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GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study (GOTCHA)

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ClinicalTrials.gov Identifier: NCT04473274
Recruitment Status : Completed
First Posted : July 16, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Samaritan Health Services

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Diabetes Drug: Pioglitazone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Matching cohort
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study
Actual Study Start Date : May 21, 2020
Actual Primary Completion Date : November 1, 2020
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pioglitazone group
Participants will receive pioglitazone 15mg to 30mg daily oral or enteral during hospitalization for up to 30 days in addition to standard of care
Drug: Pioglitazone
Receive pioglitazone 15mg - 30mg daily

No Intervention: Matching cohort group
Participants will standard of care



Primary Outcome Measures :
  1. Adverse events outcomes without attribution [ Time Frame: Baseline, until 30 days after last dose ]
    Number and type of adverse events

  2. Adverse events attributable [ Time Frame: Baseline, until 30 days after last dose ]
    Number and type of adverse events


Secondary Outcome Measures :
  1. Clinical improvement [ Time Frame: Baseline, until 30 days after last dose ]
    Disease severity as measured by 7 point ordinal scale

  2. Levels of treatment [ Time Frame: Baseline, until 30 days after last dose ]
    Type of oxygen support treatment

  3. d-Dimer [ Time Frame: Baseline, until 30 days after last dose ]
    Change from Baseline of d-Dimer

  4. C Reactive Protein [ Time Frame: Baseline, until 30 days after last dose ]
    Change from Baseline of CRP

  5. Ferritin [ Time Frame: Baseline, until 30 days after last dose ]
    Change from Baseline of Ferritin

  6. Lactate dehydrogenase [ Time Frame: Baseline, until 30 days after last dose ]
    Change from Baseline of Lactate dehydrogenase

  7. A1c [ Time Frame: Baseline, until 30 days after last dose ]
    Change from Baseline of A1c



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Laboratory confirmed COVID-19 requiring hospitalization
  • A1c greater than 5.6% as measured in the last 30 days
  • Women of child-bearing potential who agree to use highly effective method of contraception (defined as either abstinence, condom, diaphragm, and/or oral or injected hormonal contraception) during dosing and for 30 days after last dose
  • MRSA PCR screen negative

Exclusion Criteria:

  • Pregnancy or nursing
  • Congestive Heart Failure all classes (NYHA Class I, II, III or IV)
  • Liver enzyme ALT greater than 2.5 times upper limit of normal
  • End stage renal disease
  • Hypersensitivity or allergy to a TZD (thiazolidinedione)
  • Active bladder cancer
  • Currently taking a beta blocker, a CYP2C8 inhibitor or inducer such as gemfibrozil or rifampin, a TZD
  • Other current or historical illness that in the opinion of the investigator at attending provider would interfere with the subject's ability to complete the study or make it not in the best interest of the subject to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473274


Locations
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United States, Oregon
Good Samaritan Hospital Corvallis
Corvallis, Oregon, United States, 97330
Sponsors and Collaborators
Samaritan Health Services
Investigators
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Principal Investigator: Brian Delmonaco, MD Samaritan Health Services
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Responsible Party: Samaritan Health Services
ClinicalTrials.gov Identifier: NCT04473274    
Other Study ID Numbers: IRB20-042
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Samaritan Health Services:
COVID19
Diabetes
COVID-19
Coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Hypoxia
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Signs and Symptoms, Respiratory
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs