Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- The Short Form (36) Health Survey
研究概览
简要总结
The goal of this observational study is to assess the clinical response and the effect of autophagy function in patients before, during and throughout oral low dose sirolimus (rapamycin) therapy. The main questions this study aims to answer are:
- Does rapamycin reduce the overall symptom burden in this patient population and does it improve the quality of life?
- Does rapamycin change mTOR driven autophagy deficits observed in a subset of patients?
Participants will be asked to complete a series of questionnaires and quality of life instruments before starting rapamycin therapy prescribed by their physician and throughout their course of treatment. Study blood samples will be collected before starting therapy and throughout the course of treatment to assess serological markers of autophagy function.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ME/CFS that meets the Institute of Medicine (IOM) criteria
- •Diagnosis of Long-COVID (PASC clinical criteria)
排除标准
- •No diagnosis of ME/CFS or Long-COVID
研究组 & 干预措施
ME/CFS and Long-COVID patients with serological evidence of autophagy disruption
ME/CFS and Long-COVID patients with serological evidence of autophagy disruption at baseline will be prescribed once weekly rapamycin at a max dose of 6mg per week.
干预措施: Rapamycin (Drug)
ME/CFS and Long-COVID patients without serological evidence of autophagy disruption
ME/CFS and Long-COVID patients without serological evidence of autophagy disruption at baseline will be prescribed once weekly rapamycin at a max dose of 6mg per week.
干预措施: Rapamycin (Drug)
结局指标
主要结局
The Short Form (36) Health Survey
时间窗: 1 year
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Multidemensional Fatigue Inventory (MFI)
时间窗: 1 year
The MFI is a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue.
The Bell Activity Scale
时间窗: 1 year
The Bell CFIDS Disability Scale is described in the book, The Doctor's Guide to Chronic Fatigue Syndrome: Understanding, Treating and Living with CFIDS (Bell 1995). This scale assesses functional ability in adult ME/CFS patients. Eleven statements describe patient status such as level of symptoms at rest, level of symptoms with exercise, activity level, and ability to perform work, travel and self care.
次要结局
- Change in mTOR activation panel and blood markers involved in autophagy function.(1.5 year)