SARS-CoV-2 OTC At Home Test

Prospective, Multi-Center, Non-Randomized Study to Evaluate the 3EO Health SARS-CoV-2 Molecular Diagnostic Test

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19 Pandemic
• Intervention / Treatment: Diagnostic test: In Vitro

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Miami, Florida, United States, 33144
      • I.V.A.M. Clinical & Investigational Center
    • Sunrise, Florida, United States, 33325
      • Sunrise Research Institute
  • Texas
    • Humble, Texas, United States, 77346
      • Vytalus Medical Atascocita
    • Kingwood, Texas, United States, 77339
      • Vytalus Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Diagnostic test: In Vitro; In vitro diagnostic test for COVID-19 using anterior nasal swabs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.	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.	1-16 weeks

Collaborators and Investigators

• Sponsor: 3EO Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 7, 2022
• Primary Completion (ACTUAL): November 18, 2022
• Study Completion (ACTUAL): November 18, 2022

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (ACTUAL): September 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 3EO-CoV2-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No