Long COVID-19 Cutaneous Signatures: An ARPA Funded Research Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Pathology and nervous system changes that occur in patients suffering from sensory and autonomic function changes
研究概览
简要总结
This is a prospective, longitudinal study involving 300 participants for a single visit to compare Long COVID-19 neurocutaneous biosignatures with those of other disorders affecting the sensory and autonomic nervous system.
详细描述
This is a prospective, longitudinal study involving 300 participants for a single visit to compare Long COVID-19 neurocutaneous biosignatures with those of other disorders affecting the sensory and autonomic nervous system. The evaluations will include clinical assessments, neurologic exams, patient reported outcome surveys, and skin biopsies from three locations. Data will be collected on the amount of P-SYN in cutaneous nerve fibers. The cohorts of interest are as follows:
- 100 participants with Long COVID-19 defined by NIH PASC criteria
- 100 participants with acute COVID-19 who tested positive for COVID-19 without persistent symptoms defined WHO criteria
- 50 participants with postural orthostatic tachycardia syndrome (POTS)
- 50 participants with diabetic neuropathy
There are no plans for additional visits at this time.
If interested to learn more about this study, please complete the form here for someone to contact you. "here" would take you to the said form.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •, just one of the following:
- •Long COVID-19 defined by NIH PASC criteria OR
- •Acute COVID-19 who tested positive for COVID-19 without persistent symptoms OR
- •Postural orthostatic tachycardia syndrome (POTS) OR
- •Diabetic neuropathy
排除标准
- •Clinical evidence of severe peripheral vascular disease
- •History of ulceration, poor wound healing or vascular claudication
- •History of allergic reaction to local anesthesia (for biopsy collection)
- •Use of oral anticoagulants (aspirin or Plavix alone is allowed)
- •History of a bleeding disorder
研究组 & 干预措施
Diabetic neuropathy
Participants with diabetic neuropathy
Postural Orthostatic Tachycardia Syndrome (POTS)
Participants with postural orthostatic tachycardia syndrome (POTS)
Long COVID
Participants with Long COVID
Acute COVID
Participants with acute COVID who tested positive for COVID without persistent symptoms
结局指标
主要结局
Pathology and nervous system changes that occur in patients suffering from sensory and autonomic function changes
时间窗: Current - December 31,2025
This is a single site study of subjects with Long COVID, subject with a previous positive COVID test without persistent symptoms, and POTS subjects and diabetics. Neurocutaneous biosignatures will provide insight into the pathology and nervous system changes that occur in patients suffering from sensory and autonomic function changes.
次要结局
未报告次要终点