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| Name | Class |
|---|---|
| Center For Complex Diseases-Seattle, WA | UNKNOWN |
| Sierra Internal Medicine, Incline Village, NV | UNKNOWN |
| Center for Complex Diseases- Palo Alto, CA | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamycin | Drug | Once weekly oral rapamycin |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Short Form (36) Health Survey | 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. | 1 year |
| Multidemensional Fatigue Inventory (MFI) | 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. | 1 year |
| The Bell Activity Scale | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mTOR activation panel and blood markers involved in autophagy function. | Change in concentrations of phosphorylated autophagy-related gene proteins in blood | 1.5 year |
| DePaul Symptom Questionnaire Short Form- PEM |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are recruited by study clinicians who are Principal Investigators in this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Gottschalk, PhD | Simmaron Research Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Complex Diseases | Palo Alto | California | 94040 | United States | ||
| The Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35487443 | Background | 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. | |
| 37240059 |
| Label | URL |
|---|---|
| Simmaron Website | View source |
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IPD will be available to share with non-profit and academic institutions.
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Simmaron Research Inc. R&D Lab, University of Wisconsin, Milwaukee (UWM) |
| UNKNOWN |
| Bateman Horne Center, Salt Lake City, UT | UNKNOWN |
| Mayo Clinic | OTHER |
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Whole blood will be collected to isolate plasma, PBMC, serum and RNA.
|
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.
| 1 year |
| DePaul Symptom Questionnaire- COVID | 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. | 1 year |
| FACIT-F (Functional Assessment of Chronic Illness Treatment- Fatigue; Version 4) | 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. | 1 year |
| Specific Symptom Severity V2.2 | 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. | 1 year |
| FUNCAP55 (Functional Capacity) Questionnaire | 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. | 1 year |
| Sleep Questionnaire | 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. | 1 year |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Sierra Internal Medicine | Incline Village | Nevada | 89451 | United States |
| Bateman Horne Center | Salt Lake City | Utah | 84102 | United States |
| Center For Complex Diseases | Seattle | Washington | 98109 | United States |
| 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. |
| 41121328 | Result | 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. |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |