<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/NCT04414618</url>
  </required_header>
  <id_info>
    <org_study_id>ABC-110</org_study_id>
    <nct_id>NCT04414618</nct_id>
  </id_info>
  <brief_title>A Study of Opaganib in Coronavirus Disease 2019 Pneumonia</brief_title>
  <acronym>COVID-19</acronym>
  <official_title>Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2a Study, in Adult Subjects Hospitalized With SARS-CoV-2 Positive Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RedHill Biopharma Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RedHill Biopharma Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proof of concept study will take place in the US and other countries in approximately 15&#xD;
      clinical sites and will enroll about 40 hospitalized patients diagnosed with COVID-19&#xD;
      infection who have developed pneumonia and require supplemental oxygen. 20 patients will&#xD;
      receive opaganib in addition to standard of care twice each day for 14 days. 20 will receive&#xD;
      matching placebo in addition to standard of care unless the patient has been discharged from&#xD;
      the hospital without requiring supplemental oxygen, in which case study drug will only be&#xD;
      administered for 10 days. All participants will be followed up for 4 weeks after their last&#xD;
      dose of study drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Opaganib, a sphingosine kinase-2 (SphK2) inhibitor, has been broadly tested in Phase I/II&#xD;
      studies. Extensive nonclinical data indicates both anti-viral and anti-inflammatory activity&#xD;
      via selective SphK2 inhibition which may prove beneficial for treating COVID-19 infection and&#xD;
      resulting pneumonia. This proof of concept study will take place in the US and other&#xD;
      countries and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection&#xD;
      who have developed pneumonia and require supplemental oxygen. Half of the patients, i.e. 20&#xD;
      patients, will receive opaganib in addition to standard of care for 14 days. The other 20&#xD;
      will receive matching placebo (capsules that do not contain the medication) in addition to&#xD;
      standard of care. Study drug will be administered every day for 14 days, twice each day,&#xD;
      unless the patient has been discharged from the hospital without requiring supplemental&#xD;
      oxygen, in which case study drug will only be administered for 10 days. All participants will&#xD;
      be followed up for 4 weeks after their last dose of study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Actual">December 23, 2020</completion_date>
  <primary_completion_date type="Actual">November 26, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of the Change in Oxygen Requirement From Baseline</measure>
    <time_frame>14 days</time_frame>
    <description>Maximal oxygen flow (L/min) was recorded daily for the 14 days of treatment for each participant. Participant individual area under the curve (AUC) was calculated based on the trapezoidal rule, after subtracting the baseline oxygen requirement at each day. The median AUC absolute change from baseline (L/min) for each treatment arm is presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of Time to the Reduction in Oxygen Requirement.</measure>
    <time_frame>14 days</time_frame>
    <description>The time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14</measure>
    <time_frame>14 days</time_frame>
    <description>The percentage of subjects in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment</measure>
    <time_frame>6 weeks</time_frame>
    <description>The time in each arm to two consecutive negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab, at least 24 hrs. apart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14</measure>
    <time_frame>14 days</time_frame>
    <description>The percentage of subjects in each arm to achieve two consecutive negative PCR nasopharyngeal or oropharyngeal swabs for SARS-CoV-2 at Day 14, at least 24 hrs. apart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation and Mechanical Ventilation Requirements</measure>
    <time_frame>From screening phase and every day from day 1 to day 14 of treatment</time_frame>
    <description>The percentage of patients in each arm who require intubation and mechanical ventilation by Day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the Time to Intubation and Mechanical Ventilation</measure>
    <time_frame>From screening phase and every day from day 1 to day 14 of treatment</time_frame>
    <description>The time in each arm for the patient to require mechanical ventilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14</measure>
    <time_frame>From screening phase and every day from day 1 to day 14 of treatment</time_frame>
    <description>The proportion of patients in each arm, with at least one measurement of fever at baseline (defined as temperature &gt;38.0 C[100.4 F]), who are afebrile (defined as temperature &lt;37.2C [99 F]) at Day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Mortality 30 Days Post-baseline</measure>
    <time_frame>30 days after day 1 of treatment</time_frame>
    <description>The mortality in each arm 30 days post-baseline.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety TEAEs</measure>
    <time_frame>6 weeks</time_frame>
    <description>The number of subjects with treatment-emergent adverse events in each arm of all treatment-emergent adverse events (TEAEs).</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety SAEs</measure>
    <time_frame>6 weeks</time_frame>
    <description>The number of subjects with serious adverse events (SAEs) in each arm.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Coronavirus Infections</condition>
  <arm_group>
    <arm_group_label>opaganib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Study participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Opaganib</intervention_name>
    <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
    <arm_group_label>opaganib</arm_group_label>
    <other_name>Yeliva</other_name>
