GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse events outcomes without attribution
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Adverse events outcomes without attribution
时间窗: Baseline, until 30 days after last dose
Number and type of adverse events
Adverse events attributable
时间窗: Baseline, until 30 days after last dose
Number and type of adverse events
次要结局
- A1c(Baseline, until 30 days after last dose)
- d-Dimer(Baseline, until 30 days after last dose)
- Ferritin(Baseline, until 30 days after last dose)
- Clinical improvement(Baseline, until 30 days after last dose)
- Levels of treatment(Baseline, until 30 days after last dose)
- Lactate dehydrogenase(Baseline, until 30 days after last dose)
- C Reactive Protein(Baseline, until 30 days after last dose)