COVID-19 Molecular OTC At Home Test

Completed · Not applicable

Conditions studied: COVID-19 Pandemic

In brief

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.

Key facts

Study ID

NCT05704803

Run by

3EO Health

People needed

202

Starts

2022-04-11

Expected to finish

2023-04-30

Last updated by the study team

2023-09-28

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Participants must not meet ANY of the following:
• Eating or drinking 30 minutes prior, or smoking 60 minutes prior to specimen collection.
• Unable to tolerate sample collection, or has contraindications to collection such as nasal bleeding, ulcers, or surgery within the past 3 months.
• Underwent a nasal wash / aspirate as part of standard of care < 24 hours prior to the study start.
• Currently receiving or has received within the past 30 days of the study visit an experimental drug, biologic, or device including treatment or therapy.
• Previously participated in this study.

Where it is running

• Bright Research Center — Miami, Florida, United States
• I.V.A.M. Clinical & Investigational Center — Miami, Florida, United States
• Vytalus Medical Atascocita — Humble, Texas, United States
• Vytalus Medical — Kingwood, Texas, United States

Full record on ClinicalTrials.gov

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