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