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Enrolling by Invitation

NCT Number: NCT06257420

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

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.

Enrolling by Invitation

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of ME/CFS that meets the Institute of Medicine (IOM) criteria
  • Diagnosis of Long-COVID (PASC clinical criteria)

Exclusion criteria

  • No diagnosis of ME/CFS or Long-COVID

Treatment and study plan

Rapamycin

Drug

Once weekly oral rapamycin

Other names: Sirolimus, Rapamune

Primary outcomes

  1. The Short Form (36) Health Survey

    Time frame: 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.

  2. Multidemensional Fatigue Inventory (MFI)

    Time frame: 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.

  3. The Bell Activity Scale

    Time frame: 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.

Secondary outcomes

  1. Change in mTOR activation panel and blood markers involved in autophagy function.

    Time frame: 1.5 year

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

  2. DePaul Symptom Questionnaire Short Form- PEM

    Time frame: 1 year

    The DePaul Symptom Questionnaire (DSQ) Post-Exertional Malaise (PEM) items are scored based on both frequency and severity ratings for each symptom Frequency is rated on a 5-point scale from 0 (none of the time) to 4 (all of the time), and severity is rated on a 5-point scale from 0 (symptom not present) to 4 (very severe). These ratings are combined to produce composite scores for each symptom or across items. Higher scores indicate greater symptom burden.

  3. DePaul Symptom Questionnaire- COVID

    Time frame: 1 year

    The DePaul Symptom Questionnaire- COVID (DSQ-COVID) assesses symptoms using frequency and severity ratings for each item. Frequency is scored on a 5-point scale from 0 (none of the time) to 4 (all of the time, and severity is scored on a 5-point scale from 0 (symptom not present) to 4 (very severe). Higher scores indicate greater symptom burden.

  4. FACIT-F (Functional Assessment of Chronic Illness Treatment- Fatigue; Version 4)

    Time frame: 1 year

    The FACIT-F is a self-reported measure of fatigue and its impact on daily activities and functioning. It consists of 13 items, each scored on a 5-point scale from 0 (not at all) to 4 (very much). Item scores are summed to produce a total score ranging from 0 to 52. Higher scores indicate less fatigue and higher quality of life.

  5. Specific Symptom Severity V2.2

    Time frame: 1 year

    The Specific Symptom Severity questionnaire assesses the severity of individual symptoms using a number rating scale. Each symptom is scored from 0 (none) to 10 (very severe). Scores can be reported for individual symptoms or combined across items to produce a total score. Higher scores indicate greater symptom severity.

  6. FUNCAP55 (Functional Capacity) Questionnaire

    Time frame: 1 year

    The FUNCAP-55 is a self-reported measure of functional ability across a range of daily activities. It consists of 55 items. each rated on a scale reflecting the level of difficulty and limitation experienced. Item scores are summed to produce a total score, with higher scores indicating less functional impairment.

  7. Sleep Questionnaire

    Time frame: 1 year

    The Sleep Questionnaire assesses sleep patterns and disturbances using a combination of categorical and numerical responses. Several items are rated on a 5-point frequency scale from 0 (never) to 4 (always, 15-30 times a month), while other items require participants to report specific times or durations (e.g., hours of sleep, time to bed). Higher scores on frequency-based items indicate greater sleep difficulty.

Sponsors and collaborators

Lead sponsor

Simmaron Research Inc.

Other

Collaborators

  • Bateman Horne Center, Salt Lake City, UT
  • Center For Complex Diseases-Seattle, WA
  • Center for Complex Diseases- Palo Alto, CA
  • Mayo Clinic
  • Sierra Internal Medicine, Incline Village, NV
  • Simmaron Research Inc. R&D Lab, University of Wisconsin, Milwaukee (UWM)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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