search
Back to results

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

Primary Purpose

Coronavirus Infection, Diabetes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pioglitazone
Sponsored by
Samaritan Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring COVID19, Diabetes, COVID-19, Coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Good Samaritan Hospital Corvallis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pioglitazone group

Matching cohort group

Arm Description

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

Participants will standard of care

Outcomes

Primary Outcome Measures

Adverse events outcomes without attribution
Number and type of adverse events
Adverse events attributable
Number and type of adverse events

Secondary Outcome Measures

Clinical improvement
Disease severity as measured by 7 point ordinal scale
Levels of treatment
Type of oxygen support treatment
d-Dimer
Change from Baseline of d-Dimer
C Reactive Protein
Change from Baseline of CRP
Ferritin
Change from Baseline of Ferritin
Lactate dehydrogenase
Change from Baseline of Lactate dehydrogenase
A1c
Change from Baseline of A1c

Full Information

First Posted
June 22, 2020
Last Updated
December 2, 2020
Sponsor
Samaritan Health Services
search

1. Study Identification

Unique Protocol Identification Number
NCT04473274
Brief Title
GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study
Acronym
GOTCHA
Official Title
GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samaritan Health Services

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Diabetes
Keywords
COVID19, Diabetes, COVID-19, Coronavirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Matching cohort
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone group
Arm Type
Experimental
Arm Description
Participants will receive pioglitazone 15mg to 30mg daily oral or enteral during hospitalization for up to 30 days in addition to standard of care
Arm Title
Matching cohort group
Arm Type
No Intervention
Arm Description
Participants will standard of care
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
Receive pioglitazone 15mg - 30mg daily
Primary Outcome Measure Information:
Title
Adverse events outcomes without attribution
Description
Number and type of adverse events
Time Frame
Baseline, until 30 days after last dose
Title
Adverse events attributable
Description
Number and type of adverse events
Time Frame
Baseline, until 30 days after last dose
Secondary Outcome Measure Information:
Title
Clinical improvement
Description
Disease severity as measured by 7 point ordinal scale
Time Frame
Baseline, until 30 days after last dose
Title
Levels of treatment
Description
Type of oxygen support treatment
Time Frame
Baseline, until 30 days after last dose
Title
d-Dimer
Description
Change from Baseline of d-Dimer
Time Frame
Baseline, until 30 days after last dose
Title
C Reactive Protein
Description
Change from Baseline of CRP
Time Frame
Baseline, until 30 days after last dose
Title
Ferritin
Description
Change from Baseline of Ferritin
Time Frame
Baseline, until 30 days after last dose
Title
Lactate dehydrogenase
Description
Change from Baseline of Lactate dehydrogenase
Time Frame
Baseline, until 30 days after last dose
Title
A1c
Description
Change from Baseline of A1c
Time Frame
Baseline, until 30 days after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Delmonaco, MD
Organizational Affiliation
Samaritan Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Good Samaritan Hospital Corvallis
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs