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

Diabetes Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473274
• Other study ID #: IRB20-042
• Status: Completed
• Phase: Phase 4
• Start date: May 21, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: Samaritan Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Diabetes
• Hypoxia
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Pioglitazone
Receive pioglitazone 15mg - 30mg daily

Locations

Country	Name	City	State
United States	Good Samaritan Hospital Corvallis	Corvallis	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Samaritan Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events outcomes without attribution	Number and type of adverse events	Baseline, until 30 days after last dose
Primary	Adverse events attributable	Number and type of adverse events	Baseline, until 30 days after last dose
Secondary	Clinical improvement	Disease severity as measured by 7 point ordinal scale	Baseline, until 30 days after last dose
Secondary	Levels of treatment	Type of oxygen support treatment	Baseline, until 30 days after last dose
Secondary	d-Dimer	Change from Baseline of d-Dimer	Baseline, until 30 days after last dose
Secondary	C Reactive Protein	Change from Baseline of CRP	Baseline, until 30 days after last dose
Secondary	Ferritin	Change from Baseline of Ferritin	Baseline, until 30 days after last dose
Secondary	Lactate dehydrogenase	Change from Baseline of Lactate dehydrogenase	Baseline, until 30 days after last dose
Secondary	A1c	Change from Baseline of A1c	Baseline, until 30 days after last dose