    <other_name>ABC294640</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult male or female ≥18 to ≤80 years of age&#xD;
&#xD;
          2. Proven COVID-19 infection per RT-PCR assay of a pharyngeal sample (nasopharyngeal or&#xD;
             oropharyngeal) AND pneumonia defined as radiographic opacities on chest X-ray&#xD;
&#xD;
          3. The patient requires supplemental oxygen at baseline&#xD;
&#xD;
          4. The patient, guardian or legal representative has signed a written IRB-approved&#xD;
             informed consent.&#xD;
&#xD;
        5) Male participants with female partners of child-bearing potential agree to one of the&#xD;
        following methods of contraception during the treatment period and for at least 1 month&#xD;
        after the last dose of study drug:&#xD;
&#xD;
          -  Abstinence from penile-vaginal intercourse and agree to remain abstinent.&#xD;
&#xD;
          -  Male condom, with female partner using a highly effective contraceptive method. (For&#xD;
             further details regarding highly effective contraceptive methods please see section&#xD;
             9.3.)&#xD;
&#xD;
        In addition, male participants must refrain from donating sperm for the duration of the&#xD;
        study and for 1 months after last dose of study drug.&#xD;
&#xD;
        Male participants with a pregnant or breastfeeding partner must agree to remain abstinent&#xD;
        from penile-vaginal intercourse or use a male condom during each episode of penile&#xD;
        penetration for at least 1 months after the last dose of study drug&#xD;
&#xD;
        Female participants:&#xD;
&#xD;
        A female participant is eligible to participate if she is:&#xD;
&#xD;
          1. not pregnant&#xD;
&#xD;
          2. not breastfeeding&#xD;
&#xD;
          3. not a woman of child-bearing potential (WOCBP, as defined in Section 9.3)&#xD;
&#xD;
          4. a WOCBP who agrees to use a highly effective method of contraception consistently and&#xD;
             correctly during the treatment period and for at least 1 months after the last dose of&#xD;
             study drug (please see further details on Section 9.3).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any co-morbidity that may add risk to the treatment in the judgement of the&#xD;
             investigator.&#xD;
&#xD;
          2. Requiring intubation and mechanical ventilation&#xD;
&#xD;
          3. Patient having a do not intubate or do not resuscitate order&#xD;
&#xD;
          4. Oxygen saturation &gt;95% on room air&#xD;
&#xD;
          5. Any preexisting respiratory condition that requires intermittent or continuous&#xD;
             ambulatory oxygen prior to hospitalization&#xD;
&#xD;
          6. Patient is, in the investigator's clinical judgment, unlikely to survive &gt;72 hours&#xD;
&#xD;
          7. Pregnant or nursing women&#xD;
&#xD;
          8. Unwillingness or inability to comply with procedures required in this protocol.&#xD;
&#xD;
          9. Corrected QT (QTc) interval on electrocardiogram (ECG) &gt;470 ms for females or &gt;450 ms&#xD;
             for males, calculated using Friedericia's formula (QTcF)&#xD;
&#xD;
         10. AST (SGOT) or ALT (SGPT) &gt; 2.5 x upper limit of normal (ULN)&#xD;
&#xD;
         11. Bilirubin &gt;2.0 x ULN (except where bilirubin increase is due to Gilbert's Syndrome)&#xD;
&#xD;
         12. Serum creatinine &gt;2.0 X ULN&#xD;
&#xD;
         13. Absolute neutrophil count &lt;1000 cells/mm3&#xD;
&#xD;
         14. Platelet count &lt;75,000/mm3&#xD;
&#xD;
         15. Hemoglobin &lt;8.0 g/dL&#xD;
&#xD;
         16. Currently taking medications that are sensitive CYP3A4, CYP1A2, CYP2C9, or CYP2C19 or&#xD;
             CYP2D6 substrates and have a narrow therapeutic index. These should be decided in&#xD;
             discussion with the Medical Monitor on a case-by-case basis.&#xD;
&#xD;
         17. Currently taking medications that are strong inducers or inhibitors of CYP2D6 and&#xD;
             CYP3A4. These should be decided in discussion with the Medical Monitor on a&#xD;
             case-by-case basis.&#xD;
&#xD;
         18. Currently taking warfarin, apixaban, argatroban or rivaroxaban.&#xD;
&#xD;
         19. Current drug or alcohol abuse.&#xD;
&#xD;
         20. Currently participating in a clinical study assessing pharmacological treatments,&#xD;
             including anti-viral studies.&#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>Mark L Levitt, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>RedHill Biopharma Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HonorHealth Research Institute</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension St. John Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Herman Southeast Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann, Memorial City Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziv Medical Center</name>
      <address>
        <city>Safed</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <results_first_submitted>February 3, 2022</results_first_submitted>
  <results_first_submitted_qc>March 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 21, 2022</results_first_posted>
  <last_update_submitted>March 17, 2022</last_update_submitted>
  <last_update_submitted_qc>March 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2022</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>Pneumonia</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT04414618/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>December 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT04414618/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Opaganib</title>
          <description>Study participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours&#xD;
Opaganib: Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive).</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Study participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours&#xD;
