- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07343856
Long COVID Diagnostic Reactivity Assesment Test (EAV-LONGCOVID)
Development of a Personalized Alternative Non-invasive Rapid Diagnostic Test for SARS-CoV-2 in Patients With Long COVID
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tashkent, Uzbekistan, 100194
- Research Institute of Virology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic Assesment Arm
This single-arm study includes participants undergoing a non-invasive electrodiagnostic assessment to evaluate bioelectrical response patterns associated with viral antigen persistence.
No therapeutic intervention is administered.
|
A non-invasive diagnostic procedure performed during a single session to assess bioelectrical response patterns associated with viral antigen persistence.
Measurements are obtained using standardized bioelectrical assessment techniques without administration of any therapeutic agents or interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At enrollment (single diagnostic session)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Distribution of Bioelectrical Reactivity Patterns During Medicament Testing
Time Frame: Baseline(Day 1)
|
Baseline(Day 1)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Naylya Djumaeva, MD,PhD, Reseacrh Institute of Virology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- COVID-19
- Nervous System Diseases
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Autonomic Nervous System Diseases
- Pathological Conditions, Signs and Symptoms
- Post-Acute COVID-19 Syndrome
- Primary Dysautonomias
Other Study ID Numbers
- 9/36-2216
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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