Low Dose Sirolimus in People With Post-Acute Sequelae of COVID-19 (PASC) Long COVID-19
Recruiting
Phase 3Interventional Study
Long COVID-19
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
Who this trial is looking for
This trial is looking for adults with Long COVID-19. Participants will take either sirolimus or a placebo to see how well it helps with their symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have been diagnosed with Long COVID.
I have symptoms like fatigue and memory loss for at least 6 months.
I can attend all study visits in New York.
I have signed the informed consent form.
My baseline EQ-VAS score is 70 or lower.
My EQ-VAS score before my infection was 80 or higher.
You may not be able to join if
I have an autoimmune condition.
I had another post-acute infectious syndrome before 2020.
I have a history of vaccine injury.
I have had a lung or liver transplant.
I weigh less than 40 kg.
I have uncontrolled diabetes or unstable heart disease.
I am pregnant or nursing.
I have had a fever in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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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 Lo…
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.
Trial Locations
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City
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Status
Eligibility Criteria
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…
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
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