- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05555030
COVID-19 iCura SARS-CoV-2 Ag OTC: Clinical Evaluation
iCura Diagnostics, LLC / COVID-19 Antigen Rapid Home Test Over the Counter Rapid Antigen Self-Test for Detection of SARS-CoV-2 Virus: Clinical Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Coronavirus disease (COVID-19) is a disease caused by a newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1. The SARS-CoV-2 is a β-coronavirus, which is enveloped non-segmented positive-sense RNA virus 22. It is spread by human-to-human transmission via droplets or direct contact, and infection has been estimated to have mean incubation period of 6.4 days and a basic reproduction number of 2.24-3.58. Among patients with pneumonia caused by SARS-CoV-2, fever was the most common symptom, followed by cough. On 11 March 2020, the COVID-19 outbreak was characterized as a pandemic by the WHO. Since then, over 70 million people worldwide have been infected with the virus with over 1.5 million deaths attributed to the virus5. Laboratory testing for SARS-CoV-2 is currently being performed to determine if an individual has active infection via detection of viral RNA or if an individual has an immune response to the virus from a previous infection via detection of antibodies.
Specimen collection is a crucial first step in the evaluation of an individual's SARS-CoV-2 infection status. The goal of this project is to evaluate a Candidate Ag self-test kit for over the counter (OTC) use. Study subjects under EDP supervision, either in-person or via video conference, will collect and test anterior nasal swab samples and a Study Representative will collect and ship a nasopharyngeal swab sample for comparator PCR testing. The Candidate Ag self-test kit collection and testing methodology is viewed as a convenient and inexpensive method to test clinical specimens for SARS-CoV-2 and OTC access will improve the availability of COVD-19 testing.
The iCura COVID-19 Antigen Rapid Home Test (candidate test) is a rapid antigen (Ag) immunochromatography based one step in vitro test intended to detect nucleocapsid antigen from the SARS-CoV-2 virus that causes COVID-19. It is designed for over the counter (OTC) rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals within 14 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Buer Song, MD
- Phone Number: 4246452254
- Email: bsong@icuradx.com
Study Locations
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California
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Anaheim, California, United States, 92703
- Paragon
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Tennessee
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Knoxville, Tennessee, United States, 37919
- EDP Biotech
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Lay subjects greater than 2 years old that do not know their current COVID-19 status and can complete the consent/assent process in both written and spoken English may be included in the study.
Exclusion Criteria:
- Subjects less than 2 years old will be excluded.
- Participants that are or were medial and/or laboratory professionals will be excluded.
- Participants that cannot read and understand English will be excluded.
- High risk individuals will not be excluded unless they are too young or have prior training or experience that would exclude them.
- Participants who refuse to sign the informed consent/assent form(s) will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: At least 30 children between 2 and 13 years of age
Participants 2-13 years of age will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the iCura SARS-CoV-2 Antigen Rapid Home Test.
The parent or legal guardian of the child will collect an anterior nasal swab sample from the child and perform the iCura SARS-CoV-2 Antigen Rapid Home Test.
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Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
Comparator NP samples shall be collected at least 15 minutes prior to Ag samples with at least 15 minutes between nasal collections including collections that may occur prior to study enrollment.
Comparator samples will be collected first by qualified personnel at a study site or physician's office using an FDA authorized nasopharyngeal swab collection kit and SARS-CoV-2 molecular assay.
High sensitivity RT-PCR COVID-19 Test
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Experimental: Subject 14-65+ years of age
Participants will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the iCura SARS-CoV-2 Antigen Rapid Home Test.
The participant will then self-collect or, if both are over 18, collect from another study participant an anterior nasal swab sample and test using the iCura SARS-CoV-2 Antigen Rapid Home Test.
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Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
Comparator NP samples shall be collected at least 15 minutes prior to Ag samples with at least 15 minutes between nasal collections including collections that may occur prior to study enrollment.
Comparator samples will be collected first by qualified personnel at a study site or physician's office using an FDA authorized nasopharyngeal swab collection kit and SARS-CoV-2 molecular assay.
High sensitivity RT-PCR COVID-19 Test
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Percent Agreement
Time Frame: 3 months
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The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to eighty percent in a comparison between the iCura COVID-19 Antigen Rapid Home TestRT-PCR comparator test results
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3 months
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Negative Percent Agreement
Time Frame: 3 months
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The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to ninety-eight percent in a comparison between the iCura COVID-19 Antigen Rapid Home Test and the RT-PCR comparator test results.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of Asymptomatic Positives
Time Frame: 3 months
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Number of participants with a positive PCR comparator result, but reported no symptoms or epidemiological reasons to suspect COVID-19 infection within the past 14 days.
This will be compared to their iCura COVID-19 Antigen Rapid Home Test result to determine the ability of the iCura COVID-19 Antigen Rapid Home Test to detect individuals who are infected but are not symptomatic.
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3 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0.
- Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.
- Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- EDP-OTC-iCD-001
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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