<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/NCT04447404</url>
  </required_header>
  <id_info>
    <org_study_id>C928-020</org_study_id>
    <nct_id>NCT04447404</nct_id>
  </id_info>
  <brief_title>DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of DUR-928 in Subjects Infected With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Durect</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Durect</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>
      Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects&#xD;
      infected with SARS-CoV-2&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Actual">March 4, 2021</completion_date>
  <primary_completion_date type="Actual">March 4, 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>
    <intervention_model_description>3:1 randomization DUR-928:placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Endpoint of Alive and Free of Organ Failure at Day 28</measure>
    <time_frame>Day 28</time_frame>
    <description>Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alive at Days 28 and 60</measure>
    <time_frame>Day 28 and Day 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alive, Out of ICU, at Day 28</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alive, Out of Hospital, at Days 28 and 60</measure>
    <time_frame>Day 28 and Day 60</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>DUR-928</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DUR-928</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>DUR-928</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized with moderate, severe, or early critical COVID-19 illness diagnosed by&#xD;
             RT- PCR&#xD;
&#xD;
          -  Acute liver injury (including acute on chronic liver disease) or acute kidney injury&#xD;
             or moderate COVID-19 pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Critical COVID-19 illness (MAP &lt; 60 mm Hg, on mechanical ventilator for ≥ 5 days)&#xD;
&#xD;
          -  On maintenance hemodialysis or peritoneal dialysis&#xD;
&#xD;
          -  Child Pugh C cirrhosis&#xD;
&#xD;
          -  Hepatorenal syndrome&#xD;
&#xD;
          -  Ascites and/or hepatic encephalopathy&#xD;
&#xD;
          -  History of end stage renal disease or CKD with eGFR &lt; 15 mL/min/1.73m2&#xD;
&#xD;
          -  Women who are pregnant or breast feeding&#xD;
&#xD;
          -  Receipt of other concomitant experimental therapies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Gordon, MD</last_name>
    <role>Study Director</role>
    <affiliation>CTI Clinical Trial and Consulting Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 03</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <results_first_submitted>June 10, 2022</results_first_submitted>
  <results_first_submitted_qc>July 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2022</results_first_posted>
  <last_update_submitted>July 12, 2022</last_update_submitted>
  <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>December 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT04447404/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DUR-928</title>
          <description>DUR-928: IV infusion</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo: IV infusion</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Study terminated early due to lack of enrollment.</population>
      <group_list>
        <group group_id="B1">
          <title>DUR-928</title>
          <description>DUR-928: IV infusion</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo: IV infusion</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="2"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="66.5" spread="16.26"/>
                    <measurement group_id="B3" value="66.5" spread="16.26"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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>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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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="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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Composite Endpoint of Alive and Free of Organ Failure at Day 28</title>
        <description>Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure</description>
        <time_frame>Day 28</time_frame>
        <population>Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).</population>
        <group_list>
          <group group_id="O1">
            <title>DUR-928</title>
            <description>DUR-928: IV infusion</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo: IV infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Composite Endpoint of Alive and Free of Organ Failure at Day 28</title>
          <description>Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure</description>
          <population>Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).</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="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alive at Days 28 and 60</title>
        <time_frame>Day 28 and Day 60</time_frame>
        <population>Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).</population>
        <group_list>
          <group group_id="O1">
            <title>DUR-928</title>
            <description>DUR-928: IV infusion</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo: IV infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Alive at Days 28 and 60</title>
          <population>Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).</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="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alive, Out of ICU, at Day 28</title>
        <time_frame>Day 28</time_frame>
        <population>Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).</population>
        <group_list>
          <group group_id="O1">
            <title>DUR-928</title>
            <description>DUR-928: IV infusion</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo: IV infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Alive, Out of ICU, at Day 28</title>
          <population>Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).</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="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alive, Out of Hospital, at Days 28 and 60</title>
        <time_frame>Day 28 and Day 60</time_frame>
        <population>Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).</population>
        <group_list>
          <group group_id="O1">
            <title>DUR-928</title>
            <description>DUR-928: IV infusion</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo: IV infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Alive, Out of Hospital, at Days 28 and 60</title>
          <population>Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).</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="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>60 days</time_frame>
      <desc>Due to early study termination, no subjects were enrolled in the placebo treatment group.</desc>
      <group_list>
        <group group_id="E1">
          <title>DUR-928</title>
          <description>DUR-928: IV infusion</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo: IV infusion</description>
        </group>
      </group_list>
      <serious_events>
        <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="2" subjects_at_risk="2"/>
                <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="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain Injury</sub_title>
                <description>ANOXIC BRAIN INJURY SECONDARY TO CEREBRAL EDEMA AND SAH</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <description>ACUTE HYPOXIC RESPIRATORY FAILURE 2/2 COVID PNA 2/2 TERMINAL EXTUBATION</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <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>
        <default_assessment>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="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated Partial Thromboplastin Time Prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <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>The disclosure restriction on the PI is that if sponsor has not submitted a multi-site publication within 18 months of study completion, the PI can submit the sponsor results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI will remove confidential information from results communications prior to publication upon request.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early study termination led to small number (n=2) of subjects and in one treatment group.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Executive Director, Regulatory Affairs</name_or_title>
      <organization>DURECT Corporation</organization>
      <phone>408-777-1417</phone>
      <email>jill.burns@durect.com</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/NCT04447404
org study id: C928-020
nct id: NCT04447404
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects
      infected with SARS-CoV-2
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3:1 randomization DUR-928:placebo
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Composite Endpoint of Alive and Free of Organ Failure at Day 28
time frame: Day 28
description: Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure
measure: Alive at Days 28 and 60
time frame: Day 28 and Day 60
measure: Alive, Out of ICU, at Day 28
time frame: Day 28
measure: Alive, Out of Hospital, at Days 28 and 60
time frame: Day 28 and Day 60
arm group label: DUR-928
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: DUR-928
description: IV infusion
arm group label: DUR-928
intervention type: Drug
intervention name: Placebo
description: IV infusion
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Robert Gordon, MD
role: Study Director
affiliation: CTI Clinical Trial and Consulting Services
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early study termination led to small number (n=2) of subjects and in one treatment group.
point of contact: 