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

Purpose

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.

Conditions

  • Coronavirus Infection
  • Diabetes

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Matching cohort
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pioglitazone group 		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
    Receive pioglitazone 15mg - 30mg daily
No Intervention
Matching cohort group 		Participants will standard of care

Recruiting Locations

More Details

NCT ID
NCT04473274
Status
Completed
Sponsor
Samaritan Health Services