<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/NCT04440007</url>
  </required_header>
  <id_info>
    <org_study_id>STI-5656-2001</org_study_id>
    <nct_id>NCT04440007</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19</brief_title>
  <acronym>SOC</acronym>
  <official_title>A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With Standard of Care Versus Standard of Care in Subjects Hospitalized With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sorrento Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sorrento Therapeutics, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC&#xD;
      in subjects hospitalized with COVID-19&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2, open-label, randomized 2-arm multicenter study to assess the safety and&#xD;
      efficacy of STI-5656 (Abivertinib Maleate) administered orally plus Standard of Care (SOC)&#xD;
      versus SOC in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 infection and COVID-19&#xD;
      pneumonia (documented radiographically). Only hospitalized patients are eligible for this&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2020</start_date>
  <completion_date type="Actual">August 23, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Alive and Free of Respiratory Failure at Day 28</measure>
    <time_frame>Randomization to Day 28</time_frame>
    <description>Percentage of subjects alive and free of respiratory failure at Day 28, where respiratory failure, is defined based on resource utilization of any of the following modalities:&#xD;
Noninvasive positive pressure ventilation or continuous positive airway pressure&#xD;
Endotracheal intubation and mechanical ventilation&#xD;
Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates &gt;20L/min with fraction of delivered oxygen ≥ 0.5)&#xD;
Extracorporeal membrane oxygenation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events</measure>
    <time_frame>Randomization through study completion to 94 days</time_frame>
    <description>Number of Participants with Treatment-emergent Adverse Events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Alive and Free of Respiratory Failure at Day 60</measure>
    <time_frame>Randomization to Day 60</time_frame>
    <description>Percentage of subjects alive and free of respiratory failure at Day 60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-Reactive Protein (CRP)</measure>
    <time_frame>Day 7</time_frame>
    <description>Mean change in CRP on Day 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)</measure>
    <time_frame>Day 1</time_frame>
    <description>PaO2/FiO2 at Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause Mortality at Day 60 and Day 90</measure>
    <time_frame>Day 60 and Day 90</time_frame>
    <description>All-cause mortality at Day 60 and Day 90</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Alive Outside of Hospital up to Day 28</measure>
    <time_frame>Randomization up to Day 28</time_frame>
    <description>Number of days alive outside of hospital up to Day 28</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Abivertinib with Standard of Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care treatments for COVID-19 as determined appropriate by the Investigator</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abivertinib</intervention_name>
    <description>Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.</description>
    <arm_group_label>Abivertinib with Standard of Care</arm_group_label>
    <other_name>abivertinib maleate</other_name>
    <other_name>avitinib</other_name>
    <other_name>AC0010</other_name>
    <other_name>STI-5656</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of Care as determined by the Investigator</description>
    <arm_group_label>Abivertinib with Standard of Care</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed infection with SARS-CoV-2 per World Health Organization (WHO) criteria&#xD;
             (including positive RT-PCR nucleic acid test of any specimen [eg, respiratory, blood,&#xD;
             urine, stool, or other bodily fluid]) within 7 days of randomization&#xD;
&#xD;
          -  Hospitalized with COVID-19 pneumonia (documented radiographically) and oxygen&#xD;
             saturation &lt;94% on room air or subject requires supplemental oxygen&#xD;
&#xD;
          -  Able to swallow capsules&#xD;
&#xD;
          -  Willing to follow contraception guidelines&#xD;
&#xD;
          -  Subject or family member/caregiver must have provided written informed consent which&#xD;
             includes signing the institutional review board approved consent form prior to&#xD;
             participating in any study related activity. However, if obtaining written informed&#xD;
             consent is not possible, other procedures as provided in the March 27th, 2020 FDA&#xD;
             Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,&#xD;
             Question 10, may be used&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known cardio-pulmonary resuscitation within 14 days prior to randomization&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides&#xD;
             infection with SARS-CoV-2)&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) ≥ 3x upper limit of normal (ULN) and total bilirubin &gt;&#xD;
             2x ULN&#xD;
&#xD;
          -  QTcF prolongation &gt;480 milliseconds&#xD;
&#xD;
          -  Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the&#xD;
             last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects&#xD;
             with controlled, asymptomatic atrial fibrillation during screening are allowed to&#xD;
             enroll&#xD;
&#xD;
          -  Treatment with a strong cytochrome P450 (CYP3A4 inhibitor (within 14 days before first&#xD;
             dose of study drug) or inducer (within 7 days before first dose of study drug)&#xD;
&#xD;
          -  Received anti-rejection or immunomodulatory drugs (eg, anti-cytokines, BTK inhibitors,&#xD;
             JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study&#xD;
&#xD;
          -  Concurrent participation in another clinical trial involving therapeutic interventions&#xD;
             (observational study participation is acceptable)&#xD;
&#xD;
          -  Any condition that confounds the ability to interpret data from the study&#xD;
&#xD;
          -  Relevant renal impairment (eGFR &lt;60 mL/min)&#xD;
&#xD;
          -  Any significant medical condition, laboratory abnormality or psychiatric illness that&#xD;
             would interfere or prevent the subject from participating in the study&#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>Mike Royal, MD JD</last_name>
    <role>Study Director</role>
    <affiliation>Sorrento Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teradan Clinical Trials</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandria Cardiology Clinic</name>
      <address>
        <city>Alexandria</city>
        <state>Louisiana</state>
        <zip>71301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of SWLA</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality Clinical Research</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Memorial City Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <results_first_submitted>September 22, 2022</results_first_submitted>
