NCT07189936 Effect of 2-HOBA in Persistent Immune Activation in Long COVID POTS
| NCT ID | NCT07189936 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Post-Acute COVID-19 Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-12-18 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: All participants should meet diagnostic criteria for Long COVID and POTS and as outlined below: Long COVID (LC) is defined by a range of symptoms affecting multiple organs that persist for more than three months following an acute SARS-CoV-2 infection. POTS: the presence of chronic symptoms lasting more than 3 months, along with orthostatic tachycardia (a HR increase over 30 bpm upon standing or exceeding 120 bpm without orthostatic hypotension) within 10 minutes upon standing or 75-degree head up tilt. For patients aged 18 and 21, an increase of more than 40 bpm or a standing HR over 130 bpm will be required for inclusion in the study. 2 Patients need confirmation of POTS diagnosis based on orthostatic vital signs obtained prior to enrollment in the study. SARS-CoV-2 infection 3 or more months prior identified by the follow signs: A. Meets the clinical OR epidemiological criteria. 1. Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia. 2. Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Presents with acute respiratory infection with history of fever or measured fever of ≥ 38°C; and cough; with onset within the last 10 days; and who requires hospitalization); or C. Presents with no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 antigen-Rapid Diagnostic Test. D. A person with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or E. Meeting clinical criteria AND/OR epidemiological criteria (See A). With a positive professional use or self-test, SARS-CoV-2 Antigen-Rapid Diagnostic Test. F. Documented by health care provider in clinical note or encounter. Exclusion Criteria: 1. Known active acute SARS-Cov-2 infection (4 weeks from onset) 2. Moderate or severe immunocompromised patients, 3. Known history of cardiovascular disease (atrioventricular block (AV block), myocardial infarction, angina, heart failure, pacemaker, stroke, transient ischemic attack within 6 months before enrollment), 4. Uncontrolled hypertension (BP\>140/90 despite appropriate treatment); 5. Type 1 or type 2 diabetes mellitus; 6. Impaired hepatic function (AST or ALT greater than 1.5x the upper limit of normal or with total bilirubin ≥1.5mg/dl), 7. Impaired renal function test (eGFR\<60 mL/min/1.73m2), 8. Anemia (hemoglobin \<10 g/dl), 9. Pregnant or breastfeeding women, 10. Known history of autoimmune disease, steroid use or other immunotherapies, 11. Inability to provide informed consent. We will also exclude individuals with known allergy sensitivity to components of the study medication, known contraindication to the study interventions, use of central acetylcholinesterase inhibitors (e.g., pyridostigmine, donezepil), aspirin allergy because salicylic acid is a metabolite of 2-HOBA; use of monoamine oxidase inhibitors (MAO-I) because of some inhibition of MAO-A is present in the anticipated therapeutic range of 2-HOBA. \-
Contact & Investigator
Cyndya Shibao, M.D
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT07189936 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-Acute COVID-19 Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07189936 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07189936 currently recruiting?
Yes, NCT07189936 is actively recruiting participants. Contact the research team at marwa.mohamed@vumc.org for enrollment information.
Where is the NCT07189936 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07189936 clinical trial?
NCT07189936 is sponsored by Vanderbilt University Medical Center. The principal investigator is Cyndya Shibao, M.D at Vanderbilt University Medical Center. The trial plans to enroll 50 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.