Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions
NCT ID: NCT06257420
Last Updated: 2024-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
150 participants
OBSERVATIONAL
2023-12-11
2026-06-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Study of Rapamycin for the Treatment of SLE
NCT00779194
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome
NCT01156909
B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study.
NCT02229942
Drug Intervention in Chronic Fatigue Syndrome
NCT00848692
Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus
NCT05916781
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Rapamycin
Once weekly oral rapamycin
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.
Rapamycin
Once weekly oral rapamycin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rapamycin
Once weekly oral rapamycin
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of Long-COVID (PASC clinical criteria)
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center For Complex Diseases-Seattle, WA
UNKNOWN
Sierra Internal Medicine, Incline Village, NV
UNKNOWN
Center for Complex Diseases- Palo Alto, CA
UNKNOWN
Simmaron Research Inc. R&D Lab, University of Wisconsin, Milwaukee (UWM)
UNKNOWN
Bateman Horne Center, Salt Lake City, UT
UNKNOWN
Mayo Clinic
OTHER
Simmaron Research Inc.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gunnar Gottschalk, PhD
Role: PRINCIPAL_INVESTIGATOR
Simmaron Research Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center For Complex Diseases
Palo Alto, California, United States
The Mayo Clinic
Rochester, Minnesota, United States
Sierra Internal Medicine
Incline Village, Nevada, United States
Bateman Horne Center
Salt Lake City, Utah, United States
Center For Complex Diseases
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Simmaron Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SRI-RP-2023-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.