Purpose

The objective of this study is to evaluate the a molecular, OTC/At-Home COVID-19 Test in individuals presenting at a medical facility. In eligible subjects, nasal samples will be collected for use with the at-home molecular COVID-19 Test, which will be compared to the Zymo® rRT-PCR test results obtained via samples specified by the sponsor (e.g., AN [anterior nares] swab) to determine accuracy of the at-home/OTC molecular COVID-19 Test in detecting COVID-19 in participants.

Condition

Eligibility

Eligible Ages
Over 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Criteria

All Participants must meet ALL of the following:

1. ≥ 2 years of age. Subjects ages 2 ≤ x ≤ 17 will provide assent in addition to parent
/ legal guardian's consent.

2. Able to read and write in English and/or Spanish (subjects or guardians)

3. Willing and able to provide informed consent (subject or Legally authorized
Representative (LAR)). Subjects unable to consent will provide assent in addition to
LAR consent.

Symptomatic Participants must meet BOTH of the following:

1. Have at least one of the following symptoms the day of the test:

1. Fever

2. Cough

3. Shortness of Breath

4. Difficulty Breathing

5. Muscle Pain

6. Headache

7. Sore Throat

8. Chills

9. New loss of taste or smell

10. Congestion

11. Runny nose

2. Onset of symptoms occurred within the past 7 calendar days.

Asymptomatic Participants must meet BOTH of the following:

1. Not experiencing any of the following symptoms at the time of specimen collection
and testing: fever, cough, shortness of breath or difficulty breathing, new loss of
taste or smell, muscle or body aches, headache, sore throat, congestion or runny
nose, nausea or vomiting or diarrhea.

2. Exposed to known COVID-19 positive individuals or are suspected to have had COVID-19
over the past 7 calendar days.

Exclusion Criteria:

Participants must not meet ANY of the following:

1. Eating or drinking 30 minutes prior, or smoking 60 minutes prior to specimen
collection.

2. Unable to tolerate sample collection, or has contraindications to collection such as
nasal bleeding, ulcers, or surgery within the past 3 months.

3. Underwent a nasal wash / aspirate as part of standard of care < 24 hours prior to
the study start.

4. Currently receiving or has received within the past 30 days of the study visit an
experimental drug, biologic, or device including treatment or therapy.

5. Previously participated in this study.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

More Details

NCT ID
NCT05704803
Status
Completed
Sponsor
3EO Health

Detailed Description

The molevular, at-home COVID-19 Test is a unique rapid molecular test system intended to detect SARS-CoV-2 virus in the OTC setting using a dedicated reusable test reader to test nasal swab samples. Early testing will help to determine limit of detection (LOD) of the molecular COVID-19 Test and will be compared to a sensitive molecular test that has been authorized for emergency use by the FDA. The COVID-19 Test will leverage the processing and testing of the associated Swab device when inserted directly into the reaction tube (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 reusable test reader.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.