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

Samaritan Health Services

Status and phase

Completed

Phase 4

Conditions

Diabetes

Coronavirus Infection

Treatments

Drug: Pioglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT04473274

IRB20-042

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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