Development of a Personalized Alternative Non-invasive Rapid Diagnostic Test for SARS-CoV-2 in Patients With Long COVID
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of Participants With Bioelectrical Response Patterns Consistent With Viral Persistence
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of Participants With Bioelectrical Response Patterns Consistent With Viral Persistence
Time Frame: 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.
Secondary Outcomes
- Distribution of Bioelectrical Reactivity Patterns During Medicament Testing(Baseline(Day 1))