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SARS-CoV-2 OTC At Home Test

Primary Purpose

COVID-19 Pandemic

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

In Vitro

About this trial

This is an interventional diagnostic trial for COVID-19 Pandemic

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Sarkis Clinical Trials
I.V.A.M. Clinical & Investigational Center
Sunrise Research Institute
Vytalus Medical Atascocita
Vytalus Medical

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Groups

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05553964

First Posted

September 19, 2022

Last Updated

November 30, 2022

Sponsor

3EO Health

1. Study Identification

Unique Protocol Identification Number

NCT05553964

Brief Title

SARS-CoV-2 OTC At Home Test

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Terminated

Why Stopped

Further usability assessment needed.

Study Start Date

October 7, 2022 (Actual)

Primary Completion Date

November 18, 2022 (Actual)

Study Completion Date

November 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

3EO Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Pandemic

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Groups

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

In Vitro

Intervention Description

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

Primary Outcome Measure Information:

Title

Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.

Description

Time Frame

1-16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerika Acosta

Organizational Affiliation

Medicept Inc

Official's Role

Study Director

Facility Information:

Facility Name

Sarkis Clinical Trials

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

I.V.A.M. Clinical & Investigational Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Sunrise Research Institute

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33325

Country

United States

Facility Name

Vytalus Medical Atascocita

City

Humble

State/Province

Texas

ZIP/Postal Code

77346

Country

United States

Facility Name

Vytalus Medical

City

Kingwood

State/Province

Texas

ZIP/Postal Code

77339

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

SARS-CoV-2 OTC At Home Test

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