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:
Simmaron Research Inc.
Organization:
Study Overview
Official Title:
Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: