- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04348864
COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
Assessment of COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
Study Overview
Status
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Donald Cooper, Ph.D.
- Phone Number: 7204313495
- Email: COVID19study@protonmail.com
Study Contact Backup
- Name: Joe Ramos, MD/JD
- Email: covid19study@protonmail.com
Study Locations
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Colorado
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Northglenn, Colorado, United States, 80260
- Recruiting
- Neuroganics
-
Contact:
- Joe Ramos, MD/JD
- Email: covid19study@protonmail.com
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Contact:
- Donald Cooper, Ph.D.
- Phone Number: 720-431-3495
- Email: covid19study@protonmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
Parallel PCR-based testing occurs in an advanced laboratory to obtain Ct values for positive test results.
|
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 Names:
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 Names:
|
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.
|
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
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
|
1 year
|
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
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Donald Cooper, Ph.D., Neuroganics LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- COVID-19
- Infections
- Communicable Diseases
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
Other Study ID Numbers
- 2020/03/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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