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Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions

Conditions
Myalgic Encephalomyelitis
Long-COVID
Interventions
Registration Number
NCT06257420
Lead Sponsor
Simmaron Research Inc.
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
150
Inclusion Criteria
  • Diagnosis of ME/CFS that meets the Institute of Medicine (IOM) criteria
  • Diagnosis of Long-COVID (PASC clinical criteria)
Read More
Exclusion Criteria
  • No diagnosis of ME/CFS or Long-COVID
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
ME/CFS and Long-COVID patients with serological evidence of autophagy disruptionRapamycinME/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.
ME/CFS and Long-COVID patients without serological evidence of autophagy disruptionRapamycinME/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.
Primary Outcome Measures
NameTimeMethod
The Short Form (36) Health Survey1 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)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 Scale1 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.

Secondary Outcome Measures
NameTimeMethod
Change in mTOR activation panel and blood markers involved in autophagy function.1.5 year

Change in concentrations of phosphorylated autophagy-related gene proteins in blood

Trial Locations

Locations (4)

The Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Center For Complex Diseases

🇺🇸

Seattle, Washington, United States

Sierra Internal Medicine

🇺🇸

Incline Village, Nevada, United States

Bateman Horne Center

🇺🇸

Salt Lake City, Utah, United States

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