GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study
NCT ID: NCT04473274
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
10 participants
INTERVENTIONAL
2020-05-21
2020-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Pioglitazone
Receive pioglitazone 15mg - 30mg daily
Matching cohort group
Participants will standard of care
No interventions assigned to this group
Interventions
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Pioglitazone
Receive pioglitazone 15mg - 30mg daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Samaritan Health Services
OTHER
Responsible Party
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Principal Investigators
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Brian Delmonaco, MD
Role: PRINCIPAL_INVESTIGATOR
Samaritan Health Services
Locations
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Good Samaritan Hospital Corvallis
Corvallis, Oregon, United States
Countries
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Other Identifiers
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IRB20-042
Identifier Type: -
Identifier Source: org_study_id