  <results_first_submitted_qc>December 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 18, 2023</results_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 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>Abivertinib</mesh_term>
  </intervention_browse>
  <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>December 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT04440007/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT04440007/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Abivertinib With Standard of Care</title>
          <description>STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care&#xD;
Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
        </group>
        <group group_id="P2">
          <title>Placebo With Standard of Care</title>
          <description>Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </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>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <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="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inability to draw blood for labs and being transferred to a nursing facility with no transportation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinued prior to dosing</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Abivertinib With Standard of Care</title>
          <description>STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care&#xD;
Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
        </group>
        <group group_id="B2">
          <title>Placebo With Standard of Care</title>
          <description>Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator&#xD;
Standard of Care: Standard of Care as determined by the Investigator</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="48"/>
            <count group_id="B2" value="48"/>
            <count group_id="B3" value="96"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.9" spread="12.38"/>
                    <measurement group_id="B2" value="57.4" spread="12.88"/>
                    <measurement group_id="B3" value="58.6" spread="12.63"/>
                  </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="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="62"/>
                  </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="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>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>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="48"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101.94" spread="30.694"/>
                    <measurement group_id="B2" value="100.12" spread="25.855"/>
                    <measurement group_id="B3" value="101.03" spread="28.243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Alive and Free of Respiratory Failure at Day 28</title>
        <description>Percentage of subjects alive and free of respiratory failure at Day 28, where respiratory failure, is defined based on resource utilization of any of the following modalities:&#xD;
Noninvasive positive pressure ventilation or continuous positive airway pressure&#xD;
Endotracheal intubation and mechanical ventilation&#xD;
Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates &gt;20L/min with fraction of delivered oxygen ≥ 0.5)&#xD;
Extracorporeal membrane oxygenation</description>
        <time_frame>Randomization to Day 28</time_frame>
        <population>A total of 48 subjects in the STI-5656 group and 48 subjects in the placebo group were included in the analysis of the primary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the primary endpoint analysis was that they had no baseline value available.</population>
        <group_list>
          <group group_id="O1">
            <title>Abivertinib With Standard of Care</title>
            <description>STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care&#xD;
Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Standard of Care</title>
            <description>Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Alive and Free of Respiratory Failure at Day 28</title>
          <description>Percentage of subjects alive and free of respiratory failure at Day 28, where respiratory failure, is defined based on resource utilization of any of the following modalities:&#xD;
Noninvasive positive pressure ventilation or continuous positive airway pressure&#xD;
Endotracheal intubation and mechanical ventilation&#xD;
Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates &gt;20L/min with fraction of delivered oxygen ≥ 0.5)&#xD;
Extracorporeal membrane oxygenation</description>
          <population>A total of 48 subjects in the STI-5656 group and 48 subjects in the placebo group were included in the analysis of the primary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the primary endpoint analysis was that they had no baseline value available.</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="48"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events</title>
        <description>Number of Participants with Treatment-emergent Adverse Events</description>
        <time_frame>Randomization through study completion to 94 days</time_frame>
        <population>A total of 48 subjects in the STI-5656 group and 46 subjects in the placebo group were included in the analysis of the secondary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the secondary endpoint analysis was that they had no baseline value available. 46 subjects were analyzed for the placebo group as 2 subjects were randomized to the placebo group who ET prior to dosing.</population>
        <group_list>
          <group group_id="O1">
            <title>Abivertinib With Standard of Care</title>
            <description>STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care&#xD;
Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Standard of Care</title>
            <description>Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events</title>
          <description>Number of Participants with Treatment-emergent Adverse Events</description>
          <population>A total of 48 subjects in the STI-5656 group and 46 subjects in the placebo group were included in the analysis of the secondary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the secondary endpoint analysis was that they had no baseline value available. 46 subjects were analyzed for the placebo group as 2 subjects were randomized to the placebo group who ET prior to dosing.</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="48"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Alive and Free of Respiratory Failure at Day 60</title>
        <description>Percentage of subjects alive and free of respiratory failure at Day 60</description>
        <time_frame>Randomization to Day 60</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abivertinib With Standard of Care</title>
            <description>STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care&#xD;
Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Standard of Care</title>
            <description>Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Alive and Free of Respiratory Failure at Day 60</title>
          <description>Percentage of subjects alive and free of respiratory failure at Day 60</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in C-Reactive Protein (CRP)</title>
        <description>Mean change in CRP on Day 7</description>
        <time_frame>Day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abivertinib With Standard of Care</title>
