NCT05858515

REVERSE-Long COVID-19 With Baricitinib Study

REVERSE-Long COVID: A Multicenter Randomized, Placebo-Controlled Clinical Trial of Immunomodulation (With Baricitinib) for Long COVID Related Cognitive Impairment and ADRD (Alzheimer's Disease and Related Dementias)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

REVERSE-LC is a phase 3 trial of baricitinib versus placebo in adults with neurocognitive impairment (a form of Alzheimer's Disease and Related Dementias or ADRD) or cardiopulmonary symptoms due to Long COVID.

Detailed description

This is a multi-site randomized, placebo-controlled, double-blind, parallel-design REVERSE-LC phase 3 study. Individuals meeting inclusion criteria will be randomized to one of two arms: the intervention arm of baricitinib 4 mg daily for 24 weeks (dose adjusted to 2 mg or 1 mg for baseline renal dysfunction) versus the placebo arm for 24 weeks. In addition to safety, a variety of clinical and biological outcome measures will be assessed.

Conditions

• Post-Acute COVID-19 Syndrome

Interventions

Type	Name	Description
DRUG	Baricitinib 4 MG	Nonproprietary name: Baricitinib
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-10-21
• Primary completion: 2027-12-31
• Completion: 2029-12-30
• First posted: 2023-05-15
• Last updated: 2025-01-31

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study