<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/NCT04435106</url>
  </required_header>
  <id_info>
    <org_study_id>0123-20- SZMC</org_study_id>
    <nct_id>NCT04435106</nct_id>
  </id_info>
  <brief_title>Compassionate Use of Opaganib in Patients With Coronavirus Disease 2019 (COVID-19)</brief_title>
  <official_title>Compassionate Use of Opaganib in Patients With Severe COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shaare Zedek Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shaare Zedek Medical Center</source>
  <brief_summary>
    <textblock>
      Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March&#xD;
      2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem.&#xD;
      RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of&#xD;
      COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a&#xD;
      reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and&#xD;
      Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient&#xD;
      group was compared to a group of patients that received only Standard of Care. Opaganib is an&#xD;
      investigational drug under development and not approved for commercial distribution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this observational study, the two cohorts were assigned retrospectively. Patients either&#xD;
      received opaganib and Standard of Care (SOC) or SOC only. All patients were defined by the&#xD;
      treating physicians at baseline as severe COVID-19. For the control cohort, IRB approval was&#xD;
      granted to collect de-identified data. Both cohorts had similar median age and similar rates&#xD;
      of diabetes, hypertension and obesity.&#xD;
&#xD;
      The two treatment groups, opaganib and SOC vs. SOC were then analyzed for their clinical&#xD;
      outcomes including baseline characteristics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2020</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure the time to weaning from high-flow nasal cannula</measure>
    <time_frame>Every day from day 1 to day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the time to breathing ambient (room) air</measure>
    <time_frame>Every day from day 1 to day 14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure change in lymphocyte count</measure>
    <time_frame>On day of admission or day 1 of treatment and every 2-4 days, till day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure change in C-reactive protein</measure>
    <time_frame>On day of admission or day 1 of treatment and every 2-4 days, till day 14</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Coronavirus Infections</condition>
  <arm_group>
    <arm_group_label>Opaganib + Standard of Care</arm_group_label>
    <description>Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <description>Study participants received Standard of Care</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) every 12 hours in addition to Standard of Care</description>
    <arm_group_label>Opaganib + Standard of Care</arm_group_label>
    <other_name>Yeliva</other_name>
    <other_name>ABC294640</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Study participants received Standard of Care</description>
    <arm_group_label>Opaganib + Standard of Care</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with severe COVID-19 who required oxygen support via high-flow nasal cannula&#xD;
        (HFNC)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hospitalized patients with COVID-19 confirmed by a&#xD;
             reverse-transcriptase-polymerase-chain-reaction assay&#xD;
&#xD;
          -  patients with severe disease requiring oxygen support via high-flow nasal cannula&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  acceptable liver and renal function tests&#xD;
&#xD;
          -  acceptable hematologic status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or nursing women&#xD;
&#xD;
          -  patients on warfarin, apixaban, argatroban or rivaroxaban&#xD;
&#xD;
          -  patients with New York Heart Association Class III or IV cardiac disease, myocardial&#xD;
             infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on&#xD;
             ECG&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Shaare-Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</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>Coronavirus Infections</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 22, 2020</submitted>
    <returned>October 29, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04435106
org study id: 0123-20- SZMC
nct id: NCT04435106
lead sponsor: 
Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March
      2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem.
      RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of
      COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a
      reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and
      Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient
      group was compared to a group of patients that received only Standard of Care. Opaganib is an
      investigational drug under development and not approved for commercial distribution.
In this observational study, the two cohorts were assigned retrospectively. Patients either
      received opaganib and Standard of Care (SOC) or SOC only. All patients were defined by the
      treating physicians at baseline as severe COVID-19. For the control cohort, IRB approval was
      granted to collect de-identified data. Both cohorts had similar median age and similar rates
      of diabetes, hypertension and obesity.

      The two treatment groups, opaganib and SOC vs. SOC were then analyzed for their clinical
      outcomes including baseline characteristics.
observational model: Case-Control
time perspective: Retrospective
measure: Measure the time to weaning from high-flow nasal cannula
time frame: Every day from day 1 to day 14
measure: Measure the time to breathing ambient (room) air
time frame: Every day from day 1 to day 14
measure: Measure change in lymphocyte count
time frame: On day of admission or day 1 of treatment and every 2-4 days, till day 14
measure: Measure change in C-reactive protein
time frame: On day of admission or day 1 of treatment and every 2-4 days, till day 14
arm group label: Opaganib + Standard of Care
description: Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care
arm group label: Standard of Care
description: Study participants received Standard of Care
intervention type: Drug
intervention name: Opaganib
description: Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care
arm group label: Opaganib + Standard of Care
other name: Yeliva
other name: ABC294640
intervention type: Drug
intervention name: Standard of Care
description: Study participants received Standard of Care
arm group label: Opaganib + Standard of Care
arm group label: Standard of Care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Coronavirus Infections
submitted: October 22, 2020
returned: October 29, 2020