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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04348864
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : October 28, 2020
Sponsor:
Collaborator:
Neuroganics Diagnostics LLC
Information provided by (Responsible Party):
Neuroganics LLC

Brief Summary:
The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic tests, like Coris Bioconcept Ag Respi-strip COVID-19 test, and LAMP-based molecular 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. 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.

Condition or disease Intervention/treatment Phase
Communicable Disease COVID-19 Sars-CoV2 Infectious Disease Coronavirus Virus Diagnostic Test: COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support Other: Telemedicine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subject that have experienced symptoms consistent with COVID-19 and have been tested by a molecular diagnostic test (e.g. PCR or isothermal LAMP) or clinical diagnosis and have been determined to be positive or negative will undergo self-testing for antibodies or antigen or viral RNA. Roughly equal numbers of positive or negative subjects will participate in self-testing.
Masking: None (Open Label)
Masking Description: Participants are aware of their diagnosis prior to testing the antibody test. They will see the result of the self-test between 10-20 minutes after performing the test and discussing it with the qualified point of care personnel.
Primary Purpose: Diagnostic
Official Title: Assessment of COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
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. Follow-up PCR-based testing occurs in an advanced laboratory.
Diagnostic Test: 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.
Other Name: COVID-19 diagnostic rapid testing reader and software validation

Other: 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).
Other Name: virtual point-of-care

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.
Diagnostic Test: 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.
Other Name: COVID-19 diagnostic rapid testing reader and software validation

Other: 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).
Other Name: virtual point-of-care




Primary Outcome Measures :
  1. Clinical accuracy of the antibody and antigen rapid tests compared to LAMP/PCR-based test result [ Time Frame: 1 year ]
    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

  2. Clinical accuracy of the antibody and antigen rapid tests based on Clinical diagnosis [ Time Frame: 1 year ]
    Accuracy refers to the amount of agreement between the results of the rapid tests and a clinical diagnosis of COVID-19

  3. Self-test interpretation of result vs expert clinical image interpretation of result [ Time Frame: 1 year ]
    Clinical accuracy of the subject's visual interpretation of the test result vs image analysis from clinician


Secondary Outcome Measures :
  1. Ease of self-testing procedure [ Time Frame: 1 year ]
    Subjects will complete a survey to rate the testing procedure for ease of use and convenience. The survey will ask subjects to rate the ease of use on a scale from 1 (easiest procedure to complete and understand) to 10 (most complicated and confusing procedure)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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 and placing it on the sample well.
  • Individuals that have interacted with a COVID-19 positive individual and are still exhibiting symptoms will be tested by the Colorado Department of Public Health with 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348864


Contacts
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Contact: Donald Cooper, Ph.D. 7204313495 COVID19study@protonmail.com
Contact: Joe Ramos, MD/JD COVID19study@protonmail.com

Locations
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United States, Colorado
Neuroganics Recruiting
Northglenn, Colorado, United States, 80260
Contact: Donald Cooper, Ph.D.    720-431-3495    covid19study@protonmail.com   
Contact: Joe Ramos, MD/JD       covid19study@protonmail.com   
Sponsors and Collaborators
Neuroganics LLC
Neuroganics Diagnostics LLC
Investigators
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Principal Investigator: Donald Cooper, Ph.D. Neuroganics LLC
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Responsible Party: Neuroganics LLC
ClinicalTrials.gov Identifier: NCT04348864    
Other Study ID Numbers: 2020/03/18
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Neuroganics LLC:
COVIDscanDX
Antigen test
LAMP test
Diagnostic reader
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Antibodies
Immunologic Factors
Physiological Effects of Drugs