COVID-19 Diagnostic Self-testing Using Virtual Point-of-care

NCT04348864 | Unknown FDA Device

• 1 other identifier: 2020/03/18
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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; Virus

Keywords

COVIDscanDX; Antigen test; LAMP test; Diagnostic reader

Outcome Measures

Primary Outcomes (3)

• Clinical accuracy of the antibody and antigen rapid tests compared to LAMP/PCR-based test result

  Accuracy refers to the amount of agreement between the results of the antibody-based rapid test and the results of a PCR-based reference test

  1 year

• Clinical accuracy of the antibody and antigen rapid tests based on Clinical diagnosis

  Accuracy refers to the amount of agreement between the results of the rapid tests and a clinical diagnosis of COVID-19

  1 year

• Self-test interpretation of result vs expert clinical image interpretation of result

  Clinical accuracy of the subject's visual interpretation of the test result vs image analysis from clinician

  1 year

Secondary Outcomes (1)

• Ease of self-testing procedure

  1 year

Study Arms (2)

Positive-Antigen swab test for SARS-COV-2

EXPERIMENTAL

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.

Diagnostic Test: COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support; Other: Telemedicine

Negative-Antigen swab test for SARS-COV-2

SHAM COMPARATOR

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.

Diagnostic Test: COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support; Other: Telemedicine

Interventions

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

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.

Also known as: COVID-19 diagnostic rapid testing reader and software validation

Negative-Antigen swab test for SARS-COV-2; Positive-Antigen swab test for SARS-COV-2

Telemedicine OTHER

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).

Also known as: virtual point-of-care

Negative-Antigen swab test for SARS-COV-2; Positive-Antigen swab test for SARS-COV-2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Individuals with a deviated septum
• Cognitively impaired individuals resulting in the inability to provide informed consent,

Sponsors & Collaborators

• Neuroganics LLC: lead
• Neuroganics Diagnostics LLC: collaborator
• Artron Laboratories Inc: collaborator
• AllBio Science Inc.: collaborator
• Turklab: collaborator

Study Sites (1)

Neuroganics

Northglenn, Colorado, 80260, United States

RECRUITING

MeSH Terms

Conditions

Communicable Diseases; COVID-19; Coronavirus Infections; Virus Diseases

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Donald Cooper, Ph.D.

  Neuroganics LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donald Cooper, Ph.D.

CONTACT

7204313495; COVID19study@protonmail.com

Joe Ramos, MD/JD

CONTACT

COVID19study@protonmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subject with or without symptoms consistent with COVID-19 and have been tested at the point of care (POC) with a molecular diagnostic test (e.g. PCR or isothermal LAMP) or clinical diagnosis, and have been determined to be positive or negative will undergo testing for antibodies or antigen or viral RNA. Roughly three times more subjects testing negative for SARS-CoV-2 compared to positive subjects are expected to be tested from NP samples gathered at the POC by POC staff or self-swab.

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: April 16, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)