Development of a Personalized Alternative Non-invasive Rapid Diagnostic Test for SARS-CoV-2 in Patients With Long COVID
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants With Bioelectrical Response Patterns Consistent With Viral Persistence
研究概览
简要总结
This study is a diagnostic clinical investigation designed to evaluate bioelectrical response patterns assessed by electro-acupuncture-based medicament testing.
The method is used to identify individual bioelectrical reactivity associated with the presence and persistence of pathological factors and to assess patient-specific responses to tested medicinal substances.
The study involves a single-session, non-invasive diagnostic procedure without administration of pharmacological treatment. The primary objective is the methodological evaluation of the diagnostic approach and the characterization of the detected bioelectrical response patterns in the studied population.
详细描述
This study is a diagnostic clinical investigation designed to evaluate bioelectrical response patterns assessed by electro-acupuncture-based medicament testing.
The method is used to identify individual bioelectrical reactivity associated with the presence and persistence of pathological factors and to assess patient-specific responses to tested medicinal substances.
The study involves a single-session, non-invasive diagnostic procedure without pharmacological treatment. The primary objective is the methodological evaluation of the diagnostic approach and the characterization of the detected bioelectrical response patterns in the studied population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •History of confirmed SARS-CoV-2 infection
- •Persistent symptoms consistent with Long COVID lasting ≥12 weeks after acute infection
- •Ability to provide informed consent
- •Willingness to undergo non-invasive bioelectrical diagnostic assessment
排除标准
- •Acute infectious disease at the time of enrollment
- •Severe uncontrolled medical or psychiatric conditions that may interfere with diagnostic assessment
- •Implanted electronic medical devices (e.g., pacemaker)
- •Pregnancy or breastfeeding
- •Inability to comply with study procedures
结局指标
主要结局
Number of Participants With Bioelectrical Response Patterns Consistent With Viral Persistence
时间窗: At enrollment (single diagnostic session)
Non-invasive diagnostic assessment using electroacupuncture-based medicament testing to identify bioelectrical response patterns consistent with viral antigen persistence in participants with post-viral conditions.
次要结局
- Distribution of Bioelectrical Reactivity Patterns During Medicament Testing(Baseline(Day 1))