SARS-CoV-2 OTC At Home Test

COVID-19 Pandemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05553964
• Other study ID #: 3EO-CoV2-01
• Status: Terminated
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: November 18, 2022

Study information

• Verified date: November 2022
• Source: 3EO Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: November 18, 2022
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

Diagnostic Test:
• In Vitro
In vitro diagnostic test for COVID-19 using anterior nasal swabs.

Locations

Country	Name	City	State
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Vytalus Medical Atascocita	Humble	Texas
United States	Vytalus Medical	Kingwood	Texas
United States	I.V.A.M. Clinical & Investigational Center	Miami	Florida
United States	Sunrise Research Institute	Sunrise	Florida

Sponsors (1)

Lead Sponsor	Collaborator
3EO Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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