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OpenTrials
Completed

NCT Number: NCT04473274

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

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.

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Key information

Conditions

Coronavirus Infection COVID-19 Coronaviridae Infections Coronavirus Infections Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infections Lung Diseases Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Good Samaritan Hospital Corvallis

Corvallis, Oregon, 97330, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

Drug

Receive pioglitazone 15mg - 30mg daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Samaritan Health Services

Other

Registry information

Acronym: GOTCHA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2020
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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