Actively Recruiting
Low Dose Sirolimus in People With Post-Acute Sequelae of COVID-19 (PASC) Long COVID-19
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-07-18
80
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
P
PolyBio Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low Dose Sirolimus in People With Post-Acute Sequelae of COVID-19 (PASC) Long COVID-19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Any sex, aged 18 years or older
- Able to attend all study visits at 5 East 98th St, New York, NY
- Diagnosed with Long COVID with documented or suspected COVID-19 infection at least 6 months prior
- Formal Long COVID diagnosis from a physician
- At least six months of symptoms including headache, memory loss, insomnia, mood disturbance, chest pain, palpitations, shortness of breath, cough, muscle or joint pains, or gastrointestinal upset
- Moderate fatigue measured by Fatigue Severity Score
- Moderate post-exertional malaise measured by DePaul PEM screener
- Willing and able to comply with all study procedures, data collection, treatment plan, and laboratory tests
- Baseline EQ-VAS score of 70 or less; pre-infection EQ-VAS score of 80 or higher
You will not qualify if you...
- Pre-existing autoimmune conditions such as Chronic EBV, Multiple Sclerosis, Hashimoto's Disease, etc.
- Diagnosis before 2020 of another Post-Acute Infectious Syndrome like Chronic Lyme disease or Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- Documented history of vaccine injury
- History of lung or liver transplant
- Known liver or kidney impairment
- Weighing less than 40 kg
- Any other chronic condition impacting immunological profiling as judged by the research physician
- Current use of sirolimus
- Taking medications that interact with sirolimus, including strong CYP3A4 inhibitors, inducers, or drugs increasing sirolimus levels
- Concomitant use of ACE inhibitors
- Febrile illness within 3 months before baseline evaluation
- Treatment with another investigational drug within 3 months before baseline
- Uncontrolled diabetes, unstable heart disease, significant lung disease, immunodeficiency, immunosuppressive therapy, coagulopathy, or long-term anticoagulation
- Planning pregnancy or currently pregnant
- Nursing
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
D
David Putrino, PT, PhD
CONTACT
M
Mackenzie Doerstling, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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