Long-COVID, Myalgic Encephalomyelitis
Conditions
Keywords
ME/CFS, Long-COVID, Infection Associated Chronic Conditions
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.
Interventions
DRUGRapamycin
Once weekly oral rapamycin
Sponsors
Simmaron Research Inc.
Center For Complex Diseases-Seattle, WA
Sierra Internal Medicine, Incline Village, NV
Center for Complex Diseases- Palo Alto, CA
Simmaron Research Inc. R&D Lab, University of Wisconsin, Milwaukee (UWM)
Bateman Horne Center, Salt Lake City, UT
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Short Form (36) Health Survey | 1 year | 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. |
| Multidemensional Fatigue Inventory (MFI) | 1 year | 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. |
| The Bell Activity Scale | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mTOR activation panel and blood markers involved in autophagy function. | 1.5 year | Change in concentrations of phosphorylated autophagy-related gene proteins in blood |
| DePaul Symptom Questionnaire Short Form- PEM | 1 year | 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. |
| DePaul Symptom Questionnaire- COVID | 1 year | 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. |
| FACIT-F (Functional Assessment of Chronic Illness Treatment- Fatigue; Version 4) | 1 year | 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. |
| Specific Symptom Severity V2.2 | 1 year | 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. |
| FUNCAP55 (Functional Capacity) Questionnaire | 1 year | 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. |
| Sleep Questionnaire | 1 year | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGunnar Gottschalk, PhD
Simmaron Research Inc.
Outcome results
None listed