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

Completed · Phase 4

Conditions studied: Coronavirus Infection, Diabetes

In brief

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.

Key facts

Study ID

NCT04473274

Run by

Samaritan Health Services

People needed

10

Starts

2020-05-21

Expected to finish

2020-12-01

Last updated by the study team

2020-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Good Samaritan Hospital Corvallis — Corvallis, Oregon, United States

Full record on ClinicalTrials.gov

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