Communicable DiseaseNCT04348864
COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
A study testing COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support and Telemedicine in people with Communicable Disease and COVID-19, run by Neuroganics LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Communicable Disease, COVID-19, Sars-CoV2
- What is being tested?
- COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support and Telemedicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2020to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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,
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Joe Ramos, MD/JD contact
United States1 site, 1 recruiting
- Recruiting
Neuroganics
Northglenn, Colorado, 80260
Donald Cooper, Ph.D., 720-431-3495, covid19study@protonmail.com
Joe Ramos, MD/JD, covid19study@protonmail.com
About this study
Official title: Assessment of COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
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.
Read the detailed description
Two Nasopharyngeal (NP) swabs will be collected from opposite nares by health care professionals at the POC from minimally 500 subjects enrolled at a minimum of 2 point- of-care (POC) clinical sites. One swab will be tested for the presence of SARS-CoV-2 responsible for COVID -19 using antigen-based tests. A second swab will be placed in transport media and transferred to a laboratory for testing using a high sensitivity EUA real-time (RT) PCR assay as the comparator method and the Ct values used to determine positive or negative. The order of sample collection will be randomized.
Serial testing for home use of the Test-It (Turklab) COVID-19 Rapid Antigen test will be tested in symptomatic and asymptomatic subjects.
Positive tests will be tested for SARS-CoV-2 variant using Whole Genome Sequencing Method by Amplicon-Based NGS (Quest Diagnostics).
Two to 4 health care professional operators per site, with a range of education and training, at a point of care setting will perform a COVID-19 Rapid test assay utilizing the Instructions for Use and/or Quick Reference Instruction.
Sample Population: Males and females, age 2 and older, with or without symptoms consistent with SARS-CoV-2 infection (COVID-19).
Outcome measures: 1) Sensitivity and specificity will be calculated for comparison of results between the Rapid test and the high sensitivity EUA real-time (RT) PCR assay comparator. 2) Evidence that a Health Care Professional (HCP) at Point of Care (POC) can safely and effectively utilize the Rapid test and the COVIDscanDX reader after reading the Instructions For Use (IFU) and/or brief instruction video.
Antibody testing will be performed after PCR/antigen testing or after vaccination with and FDA EUA allowed SARS-CoV-2 vaccine. A finger-stick blood drop, nasopharyngeal swab or saliva sample in buffer is applied to a lateral flow test to measure either SARS-CoV-2 antigen or IgM and IgG antibodies either once or up to five times separated by a week for 35 days after vaccination. Follow-up tests may be performed to measure the longevity of the antibody response over time up to a year.
- Conditions
- Communicable Disease, COVID-19, Sars-CoV2, Infectious Disease, Coronavirus, Virus
- Being tested
- COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support, Telemedicine
- Keywords
- COVIDscanDX, Antigen test, LAMP test, Diagnostic reader
- Medical subject headings
- Communicable Diseases, COVID-19, Coronavirus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine supportDiagnostic test
Also called COVID-19 diagnostic rapid testing reader and software validation
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.
TelemedicineOther
Also called virtual point-of-care
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support; Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 year
Secondary outcomes (1)
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start16 Apr 2020
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communicable DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuroganics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neuroganics Diagnostics LLC, Artron Laboratories Inc, AllBio Science Inc., Turklab
- Responsible party
- Sponsor
- Investigators
- Donald Cooper, Ph.D., Principal investigator, Neuroganics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348864
- Sponsor's protocol ID
- 2020/03/18
- Status last verified
- Mar 2022
- First submitted
- 13 Apr 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
- ClinicalTrials.gov ID
- NCT04348864
- Acronym / sponsor ID
- 2020/03/18
- Conditions
- Communicable Disease, COVID-19, Sars-CoV2, Infectious Disease, Coronavirus, Virus
- Keywords
- COVIDscanDX, Antigen test, LAMP test, Diagnostic reader
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Neuroganics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Neuroganics Diagnostics LLC, Artron Laboratories Inc, AllBio Science Inc., Turklab
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Two Nasopharyngeal (NP) swabs will be collected from opposite nares by health care professionals at the POC from minimally 500 subjects enrolled at a minimum of 2 point- of-care (POC) clinical sites. One swab will be tested for the presence of SARS-CoV-2 responsible for COVID -19 using antigen-based tests. A second swab will be placed in transport media and transferred to a laboratory for testing using a high sensitivity EUA real-time (RT) PCR assay as the comparator method and the Ct values used to determine positive or negative. The order of sample collection will be randomized.
Serial testing for home use of the Test-It (Turklab) COVID-19 Rapid Antigen test will be tested in symptomatic and asymptomatic subjects.
Positive tests will be tested for SARS-CoV-2 variant using Whole Genome Sequencing Method by Amplicon-Based NGS (Quest Diagnostics).
Two to 4 health care professional operators per site, with a range of education and training, at a point of care setting will perform a COVID-19 Rapid test assay utilizing the Instructions for Use and/or Quick Reference Instruction.
Sample Population: Males and females, age 2 and older, with or without symptoms consistent with SARS-CoV-2 infection (COVID-19).
Outcome measures: 1) Sensitivity and specificity will be calculated for comparison of results between the Rapid test and the high sensitivity EUA real-time (RT) PCR assay comparator. 2) Evidence that a Health Care Professional (HCP) at Point of Care (POC) can safely and effectively utilize the Rapid test and the COVIDscanDX reader after reading the Instructions For Use (IFU) and/or brief instruction video.
Antibody testing will be performed after PCR/antigen testing or after vaccination with and FDA EUA allowed SARS-CoV-2 vaccine. A finger-stick blood drop, nasopharyngeal swab or saliva sample in buffer is applied to a lateral flow test to measure either SARS-CoV-2 antigen or IgM and IgG antibodies either once or up to five times separated by a week for 35 days after vaccination. Follow-up tests may be performed to measure the longevity of the antibody response over time up to a year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Positive-Antigen swab test for SARS-COV-2 | Experimental | Diagnostic Test: COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support, Other: TelemedicineSubjects 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. |
| Negative-Antigen swab test for SARS-COV-2 | Sham comparator | Diagnostic Test: COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support, Other: TelemedicineSubjects 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine supportAlso: COVID-19 diagnostic rapid testing reader and software validationAn 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. | Diagnostic test | Negative-Antigen swab test for SARS-COV-2, Positive-Antigen swab test for SARS-COV-2 |
| TelemedicineAlso: virtual point-of-careImaging 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 | Negative-Antigen swab test for SARS-COV-2, Positive-Antigen swab test for SARS-COV-2 |
Primary outcome
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
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
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
1 secondary outcome
Ease of self-testing procedure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Ramos, MD/JD contact
Donald Cooper, Ph.D. principal investigator
Neuroganics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support and Telemedicine in people with Communicable Disease and COVID-19, run by Neuroganics LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donald Cooper, Ph.D. (7204313495, COVID19study@protonmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical accuracy of the antibody and antigen rapid tests compared to LAMP/PCR-based test result (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.