Effect of 2-HOBA in Persistent Immune Activation in Long COVID POTS

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07189936
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Long COVID19
  • Post-Acute COVID-19 Syndrome
  • Postural Tachycardia Syndrome (POTS)
  • SARS CoV 2 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • To Measure levels of circulating monocyte/ T cell doublets at Baseline — DRUG
    To 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 — DRUG
    Subjects 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 — DRUG
    The 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_TEST
    We 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_TEST
    We 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_TEST
    To 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_TEST
    To 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

Study Details

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

Key Dates

Start date
Dec 18, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Levels of circulating monocyte/ T cell doublets, and inflammatory cytokines in 2 HoBA Vs Placebo
    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
  • Placebo Comparator: Effect of 2HOBA on Splanchnic venous capacitance and compare with placebo group on POTS patients
    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
  • Active Comparator: Effect of 2HOBA on Orthostatic Tachycardia compare with placebo group during 30 minutes head up tilt
    To test that IsoLG-adducts directly effect Orthostatic tachycardia in LCPOTS, during 30-minute head-up tilt.

Primary Outcome Measure

Effect IsoLG-adducts (2-HOBA) measured by levels of monocyte/T cell doublets in LCPOTS. [ Time Frame: Baseline (Day 0) to after 28 days of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cyndya ShibaoNashvilleTennessee37027
Marwa Mohamed, Phd
[email protected]
615-970-2384
Tatiana Solis, MPH
[email protected]
615 322 3447
Cyndya A Shibao, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By research site
Cyndya Shibao· Nashville, TN

Related Studies