<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/NCT04410354</url>
  </required_header>
  <id_info>
    <org_study_id>VC-02-01</org_study_id>
    <nct_id>NCT04410354</nct_id>
  </id_info>
  <brief_title>Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19</brief_title>
  <official_title>A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination With Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ViralClear Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ViralClear Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral&#xD;
      solution when administered in combination with remdesivir in adult patients with advanced&#xD;
      COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase 2 randomized, double-blind, placebo-controlled study will enroll approximately 80&#xD;
      adult patients with advanced coronavirus disease 2019 (COVID-19). Approximately 80 patients&#xD;
      will be randomized 1:1 to receive oral administration of MMPD + remdesivir or placebo +&#xD;
      remdesivir. The first 40 patients will have a score of 3 or 4 on the National Institute of&#xD;
      Allergy and Infectious Disease (NIAID) 8-point ordinal scale and at least one of the&#xD;
      following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at&#xD;
      rest or with exertion, confusion or symptoms of severe lower respiratory symptoms; the final&#xD;
      40 patients will have a score of 3 on the NIAID scale.&#xD;
&#xD;
      Study subjects will undergo screening evaluations prior to the first dose of study drug.&#xD;
      Study drug treatment (MMPD or placebo) will continue for 10 days, unless the patient is&#xD;
      discharged from the hospital before completing the 10-day randomized treatment period. Both&#xD;
      treatment arms will also receive remdesivir per the Emergency Use Authorization labeling.&#xD;
      Evaluations will be performed on Days 0-10 and every day thereafter until the subject no&#xD;
      longer requires any form of respiratory support or they reach the last planned day of&#xD;
      in-person study assessments and still require respiratory support. The final in-person study&#xD;
      evaluations will be performed 4 weeks after completion of study drug (MMPD or placebo)&#xD;
      treatment (Day 37). The final study evaluation will be a telephone call on Day 56.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Failure to meet primary endpoint&#xD;
  </why_stopped>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Eligible study subjects will be randomized 1:1 to receive oral administration of study drug or placebo. Both treatment arms will also receive remdesivir.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Pharmacy prepares medications that are coded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects not hospitalized or, if hospitalized, free of respiratory failure</measure>
    <time_frame>Day 0 to Day 28</time_frame>
    <description>Proportion of subjects alive at Day 28 who are not hospitalized or if hospitalized are free of respiratory failure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Day 0 to Day 56</time_frame>
    <description>Number of Adverse Events (AEs) and number &amp; percentage of subjects experiencing AEs after administration of the first dose of study drug</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale</measure>
    <time_frame>Day 0 to Day 28</time_frame>
    <description>Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature</measure>
    <time_frame>Day 0 to Day 37</time_frame>
    <description>Duration of fever</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Day 0 to Day 56</time_frame>
    <description>Number of deaths</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation</measure>
    <time_frame>Day 0 to Day 56</time_frame>
    <description>Need and duration of mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasopressor Support</measure>
    <time_frame>Day 0 to Day 56</time_frame>
    <description>Duration of vasopressor support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen Therapy</measure>
    <time_frame>Day 0 to Day 37</time_frame>
    <description>Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cessation of Viral Shedding</measure>
    <time_frame>Day 0 to Day 37</time_frame>
    <description>Time to cessation of viral shedding based on absence of SARS-CoV-2 in a PCR based COVID-19 test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Oxygen Saturation/Fraction of Inspired Oxygen</measure>
    <time_frame>Day 0 to Day 37</time_frame>
    <description>Change in SpO2/FiO2</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>MMPD + remdesivir</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study subjects will receive MMPD oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + remdesivir</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Study subjects will receive matching placebo oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Merimepodib</intervention_name>
    <description>400 mg (total daily dose of 1200 mg) for 10 days</description>
    <arm_group_label>MMPD + remdesivir</arm_group_label>
    <other_name>VX-497</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo</intervention_name>
    <description>0 mg (total daily dose of 0 mg) for 10 days</description>
    <arm_group_label>Placebo + remdesivir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remdesivir</intervention_name>
    <description>200 mg loading dose on Day 0 followed by 100 mg daily dose for 4 days. If a subject does not demonstrate clinical improvement, 100 mg daily dose may be extended for up to 5 additional days (for a total of up to 10 days)</description>
    <arm_group_label>MMPD + remdesivir</arm_group_label>
    <arm_group_label>Placebo + remdesivir</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  Confirmed SARS-CoV-2 viral infection&#xD;
&#xD;
          -  Advanced COVID-19 with score of 3 or 4 on NIAID scale (first 40 patients) or score of&#xD;
             3 on NIAID scale (last 40 patient&#xD;
&#xD;
          -  Has at least one of the following: fever, cough, sore throat, malaise, headache,&#xD;
             muscle pain, shortness of breath, confusion or severe lower respiratory symptoms&#xD;
&#xD;
          -  Off antiviral medications at least 24 hours prior to first dose of study drug (except&#xD;
             for remdesivir)&#xD;
&#xD;
          -  Able to provide consent&#xD;
&#xD;
          -  Agree to appropriate methods of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In critical condition or has ARDS&#xD;
&#xD;
          -  On invasive mechanical ventilation or ECMO&#xD;
&#xD;
          -  Bacterial or fungal infection&#xD;
&#xD;
          -  Pregnant or lactating (women)&#xD;
&#xD;
