<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/NCT04473274</url>
  </required_header>
  <id_info>
    <org_study_id>IRB20-042</org_study_id>
    <nct_id>NCT04473274</nct_id>
  </id_info>
  <brief_title>GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study</brief_title>
  <acronym>GOTCHA</acronym>
  <official_title>GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samaritan Health Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samaritan Health Services</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pioglitazone is an approved anti-hyperglycemic medication and is thought to have&#xD;
      anti-inflammatory properties. This study seeks to gather safety and tolerability data related&#xD;
      to pioglitazone when given to patients who require hospital admission for confirmed positive&#xD;
      COVID-19 infections with elevated blood sugar levels as compared to patients who did not&#xD;
      receive pioglitazone during their hospitalization for COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Matching cohort</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events outcomes without attribution</measure>
    <time_frame>Baseline, until 30 days after last dose</time_frame>
    <description>Number and type of adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events attributable</measure>
    <time_frame>Baseline, until 30 days after last dose</time_frame>
    <description>Number and type of adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>Baseline, until 30 days after last dose</time_frame>
    <description>Disease severity as measured by 7 point ordinal scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of treatment</measure>
    <time_frame>Baseline, until 30 days after last dose</time_frame>
    <description>Type of oxygen support treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>d-Dimer</measure>
    <time_frame>Baseline, until 30 days after last dose</time_frame>
    <description>Change from Baseline of d-Dimer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C Reactive Protein</measure>
    <time_frame>Baseline, until 30 days after last dose</time_frame>
    <description>Change from Baseline of CRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin</measure>
    <time_frame>Baseline, until 30 days after last dose</time_frame>
    <description>Change from Baseline of Ferritin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lactate dehydrogenase</measure>
    <time_frame>Baseline, until 30 days after last dose</time_frame>
    <description>Change from Baseline of Lactate dehydrogenase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A1c</measure>
    <time_frame>Baseline, until 30 days after last dose</time_frame>
    <description>Change from Baseline of A1c</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Pioglitazone group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive pioglitazone 15mg to 30mg daily oral or enteral during hospitalization for up to 30 days in addition to standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching cohort group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pioglitazone</intervention_name>
    <description>Receive pioglitazone 15mg - 30mg daily</description>
    <arm_group_label>Pioglitazone group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Laboratory confirmed COVID-19 requiring hospitalization&#xD;
&#xD;
          -  A1c greater than 5.6% as measured in the last 30 days&#xD;
&#xD;
          -  Women of child-bearing potential who agree to use highly effective method of&#xD;
             contraception (defined as either abstinence, condom, diaphragm, and/or oral or&#xD;
             injected hormonal contraception) during dosing and for 30 days after last dose&#xD;
&#xD;
          -  MRSA PCR screen negative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or nursing&#xD;
&#xD;
          -  Congestive Heart Failure all classes (NYHA Class I, II, III or IV)&#xD;
&#xD;
          -  Liver enzyme ALT greater than 2.5 times upper limit of normal&#xD;
&#xD;
          -  End stage renal disease&#xD;
&#xD;
          -  Hypersensitivity or allergy to a TZD (thiazolidinedione)&#xD;
&#xD;
          -  Active bladder cancer&#xD;
&#xD;
          -  Currently taking a beta blocker, a CYP2C8 inhibitor or inducer such as gemfibrozil or&#xD;
             rifampin, a TZD&#xD;
&#xD;
          -  Other current or historical illness that in the opinion of the investigator at&#xD;
             attending provider would interfere with the subject's ability to complete the study or&#xD;
             make it not in the best interest of the subject to participate&#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>Brian Delmonaco, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samaritan Health Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Good Samaritan Hospital Corvallis</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97330</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>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>December 2, 2020</last_update_submitted>
  <last_update_submitted_qc>December 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID19</keyword>
  <keyword>Diabetes</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Coronavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pioglitazone</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/NCT04473274
org study id: IRB20-042
nct id: NCT04473274
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Pioglitazone is an approved anti-hyperglycemic medication and is thought to have
      anti-inflammatory properties. This study seeks to gather safety and tolerability data related
      to pioglitazone when given to patients who require hospital admission for confirmed positive
      COVID-19 infections with elevated blood sugar levels as compared to patients who did not
      receive pioglitazone during their hospitalization for COVID-19.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Matching cohort
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events outcomes without attribution
time frame: Baseline, until 30 days after last dose
description: Number and type of adverse events
measure: Adverse events attributable
time frame: Baseline, until 30 days after last dose
description: Number and type of adverse events
measure: Clinical improvement
time frame: Baseline, until 30 days after last dose
description: Disease severity as measured by 7 point ordinal scale
measure: Levels of treatment
time frame: Baseline, until 30 days after last dose
description: Type of oxygen support treatment
measure: d-Dimer
time frame: Baseline, until 30 days after last dose
description: Change from Baseline of d-Dimer
measure: C Reactive Protein
time frame: Baseline, until 30 days after last dose
description: Change from Baseline of CRP
measure: Ferritin
time frame: Baseline, until 30 days after last dose
description: Change from Baseline of Ferritin
measure: Lactate dehydrogenase
time frame: Baseline, until 30 days after last dose
description: Change from Baseline of Lactate dehydrogenase
measure: A1c
time frame: Baseline, until 30 days after last dose
description: Change from Baseline of A1c
arm group label: Pioglitazone group
arm group type: Experimental
description: Participants will receive pioglitazone 15mg to 30mg daily oral or enteral during hospitalization for up to 30 days in addition to standard of care
arm group label: Matching cohort group
arm group type: No Intervention
description: Participants will standard of care
intervention type: Drug
intervention name: Pioglitazone
description: Receive pioglitazone 15mg - 30mg daily
arm group label: Pioglitazone group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Delmonaco, MD
role: Principal Investigator
affiliation: Samaritan Health Services
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronavirus Infections
mesh term: Hypoxia
mesh term: Pioglitazone
sharing ipd: No