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New treatment option for Post-Acute COVID-19 Syndrome
Official title Effect of 2-HOBA in Persistent Immune Activation in Long COVID POTS
ClinicalTrials.gov ID: NCT07189936
What this study is testing
What is To Measure levels of circulating monocyte/ T cell doublets at Baseline?
To Measure levels of circulating monocyte/ T cell doublets at Baseline is an investigational medicine, given as an once-daily, being studied as a potential treatment for post-acute covid-19 syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Presents with acute respiratory infection...
You likely can't join if
- 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...
- Uncontrolled hypertension (BP\>140/90 despite appropriate treatment);
- Type 1 or type 2 diabetes mellitus;
- Impaired hepatic function (AST or ALT greater than 1.5x the upper limit of normal or with total bilirubin ≥1.5mg/dl),
See the full eligibility 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...
- 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...
- 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...
- 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);
- Type 1 or type 2 diabetes mellitus;
- Impaired hepatic function (AST or ALT greater than 1.5x the upper limit of normal or with total bilirubin ≥1.5mg/dl),
- Impaired renal function test (eGFR\<60 mL/min/1.73m2),
- Anemia (hemoglobin \<10 g/dl),
- Pregnant or breastfeeding women,
- Known history of autoimmune disease, steroid use or other immunotherapies,
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.