Clinical trial NCT05553964: 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
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19 Pandemic
Lead sponsor: 3EO Health
Sponsor class: INDUSTRY
First posted: 2022-09-26
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.
timeFrame: 1-16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Miami
country: United States
facility: I.V.A.M. Clinical & Investigational Center
state: Florida
city: Sunrise
country: United States
facility: Sunrise Research Institute
state: Florida
city: Humble
country: United States
facility: Vytalus Medical Atascocita
state: Texas
city: Kingwood
country: United States
facility: Vytalus Medical
state: Texas
Study officials:
affiliation: Medicept Inc.
name: Jerika Acosta
role: STUDY_DIRECTOR
References: