COVID-19 Clinical Trial
Official title:
Assessment of COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
NCT number | NCT04348864 |
Other study ID # | 2020/03/18 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 16, 2020 |
Est. completion date | April 2022 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 2022 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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, |
Country | Name | City | State |
---|---|---|---|
United States | Neuroganics | Northglenn | Colorado |
Lead Sponsor | Collaborator |
---|---|
Neuroganics LLC | AllBio Science Inc., Artron Laboratories Inc, Neuroganics Diagnostics LLC, Turklab |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Ease of self-testing procedure | 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) | 1 year |
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