Clinical trial NCT04473274: GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study
Official title: GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronavirus Infection
Diabetes
Keywords: COVID19
Diabetes
COVID-19
Coronavirus
Lead sponsor: Samaritan Health Services
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Matching cohort
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adverse events outcomes without attribution
timeFrame: Baseline, until 30 days after last dose
measure: Adverse events attributable
timeFrame: Baseline, until 30 days after last dose
Secondary outcomes:
measure: Clinical improvement
timeFrame: Baseline, until 30 days after last dose
measure: Levels of treatment
timeFrame: Baseline, until 30 days after last dose
measure: d-Dimer
timeFrame: Baseline, until 30 days after last dose
measure: C Reactive Protein
timeFrame: Baseline, until 30 days after last dose
measure: Ferritin
timeFrame: Baseline, until 30 days after last dose
measure: Lactate dehydrogenase
timeFrame: Baseline, until 30 days after last dose
measure: A1c
timeFrame: Baseline, until 30 days after last dose
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Good Samaritan Hospital Corvallis
state: Oregon
Study officials:
affiliation: Samaritan Health Services
name: Brian Delmonaco, MD
role: PRINCIPAL_INVESTIGATOR
References: