COVID-19 iCura SARS-CoV-2 Ag OTC: Clinical Evaluation

NCT05555030 | Completed FDA Device

• 1 other identifier: EDP-OTC-iCD-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

SARS-CoV-2 rapid antigen over the counter clinical performance evaluation.

Conditions

SARS-CoV-2 Infection; COVID-19

Outcome Measures

Primary Outcomes (2)

• Positive Percent Agreement

  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

  3 months

• Negative Percent Agreement

  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.

  3 months

Secondary Outcomes (1)

• Detection of Asymptomatic Positives

  3 months

Study Arms (2)

At least 30 children between 2 and 13 years of age

EXPERIMENTAL

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.

Device: iCura COVID-19 Antigen Rapid Home Test; Diagnostic Test: RT-PCR Test

Subject 14-65+ years of age

EXPERIMENTAL

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.

Device: iCura COVID-19 Antigen Rapid Home Test; Diagnostic Test: RT-PCR Test

Interventions

iCura COVID-19 Antigen Rapid Home Test DEVICE

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.

At least 30 children between 2 and 13 years of age; Subject 14-65+ years of age

RT-PCR Test DIAGNOSTIC_TEST

High sensitivity RT-PCR COVID-19 Test

At least 30 children between 2 and 13 years of age; Subject 14-65+ years of age

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Day Diagnostics: lead
• Paragon Rx Clinical, Inc.: collaborator
• iCura Diagnostics, LLC: collaborator

Study Sites (2)

Paragon

Anaheim, California, 92703, United States

Location

EDP Biotech

Knoxville, Tennessee, 37919, United States

Location

Related Publications (3)

• 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.

  PMID: 32113704 BACKGROUND

• 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.

  PMID: 32169119 BACKGROUND

• 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.

  PMID: 32081636 BACKGROUND

Related Links

• WHO. 2022
• Johns Hopkins University Center for Health Security Website. 2020

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jason Liggett, PhD

  New Day Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Scientist

Model Details: This is an open-label, prospective study to evaluate the sensitivity and specificity of the iCura COVID-19 Antigen Rapid Home Test when a lay person conducts the test on themselves or another study participant. Potential subjects will be those presenting for COVID-19 testing. The study will evaluate the performance of the iCura COVID-19 Antigen Rapid Home Test by comparing it to a high sensitivity EUA SARS-CoV-2 RT-PCR assay to calculate both the positive percent agreement (PPA, or sensitivity) and the negative percent agreement (NPA, or specificity).

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 26, 2022
• Study Start: August 4, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)