Placebo: Study participants will receive placebo 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </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>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </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="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Opaganib</title>
          <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</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="23"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="42"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;70 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=70 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </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="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_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="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="20"/>
                  </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="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="33"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="23"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Measurement of the Change in Oxygen Requirement From Baseline</title>
        <description>Maximal oxygen flow (L/min) was recorded daily for the 14 days of treatment for each participant. Participant individual area under the curve (AUC) was calculated based on the trapezoidal rule, after subtracting the baseline oxygen requirement at each day. The median AUC absolute change from baseline (L/min) for each treatment arm is presented.</description>
        <time_frame>14 days</time_frame>
        <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication).</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>Measurement of the Change in Oxygen Requirement From Baseline</title>
          <description>Maximal oxygen flow (L/min) was recorded daily for the 14 days of treatment for each participant. Participant individual area under the curve (AUC) was calculated based on the trapezoidal rule, after subtracting the baseline oxygen requirement at each day. The median AUC absolute change from baseline (L/min) for each treatment arm is presented.</description>
          <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication).</population>
          <units>L/min*day</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-38.8" lower_limit="-56.5" upper_limit="0"/>
                    <measurement group_id="O2" value="-33.0" lower_limit="-149.5" upper_limit="-12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measurement of Time to the Reduction in Oxygen Requirement.</title>
        <description>The time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min.</description>
        <time_frame>14 days</time_frame>
        <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, one subject who did not have supplemental oxygen requirement at randomization was excluded from this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>Measurement of Time to the Reduction in Oxygen Requirement.</title>
          <description>The time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min.</description>
          <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, one subject who did not have supplemental oxygen requirement at randomization was excluded from this analysis.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" lower_limit="4.00" upper_limit="12.00"/>
                    <measurement group_id="O2" value="8.00" lower_limit="4.00" upper_limit="NA">Some subjects didn't reach 50% reduction in oxygen requirement.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14</title>
        <description>The percentage of subjects in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14.</description>
        <time_frame>14 days</time_frame>
        <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication).</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14</title>
          <description>The percentage of subjects in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14.</description>
          <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication).</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="22"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment</title>
        <description>The time in each arm to two consecutive negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab, at least 24 hrs. apart.</description>
        <time_frame>6 weeks</time_frame>
        <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, as most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment</title>
          <description>The time in each arm to two consecutive negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab, at least 24 hrs. apart.</description>
          <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, as most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">As most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">As most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14</title>
        <description>The percentage of subjects in each arm to achieve two consecutive negative PCR nasopharyngeal or oropharyngeal swabs for SARS-CoV-2 at Day 14, at least 24 hrs. apart.</description>
        <time_frame>14 days</time_frame>
        <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, as most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14</title>
          <description>The percentage of subjects in each arm to achieve two consecutive negative PCR nasopharyngeal or oropharyngeal swabs for SARS-CoV-2 at Day 14, at least 24 hrs. apart.</description>
          <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, as most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses.</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="22"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">As most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses.</measurement>
                    <measurement group_id="O2" value="NA">As most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intubation and Mechanical Ventilation Requirements</title>
        <description>The percentage of patients in each arm who require intubation and mechanical ventilation by Day 14</description>
