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Enrolling by invitation NCT06257420

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

— Observational Myalgic Encephalomyelitis Long-COVID

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rapamycin.
Who it may be relevant to
Registry conditions: Myalgic Encephalomyelitis, Long-COVID. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Rapamycin
    Once weekly oral rapamycin

Primary outcome measures

  • The Short Form (36) Health Survey [Time frame: 1 year]
  • Multidemensional Fatigue Inventory (MFI) [Time frame: 1 year]
  • The Bell Activity Scale [Time frame: 1 year]
Secondary outcome measures (7)
  • Change in mTOR activation panel and blood markers involved in autophagy function. [Time frame: 1.5 year]
  • DePaul Symptom Questionnaire Short Form- PEM [Time frame: 1 year]
  • DePaul Symptom Questionnaire- COVID [Time frame: 1 year]
  • FACIT-F (Functional Assessment of Chronic Illness Treatment- Fatigue; Version 4) [Time frame: 1 year]
  • Specific Symptom Severity V2.2 [Time frame: 1 year]
  • FUNCAP55 (Functional Capacity) Questionnaire [Time frame: 1 year]
  • Sleep Questionnaire [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 5 centers
  • Center For Complex Diseases — Palo Alto
  • The Mayo Clinic — Rochester
  • Sierra Internal Medicine — Incline Village
  • Bateman Horne Center — Salt Lake City
  • Center For Complex Diseases — Seattle

Publications

  • Gottschalk G, Peterson D, Knox K, Maynard M, Whelan RJ, Roy A. Elevated ATG13 in serum of patients with ME/CFS stimulates oxidative stress response in microglial cells via activation of receptor for advanced glycation end products (RAGE). Mol Cell Neurosci. 2022 May;120:103731. doi: 10.1016/j.mcn.2022.103731. Epub 2022 Apr 26. PMID 35487443
  • Gottschalk CG, Whelan R, Peterson D, Roy A. Detection of Elevated Level of Tetrahydrobiopterin in Serum Samples of ME/CFS Patients with Orthostatic Intolerance: A Pilot Study. Int J Mol Sci. 2023 May 13;24(10):8713. doi: 10.3390/ijms24108713. PMID 37240059
  • Ruan BT, Bulbule S, Gile B, Reyes A, Chheda B, Bateman L, Bell J, Yellman B, Grach SL, Berner J, Peterson DL, Kaufman D, Roy A, Gottschalk CG. Low-dose rapamycin alleviates clinical symptoms of fatigue and PEM in ME/CFS patients via improvement of autophagy: a pilot study. J Transl Med. 2025 Oct 21;23(1):1148. doi: 10.1186/s12967-025-07213-8. PMID 41121328
  • Gile B, Bulbule S, Toriola MA, Ruan BT, Marium S, Benko A, Grach S, Mueller M, Bateman L, Bell J, Yellman B, Berner J, Chheda B, Kaufman D, Gottschalk G, Roy A. Association of rapamycin treatment with the modulation of purine metabolism, reduced microglial inflammatory responses, improved mitochondrial energy metabolism, and alleviation of fatigue symptoms in ME/CFS subjects: pilot findings from p PMID 42432754

Identifiers

NCT: NCT06257420 · SRI-RP-2023-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