Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07189936

Effect of 2-HOBA in Persistent Immune Activation in Long COVID POTS

Led by Vanderbilt University Medical Center · Updated on 2026-01-22

50

Participants Needed

1

Research Sites

184 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

A

American Heart Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

Long COVID is defined by a range of symptoms affecting multiple organs that persist for more than three months following an acute SARS-CoV-2 infection. Approximately 7% of individuals who recover from SARS-Cov-2 infection develop Long COVID. Long COVID Postural Orthostatic Tachycardia Syndrome (LCPOTS) symptoms include fatigue, exercise intolerance, orthostatic intolerance, syncope, and heightened orthostatic tachycardia. Research has found that decreased parasympathetic activity in LCPOTS increases the production of highly immunogenic neoantigens Isolevuglandins (IsoLG-adducts). IsoLG-adducts induce formation of circulating monocyte/T cell complexes(doublets) leading to the persistent and unresolved immune response that continues after the initial infection. The purpose of the this research, is to study the effects of 2-hydroxybenzylamine (2-HOBA), an Iso-LG-adduct scavenger, its effects in immune markers and compare it with Placebo

CONDITIONS

Official Title

Effect of 2-HOBA in Persistent Immune Activation in Long COVID POTS

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • Diagnosed with Long COVID defined by symptoms lasting more than three months after SARS-CoV-2 infection
  • Diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS) with chronic symptoms over 3 months
  • Orthostatic tachycardia defined as heart rate increase over 30 bpm upon standing or exceeding 120 bpm within 10 minutes, or over 40 bpm increase or heart rate over 130 bpm for ages 18 to 21
  • Confirmation of POTS diagnosis based on orthostatic vital signs prior to enrollment
  • Documented SARS-CoV-2 infection at least 3 months prior by clinical, epidemiological, antigen test, or nucleic acid test criteria
  • Clinical confirmation by healthcare provider in medical records
Not Eligible

You will not qualify if you...

  • Active acute SARS-CoV-2 infection within 4 weeks from onset
  • Moderate or severe immunocompromised status
  • History of cardiovascular disease including atrioventricular block, myocardial infarction, angina, heart failure, pacemaker, stroke, or transient ischemic attack within 6 months
  • Uncontrolled hypertension with blood pressure over 140/90 despite treatment
  • Type 1 or type 2 diabetes mellitus
  • Impaired liver function with AST or ALT greater than 1.5 times the upper limit, or bilirubin 1.5 mg/dl or higher
  • Impaired kidney function with estimated glomerular filtration rate below 60 mL/min/1.73 m2
  • Anemia with hemoglobin less than 10 g/dl
  • Pregnant or breastfeeding women
  • Known autoimmune disease or use of steroids or other immunotherapies
  • Inability to provide informed consent
  • Allergy or sensitivity to study medication components
  • Contraindications to study interventions
  • Use of central acetylcholinesterase inhibitors (e.g., pyridostigmine, donepezil)
  • Aspirin allergy
  • Use of monoamine oxidase inhibitors (MAO-I)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cyndya Shibao

Nashville, Tennessee, United States, 37027

Actively Recruiting

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Research Team

M

Marwa Mohamed, PhD

CONTACT

C

Cyndya Shibao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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