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Low Dose Sirolimus in People With Post-Acute Sequelae of COVID-19 (PASC) Long COVID-19 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT06960928•Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+3 more criteria

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:
+11 more criteria

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Key Dates

Start Date

April 18, 2025

Primary Completion Date

November 30, 2026

Completion Date

November 30, 2026

Last Updated

July 18, 2025

Enrollment

ESTIMATED participants

Conditions

Long COVID-19

Interventions

Low-dose sirolimus

DRUG

Placebo

DRUG

Contacts

David Putrino, PT, PhD

CONTACT

212-241-7658 coreresearch@mountsinai.org

Mackenzie Doerstling, MPH

CONTACT

212-241-7658 coreresearch@mountsinai.org

LOng COvid COmorbidities: Andrological, Reproductive, Sexual Dysfunctions in Patients Recovered From COVID-19

NCT05379556

Long Covid-19

View study

ACTIVE_NOT_RECRUITINGPHASE2

RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)

NCT06305793

Long COVIDLong Coronavirus Disease 2019 (Covid19)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

LOng COvid COmorbidities: Andrological, Reproductive, Sexual Dysfunctions in Patients Recovered From COVID-19

RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)

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