SARS-CoV-2 OTC At Home Test

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

TERMINATED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2022-11-18

Brief Summary

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The objective of this study is to evaluate the 3EO Health COVID-19 Test in individuals presenting at a medical facility. In eligible subjects, nasal samples will be collected for use with the 3EO Health COVID-19 Test, which will be compared to the Zymo® rRT-PCR test results obtained via samples specified by the manufacturer (e.g., AN \[anterior nares\] swab) to determine accuracy of the 3EO Health COVID-19 Test in detecting COVID-19 in participants.

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Detailed Description

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3EO Health, Inc. has developed the 3EO Health COVID-19 Test, a unique rapid molecular test system, to detect SARS-CoV-2 virus in the OTC setting using a dedicated test reader "3EO Cube" to test nasal swab samples. Early testing will help to determine limit of detection (LOD) of the 3EO Health COVID-19 Test and will be compared to a sensitive molecular test that has been authorized for emergency use by the FDA. The 3EO Health COVID-19 Test will leverage the processing and testing of the 3EO Health Swab device when inserted directly into the reaction tube (3EO Key) where reverse transcription, Loop-Mediated Isothermal DNA Amplifications (LAMP) processing and sequence-specific probe technologies to detect segments of the SARS-CoV-2 genome are managed automatically by the 3EO Health Cube test reader.

Conditions

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COVID-19 Pandemic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Groups

Positives: Symptomatic vs. Asymptomatic Negatives: Symptomatic vs. Asymptomatic

Each broken down by age groups:

2-14 years old 15-24 years old 25-64 years old 65+ years old

Group Type EXPERIMENTAL

In Vitro

Intervention Type DIAGNOSTIC_TEST

In vitro diagnostic test for COVID-19 using anterior nasal swabs.

Interventions

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In Vitro

In vitro diagnostic test for COVID-19 using anterior nasal swabs.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Individuals suspected of COVID-19 disease by a healthcare provider or individuals who have tested positive within the past 7 calendar days with a confirmed positive COVID-19 test
2. Individuals able to self-administer the investigational test either upon themselves or upon their child (under sixteen (16) years of age) as a parent or guardian
3. Individuals willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)

Exclusion Criteria

1. If symptomatic, individuals with self-declared symptoms greater than 7 days (plus/minus 1 day, if symptoms start not definite)
2. Unable to provide consent or obtain consent from a LAR
3. Unwilling or unable to collect all sample types
4. Enrolled in a study to evaluate an investigational drug
5. Eating/drinking/smoking 30 minutes prior to specimen collection
6. Prisoner or under incarceration
7. Have contraindications to the collection of nasal specimens from the nares/nostrils, such as but not limited to nasal ulcers or nasal surgery within 3 months prior to sample collection

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes