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

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samaritan Health Services
• Treatments: Pioglitazone

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