NCT04537299终止2 期
COVID-FIS: A Phase 2 Placebo-Controlled Pilot Study in COVID-19 of Fisetin to Alleviate Dysfunction and Excessive Inflammatory Response in Older Adults in Nursing Homes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in COVID-19 Severity
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
This study is a pilot, randomized, placebo-controlled, single-center study of Fisetin in elderly nursing home participants with non-, mildly-, or moderately-symptomatic and confirmed SARS-CoV-2 infection.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or post-menopausal women age ≥65 years.
- •Current nursing home resident.
- •CoV severity of moderate or less OR SpO2 ≥ 85% (on room air or ≤ 2 L of supplemental oxygen) at time of enrollment.
- •SARS-CoV-2 infection confirmed by mRNA-PCR test at Mayo Clinic or other CLIA certified laboratory, within 10 days before randomization.
- •Willing and able to provide written informed consent or have a legally authorized representative (LAR) who will provide informed consent.
排除标准
- •Presence of any condition that the Investigator or the subject's attending physician, physician's assistant, or nurse-practitioner believes would put the subject at risk or would preclude the patient from successfully completing the trial.
- •Pregnancy (note that only post-menopausal women will be enrolled).
- •Total bilirubin >3X upper limit of normal or as per clinical judgment.
- •Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) >4x the upper limits of normal or as per clinical judgment.
- •Hemoglobin <7 g/dL; white blood cell count ≤2,000/mm3 (≤2.0 x 109/L) or ≥20,000/mm3 (≥20 x 109/L); platelet count ≤ 25,000/μL (≤25 x 109/L); absolute neutrophil count ≤1 x 109/L; lymphocyte count <0.3 x 109/L at screening or as per clinical judgment.
- •Unstable (as per clinical judgment) major cardiovascular, renal, endocrine, immunological, or hepatic disorder.
- •eGFR <25 ml/ min/ 1.73 m2 or as per clinical judgment.
- •Plasma and/or serum glucose >300 or as per clinical judgment.
- •Human immunodeficiency virus infection.
- •Known active hepatitis B or C infection.
- •Invasive fungal infection.
- •Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites.
- •History of diverticulitis or diverticulosis with GI bleeding, as per clinical judgment.
- •New/active invasive cancer except non-melanoma skin cancers as per clinical judgment.
- •Known condition associated with major immunodeficiency as per clinical judgment.
- •Known hypersensitivity or allergy to Fisetin.
- •Subjects taking any of the medications listed in the Investigator Brochure may participate if they are otherwise eligible AND the medication can be safely held during the following times:
- •Immediately before the 1st IP administration (Day 0) until at least 10 hours after the 2nd IP administration (Day 1)
- •Immediately before the 3rd IP administration (Day 8) until at least 10 hours after the 4th IP administration (Day 9)
- •Participation in other clinical trials involving treatment for COVID-19 (unless reviewed and approved by the Principle Investigator.) Note that institutional standard of care treatment of COVID-19 including glucocorticoids, hydroxychloroquine, azithromycin, remdesivir, anti-spike antibodies, and/or convalescent plasma are not excluded from the study.
研究组 & 干预措施
Treatment Group
Experimental
Subjects will receive treatment drug (Fisetin)
干预措施: Fisetin (Drug)
Placebo Group
Placebo Comparator
Subjects will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in COVID-19 Severity
时间窗: Baseline, Day 2, 8, 10, 14, 30, 90 and 180
The Ordinal Scale for Clinical Improvement was used to assess change in COVID-19 Severity. The scale has a minimum value of 0 (no clinical or virological evidence of infection) and a maximum value of 8 (death) with higher scores indicating a worse outcome.
次要结局
未报告次要终点
研究者
James L. Kirkland, MD, PhD
Principal Investigator
Mayo Clinic
研究点 (1)
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