Long COVID Immune Profiling
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- IL-6 levels
研究概览
简要总结
Parasympathetic nervous system (PNS) is part of the body's autonomic nervous system(PNS) protects body against inflammation. Study shows that reduced PNS function activity is associated with persistent inflammation.
Preliminary data from the studies shows, that post-COVID-19 POTS patients have reduced parasympathetic (PNS) function. Given that the PNS protects against inflammation, this clinical trial aims to prove that post-COVID-19 POTS is caused by reduced PNS activity, which in turn, contributes to persistent inflammation, orthostatic intolerance, and OI symptoms.
The study will evaluate immune cell activation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity.
详细描述
COVID-19 infections can cause a disabling syndrome that persists beyond the 3-month convalescence period. The term post-acute COVID-19 syndrome or Long COVID is coined to describe a cluster of symptoms consisting of fatigue, chest pain, reduced exercise tolerance, tachycardia, and cognitive impairment.
Persistent tachycardia remains one of the most common complaints, reported in 9% of patients at 6 months post-infection. These symptoms overlap with those present in patients with Postural orthostatic tachycardia syndrome (POTS). It is noteworthy that about half of POTS patients also report a history of viral infection prior to the development of these symptoms.
Post-COVID-19 tachycardia syndrome, POTS variant: It present with chronic tachycardia with symptoms of orthostatic intolerance (OI) without any other identifiable cause. In addition, non-specific symptoms such as fatigue, headache, and "brain fog", commonly described in POTS patients are also present in this novel condition.
Elevated levels of inflammatory markers CRP,D-dimer and IL-6 are found in Long COVID patients. Data in POTS, which resembles post-COVID tachycardia syndrome, shows increased cytokines including IL-6, IL-1b, and TNF-a.
Notably, stimulation of the efferent vagus nerve (PNS), has been shown to reduce proinflammatory markers production and systemic inflammation. Hence, decreased PNS function, as reported with acute SARS-CoV-2 infection and in post-COVID-19 POTS patients, may render these patients prone to persistent inflammation. To determine the link between PNS activity and immune activation in post-COVID-19 POTS, the study aims to evaluate immune cell activation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be 18 years or older, men and women.
- •History of confirmed COVID-19 infection (positive contact and symptoms, antigen test or PCR).
- •POTS will be defined as the presence of orthostatic tachycardia (>30 bpm) and chronic (>3 months) pre-syncopal symptoms.
- •Post-COVID-19 POTS will be defined as the presence of orthostatic tachycardia (>30 bpm) and chronic (>3 months) pre-syncopal symptoms. Symptoms occurred within 2 months after COVID infection and persistent until enrollment in the study.
排除标准
- •Individuals with a history of physician diagnosed myocardial infarction, angina, heart failure, stroke, or transient ischemic attack, or who had undergone an invasive procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement, pacemaker placement or other vascular surgeries).
- •Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- •Chronic use of steroids, anti-IL6 (omalizumab), anti-TNF-alpha, other immunosuppressants.
- •Chronic use of NSAID. Should not enroll if taking without one week prior to blood sampling.
- •Treatment with plasmapheresis, IVIG or other immune modulator
研究组 & 干预措施
Post- COVID 19 POTS patients
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31): In post-COVID-19 POTS (cases).
干预措施: cytokines (IL-17, and IFN-ɣ) (Diagnostic Test)
Post- COVID 19 POTS patients
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31): In post-COVID-19 POTS (cases).
干预措施: Compass 31 (Behavioral)
POTS patients
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31):Gender, age, and BMI-matched: patients with diagnosis of POTS
干预措施: cytokines (IL-17, and IFN-ɣ) (Diagnostic Test)
POTS patients
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31):Gender, age, and BMI-matched: patients with diagnosis of POTS
干预措施: Compass 31 (Behavioral)
Post- COVID 19 POTS patients with Controls
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31):Gender, age, and BMI-matched: Controls are :COVID-19 infected without sequelae
干预措施: cytokines (IL-17, and IFN-ɣ) (Diagnostic Test)
Post- COVID 19 POTS patients with Controls
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31):Gender, age, and BMI-matched: Controls are :COVID-19 infected without sequelae
干预措施: Compass 31 (Behavioral)
POTS patients
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31):Gender, age, and BMI-matched: patients with diagnosis of POTS
干预措施: IL-6 (Diagnostic Test)
Post- COVID 19 POTS patients with Controls
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31):Gender, age, and BMI-matched: Controls are :COVID-19 infected without sequelae
干预措施: IL-6 (Diagnostic Test)
Post- COVID 19 POTS patients
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31): In post-COVID-19 POTS (cases).
干预措施: IL-6 (Diagnostic Test)
结局指标
主要结局
IL-6 levels
时间窗: Baseline
Parasympathetic (PNS) function, protects against inflammation. To Evaluate level of inflammation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity. The primary endpoint is IL-6 levels
次要结局
- cytokines (IL-17, and IFN-ɣ)(Baseline)
- Orthostatic Symptoms Score(Baseline)
研究者
Cyndya Shibao, MD
Associate Professor
Vanderbilt University Medical Center