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

Phase 4

Completed

• Conditions: Coronavirus Infection; Diabetes
• Interventions: Drug: Pioglitazone

• Registration Number: NCT04473274
• Lead Sponsor: Samaritan Health Services

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-21
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-16
• Primary Completion: 2020-11-01
• Status Verified: 2020-12
• Study Completion: 2020-12-01
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Adverse events outcomes without attribution	Baseline, until 30 days after last dose	Number and type of adverse events
Adverse events attributable	Baseline, until 30 days after last dose	Number and type of adverse events

Secondary Outcome Measures

Name	Time	Method
A1c	Baseline, until 30 days after last dose	Change from Baseline of A1c
d-Dimer	Baseline, until 30 days after last dose	Change from Baseline of d-Dimer
Ferritin	Baseline, until 30 days after last dose	Change from Baseline of Ferritin
Clinical improvement	Baseline, until 30 days after last dose	Disease severity as measured by 7 point ordinal scale
Levels of treatment	Baseline, until 30 days after last dose	Type of oxygen support treatment
Lactate dehydrogenase	Baseline, until 30 days after last dose	Change from Baseline of Lactate dehydrogenase
C Reactive Protein	Baseline, until 30 days after last dose	Change from Baseline of CRP

Trial Locations

Locations (1)

Good Samaritan Hospital Corvallis; 🇺🇸 Corvallis, Oregon, United States