          -  ALT &gt;5x ULN, bilirubin &gt;2x ULN, INR outside of normal limits at screening&#xD;
&#xD;
          -  eGFR &lt;30 mL/min&#xD;
&#xD;
          -  Clinically relevant serious co-morbid medical conditions&#xD;
&#xD;
          -  Treatment with any immunosuppressive therapy within 30 days prior to screening&#xD;
&#xD;
          -  Treatment with another investigational drug within 30 days or 5 half-lives of drug&#xD;
             prior to screening&#xD;
&#xD;
          -  Prior treatment with the study drug (MMPD) or treatment with remdesivir more than 24&#xD;
             hours prior to the first randomized dose of study drug&#xD;
&#xD;
          -  Known hypersensitivity to the inactive ingredients in the study drug (MMPD or placebo)&#xD;
             or any ingredient of remdesivir&#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>Andrew Badley, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Health System / Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Health System / Overlook Medical Center</name>
      <address>
        <city>Summit</city>
        <state>New Jersey</state>
        <zip>07901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. David's South Austin Medical Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. David's Medical Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCA Houston Healthcare Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCA Houston Healthcare Mainland</name>
      <address>
        <city>Texas City</city>
        <state>Texas</state>
        <zip>77591</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>April 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>December 4, 2020</last_update_submitted>
  <last_update_submitted_qc>December 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus</keyword>
  <keyword>Advanced Coronavirus Disease 2019</keyword>
  <keyword>SARS-Cov-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remdesivir</mesh_term>
  </intervention_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/NCT04410354
org study id: VC-02-01
nct id: NCT04410354
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral
      solution when administered in combination with remdesivir in adult patients with advanced
      COVID-19.
This phase 2 randomized, double-blind, placebo-controlled study will enroll approximately 80
      adult patients with advanced coronavirus disease 2019 (COVID-19). Approximately 80 patients
      will be randomized 1:1 to receive oral administration of MMPD + remdesivir or placebo +
      remdesivir. The first 40 patients will have a score of 3 or 4 on the National Institute of
      Allergy and Infectious Disease (NIAID) 8-point ordinal scale and at least one of the
      following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at
      rest or with exertion, confusion or symptoms of severe lower respiratory symptoms; the final
      40 patients will have a score of 3 on the NIAID scale.

      Study subjects will undergo screening evaluations prior to the first dose of study drug.
      Study drug treatment (MMPD or placebo) will continue for 10 days, unless the patient is
      discharged from the hospital before completing the 10-day randomized treatment period. Both
      treatment arms will also receive remdesivir per the Emergency Use Authorization labeling.
      Evaluations will be performed on Days 0-10 and every day thereafter until the subject no
      longer requires any form of respiratory support or they reach the last planned day of
      in-person study assessments and still require respiratory support. The final in-person study
      evaluations will be performed 4 weeks after completion of study drug (MMPD or placebo)
      treatment (Day 37). The final study evaluation will be a telephone call on Day 56.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Eligible study subjects will be randomized 1:1 to receive oral administration of study drug or placebo. Both treatment arms will also receive remdesivir.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Pharmacy prepares medications that are coded
measure: Number of subjects not hospitalized or, if hospitalized, free of respiratory failure
time frame: Day 0 to Day 28
description: Proportion of subjects alive at Day 28 who are not hospitalized or if hospitalized are free of respiratory failure
measure: Adverse Events
time frame: Day 0 to Day 56
description: Number of Adverse Events (AEs) and number & percentage of subjects experiencing AEs after administration of the first dose of study drug
measure: National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale
time frame: Day 0 to Day 28
description: Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities
measure: Temperature
time frame: Day 0 to Day 37
description: Duration of fever
measure: Death
time frame: Day 0 to Day 56
description: Number of deaths
measure: Mechanical ventilation
time frame: Day 0 to Day 56
description: Need and duration of mechanical ventilation
measure: Vasopressor Support
time frame: Day 0 to Day 56
description: Duration of vasopressor support
measure: Oxygen Therapy
time frame: Day 0 to Day 37
description: Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula
measure: Cessation of Viral Shedding
time frame: Day 0 to Day 37
description: Time to cessation of viral shedding based on absence of SARS-CoV-2 in a PCR based COVID-19 test
measure: Change in Oxygen Saturation/Fraction of Inspired Oxygen
time frame: Day 0 to Day 37
description: Change in SpO2/FiO2
arm group label: MMPD + remdesivir
arm group type: Active Comparator
description: Study subjects will receive MMPD oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days).
arm group label: Placebo + remdesivir
arm group type: Placebo Comparator
description: Study subjects will receive matching placebo oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days).
intervention type: Drug
intervention name: Merimepodib
description: 400 mg (total daily dose of 1200 mg) for 10 days
arm group label: MMPD + remdesivir
other name: VX-497
intervention type: Drug
intervention name: Matching Placebo
description: 0 mg (total daily dose of 0 mg) for 10 days
arm group label: Placebo + remdesivir
intervention type: Drug
intervention name: Remdesivir
description: 200 mg loading dose on Day 0 followed by 100 mg daily dose for 4 days. If a subject does not demonstrate clinical improvement, 100 mg daily dose may be extended for up to 5 additional days (for a total of up to 10 days)
arm group label: MMPD + remdesivir
arm group label: Placebo + remdesivir
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Badley, MD
role: Study Director
affiliation: Mayo Clinic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Remdesivir
sharing ipd: No