Coronavirus Infection, Diabetes
Conditions
Keywords
COVID19, Diabetes, COVID-19, Coronavirus
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.
Interventions
DRUGPioglitazone
Receive pioglitazone 15mg - 30mg daily
Sponsors
Samaritan Health Services
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Matching cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events outcomes without attribution | Baseline, until 30 days after last dose | Number and type of adverse events |
| Adverse events attributable | Baseline, until 30 days after last dose | Number and type of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| d-Dimer | Baseline, until 30 days after last dose | Change from Baseline of d-Dimer |
| C Reactive Protein | Baseline, until 30 days after last dose | Change from Baseline of CRP |
| Lactate dehydrogenase | Baseline, until 30 days after last dose | Change from Baseline of Lactate dehydrogenase |
| Clinical improvement | Baseline, until 30 days after last dose | Disease severity as measured by 7 point ordinal scale |
| Levels of treatment | Baseline, until 30 days after last dose | Type of oxygen support treatment |
| Ferritin | Baseline, until 30 days after last dose | Change from Baseline of Ferritin |
| A1c | Baseline, until 30 days after last dose | Change from Baseline of A1c |
Countries
United States
Outcome results
None listed