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

Sponsor
Samaritan Health Services (Other)
Overall Status
Completed
CT.gov ID
NCT04473274
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
6.4
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Matching cohortMatching cohort
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study
Actual Study Start Date :
May 21, 2020
Actual Primary Completion Date :
Nov 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Adverse events outcomes without attribution [Baseline, until 30 days after last dose]

    Number and type of adverse events

  2. Adverse events attributable [Baseline, until 30 days after last dose]

    Number and type of adverse events

Secondary Outcome Measures

  1. Clinical improvement [Baseline, until 30 days after last dose]

    Disease severity as measured by 7 point ordinal scale

  2. Levels of treatment [Baseline, until 30 days after last dose]

    Type of oxygen support treatment

  3. d-Dimer [Baseline, until 30 days after last dose]

    Change from Baseline of d-Dimer

  4. C Reactive Protein [Baseline, until 30 days after last dose]

    Change from Baseline of CRP

  5. Ferritin [Baseline, until 30 days after last dose]

    Change from Baseline of Ferritin

  6. Lactate dehydrogenase [Baseline, until 30 days after last dose]

    Change from Baseline of Lactate dehydrogenase

  7. A1c [Baseline, until 30 days after last dose]

    Change from Baseline of A1c

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Good Samaritan Hospital Corvallis Corvallis Oregon United States 97330

Sponsors and Collaborators

  • Samaritan Health Services

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samaritan Health Services
ClinicalTrials.gov Identifier:
NCT04473274
Other Study ID Numbers:
  • IRB20-042
First Posted:
Jul 16, 2020
Last Update Posted:
Dec 4, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Samaritan Health Services
COVID19
Diabetes
COVID-19
Coronavirus
Additional relevant MeSH terms:
Coronavirus Infections
Hypoxia
Pioglitazone

Study Results

No Results Posted as of Dec 4, 2020