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New treatment option for Long COVID-19
Official title Low Dose Sirolimus in People With Post-Acute Sequelae of COVID-19 (PASC) Long COVID-19
ClinicalTrials.gov ID: NCT06960928
What this study is testing
What is Low-dose sirolimus?
Low-dose sirolimus is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for long covid-19.
Also referred to as rapamycin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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)
- 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...
- Strong CYP3A4 Inducers - carbamazepine, dexamethasone, ethosuximide, glucocorticoids, griseofulvin, phenytoin, primidone, progesterone, rifabutin, rifampin, nafcillin, nelfinavir, nevirapine, oxcarbazepine...
- 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...
- Uncontrolled diabetes, unstable ischemic heart disease, clinically significant underlying pulmonary disease, history of an immunodeficiency or receiving immunosuppressive therapy; history of coagulopathy or medication...
- Participants who are planning to be or are pregnant
- Participants who are nursing
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.