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Long COVID-19Phase 3NCT06960928

Low Dose Sirolimus in People With Post-Acute Sequelae of COVID-19 (PASC) Long COVID-19

A Phase 3 study testing Low-dose sirolimus in people with Long COVID-19, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Long COVID-19
What is being tested?
Low-dose sirolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteUnited States
Study dates
18 Apr 2025to 31 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David Putrino, PT, PhD contact

212-241-7658

coreresearch@mountsinai.org

Mackenzie Doerstling, MPH contact

212-241-7658

coreresearch@mountsinai.org

United States1 site, 1 recruiting
  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Mackenzie Doerstling, MPH, CoreResearch@mountsinai.com

    David Putrino, PT, PhD

    Recruiting

Other trials in United States

About this study

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.

Conditions
Long COVID-19
Being tested
Low-dose sirolimus, Placebo
Keywords
Long COVID-19, Post-Acute Sequelae of COVID-19 (PASC), Sirolimus, Rapamycin
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-dose sirolimusDrug

    Also called rapamycin

    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)
  • PlaceboDrug

    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)
Study groups in NCT06960928
Study groupRoleWhat they receive
Low-dose sirolimusExperimentalParticipants will follow the escalation scheme and receive sirolimus for up to 12 weeks.
Receives: Drug: Low-dose sirolimus
PlaceboPlacebo comparatorParticipants will follow the escalation scheme and receive the placebo for up to 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. European Quality of Life-Visual Analogue Scale (EQ-VAS)

    The EQ VAS records the patient's self-rated health on a visual analogue scale where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0), with higher scores indicating better health state. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

Secondary outcomes (14)
  1. The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)

    The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

  2. Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)

    The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

  3. General Symptom Questionnaire (GSQ-30)

    The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

  4. Patient Health Questionnaire (PHQ-9)

    The PHQ-9 is a series of questions assessing presence and severity of depression symptoms. It evaluates each of the DSM-IV depression criteria and scores the responses from 0 ("Not at all") to 3 ("Nearly every day"). PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Full scale from 0-27, with higher score indicating more severe symptoms.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

  5. Generalized Anxiety Disorder (GAD-7)

    The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 ("Not at all") to 3 ("Nearly every day"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

  6. Neuro-QoL™ v2.0 Cognitive Function-Short Form

    The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

  7. Single-item Sleep Quality Scale (SQS)

    The SQS is a visual analog scale that instructs respondents to rate their overall quality of sleep over a 7-day recall period from 0 to 10. Scores of 0, 1, 4, 7, and 10 correspond to terrible, poor, fair, good, and excellent, respectively. Higher scores indicate better sleep quality.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)]

  8. Fatigue Severity Scale

    The Fatigue Severity Scale (FSS) uses a 7-point scale (1-7) to assess fatigue, with higher scores indicating greater severity, and a total score ranging from 9 to 63. Higher scores indicate more severe fatigue.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

  9. Fatigue Visual Analogue Scale [F-VAS])

    The F-VAS consists of 18 items related to fatigue and energy in a visual analogue scale from 0 to 100. A higher score indicates more fatigue.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

  10. DePaul Post-Exertional Malaise Questionnaire (DSQ)

    The DSQ is designed to evaluate 54 classic ME/CFS symptoms, including fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments, and autonomic, neuroendocrine, and immune symptoms. Each symptom's frequency and intensity are rated on a 5-point scale (0-4). Frequency and severity scores are multiplied by 25, added together, and then divided by 2 to create a composite frequency/severity score for each symptom. These scores range from 0 to 100, with higher scores indicating a greater symptom burden.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

  11. Composite Autonomic Symptom Score 31(COMPASS-31)

    The COMPASS-31 is a 31-question self-assessment instrument of autonomic symptoms and function that is up-to-date, broadly applicable, easy to administer in a short amount of time, and based on a scientific approach. The total score ranges from 0 to 100, with higher scores indicating greater autonomic dysfunction.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

  12. Pain (P-VAS)

    Using a visual analogue scale, patients mark a point on a line representing a continuum from "no pain" to "worst pain," with scores ranging from 0 to 100, where higher scores indicate greater pain.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)]

  13. University of California-Los Angeles (UCLA) Loneliness Scale (3-item)

    The UCLA Loneliness (3-item) Scale scores range from 3 to 9, with higher scores indicating greater perceived loneliness.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

  14. Adapted Berkman-Syme Social Network/Connection Index

    This is a self-report questionnaire used to assess social integration and isolation, focusing on marital status, frequency of contact, and participation in social activities, particularly relevant for older adults. Each item is scored on a scale from 1-4 where higher values reflect greater frequency (e.g., 4 = "5 or more times a week"). For each respondent, a sum score is calculated by adding the scores of all five items, yielding a possible score range of 5-25. Higher sum scores reflect higher levels of social connection and lower social isolation.

    Measured: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study start18 Apr 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06960928
Sponsor's protocol ID
STUDY-24-01366
Status last verified
Mar 2026
First submitted
29 Apr 2025
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Low-dose sirolimus in people with Long COVID-19, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Putrino, PT, PhD (212-241-7658, coreresearch@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

European Quality of Life-Visual Analogue Scale (EQ-VAS) (time frame: Baseline (Week 0) and Post-treatment (Week 12 and Week 24)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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