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
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.
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);
Parallel
To Measure levels of circulating monocyte/ T cell doublets at Baseline
DrugTo determine the levels of circulating monocyte/ T cell doublets on all the LCPOTS subjects
To measure levels of circulating monocyte/ T cell doublets after 28 days of 2 HOBA treatment
DrugSubjects will be randomized 1:1 to 2-HOBA or matching placebo. The levels of circulating monocyte/ T cell doublets (immune burden) after 28 days of 2 HOBA treatment
To measure levels of circulating monocyte/ T cell doublets after 28 days of Placebo treatment
DrugThe levels of circulating monocyte/ T cell doublets (immune burden) after 28 days of 2 HOBA treatment and compare it to the placebo arms
To Measure Splanchnic venous capacitance after 28 days of Treatment with 2HOBA
Diagnostic testWe will Measure changes in Splanchnic venous capacitance after 28 days of Treatment with 2HOBA and compare it with baseline during 30 Mins head up tilt . All the LCPOTS subjects will be randomized 1:1 to 2-HOBA or matching placebo
To Measure Splanchnic venous capacitance after 28 days of Treatment with Placebo
Diagnostic testWe will Measure changes in splanchnic venous capacitance during 30 mins head up tilt ,after 28 days of Treatment with Placebo, we will compare it to the subjects who received 2 HOBA for 28 days
To Measure Orthostatic Tachycardia after 28 days of Treatment with 2HOBA
Diagnostic testTo Measure changes in Orthostatic Tachycardia after 28 days of Treatment with 2HOBA at 30 minutes of head up Tilt
To Measure Orthostatic Tachycardia after 28 days of Treatment with Placebo
Diagnostic testTo Measure changes in Orthostatic Tachycardia after 28 days of Treatment with Placebo at 30 minutes of head up Tilt and compare it with the subjects who received 28 days of 2HOBA
Effect IsoLG-adducts (2-HOBA) measured by levels of monocyte/T cell doublets in LCPOTS.
The effect of 28-day treatment with Iso-LG-adduct scavenger, 2-hydroxybenzylamine (2-HOBA) versus placebo on circulating monocyte/ T cell doublets, and inflammatory cytokines and compare it to the placebo
Changes in Splanchnic venous capacitance before and after 28 days of treatment
Changes in Splanchnic venous capacitance at 30 mins Head up tilt, before and after 28 days of treatment and compare it with 2-HOBA group with placebo group
Measure the effects of 2- HOBA on Orthostatic Tachycardia at HUT
To see the effects of IsoLG-adducts (2-HOBA) on Orthostatic Tachycardia in LCPOTS subjects at 30 mins Head up Tilt (HUT) and compare it with Placebo group
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Vanderbilt University Medical Center
Lead sponsor
American Heart Association
Collaborator