        <time_frame>From screening phase and every day from day 1 to day 14 of treatment</time_frame>
        <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication).</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>Intubation and Mechanical Ventilation Requirements</title>
          <description>The percentage of patients in each arm who require intubation and mechanical ventilation by Day 14</description>
          <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication).</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="22"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of the Time to Intubation and Mechanical Ventilation</title>
        <description>The time in each arm for the patient to require mechanical ventilation.</description>
        <time_frame>From screening phase and every day from day 1 to day 14 of treatment</time_frame>
        <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication).</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of the Time to Intubation and Mechanical Ventilation</title>
          <description>The time in each arm for the patient to require mechanical ventilation.</description>
          <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication).</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">The median time to intubation and mechanical ventilation was not reached in either group.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">The median time to intubation and mechanical intubation was not reached in either group.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14</title>
        <description>The proportion of patients in each arm, with at least one measurement of fever at baseline (defined as temperature &gt;38.0 C[100.4 F]), who are afebrile (defined as temperature &lt;37.2C [99 F]) at Day 14</description>
        <time_frame>From screening phase and every day from day 1 to day 14 of treatment</time_frame>
        <population>Patients in the Modified ITT (mITT) population (randomized and treated with at least one dose of study medication) with at least one measurement of fever at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14</title>
          <description>The proportion of patients in each arm, with at least one measurement of fever at baseline (defined as temperature &gt;38.0 C[100.4 F]), who are afebrile (defined as temperature &lt;37.2C [99 F]) at Day 14</description>
          <population>Patients in the Modified ITT (mITT) population (randomized and treated with at least one dose of study medication) with at least one measurement of fever at baseline.</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="4"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Mortality 30 Days Post-baseline</title>
        <description>The mortality in each arm 30 days post-baseline.</description>
        <time_frame>30 days after day 1 of treatment</time_frame>
        <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication).</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Mortality 30 Days Post-baseline</title>
          <description>The mortality in each arm 30 days post-baseline.</description>
          <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication).</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="22"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Safety TEAEs</title>
        <description>The number of subjects with treatment-emergent adverse events in each arm of all treatment-emergent adverse events (TEAEs).</description>
        <time_frame>6 weeks</time_frame>
        <population>Safety population includes all subjects randomized and treated with at least one dose of study medication. One subject randomized to receive placebo, was mistakenly given 2 doses of opaganib and is therefore included twice.</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>Safety TEAEs</title>
          <description>The number of subjects with treatment-emergent adverse events in each arm of all treatment-emergent adverse events (TEAEs).</description>
          <population>Safety population includes all subjects randomized and treated with at least one dose of study medication. One subject randomized to receive placebo, was mistakenly given 2 doses of opaganib and is therefore included twice.</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="23"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Safety SAEs</title>
        <description>The number of subjects with serious adverse events (SAEs) in each arm.</description>
        <time_frame>6 weeks</time_frame>
        <population>Safety population includes all subjects randomized and treated with at least one dose of study medication. One subject randomized to receive placebo, was mistakenly given 2 doses of opaganib and is therefore included twice.</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>Safety SAEs</title>
          <description>The number of subjects with serious adverse events (SAEs) in each arm.</description>
          <population>Safety population includes all subjects randomized and treated with at least one dose of study medication. One subject randomized to receive placebo, was mistakenly given 2 doses of opaganib and is therefore included twice.</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="23"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Percent Change in Measurement of the Daily Oxygen Requirement</title>
        <description>The changes in supplemental oxygen requirement [oxygen flow (L/min)] were calculated as percent change from baseline to account for the variability of baseline values, up to Day 14. Percentage from baseline area under the (AUC) is calculated by dividing the baseline adjusted AUC with the baseline. The median AUC absolute change from baseline (L/min) for each treatment arm is presented.</description>
        <time_frame>14 days</time_frame>
        <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, one subject who did not have supplemental oxygen requirement at randomization was excluded from this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Measurement of the Daily Oxygen Requirement</title>
