<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/NCT04502069</url>
  </required_header>
  <id_info>
    <org_study_id>ABC-112</org_study_id>
    <nct_id>NCT04502069</nct_id>
  </id_info>
  <brief_title>Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen</brief_title>
  <acronym>Opaganib-RHB</acronym>
  <official_title>Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen But Not Mechanical Ventilation</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg&#xD;
      Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on&#xD;
      room air (if earlier than 2 weeks).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients diagnosed with COVID-19 infection by nasopharyngeal viral swab, classified as severe&#xD;
      disease, category 5, by the WHO Ordinal Scale For Clinical Improvement (who require oxygen&#xD;
      support by high flow nasal cannula but do not require mechanical ventilation) at the time of&#xD;
      initiation of therapy will be offered treatment with Opaganib, 500 mg Q12 hours.&#xD;
&#xD;
      Opaganib will be continuously administered for up to 2 weeks, until discharged on room air&#xD;
      (if earlier than 2 weeks), upon voluntary withdrawal is initiated by the patient or when the&#xD;
      physician decides that it is not in the patient's best interest to continue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    To be replaced with a randomized placebo-controlled study.&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to breathing room air</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>To determine the time to breathing room air (off of supplemental oxygen) after the start of opaganib treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Event Grading and Coding</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>All adverse events will be graded according to the revised NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0). If an AE is not listed in the NCI-CTCAE v.5.0, then the Investigator will use the terms: mild, moderate, severe, life-threatening, or death to describe the maximum intensity of the AE.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID-19</condition>
  <condition>Lung Infection</condition>
  <arm_group>
    <arm_group_label>Open label opaganib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>opaganib dosed at 500 mg Q12 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Opaganib</intervention_name>
    <description>500 mg Q12 hours orally</description>
    <arm_group_label>Open label opaganib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with proven COVID-19 infection diagnosed by nasopharyngeal viral swab who&#xD;
             require external oxygen support by high flow nasal cannulas (HFNC) but not mechanical&#xD;
             ventilation.&#xD;
&#xD;
          2. Pneumonia documented by chest x-ray (CXR)&#xD;
&#xD;
          3. The patient or guardian must have signed a written IRB-approved informed consent.&#xD;
&#xD;
          4. A negative pregnancy test (if woman of childbearing potential).&#xD;
&#xD;
          5. Acceptable liver and renal function:&#xD;
&#xD;
               1. Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 2 baseline)&#xD;
&#xD;
               2. AST (SGOT), ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN),&#xD;
&#xD;
               3. Serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline)&#xD;
&#xD;
          6. Acceptable hematologic status:&#xD;
&#xD;
               1. Absolute neutrophil count ≥1000 cells/mm3&#xD;
&#xD;
               2. Platelet count ≥75,000 (plt/mm3) (CTCAE Grade 1 baseline)&#xD;
&#xD;
               3. Hemoglobin ≥ 9 g/dL&#xD;
&#xD;
          7. Clinically acceptable blood sugar control if diabetic&#xD;
&#xD;
          8. EKG showing no QTc prolongation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any co-morbidity that that is considered by the treating investigator as an&#xD;
             unacceptable risk&#xD;
&#xD;
          2. Pregnant or nursing women&#xD;
&#xD;
          3. Unwillingness or inability to comply with procedures required in this protocol.&#xD;
&#xD;
          4. Caution must be exercised in patients who are receiving drugs that were sensitive&#xD;
             substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of&#xD;
             all major CYP450 isozymes that cannot be stopped or replaced with another appropriate&#xD;
             medication or not given for the duration of the clinical study. These patients must be&#xD;
             discussed with the sponsor in order to determine appropriateness for opaganib therapy.&#xD;
&#xD;
          5. Patients who are taking warfarin, apixaban, argatroban or rivaroxaban&#xD;
&#xD;
          6. Patients with QTc prolongation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark L Levitt, MD</last_name>
    <role>Study Director</role>
    <affiliation>RedHill Biopharma Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 9, 2020</last_update_submitted>
  <last_update_submitted_qc>August 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Therapeutic Use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04502069
org study id: ABC-112
nct id: NCT04502069
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Patients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg
      Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on
      room air (if earlier than 2 weeks).
Patients diagnosed with COVID-19 infection by nasopharyngeal viral swab, classified as severe
      disease, category 5, by the WHO Ordinal Scale For Clinical Improvement (who require oxygen
      support by high flow nasal cannula but do not require mechanical ventilation) at the time of
      initiation of therapy will be offered treatment with Opaganib, 500 mg Q12 hours.

      Opaganib will be continuously administered for up to 2 weeks, until discharged on room air
      (if earlier than 2 weeks), upon voluntary withdrawal is initiated by the patient or when the
      physician decides that it is not in the patient's best interest to continue.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to breathing room air
time frame: Up to 2 weeks
description: To determine the time to breathing room air (off of supplemental oxygen) after the start of opaganib treatment.
measure: Adverse Event Grading and Coding
time frame: Up to 2 weeks
description: All adverse events will be graded according to the revised NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0). If an AE is not listed in the NCI-CTCAE v.5.0, then the Investigator will use the terms: mild, moderate, severe, life-threatening, or death to describe the maximum intensity of the AE.
arm group label: Open label opaganib
arm group type: Experimental
description: opaganib dosed at 500 mg Q12 hours
intervention type: Drug
intervention name: Opaganib
description: 500 mg Q12 hours orally
arm group label: Open label opaganib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark L Levitt, MD
role: Study Director
affiliation: RedHill Biopharma Limited
facility: 
country: Israel
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
sharing ipd: No