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

S

Samaritan Health Services

Status and phase

Completed
Phase 4

Conditions

Diabetes
Coronavirus Infection

Treatments

Drug: Pioglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT04473274
IRB20-042

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Pioglitazone group
Experimental group
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
Treatment:
Drug: Pioglitazone
Matching cohort group
No Intervention group
Description:
Participants will standard of care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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