SARS-CoV-2 OTC At Home Test

Sponsor

3EO Health (Industry)

Overall Status

Terminated

CT.gov ID

NCT05553964

Collaborator

(none)

Enrollment

Locations

Arm

1.4

Actual Duration (Months)

12.8

Patients Per Site

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pandemic	Diagnostic Test: In Vitro	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 7, 2022

Actual Primary Completion Date :

Nov 18, 2022

Actual Study Completion Date :

Nov 18, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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
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
Individuals willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)

Exclusion Criteria:

If symptomatic, individuals with self-declared symptoms greater than 7 days (plus/minus 1 day, if symptoms start not definite)
Unable to provide consent or obtain consent from a LAR
Unwilling or unable to collect all sample types
Enrolled in a study to evaluate an investigational drug
Eating/drinking/smoking 30 minutes prior to specimen collection
Prisoner or under incarceration
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sarkis Clinical Trials	Gainesville	Florida	United States	32607
2	I.V.A.M. Clinical & Investigational Center	Miami	Florida	United States	33144
3	Sunrise Research Institute	Sunrise	Florida	United States	33325
4	Vytalus Medical Atascocita	Humble	Texas	United States	77346
5	Vytalus Medical	Kingwood	Texas	United States	77339

Sponsors and Collaborators

3EO Health

Investigators

Study Director: Jerika Acosta, Medicept Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

3EO Health

ClinicalTrials.gov Identifier:

NCT05553964

Other Study ID Numbers:

3EO-CoV2-01

First Posted:

Sep 26, 2022

Last Update Posted:

Dec 2, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Dec 2, 2022