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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronavirus Infection, Diabetes

Intervention / Treatment
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* Drug: Pioglitazone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Matching cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pioglitazone group<br>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<br>* Receive pioglitazone 15mg - 30mg daily<br>|
| No Intervention: Matching cohort group<br>Participants will standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events outcomes without attribution | Number and type of adverse events | Baseline, until 30 days after last dose | 
| Adverse events attributable | Number and type of adverse events | Baseline, until 30 days after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Disease severity as measured by 7 point ordinal scale | Baseline, until 30 days after last dose | 
| Levels of treatment | Type of oxygen support treatment | Baseline, until 30 days after last dose | 
| d-Dimer | Change from Baseline of d-Dimer | Baseline, until 30 days after last dose | 
| C Reactive Protein | Change from Baseline of CRP | Baseline, until 30 days after last dose | 
| Ferritin | Change from Baseline of Ferritin | Baseline, until 30 days after last dose | 
| Lactate dehydrogenase | Change from Baseline of Lactate dehydrogenase | Baseline, until 30 days after last dose | 
| A1c | Change from Baseline of A1c | Baseline, until 30 days after last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, Diabetes, COVID-19, Coronavirus