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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-04

Study Completion Date

2022-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HCV Self-testing in Malaysia

NCT04982718

Hepatitis C Diagnostic Self Evaluation

UNKNOWN NA

Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)

NCT05016609

Hepatitis C

RECRUITING PHASE4

Treatment of Recently Acquired Hepatitis C Virus Infection

NCT01336010

Acute Hepatitis C

COMPLETED PHASE4

Rapid Point-of-care Testing for Hepatitis C in Community Clinics (RAPID-EC) Pilot Study

NCT03231930

Hepatitis C

COMPLETED NA

Comparison of OraQuick HCV Rapid Antibody Test and Standard Serologic Screening for Hepatitis C: Validity, Acceptability and Impact on Linkage to Care

NCT02084719

Active or Ex-injection Drug Users Indication of Hepatitis C Screening

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2 Infection COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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).

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

iCura COVID-19 Antigen Rapid Home Test

Intervention Type 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.

RT-PCR Test

Intervention Type DIAGNOSTIC_TEST

High sensitivity RT-PCR COVID-19 Test

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.

Group Type EXPERIMENTAL

iCura COVID-19 Antigen Rapid Home Test

Intervention Type 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.

RT-PCR Test

Intervention Type DIAGNOSTIC_TEST

High sensitivity RT-PCR COVID-19 Test

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iCura COVID-19 Antigen Rapid Home Test

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.

Intervention Type DEVICE

RT-PCR Test

High sensitivity RT-PCR COVID-19 Test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes