SARS-CoV-2 OTC At Home Test

Not Applicable

Terminated

• Conditions: COVID-19 Pandemic
• Interventions: Diagnostic Test: In Vitro

• Registration Number: NCT05553964
• Lead Sponsor: 3EO Health

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-26
• Study Start: 2022-10-07
• Status Verified: 2022-11
• Primary Completion: 2022-11-18
• Study Completion: 2022-11-18
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Groups	In Vitro	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

Primary Outcome Measures

Name	Time	Method
Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.	1-16 weeks	The primary endpoints of this study will be the correlation of the 3EO Health SARS-CoV-2 OTC At Home Test results from nasal samples to the comparator, standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.

Trial Locations

Locations (5)

Sarkis Clinical Trials; 🇺🇸 Gainesville, Florida, United States

I.V.A.M. Clinical & Investigational Center; 🇺🇸 Miami, Florida, United States

Sunrise Research Institute; 🇺🇸 Sunrise, Florida, United States

Vytalus Medical; 🇺🇸 Kingwood, Texas, United States

Vytalus Medical Atascocita; 🇺🇸 Humble, Texas, United States