The study is conducted in New York, New York at The Cohen Center for Recovery fromComplex Chronic Illness at Mount Sinai.This is an IND-exempt, off-label, multi-ascending, randomized, placebo-controlledclinical trial of sirolimus (also known as rapamycin) in adults with Long COVID. Thereare 2 arms: Sirolimus and Placebo.This study aims to evaluate the efficacy of Sirolimus in adults with Long COVID. Efficacywill be evaluated by measuring patient-reported outcomes in response to Sirolimus.
Not Provided
Drug: Low-dose sirolimus
Participants will take sirolimus, at home, for 12 weeks (3 months).
- 1 pill once a week for 2 weeks (1mg)
- 2 pills once a week for 2 weeks (2mg)
- 4 pills once a week for 8 weeks (4mg)
Other Name: rapamycin
Drug: Placebo
Participants will take a matching placebo, at home, for 12 weeks (3 months).
- 1 pill once a week for 2 weeks (0mg)
- 2 pills once a week for 2 weeks (0mg)
- 4 pills once a week for 8 weeks (0mg)
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Any sex, aged 18+
- 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 one of the following symptoms following
SARSCoV-2 infection:
- headache, memory loss, insomnia, mood disturbance, chest pain,
palpitations, shortness of breath, cough, muscle pains, joint pains,
or GI upset
- AND at least moderate fatigue (measured by Fatigue Severity Score)
- AND at least moderate post-exertional malaise (PEM) (measured by
DePaul PEM screener)
- Participants who are willing and able to comply with all data
collection, treatment plan, laboratory tests, lifestyle
considerations, and other study procedures.
- Baseline EQ-VAS ≤70; EQ-VAS before the index infection ≥80 (this
information is collected before randomization as part of the baseline
survey)
Exclusion Criteria:
- Pre-existing conditions including, but not limited to:
- Autoimmune conditions such as Chronic EBV, Multiple Sclerosis, Hashimoto's
Disease, etc. which would impact the immunological profiling analysis.
- A pre-2020 diagnosis of another Post-Acute Infectious Syndrome such as Chronic
Lyme disease, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, etc.
- Documented history of vaccine injury
- History of lung or liver transplant
- Known hepatic or renal impairment
- Weighing less than 40 kg
- Or any other chronic condition that has the potential to impact on
immunological profiling, at the discretion of the research physician
- Current use of sirolimus
- Taking a medication with known interactions to sirolimus:
- Strong CYP3A4 Inhibitors - clarithromycin, telithromycin, nefazodone,
itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir,
nelfinavir, ritonavir, saquinavir, tipranavir, such that dose reduction may be
necessary
- Strong CYP3A4 Inducers - carbamazepine, dexamethasone, ethosuximide,
glucocorticoids, griseofulvin, phenytoin, primidone, progesterone, rifabutin,
rifampin, nafcillin, nelfinavir, nevirapine, oxcarbazepine, phenobarbital,
phenylbutazone, rofecoxib (mild), St John's wort, sulfadimidine,
sulfinpyrazone, troglitazone, and grapefruit, such that dose increase may be
necessary.
- Drugs that may increase concentration when given with sirolimus - Verapamil,
such that dose reduction may be necessary
- Other drugs that have the potential to increase sirolimus blood concentrations
include (but are not limited to): fluconazole, clotrimazole, troleandomycin,
nicardipine, cisapride, and metoclopramide
- Concomitant use of angiotensin-converting enzyme (ACE) inhibitors may increase
the risk of developing angioedema.
- Febrile illness within the last 3 months of planned baseline evaluation
- Treatment with another investigational drug or other investigational intervention
within 3 months of planned baseline evaluation
- Prophylactic use of aspirin (325 mg daily) for cardiovascular indications will be
permitted in participants. All other medications for chronic medical conditions
should be initiated at least two months prior to enrollment.
- Uncontrolled diabetes, unstable ischemic heart disease, clinically significant
underlying pulmonary disease, history of an 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
- Participants who are planning to be or are pregnant
- Participants who are nursing
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Investigator: Mackenzie Doerstling, MPH
CoreResearch@mountsinai.com
Investigator: David Putrino, PT, PhD
David Putrino, PT, PhD
212-241-7658
coreresearch@mountsinai.org
Mackenzie Doerstling, MPH
212-241-7658
coreresearch@mountsinai.org
David Putrino, PT, PhD, Principal Investigator
Icahn School of Medicine at Mount Sinai