD;
          9. Pregnant or lactating women&#xD;
&#xD;
         10. Enrolled in other trial of unapproved therapies, unless approved by trial Principal&#xD;
             Investigator. In general, co-enrollment will be permitted unless there are safety&#xD;
             concerns, mechanistic incompatibility or inability to adjudicate serious adverse&#xD;
             events and will be decided on a case by case basis.&#xD;
&#xD;
         11. If in the opinion of the clinical team, progression to death is imminent and&#xD;
             inevitable within the next 24 hours, irrespective of the provision of treatments&#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>Sripal Bangalore, MD, MHA</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HSHS St. John's Hospital (Prairie Education and Research Cooperative)</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62769</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SIU School of Medicine</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Hospital - Brooklyn</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coney Island Hospital</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elmhurst Hospital Center</name>
      <address>
        <city>Elmhurst</city>
        <state>New York</state>
        <zip>11373</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Winthrop Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Bellevue Hospital Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <results_first_submitted>January 7, 2022</results_first_submitted>
  <results_first_submitted_qc>January 7, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 12, 2022</results_first_posted>
  <last_update_submitted>January 11, 2022</last_update_submitted>
  <last_update_submitted_qc>January 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bardoxolone Methyl</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared upon reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will become available beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
    <ipd_access_criteria>The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Sripal.Bangalore@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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>September 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT04494646/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bardoxolone Methyl</title>
          <description>Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo&#xD;
Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg)</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo&#xD;
Placebo: Once-daily administration of matching placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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>
      <group_list>
        <group group_id="B1">
          <title>Bardoxolone Methyl</title>
          <description>Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo&#xD;
Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg)</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo&#xD;
Placebo: Once-daily administration of matching placebo</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="21"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.3" spread="16.3"/>
                    <measurement group_id="B2" value="60.5" spread="12.5"/>
                    <measurement group_id="B3" value="57.4" spread="14.2"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Serious Adverse Events</title>
        <time_frame>Day 29</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bardoxolone Methyl</title>
            <description>Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo&#xD;
Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo&#xD;
Placebo: Once-daily administration of matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Serious Adverse Events</title>
          <units>Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>29 Days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bardoxolone Methyl</title>
          <description>Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo&#xD;
Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg)</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo&#xD;
Placebo: Once-daily administration of matching placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure acute, Acute on chronic systolic (congestive) heart failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia due to covid-19 virus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Splenic rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Abdominal wall wound, Worsening abdominal wound</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Splenic laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope, Pre-syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis, Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia, Worsening hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Respiratory failure Worsening hypoxemic respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Mechanical ventilation, Invasive mechanical ventilation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Mechanical ventilation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fungal Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness and Lightheadedness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Loss of Consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Blackouts</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </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>Sripal Bangalore, MD, MHA</name_or_title>
      <organization>NYU Langone Health</organization>
      <phone>(212) 263 3540</phone>
      <email>Sripal.Bangalore@nyulangone.org</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/NCT04494646
org study id: 20-00591
nct id: NCT04494646
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This multi-center, double-blind, placebo-controlled, randomized Phase 2 trial will study the
      safety, tolerability, and efficacy of bardoxolone methyl in patients hospitalized with
      confirmed COVID-19. The trial will include approximately 40 patients and is designed to
      provide an early interim analysis of safety. Patients will be randomized using permuted block
      randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20
      mg) or matching placebo and treatment will be administered for the duration of
      hospitalization (until recovery), with a maximum treatment duration of 29 days.
Following randomization on Day 1, patients will be assessed while hospitalized on Days 3, 5,
      8, 11, 15, 22, and 29. Assessments will include clinical status assessments, vital sign
      measurements, clinical chemistry collection, and adverse event collection. Patients that
      recover prior to Day 29 will complete an end-of-treatment visit. Patients will have an
      in-person follow-up on Day 29, regardless of treatment adherence and recovery status prior to
      Day 29, and a safety follow-up 60 days after randomization for clinical status assessments,
      vital sign measurements, clinical chemistry collection, and adverse event collection.
      Follow-up in-person visits are preferred but recognizing quarantine and other factors may
      limit the subject's ability to return to the site for the visit. In this case, the visit may
      be performed by phone. An independent Data and Safety Monitoring Board will advise the study
      leadership on safety aspects and overall progress of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: All patients, investigators, site personnel, laboratories, and study personnel with direct involvement in the conduct of the study or their designees will be blinded to treatment assignments. To prevent potential bias, appropriate measures will be taken to ensure the blind is maintained for the patients and personnel mentioned previously. To maintain the blind, investigators will distribute blinded study drug treatment to patients as directed by the IWRS system. Investigators and patients will not be blinded to dose level, but will be blinded to treatment assignment (i.e., bardoxolone methyl vs. placebo).
measure: Number of Serious Adverse Events
time frame: Day 29
arm group label: Bardoxolone Methyl
arm group type: Experimental
description: Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo
intervention type: Drug
intervention name: Bardoxolone Methyl
description: Once-daily administration of bardoxolone methyl (20mg)
arm group label: Bardoxolone Methyl
intervention type: Drug
intervention name: Placebo
description: Once-daily administration of matching placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sripal Bangalore, MD, MHA
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared upon reasonable request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will become available beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
ipd access criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Sripal.Bangalore@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 