Long COVID-19 study: Low-dose sirolimus
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?
This is an investigational pill being studied to see if it helps with Long COVID-19 symptoms. It is designed to block a protein in the body that helps cells grow and divide.
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
- This study wants to find out if taking sirolimus improves how people with Long COVID-19 feel and function.
- Who it's for
- The study is looking for adults who have Long COVID-19.
- What's involved
- Participants will be randomly assigned to take either sirolimus or a placebo (a pill with no active medicine) and report on their symptoms.
- Time commitment
- The source text does not specify the total duration or the number of visits required.
- 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
- 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
You likely can't join if
- 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
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
- 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
- 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)
- 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
- 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.
- Uncontrolled diabetes, unstable ischemic heart disease, clinically significant underlying pulmonary disease, history of an immunodeficiency or receiving immunosuppressive therapy
- Participants who are planning to be or are pregnant
- Participants who are nursing
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.