NCT06257420

Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Simmaron Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myalgic Encephalomyelitis
• Long-COVID

Interventions

Type	Name	Description
DRUG	Rapamycin	Once weekly oral rapamycin

Timeline

• Start date: 2023-12-11
• Primary completion: 2025-12-11
• Completion: 2026-06-11
• First posted: 2024-02-14
• Last updated: 2024-11-05

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study