2-HOBA for Long COVID POTS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called 2-HOBA for individuals experiencing Long COVID with Postural Orthostatic Tachycardia Syndrome (POTS). Researchers aim to determine if 2-HOBA can reduce certain immune markers and improve symptoms like fatigue, dizziness when standing, and exercise intolerance. Participants will receive either 2-HOBA or a placebo (a harmless pill with no active ingredient) to compare results. The trial seeks individuals who have experienced Long COVID and POTS symptoms for more than three months, such as dizziness or a rapid heartbeat when standing up. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot participate if you are using certain medications like central acetylcholinesterase inhibitors, monoamine oxidase inhibitors, or if you have an aspirin allergy. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that 2-HOBA is likely to be safe for humans?
Research has shown that 2-hydroxybenzylamine (2-HOBA) is under study for its potential to alleviate Long COVID symptoms, particularly those related to postural orthostatic tachycardia syndrome (POTS). While detailed safety information for 2-HOBA specifically for Long COVID POTS is still being gathered, earlier studies have shown promising results.
2-HOBA targets harmful molecules that can cause inflammation and immune system issues. In trials for other conditions, it reduced these harmful molecules, suggesting it might be well-tolerated. However, more information is needed to fully understand its safety for Long COVID POTS.
Since this trial is in an early phase, researchers are still testing the treatment for safety and effectiveness. This phase helps determine if 2-HOBA is safe enough for larger group testing. Prospective participants should know that safety is a key focus of the current research.12345Why do researchers think this study treatment might be promising for Long COVID POTS?
Unlike the standard treatments for Long COVID POTS, which mainly focus on managing symptoms like increasing blood volume or using medications to support the nervous system, 2-HOBA targets a new pathway. Researchers are excited about 2-HOBA because it acts as an IsoLG-adduct scavenger, potentially reducing inflammation and improving blood vessel function. This unique mechanism of action could directly address underlying causes of symptoms such as orthostatic tachycardia and splanchnic vasodilation, offering a novel approach to treatment that goes beyond merely alleviating symptoms.
What evidence suggests that 2-HOBA might be an effective treatment for Long COVID POTS?
Research has shown that 2-HOBA, which participants in this trial may receive, might help with Long COVID POTS by addressing immune system issues. In people with LCPOTS, studies have found increased interactions between immune cells, known as doublets. These doublets link to IsoLG-adducts, which may keep the immune system overly active. 2-HOBA works by removing these IsoLG-adducts, potentially calming the immune response. Additional research suggests that these adducts might also cause problems with blood vessels, such as widening in the abdomen, affecting blood flow and heart rate. By reducing these effects, 2-HOBA could improve symptoms like dizziness and rapid heartbeat in LCPOTS patients.12467
Who Is on the Research Team?
Cyndya Shibao, M.D
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
This trial is for adults who've had COVID-19 and are experiencing long-term symptoms like fatigue, exercise intolerance, or rapid heartbeat when standing (LCPOTS), lasting over three months. Participants must have a confirmed POTS diagnosis and past SARS-CoV-2 infection documented by a healthcare provider.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 2-HOBA or placebo for 28 days to assess effects on immune markers and symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 2-HOBA
Trial Overview
The study tests the effects of 2-HOBA, a compound that targets harmful immune system byproducts linked to LCPOTS. It compares changes in immune markers and heart rate responses between those taking 2-HOBA and those on placebo after 28 days.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
To test that IsoLG-adducts directly effect Orthostatic tachycardia in LCPOTS, during 30-minute head-up tilt.
to test the effect of 28-day treatment with Iso-LG-adduct scavenger, 2-hydroxybenzylamine (2-HOBA) versus placebo on circulating monocyte/ T cell doublets (CD14+CD3+) , and inflammatory cytokines
To test the hypothesis that IsoLG-adducts directly contribute to splanchnic vasodilation, by assessing changes in splanchnic venous capacitance with 2-HOBA treatment at head up Tilt
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
American Heart Association
Collaborator
Citations
Effect of 2-HOBA in Persistent Immune Activation in Long ...
The preliminary data show that: 1) LCPOTS subjects have markedly increased circulating doublets compared to controls; 2) T cells in these doublets produce ...
Vanderbilt Clinical Trials
Effect of 2-HOBA in Persistent Immune Activation in Long COVID POTS ... Long COVID POTS - Postural Orthostatic Tachycardia Syndrome Autonomic Dysfunction.
3.
aging.networkofcare.org
aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT07189936?keyword=%22Postural%20Tachycardia%20Syndrome%22Effect of 2-HOBA in Persistent Immune Activation in Long ...
~Aim 2: To test the hypothesis that IsoLG-adducts directly contribute to splanchnic vasodilation, orthostatic tachycardia, and symptom burden in LCPOTS.~Aim 2 ...
Self-reported Data From the LISTEN Study - PubMed
Results: Of the 578 individuals included, 167 (28.9%) reported new-onset POTS and 411 (71.1%) did not report POTS as one of their long COVID-associated ...
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