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

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 Overview

• Status: Completed
• Conditions: Coronavirus Infection; Diabetes
• Intervention / Treatment: Drug: Pioglitazone

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Good Samaritan Hospital Corvallis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Pioglitazone; Receive pioglitazone 15mg - 30mg daily
No Intervention: Matching cohort group; Participants will standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events outcomes without attribution	Number and type of adverse events	Baseline, until 30 days after last dose
Adverse events attributable	Number and type of adverse events	Baseline, until 30 days after last dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samaritan Health Services
• Investigators: Principal Investigator: Brian Delmonaco, MD, Samaritan Health Services

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes; Coronavirus; COVID-19; COVID19
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Signs and Symptoms, Respiratory; Coronavirus Infections; Hypoxia; Hypoglycemic Agents; Physiological Effects of Drugs; Pioglitazone
• Other Study ID Numbers: IRB20-042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No