          <description>The changes in supplemental oxygen requirement [oxygen flow (L/min)] were calculated as percent change from baseline to account for the variability of baseline values, up to Day 14. Percentage from baseline area under the (AUC) is calculated by dividing the baseline adjusted AUC with the baseline. The median AUC absolute change from baseline (L/min) for each treatment arm is presented.</description>
          <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, one subject who did not have supplemental oxygen requirement at randomization was excluded from this analysis.</population>
          <units>Percentage of change from baseline*day</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-770.0" lower_limit="-1044.3" upper_limit="0.0"/>
                    <measurement group_id="O2" value="-583.6" lower_limit="-916.7" upper_limit="-223.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Measurement of the Relative Benefit for Each Treatment Are as Derived From Oxygen Requirements</title>
        <description>The relative benefit for each treatment group derived from total oxygen requirement [area under the curve (AUC)] for each arm using daily supplemental oxygen flow (L/min) over 14 days based on the daily percent change (reduction or increase) from baseline adjusted for each subject. As the maximal possible AUC benefit of -1250% is achieved if reduction to zero (100% reduction) occurred the day after baseline and was maintained through Day 14, the relative benefit derived for each group was calculated.</description>
        <time_frame>14 days</time_frame>
        <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, one subject who did not have supplemental oxygen requirement at randomization was excluded from this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Opaganib</title>
            <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).</description>
          </group>
        </group_list>
        <measure>
          <title>Measurement of the Relative Benefit for Each Treatment Are as Derived From Oxygen Requirements</title>
          <description>The relative benefit for each treatment group derived from total oxygen requirement [area under the curve (AUC)] for each arm using daily supplemental oxygen flow (L/min) over 14 days based on the daily percent change (reduction or increase) from baseline adjusted for each subject. As the maximal possible AUC benefit of -1250% is achieved if reduction to zero (100% reduction) occurred the day after baseline and was maintained through Day 14, the relative benefit derived for each group was calculated.</description>
          <population>Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, one subject who did not have supplemental oxygen requirement at randomization was excluded from this analysis.</population>
          <units>Percentage of relative benefit</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.6"/>
                    <measurement group_id="O2" value="46.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <desc>One participant in the placebo arm was not dosed and therefore was removed from the safety population.&#xD;
One participant was randomized to receive placebo, was mistakenly given 2 doses of opaganib and is therefore included twice, once in each arm.</desc>
      <group_list>
        <group group_id="E1">
          <title>Opaganib</title>
          <description>Study participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours&#xD;
Opaganib: Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive).</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Study participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours&#xD;
Placebo: Study participants will receive placebo 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive).</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="3" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </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="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
              </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="11" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Megacolon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
              </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="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Traumatic chest injury NOS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Wound complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood calcium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Fibrin D dimer increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Troponin I increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Glucose tolerance impaired</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Hypermagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </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="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </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 are disclosure agreements between the Sponsor and each of the participating clinical sites and PI that slightly differ.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vered Katz Ben-Yair</name_or_title>
      <organization>RedHill Biopharma Ltd.</organization>
      <phone>+13474144462</phone>
      <email>vered@redhillbio.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/NCT04414618
org study id: ABC-110
nct id: NCT04414618
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This proof of concept study will take place in the US and other countries in approximately 15
      clinical sites and will enroll about 40 hospitalized patients diagnosed with COVID-19
      infection who have developed pneumonia and require supplemental oxygen. 20 patients will
      receive opaganib in addition to standard of care twice each day for 14 days. 20 will receive
      matching placebo in addition to standard of care unless the patient has been discharged from
      the hospital without requiring supplemental oxygen, in which case study drug will only be
      administered for 10 days. All participants will be followed up for 4 weeks after their last
      dose of study drug.
