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GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

NCT ID: NCT05140005

Last Updated: 2021-12-20

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-06

Study Completion Date

2021-12-17

Brief Summary

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The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.

Detailed Description

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The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use. The Arion Bio GlowTest COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. The test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult collected anterior nares swab samples from individuals aged 2 to 13. The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.

30 subjects (including both English speaking and Spanish speaking) will be split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child). There will be one testing site in the United States (US).

Conditions

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Covid 19

Keywords

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Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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15 subjects testing themselves

15 subjects will use the Glow Test Kit to test themselves for Covid 19.

Group Type OTHER

GlowTest COVID-19 Antigen Home Test

Intervention Type DIAGNOSTIC_TEST

diagnostic testing for Covid 19

15 subjects testing someone else

15 subjects will use the Glow Test Kit to test someone else (a child) for Covid 19.

Group Type OTHER

GlowTest COVID-19 Antigen Home Test

Intervention Type DIAGNOSTIC_TEST

diagnostic testing for Covid 19

Interventions

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GlowTest COVID-19 Antigen Home Test

diagnostic testing for Covid 19

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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GlowTest

Eligibility Criteria

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Inclusion Criteria

* An Institutional Review Board (IRB) approved informed consent/assent is signed and dated prior to any study-related activities.
* Males and females ages 2 and older.
* Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult.)
* Subject agrees to complete all aspects of the study

Exclusion Criteria

* Subject has a visual impairment that cannot be restored with glasses or contact lenses.
* Subject has prior medical or laboratory training.
* Subject uses home diagnostics, e.g., glucose meters, HIV tests.
* Subject has prior experience with home COVID test kits.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CSSi Life Sciences

INDUSTRY

Sponsor Role collaborator

Arion Bio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Geller, MD

Role: PRINCIPAL_INVESTIGATOR

Centennial Medical Group

Locations

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Centennial Medical

Elkridge, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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AB-001-01

Identifier Type: -

Identifier Source: org_study_id