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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Simmaron Research Inc.
Study ID
NCT06257420
Status
Enrolling By Invitation

Conditions

  • Long-COVID
  • Myalgic Encephalomyelitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rapamycin — DRUG
    Once weekly oral rapamycin

Study Details

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.

Key Dates

Start date
Dec 11, 2023
Status verified
Apr 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: ME/CFS and Long-COVID patients with serological evidence of autophagy disruption
    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.
  • Arm: ME/CFS and Long-COVID patients without serological evidence of autophagy disruption
    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.

Primary Outcome Measure

The Short Form (36) Health Survey [ Time Frame: 1 year ]

Locations (5)

FacilityCityStateZIPSite coordinators
Center For Complex DiseasesPalo AltoCalifornia94040-
The Mayo ClinicRochesterMinnesota55905-
Sierra Internal MedicineIncline VillageNevada89451-
Bateman Horne CenterSalt Lake CityUtah84102-
Center For Complex DiseasesSeattleWashington98109-

Find similar trials in Palo Alto, CA

By research site
Center For Complex Diseases· Palo Alto, CAThe Mayo Clinic· Rochester, MNSierra Internal Medicine· Incline Village, NVBateman Horne Center· Salt Lake City, UTCenter For Complex Diseases· Seattle, WA

Related Studies