Opaganib, a sphingosine kinase-2 (SphK2) inhibitor, has been broadly tested in Phase I/II
      studies. Extensive nonclinical data indicates both anti-viral and anti-inflammatory activity
      via selective SphK2 inhibition which may prove beneficial for treating COVID-19 infection and
      resulting pneumonia. This proof of concept study will take place in the US and other
      countries and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection
      who have developed pneumonia and require supplemental oxygen. Half of the patients, i.e. 20
      patients, will receive opaganib in addition to standard of care for 14 days. The other 20
      will receive matching placebo (capsules that do not contain the medication) in addition to
      standard of care. Study drug will be administered every day for 14 days, twice each day,
      unless the patient has been discharged from the hospital without requiring supplemental
      oxygen, in which case study drug will only be administered for 10 days. All participants will
      be followed up for 4 weeks after their last dose of study drug.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Measurement of the Change in Oxygen Requirement From Baseline
time frame: 14 days
description: Maximal oxygen flow (L/min) was recorded daily for the 14 days of treatment for each participant. Participant individual area under the curve (AUC) was calculated based on the trapezoidal rule, after subtracting the baseline oxygen requirement at each day. The median AUC absolute change from baseline (L/min) for each treatment arm is presented.
measure: Measurement of Time to the Reduction in Oxygen Requirement.
time frame: 14 days
description: The time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min.
measure: The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14
time frame: 14 days
description: The percentage of subjects in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14.
measure: Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment
time frame: 6 weeks
description: The time in each arm to two consecutive negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab, at least 24 hrs. apart.
measure: The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14
time frame: 14 days
description: The percentage of subjects in each arm to achieve two consecutive negative PCR nasopharyngeal or oropharyngeal swabs for SARS-CoV-2 at Day 14, at least 24 hrs. apart.
measure: Intubation and Mechanical Ventilation Requirements
time frame: From screening phase and every day from day 1 to day 14 of treatment
description: The percentage of patients in each arm who require intubation and mechanical ventilation by Day 14
measure: Evaluation of the Time to Intubation and Mechanical Ventilation
time frame: From screening phase and every day from day 1 to day 14 of treatment
description: The time in each arm for the patient to require mechanical ventilation.
measure: Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14
time frame: From screening phase and every day from day 1 to day 14 of treatment
description: The proportion of patients in each arm, with at least one measurement of fever at baseline (defined as temperature >38.0 C[100.4 F]), who are afebrile (defined as temperature <37.2C [99 F]) at Day 14
measure: Evaluation of Mortality 30 Days Post-baseline
time frame: 30 days after day 1 of treatment
description: The mortality in each arm 30 days post-baseline.
measure: Safety TEAEs
time frame: 6 weeks
description: The number of subjects with treatment-emergent adverse events in each arm of all treatment-emergent adverse events (TEAEs).
measure: Safety SAEs
time frame: 6 weeks
description: The number of subjects with serious adverse events (SAEs) in each arm.
arm group label: opaganib
arm group type: Active Comparator
description: Study participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours
arm group label: placebo
arm group type: Placebo Comparator
description: Study participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours
intervention type: Drug
intervention name: Opaganib
description: Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
arm group label: opaganib
other name: Yeliva
other name: ABC294640
intervention type: Drug
intervention name: Placebo
description: Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mark L Levitt, MD, PhD
role: Study Director
affiliation: RedHill Biopharma Limited
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country: Israel
country: United States
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Coronavirus Infections
sharing ipd: No
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