COVFIS-HOME: A Phase 2 Placebo-Controlled Pilot Study in COVID-19 of Fisetin to Alleviate Dysfunction and Decrease Complications in At-Risk Outpatients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- World Health Organization (WHO) Ordinal Scale Score
研究概览
简要总结
The purpose of this study is to test whether Fisetin, a senolytic drug can assist in the reduction of complications in patients with COVID-19 infection.
详细描述
To determine whether short-term treatment with Fisetin reduces the rate of death and long term complications related to COVID-19 and to determine the safety of treatment with 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
- •Males and females, at least 18 years of age, capable and willing to provide informed consent;
- •Patient must have received a diagnosis of COVID-19 infection within the last 3 days;
- •Outpatient setting (not currently hospitalized);
- •Patient must possess at least one of the following high-risk criteria: 60 years or more of age, obesity (BMI ≥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease (including asthma, chronic obstructive pulmonary disease, or present or past smoking), known heart failure, known coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, the combination of high neutrophil count and low lymphocyte count;
- •Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion;
- •Patient or their caregiver must be able and willing to comply with the requirements of this study protocol.
排除标准
- •Patient currently hospitalized or under immediate consideration for hospitalization;
- •Patient currently in shock or with hemodynamic instability;
- •Patient with severe hepatic disease (as per clinical judgement) and liver enzymes >10x the upper limit of normal;
- •Female patient who is pregnant, breast-feeding, or is considering becoming pregnant during the study or for 1 day after the last dose of study medication;
- •Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases);
- •On Warfarin therapy;
- •Patient with a history of an allergic reaction or significant sensitivity to Fisetin;
- •Patient undergoing chemotherapy for cancer;
- •Patient is considered by the investigator, for any reason, to be an unsuitable study candidate.
研究组 & 干预措施
Treatment Group
Subjects will receive treatment drug Fisetin
干预措施: Fisetin (Drug)
Placebo
Subjects will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
World Health Organization (WHO) Ordinal Scale Score
时间窗: 60 days
The number of subjects who scored as No limitations (Score 0-1) and Ambulatory, limitations (score 2-8) on the WHO Ordinal Scale score. The 9 points of the WHO ordinal clinical severity scale are as follows: 0: no clinical or virological evidence of infection; 1: ambulatory, no activity limitation; 2: ambulatory, activity limitation; 3: hospitalized, no oxygen therapy; 4: hospitalized, oxygen mask or nasal prongs; 5: hospitalized, noninvasive mechanical ventilation (NIMV) or high-flow nasal cannula (HFNC); 6: hospitalized, intubation and invasive mechanical ventilation (IMV); 7: hospitalized, IMV + additional support such as pressors or extracardiac membranous oxygenation (ECMO); 8: death. Total scores range from 0-8. Lower scales indicate less limitations, higher scores indicate more limitations.
次要结局
- Serious Adverse Events(60 days)
研究者
James L. Kirkland, MD, PhD
Co-Principal Investigator and Regulatory Sponsor
Mayo Clinic