Actively Recruiting
Mechanism of Isolevuglandin-Protein Adduct Formation 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
52 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
Researchers are studying Long COVID Postural Orthostatic Tachycardia Syndrome (LCPOTS), a condition where symptoms like fatigue, exercise intolerance, and rapid heartbeat upon standing last for more than three months after a COVID-19 infection. This study aims to evaluate the effects of 2-hydroxybenzylamine (2-HOBA), a substance that targets harmful immune markers called IsoLG-adducts, by comparing it with a placebo in people with LCPOTS. The study focuses on understanding persistent immune activation and related symptoms in this condition. Participants will be randomly assigned to receive either 2-HOBA or a placebo for 28 days. The 2-HOBA treatment is given as a 500 mg dose three times daily. The study involves three in-person visits and one telemedicine visit, during which researchers will measure immune markers, inflammatory cytokines, splanchnic venous capacitance, and orthostatic tachycardia. The trial uses tests like 30-minute head-up tilt to assess changes caused by the treatment. During the study, participants will have blood tests to measure immune cell complexes and inflammatory signals, as well as assessments of blood flow and heart rate responses to posture changes. Researchers will track these outcomes before and after the 28-day treatment period. Safety monitoring will include tracking any adverse effects and reviewing data quality regularly. The study plans to enroll a total of 50 participants and will maintain privacy through coded data storage.
CONDITIONS
Brief Title
Effect of 2-HOBA in Persistent Immune Activation in Long COVID POTS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with Long COVID, with symptoms lasting more than three months after acute SARS-CoV-2 infection
- Diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS) confirmed by orthostatic vital signs showing heart rate increase as specified
- SARS-CoV-2 infection confirmed 3 or more months prior by clinical, epidemiological, or diagnostic criteria
- Ability to provide informed consent
You will not qualify if you...
- Active acute SARS-CoV-2 infection within 4 weeks of onset
- Moderate or severe immunocompromised status
- History of cardiovascular disease including AV block, myocardial infarction, angina, heart failure, pacemaker, stroke, or transient ischemic attack within 6 months before enrollment
- Uncontrolled hypertension (blood pressure over 140/90 despite treatment)
- Type 1 or type 2 diabetes mellitus
- Impaired liver function (AST or ALT greater than 1.5 times upper limit normal or total bilirubin above 1.5 mg/dl)
- Impaired kidney function (eGFR less than 60 mL/min/1.73m2)
- Anemia with hemoglobin less than 10 g/dl
- Pregnant or breastfeeding women
- History of autoimmune disease, current steroid or immunotherapy use
- Allergy or contraindication to study medication components
- Use of central acetylcholinesterase inhibitors or monoamine oxidase inhibitors
- Inability to provide informed consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
3 in-person study visits and 1 telemedicine visit
Duration - 28 days
Participants receive 28 days of treatment with either 2-HOBA, an IsoLG-adduct scavenger, or placebo to assess effects on immune activation and symptoms.
1 baseline visit and 2 follow-up visits (in-person)
Duration - Short-term post-treatment monitoring
Participants are monitored for changes in immune markers, splanchnic venous capacitance, and orthostatic tachycardia after treatment completion.
Visits included in treatment stage assessments
Trial Site Locations
Total: 1 location
1
Cyndya Shibao
Nashville, Tennessee, United States, 37027
Actively Recruiting
Research Team
M
Marwa Mohamed, PhD
C
Cyndya Shibao, MD
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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