            <description>STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care&#xD;
Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Standard of Care</title>
            <description>Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
        </group_list>
        <measure>
          <title>Change in C-Reactive Protein (CRP)</title>
          <description>Mean change in CRP on Day 7</description>
          <units>ng/ml</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.43" spread="527.102"/>
                    <measurement group_id="O2" value="66.67" spread="755.613"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)</title>
        <description>PaO2/FiO2 at Day 1</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abivertinib With Standard of Care</title>
            <description>STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care&#xD;
Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Standard of Care</title>
            <description>Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
        </group_list>
        <measure>
          <title>Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)</title>
          <description>PaO2/FiO2 at Day 1</description>
          <units>mmHG</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="210.61" spread="112.686"/>
                    <measurement group_id="O2" value="253.34" spread="103.679"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All-cause Mortality at Day 60 and Day 90</title>
        <description>All-cause mortality at Day 60 and Day 90</description>
        <time_frame>Day 60 and Day 90</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abivertinib With Standard of Care</title>
            <description>STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care&#xD;
Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Standard of Care</title>
            <description>Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality at Day 60 and Day 90</title>
          <description>All-cause mortality at Day 60 and Day 90</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 60</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Alive Outside of Hospital up to Day 28</title>
        <description>Number of days alive outside of hospital up to Day 28</description>
        <time_frame>Randomization up to Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abivertinib With Standard of Care</title>
            <description>STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care&#xD;
Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Standard of Care</title>
            <description>Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Alive Outside of Hospital up to Day 28</title>
          <description>Number of days alive outside of hospital up to Day 28</description>
          <units>days</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="13.97" upper_limit="19.40"/>
                    <measurement group_id="O2" value="17.1" lower_limit="14.37" upper_limit="19.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From signing of informed consent until end-of-trial visit, up to 94 days</time_frame>
      <desc>Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary.&#xD;
AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Abivertinib With Standard of Care</title>
          <description>STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care&#xD;
Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
        </group>
        <group group_id="E2">
          <title>Placebo With Standard of Care</title>
          <description>Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator&#xD;
Standard of Care: Standard of Care as determined by the Investigator</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v23.0</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="8" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Brain death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Ischaemic hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v23.0</default_vocab>
        <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="31" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mike Royal, MD</name_or_title>
      <organization>Sorrento Therapeutics, Inc.</organization>
      <phone>858-203-4100 ext 4146</phone>
      <email>mroyal@sorrentotherapeutics.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/NCT04440007
org study id: STI-5656-2001
nct id: NCT04440007
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC
      in subjects hospitalized with COVID-19
This is a Phase 2, open-label, randomized 2-arm multicenter study to assess the safety and
      efficacy of STI-5656 (Abivertinib Maleate) administered orally plus Standard of Care (SOC)
      versus SOC in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 infection and COVID-19
      pneumonia (documented radiographically). Only hospitalized patients are eligible for this
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Subjects Alive and Free of Respiratory Failure at Day 28
time frame: Randomization to Day 28
description: Percentage of subjects alive and free of respiratory failure at Day 28, where respiratory failure, is defined based on resource utilization of any of the following modalities:
Noninvasive positive pressure ventilation or continuous positive airway pressure
Endotracheal intubation and mechanical ventilation
Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥ 0.5)
Extracorporeal membrane oxygenation
measure: Number of Participants With Treatment-emergent Adverse Events
time frame: Randomization through study completion to 94 days
description: Number of Participants with Treatment-emergent Adverse Events
measure: Percentage of Subjects Alive and Free of Respiratory Failure at Day 60
time frame: Randomization to Day 60
description: Percentage of subjects alive and free of respiratory failure at Day 60
measure: Change in C-Reactive Protein (CRP)
time frame: Day 7
description: Mean change in CRP on Day 7
measure: Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)
time frame: Day 1
description: PaO2/FiO2 at Day 1
measure: All-cause Mortality at Day 60 and Day 90
time frame: Day 60 and Day 90
description: All-cause mortality at Day 60 and Day 90
measure: Number of Days Alive Outside of Hospital up to Day 28
time frame: Randomization up to Day 28
description: Number of days alive outside of hospital up to Day 28
arm group label: Abivertinib with Standard of Care
arm group type: Experimental
description: STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care
arm group label: Standard of Care
arm group type: Active Comparator
description: Standard of care treatments for COVID-19 as determined appropriate by the Investigator
intervention type: Drug
intervention name: Abivertinib
description: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.
arm group label: Abivertinib with Standard of Care
other name: abivertinib maleate
other name: avitinib
other name: AC0010
other name: STI-5656
intervention type: Other
intervention name: Standard of Care
description: Standard of Care as determined by the Investigator
arm group label: Abivertinib with Standard of Care
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mike Royal, MD JD
role: Study Director
affiliation: Sorrento Therapeutics, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Abivertinib
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 