Trial | NCT04473274  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
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.
Study Started
May 21
2020
Primary Completion
Nov 01
2020
Study Completion
Dec 01
2020
Last Update
Dec 04
2020

Drug Pioglitazone

Receive pioglitazone 15mg - 30mg daily

Pioglitazone group Experimental

Participants will receive pioglitazone 15mg to 30mg daily oral or enteral during hospitalization for up to 30 days in addition to standard of care

Matching cohort group No Intervention

Participants will standard of care

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
No Results Posted