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Diagnostic Test

Positive-Antigen swab test for SARS-COV-2 for COVID-19

N/A
Waitlist Available
Led By Donald Cooper, Ph.D.
Research Sponsored by Neuroganics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial assesses the clinical accuracy of rapid COVID-19 diagnostic tests compared to a reference test, and whether self-testing with mobile device imaging and telemedicine support is as accurate and safe as testing in a clinical setting. Antibodies to SARS-CoV-2 are also being tested after diagnosis or vaccination.

Eligible Conditions
  • COVID-19
  • Contagious Diseases
  • Coronavirus Infection
  • Viruses
  • Coronavirus
  • Infectious Diseases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antibodies
Clinical accuracy of the antibody and antigen rapid tests compared to LAMP/PCR-based test result
Self-test interpretation of result vs expert clinical image interpretation of result
Secondary outcome measures
Ease of self-testing procedure

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Positive-Antigen swab test for SARS-COV-2Experimental Treatment2 Interventions
Subjects who have tested positive for the presence of SARS-COV-2 viral antigen using a rapid test or LAMP/PCR-based molecular test from nasal pharyngeal self-swab or a swab administered in a clinical setting at the point of care by a trained clinician. Parallel PCR-based testing occurs in an advanced laboratory to obtain Ct values for positive test results.
Group II: Negative-Antigen swab test for SARS-COV-2Placebo Group2 Interventions
Subjects who have tested negative for the presence of SARS-COV-2 viral antigen using a rapid test or LAMP/PCR-based molecular nasal pharyngeal self-swab or a swab administered in a clinical setting by a trained clinician. PCR-based testing occurs in an advanced laboratory.

Find a Location

Who is running the clinical trial?

AllBio Science Inc.UNKNOWN
Neuroganics Diagnostics LLCUNKNOWN
Neuroganics LLCLead Sponsor
2 Previous Clinical Trials
101,000 Total Patients Enrolled
1 Trials studying COVID-19
100,000 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
2020. "COVID-19 Diagnostic Self-testing Using Virtual Point-of-care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04348864.
All > Covid
~40 spots leftby Apr 2025
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