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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone group | Experimental | Participants will receive pioglitazone 15mg to 30mg daily oral or enteral during hospitalization for up to 30 days in addition to standard of care |
|
| Matching cohort group | No Intervention | Participants will standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Receive pioglitazone 15mg - 30mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events outcomes without attribution | Number and type of adverse events | Baseline, until 30 days after last dose |
| Adverse events attributable | Number and type of adverse events | Baseline, until 30 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement | Disease severity as measured by 7 point ordinal scale | Baseline, until 30 days after last dose |
| Levels of treatment | Type of oxygen support treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Delmonaco, MD | Samaritan Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital Corvallis | Corvallis | Oregon | 97330 | United States |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D003920 | Diabetes Mellitus |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Matching cohort
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| Baseline, until 30 days after last dose |
| d-Dimer | Change from Baseline of d-Dimer | Baseline, until 30 days after last dose |
| C Reactive Protein | Change from Baseline of CRP | Baseline, until 30 days after last dose |
| Ferritin | Change from Baseline of Ferritin | Baseline, until 30 days after last dose |
| Lactate dehydrogenase | Change from Baseline of Lactate dehydrogenase | Baseline, until 30 days after last dose |
| A1c | Change from Baseline of A1c | Baseline, until 30 days after last dose |
| D007239 |
| Infections |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |