Apply to Trial

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

80 Participants Needed

Low-Dose Sirolimus for Long COVID Syndrome

Overseen ByMackenzie Doerstling, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers, ACE inhibitors, others

Disqualifiers: Autoimmune conditions, Chronic Lyme, Hepatic impairment, others

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with sirolimus, such as some antibiotics, antifungals, and other drugs that affect sirolimus levels. If you're on any of these, you might need to adjust your dose or stop them. It's best to discuss your current medications with the study team to see if any changes are needed.

How is the drug Sirolimus unique for treating Long COVID?

Sirolimus is unique for treating Long COVID because it is an immunosuppressive drug that works by blocking cell-cycle progression and inhibiting certain immune responses, which is different from other treatments that may not target the immune system in this way. Additionally, it is administered orally, which can be more convenient compared to treatments that require injections or infusions.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

The study is conducted in New York, New York at The Cohen Center for Recovery from Complex Chronic Illness at Mount Sinai.This is an IND-exempt, off-label, multi-ascending, randomized, placebo-controlled clinical trial of sirolimus (also known as rapamycin) in adults with Long COVID. There are 2 arms: Sirolimus and Placebo.This study aims to evaluate the efficacy of Sirolimus in adults with Long COVID. Efficacy will be evaluated by measuring patient-reported outcomes in response to Sirolimus.

Research Team

David Putrino, PT, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for adults with Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC), who are seeking treatment. Specific eligibility criteria details were not provided, so interested individuals should contact the study organizers for more information.

Inclusion Criteria

Provision of signed and dated informed consent form

Must be able to attend all study visits located at 5 East 98th St, New York, NY

Diagnosed with Long COVID: Documented clinical history of confirmed or suspected acute SARS-CoV-2 infection a minimum of 6 months prior to contact with the study team, Formal diagnosis of Long COVID from a physician, At least a six-month history of specific symptoms following SARSCoV-2 infection, Participants who are willing and able to comply with all study procedures, Baseline EQ-VAS ≤70; EQ-VAS before the index infection ≥80

Exclusion Criteria

Pre-existing conditions impacting immunological profiling analysis, Pre-2020 diagnosis of another Post-Acute Infectious Syndrome, Documented history of vaccine injury, History of lung or liver transplant, Known hepatic or renal impairment, Weighing less than 40 kg, Current use of sirolimus, Taking medications with known interactions to sirolimus, Febrile illness within the last 3 months of planned baseline evaluation, Treatment with another investigational drug within 3 months of planned baseline evaluation, Uncontrolled diabetes, unstable ischemic heart disease, clinically significant underlying pulmonary disease, history of immunodeficiency or receiving immunosuppressive therapy, history of coagulopathy or medication condition requiring long-term anticoagulation, history of hepatic impairment, taking angiotensin-converting enzyme (ACE) inhibitors, Planning to be or are pregnant, Nursing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either low-dose sirolimus or placebo for up to 12 weeks

12 weeks

Regular visits for monitoring and dose escalation

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Post-treatment assessments at Week 12 and Week 24

Treatment Details

Interventions

Sirolimus

Trial Overview The trial is testing low-dose sirolimus against a placebo to see if it can help with Long COVID symptoms. It's a randomized and controlled study at Mount Sinai in New York, aiming to measure improvements based on patient-reported outcomes.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Low-dose sirolimusExperimental Treatment1 Intervention

Participants will follow the escalation scheme and receive sirolimus for up to 12 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will follow the escalation scheme and receive the placebo for up to 12 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

The Anlyan Center

Collaborator

PolyBio Research Foundation

Collaborator

Trials

Recruited

250+

PolyBio Research Foundation

Collaborator

Findings from Research

A 14-day study of sirolimus in renal transplant patients showed that it can be safely combined with cyclosporine and corticosteroids, as it did not significantly affect kidney function or blood pressure.

While sirolimus caused a reversible decrease in platelet and white blood cell counts and increased cholesterol levels, these side effects were manageable and distinct from the nephrotoxic effects of cyclosporine, suggesting a potential for effective immunosuppression without added toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The side effect profile of sirolimus: a phase I study in quiescent cyclosporine-prednisone-treated renal transplant patients.Murgia, MG., Jordan, S., Kahan, BD.[2019]