COVID-FISETIN: A Phase 2 Placebo-Controlled Pilot Study in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Excessive Inflammatory Response in Hospitalized Adults
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in oxygenation status
研究概览
简要总结
The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction.
详细描述
To determine if Fisetin treatment can prevent deterioration of oxygenation status as measured by S/F ratio: SpO2/ FiO2, as well as prevent deterioration in physical function (frailty) and hyper-inflammation, other measures of oxygenation status (progression to supplemental oxygen requirement, assisted breathing/ ventilation), and progression from mild/ moderate to severe/ critical proven SARS-CoV-2 infection in hospitalized patients and to evaluate the safety and tolerability of Fisetin in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment Group
Subjects will receive treatment drug Fisetin
干预措施: Fisetin (Drug)
Placebo Group
Subjects will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in oxygenation status
时间窗: baseline, Day 3, 7, 10, 14, 17 and 30; Months 3 and 6
change in oxygenation levels as measured by S/F ratio (SPO2/FiO2)
Serious Adverse Events
时间窗: 6 months
Number of participants to experience serious adverse events and hypersensitivity reactions.
次要结局
- CoV Severity Category(6 months)
研究者
Paschalis Vergidis
Principal Investigator
Mayo Clinic