Could a Low-Dose immune drug ease long COVID symptoms?

NCT ID NCT06960928

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a low dose of sirolimus (rapamycin), a drug that calms the immune system, can help adults with Long COVID feel better. Eighty participants will take either sirolimus or a placebo pill once a week for 12 weeks. The main goal is to see if the drug improves self-rated health and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sirolimus (rapamycin)
What this could lead to
If it works, this could point toward a treatment that improves overall health and quality of life for people with Long COVID.
What could go wrong
This is a small, early Phase 3 trial with only 80 participants. The drug is being used off-label, and results may not apply to everyone with Long COVID. Side effects of sirolimus are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

    Contact Email: •••••@•••••

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