Recruiting

COVID-19 Testing

Sponsor:

Neuroganics LLC

Code:

NCT04348864

Conditions

Communicable Disease

COVID-19

Sars-CoV2

Infectious Disease

Coronavirus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support

Telemedicine

Study Details

Brief summary:

The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic antibody tests, like Cellex qSARS-CoV-2 IgG/IgM Rapid Test, or antigen tests, like Turklab Test-It COVID-19 Home Test, AllBio Science Inc. and Artron Laboratories Inc. rapid COVID-19 antigen tests in order to judge their clinical accuracy compared to Centers for Disease Control (CDC)-recommended molecular genetic testing and clinical diagnosis. Second, it is our goal to determine if self-testing assisted by COVIDscanDX mobile device camera acquisition software platform and telemedicine clinical/technical support (virtual point-of-care) improves the ease of use and immediate interpretation of the tests, thus making self-testing comparable in accuracy and safety to testing in a clinical setting. Third, we are testing antibodies to SARS-CoV-2 after diagnosis with COVID-19 or following vaccination to measure the onset and time course of detectable antibodies from finger-stick blood drops and rapid antibody lateral flow tests. The overall purpose of the study is to dramatically increase the capacity of COVID-19 testing by establishing the safety, ease-of-use and validity of self-testing assisted by mobile device imaging and telemedicine remote support and provide evidence of antibody time-course response to vaccination.

Conditions

Communicable Disease

COVID-19

Sars-CoV2

Infectious Disease

Coronavirus

Study ID

NCT04348864

Start date

Apr 16, 2020

Status verified date

Mar, 2022

Completion date

Apr, 2022

Anticipated

Primary completion date

Apr, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Individuals who have experienced symptoms of COVID-19 and have been tested using a CDC approved or FDA registered and listed nucleic acid based test within 1 year of Feb 1, 2020.
  • Individuals who have been clinically diagnosed or suspected to have had COVID-19.
  • Individuals who are at the time of enrollment in the study currently or in the recent past (3 weeks) exhibiting symptoms of COVID-19.
  • Individuals capable of performing a finger stick blood drop draw or saliva collection and placing it in a sample collection tube.
  • Individuals that have interacted with a COVID-19 positive individual and are still exhibiting symptoms will be tested by a CDC approved or FDA registered nucleic acid based device.
  • Individuals must be capable of navigating a mobile device to take an image of the test using the camera and enter information into fields on the device and wireless/cellular capability to upload one or more images to a website server.

Exclusion Criteria: Individuals incapable of pricking their finger and placing a drop of blood into a sample well.

  • Individuals who cannot navigate a mobile device and see the screen to navigate and enter information in fields or align the camera with the test image.
  • Pregnant woman are not excluded if they meet the inclusion criteria and age requirements.
  • Individuals with a deviated septum
  • Cognitively impaired individuals resulting in the inability to provide informed consent,

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Positive-Antigen swab test for SARS-COV-2

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.

sham comparator: Negative-Antigen swab test for SARS-COV-2

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.

Interventions

COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support

An immunodiagnostic rapid (5-20 minute) test detects circulating antibodies in the blood, serum or plasma of individuals who have been infected with the novel coronavirus SARS-COV-2 as detected by rapid antigen test or LAMP/PCR-based molecular test taken from nasopharyngeal swab samples in the recent past.

Telemedicine

Imaging of the test using the software application COVIDscanDX and upload to server by the subject and phone, video or messaging consult with a clinician for interpretation and instructions establishes the telemedicine (i.e. virtual point-of-care).

Primary outcome measure

  • Clinical accuracy of the antibody and antigen rapid tests compared to LAMP/PCR-based test result [ Time Frame: 1 year ]
  • Clinical accuracy of the antibody and antigen rapid tests based on Clinical diagnosis [ Time Frame: 1 year ]
  • Self-test interpretation of result vs expert clinical image interpretation of result [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Donald Cooper, Ph.D.

7204313495COVID19study@protonmail.com

Joe Ramos, MD/JD

COVID19study@protonmail.com

Locations

Neuroganics

Recruiting

Northglenn, Colorado, United States, 80260

Contacts

Donald Cooper, Ph.D.

720-431-3495covid19study@protonmail.com

Joe Ramos, MD/JD

covid19study@protonmail.com

More Information

Sponsor

Neuroganics LLC

Last update posted

Mar 23, 2022

Last verified

Mar, 2022

Keywords

  • COVIDscanDX
  • Antigen test
  • LAMP test
  • Diagnostic reader

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neuroganics LLC on 2022-03-23.