<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/NCT04452669</url>
  </required_header>
  <id_info>
    <org_study_id>APC-VPCOV-CLN-001</org_study_id>
    <nct_id>NCT04452669</nct_id>
  </id_info>
  <brief_title>VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation</brief_title>
  <acronym>VPCOVID</acronym>
  <official_title>Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of VentaProst (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aerogen Pharma Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aerogen Pharma Limited</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 investigate whether inhaled epoprostenol given via a breath&#xD;
      actuated delivery system will help improve oxygen levels and treatment outcomes in patients&#xD;
      with COVID-19 who are on mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the potential therapeutic benefit of VentaProst in treating patients&#xD;
      with COVID-19 at risk for respiratory and/ or cardiac/circulatory failure. This is a&#xD;
      double-blind, placebo controlled study of VentaProst in 10 confirmed COVID-19 patients&#xD;
      compared to 10- COVID-19 placebo patients to assess the efficacy and safety of VentaProst&#xD;
      given over 10 days at varying doses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">June 29, 2021</completion_date>
  <primary_completion_date type="Actual">June 29, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Double-blind, placebo controlled study comparing study treatment group to placebo controls who received SOC</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Placebo controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in Respiratory Failure</measure>
    <time_frame>10 days</time_frame>
    <description>Number of participants that require ECMO&#xD;
Number of participants that cannot be extubated within 10 days or&#xD;
A downward change in Oxygenation Index by &gt;15% from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction in Cardiac/Circulatory Failure</measure>
    <time_frame>10 days</time_frame>
    <description>Number of participants that require ECMO&#xD;
Number of participants requiring inotropic therapy&#xD;
Number of participants that require mechanical circulatory support&#xD;
A change in Cardiac Troponin &gt;20% from baseline or&#xD;
A change in BNP &gt;15% from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in Oxygenation</measure>
    <time_frame>10 days</time_frame>
    <description>Number of participants that demonstrate a change in FiO2 by 50% or more.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved Clinical Outcomes</measure>
    <time_frame>28 days</time_frame>
    <description>Number of participants with a reduction in the time to extubation&#xD;
Number of participants with a reduction in ICU days&#xD;
Number of participants with a reduction in hospital days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Study Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 10 days of inhaled epoprostenol delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Up to 10 days of inhaled 0.9% sodium chloride solution delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)</intervention_name>
    <description>VentaProst delivered for up to 10 days via mechanical ventilation at a dose range that may be up or down titrated to a patient's clinical condition.</description>
    <arm_group_label>Placebo Control</arm_group_label>
    <arm_group_label>Study Treatment</arm_group_label>
    <other_name>inhaled Flolan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed COVID-19 positive by RT-PCR test&#xD;
&#xD;
          -  Patients who require invasive mechanical ventilation.&#xD;
&#xD;
          -  Consent or professional consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on ECMO support.&#xD;
&#xD;
          -  Patients receiving another inhalation research medication or inhaled nitric oxide.&#xD;
&#xD;
          -  Not expected to survive for 48 hours.&#xD;
&#xD;
          -  Allergy to Epoprostenol and its diluent&#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>Veronica Franco, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>ARDS</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>Epoprostenol</mesh_term>
    <mesh_term>Tezosentan</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04452669
org study id: APC-VPCOV-CLN-001
nct id: NCT04452669
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to investigate whether inhaled epoprostenol given via a breath
      actuated delivery system will help improve oxygen levels and treatment outcomes in patients
      with COVID-19 who are on mechanical ventilation.
This study will evaluate the potential therapeutic benefit of VentaProst in treating patients
      with COVID-19 at risk for respiratory and/ or cardiac/circulatory failure. This is a
      double-blind, placebo controlled study of VentaProst in 10 confirmed COVID-19 patients
      compared to 10- COVID-19 placebo patients to assess the efficacy and safety of VentaProst
      given over 10 days at varying doses.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-blind, placebo controlled study comparing study treatment group to placebo controls who received SOC
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Placebo controlled
measure: Reduction in Respiratory Failure
time frame: 10 days
description: Number of participants that require ECMO
Number of participants that cannot be extubated within 10 days or
A downward change in Oxygenation Index by >15% from baseline
measure: Reduction in Cardiac/Circulatory Failure
time frame: 10 days
description: Number of participants that require ECMO
Number of participants requiring inotropic therapy
Number of participants that require mechanical circulatory support
A change in Cardiac Troponin >20% from baseline or
A change in BNP >15% from baseline
measure: Improvement in Oxygenation
time frame: 10 days
description: Number of participants that demonstrate a change in FiO2 by 50% or more.
measure: Improved Clinical Outcomes
time frame: 28 days
description: Number of participants with a reduction in the time to extubation
Number of participants with a reduction in ICU days
Number of participants with a reduction in hospital days
arm group label: Study Treatment
arm group type: Experimental
description: Up to 10 days of inhaled epoprostenol delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.
arm group label: Placebo Control
arm group type: Placebo Comparator
description: Up to 10 days of inhaled 0.9% sodium chloride solution delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.
intervention type: Drug
intervention name: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)
description: VentaProst delivered for up to 10 days via mechanical ventilation at a dose range that may be up or down titrated to a patient's clinical condition.
arm group label: Placebo Control
arm group label: Study Treatment
other name: inhaled Flolan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Veronica Franco, MD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Epoprostenol
mesh term: Tezosentan