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

Simmaron Research Inc.

Status: Invitation-only

Conditions: Myalgic Encephalomyelitis; Long-COVID

Treatments: Drug: Rapamycin

Study type: Observational

Funder types: Other

Identifiers

NCT06257420

SRI-RP-2023-1

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

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.

Treatment:

Drug: Rapamycin

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.

Treatment:

Drug: Rapamycin