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

NCT04473274 | Completed Phase 4 FDA Drug

• 1 other identifier: IRB20-042
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection; Diabetes

Keywords

COVID19; Diabetes; COVID-19; Coronavirus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Clinical improvement

  Baseline, until 30 days after last dose

• Levels of treatment

  Baseline, until 30 days after last dose

• d-Dimer

  Baseline, until 30 days after last dose

• C Reactive Protein

  Baseline, until 30 days after last dose

• Ferritin

  Baseline, until 30 days after last dose

Study Arms (2)

Pioglitazone group

EXPERIMENTAL

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

Matching cohort group

NO INTERVENTION

Participants will standard of care

Interventions

Pioglitazone DRUG

Receive pioglitazone 15mg - 30mg daily

Pioglitazone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samaritan Health Services: lead

Study Sites (1)

Good Samaritan Hospital Corvallis

Corvallis, Oregon, 97330, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; Diabetes Mellitus; COVID-19

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Brian Delmonaco, MD

  Samaritan Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Matching cohort

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 16, 2020
• Study Start: May 21, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)