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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Rapamycin
    Once weekly oral rapamycin
    Other names:
    • Sirolimus
    • Rapamune
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.
  • Drug: Rapamycin
    Once weekly oral rapamycin
    Other names:
    • Sirolimus
    • Rapamune

Recruiting Locations

More Details

NCT ID
NCT06257420
Status
Enrolling by invitation
Sponsor
Simmaron Research Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.