About this trial
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
Qualifiers
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.
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.
Disqualifiers
Known active acute SARS-Cov-2 infection (4 weeks from onset)
Moderate or severe immunocompromised patients,
Known history of cardiovascular disease (atrioventricular block (AV block), myocardial infarction, angina, heart failure, pacemaker, stroke, transient ischemic attack within 6 months before enrollment),
Uncontrolled hypertension (BP>140/90 despite appropriate treatment);
Trial design
Treatments tested in this trial
- To Measure levels of circulating monocyte/ T cell doublets at Baseline
- To measure levels of circulating monocyte/ T cell doublets after 28 days of 2 HOBA treatment
- To measure levels of circulating monocyte/ T cell doublets after 28 days of Placebo treatment
- To Measure Splanchnic venous capacitance after 28 days of Treatment with 2HOBA
- To Measure Splanchnic venous capacitance after 28 days of Treatment with Placebo
- To Measure Orthostatic Tachycardia after 28 days of Treatment with 2HOBA
- To Measure Orthostatic Tachycardia after 28 days of Treatment with Placebo
Treatment groups
Sponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
American Heart Association
Collaborator