Clinical trial NCT06257420: Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions
Official title: Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Myalgic Encephalomyelitis
Long-COVID
Keywords: ME/CFS
Long-COVID
Infection Associated Chronic Conditions
Lead sponsor: Simmaron Research Inc.
Sponsor class: OTHER
Collaborators: name: Center For Complex Diseases-Seattle, WA
name: Sierra Internal Medicine, Incline Village, NV
name: Center for Complex Diseases- Palo Alto, CA
name: Simmaron Research Inc. R&D Lab, University of Wisconsin, Milwaukee (UWM)
name: Bateman Horne Center, Salt Lake City, UT
name: Mayo Clinic
First posted: 2024-02-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited by study clinicians who are Principal Investigators in this trial.

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.


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

Primary outcomes:
measure: The Short Form (36) Health Survey
timeFrame: 1 year
measure: Multidemensional Fatigue Inventory (MFI)
timeFrame: 1 year
measure: The Bell Activity Scale
timeFrame: 1 year
Secondary outcomes:
measure: Change in mTOR activation panel and blood markers involved in autophagy function.
timeFrame: 1.5 year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Center For Complex Diseases
state: California
city: Rochester
country: United States
facility: The Mayo Clinic
state: Minnesota
city: Incline Village
country: United States
facility: Sierra Internal Medicine
state: Nevada
city: Salt Lake City
country: United States
facility: Bateman Horne Center
state: Utah
city: Seattle
country: United States
facility: Center For Complex Diseases
state: Washington
Study officials:
affiliation: Simmaron Research Inc.
name: Gunnar Gottschalk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.