<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/NCT04456452</url>
  </required_header>
  <id_info>
    <org_study_id>AP-016</org_study_id>
    <nct_id>NCT04456452</nct_id>
  </id_info>
  <brief_title>Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation</brief_title>
  <official_title>A Randomized Controlled Trial to Evaluate the Safety of Intravenous Ampion™ in Adult COVID-19 Patients Requiring Oxygen Supplementation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ampio Pharmaceuticals. Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ampio Pharmaceuticals. Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV&#xD;
      Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19&#xD;
      infection who require supplemental oxygen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 8, 2020</primary_completion_date>
  <phase>Phase 1</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of adverse events</measure>
    <time_frame>Primary endpoint at day 5</time_frame>
    <description>Incidence and severity of adverse events</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Ampion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ampion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard of Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ampion</intervention_name>
    <description>Ampion, administered by intravenous infusion</description>
    <arm_group_label>Ampion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of Care</description>
    <arm_group_label>Ampion</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, 18 years to 89 years old (inclusive).&#xD;
&#xD;
          2. Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming&#xD;
             infection with SARS-COV-2.&#xD;
&#xD;
          3. Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) &lt;88%, labored&#xD;
             breathing, increased respiratory rate, dyspnea on rest or exertion).&#xD;
&#xD;
          4. A signed informed consent form from the patient or the patient's legal representative&#xD;
             must be available.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. In the opinion of the clinical team, progression to death is imminent and inevitable,&#xD;
             irrespective of the provision of treatments.&#xD;
&#xD;
          2. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal&#xD;
             failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).&#xD;
&#xD;
          3. Patient is on chronic immunosuppressive medication.&#xD;
&#xD;
          4. As a result of the medical review and screening investigation, the Principal&#xD;
             Investigator considers the patient unfit for the study.&#xD;
&#xD;
          5. A history of allergic reactions to human albumin (reaction to non-human albumin such&#xD;
             as egg albumin is not an exclusion criterion) or excipients in 5% human albumin&#xD;
             (N-acetyltryptophan, sodium caprylate).&#xD;
&#xD;
          6. Patient has known pregnancy or is currently breastfeeding.&#xD;
&#xD;
          7. Participation in another clinical trial.&#xD;
&#xD;
          8. Baseline QT prolongation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</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>COVID-19</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 25, 2022</submitted>
    <returned>July 18, 2023</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/NCT04456452
org study id: AP-016
nct id: NCT04456452
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV
      Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19
      infection who require supplemental oxygen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Incidence and severity of adverse events
time frame: Primary endpoint at day 5
description: Incidence and severity of adverse events
arm group label: Ampion
arm group type: Experimental
description: Ampion
arm group label: Standard of Care
arm group type: Other
description: Standard of Care
intervention type: Biological
intervention name: Ampion
description: Ampion, administered by intravenous infusion
arm group label: Ampion
intervention type: Other
intervention name: Standard of Care
description: Standard of Care
arm group label: Ampion
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
submitted: August 25, 2022
returned: July 18, 2023