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

Conditions

• Long COVID-19

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Low-dose sirolimus — DRUG
  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)
• Placebo — DRUG
  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 Details

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.

Key Dates

Start date

Apr 18, 2025

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

May 31, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Low-dose sirolimus
  Participants will follow the escalation scheme and receive sirolimus for up to 12 weeks.
• Placebo Comparator: Placebo
  Participants will follow the escalation scheme and receive the placebo for up to 12 weeks.

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) ]

Central Contacts

• David Putrino, PT, PhD
  212-241-7658
  [email protected]
• Mackenzie Doerstling, MPH
  212-241-7658
  [email protected]

Locations (1)

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