Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06257420
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-11-05
First Post:
2024-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood will be collected to isolate plasma, PBMC, serum and RNA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-06-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-01', 'studyFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Short Form (36) Health Survey', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Multidemensional Fatigue Inventory (MFI)', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'The Bell Activity Scale', 'timeFrame': '1 year', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Change in mTOR activation panel and blood markers involved in autophagy function.', 'timeFrame': '1.5 year', 'description': 'Change in concentrations of phosphorylated autophagy-related gene proteins in blood'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ME/CFS', 'Long-COVID', 'Infection Associated Chronic Conditions'], 'conditions': ['Myalgic Encephalomyelitis', 'Long-COVID']}, 'referencesModule': {'references': [{'pmid': '35487443', 'type': 'BACKGROUND', '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.'}, {'pmid': '37240059', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.simmaron.com', 'label': 'Simmaron Website'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* Does rapamycin reduce the overall symptom burden in this patient population and does it improve the quality of life?\n* Does rapamycin change mTOR driven autophagy deficits observed in a subset of patients?\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are recruited by study clinicians who are Principal Investigators in this trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ME/CFS that meets the Institute of Medicine (IOM) criteria\n* Diagnosis of Long-COVID (PASC clinical criteria)\n\nExclusion Criteria:\n\n* No diagnosis of ME/CFS or Long-COVID'}, 'identificationModule': {'nctId': 'NCT06257420', 'briefTitle': 'Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Simmaron Research Inc.'}, 'officialTitle': 'Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions', 'orgStudyIdInfo': {'id': 'SRI-RP-2023-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ME/CFS and Long-COVID patients with serological evidence of autophagy disruption', 'description': '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.', 'interventionNames': ['Drug: Rapamycin']}, {'label': 'ME/CFS and Long-COVID patients without serological evidence of autophagy disruption', 'description': '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.', 'interventionNames': ['Drug: Rapamycin']}], 'interventions': [{'name': 'Rapamycin', 'type': 'DRUG', 'otherNames': ['Sirolimus', 'Rapamune'], 'description': 'Once weekly oral rapamycin', 'armGroupLabels': ['ME/CFS and Long-COVID patients with serological evidence of autophagy disruption', 'ME/CFS and Long-COVID patients without serological evidence of autophagy disruption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Center For Complex Diseases', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'The Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '89451', 'city': 'Incline Village', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Internal Medicine', 'geoPoint': {'lat': 39.2513, 'lon': -119.97297}}, {'zip': '84102', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Bateman Horne Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Center For Complex Diseases', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Gunnar Gottschalk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simmaron Research Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be available to share with non-profit and academic institutions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simmaron Research Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center For Complex Diseases-Seattle, WA', 'class': 'UNKNOWN'}, {'name': 'Sierra Internal Medicine, Incline Village, NV', 'class': 'UNKNOWN'}, {'name': 'Center for Complex Diseases- Palo Alto, CA', 'class': 'UNKNOWN'}, {'name': 'Simmaron Research Inc. R&D Lab, University of Wisconsin, Milwaukee (UWM)', 'class': 'UNKNOWN'}, {'name': 'Bateman Horne Center, Salt Lake City, UT', 'class': 'UNKNOWN'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}