Status:
COMPLETED
GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study
Lead Sponsor:
Samaritan Health Services
Conditions:
Coronavirus Infection
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 give...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04473274
Start Date
May 21 2020
End Date
December 1 2020
Last Update
December 4 2020
Active Locations (1)
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1
Good Samaritan Hospital Corvallis
Corvallis, Oregon, United States, 97330