NCT06960928

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Long COVID-19

Interventions

Type	Name	Description
DRUG	Low-dose sirolimus	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)
DRUG	Placebo	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)

Timeline

• Start date: 2025-04-18
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2025-05-07
• Last updated: 2025-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study