SARS-CoV-2 OTC At Home Test
Stopped early · Not applicable
Conditions studied: COVID-19 Pandemic
In brief
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.
Key facts
- Study ID
- NCT05553964
- Run by
- 3EO Health
- People needed
- 64
- Starts
- 2022-10-07
- Expected to finish
- 2022-11-18
- Last updated by the study team
- 2022-12-02
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Sarkis Clinical Trials — Gainesville, Florida, United States
- I.V.A.M. Clinical & Investigational Center — Miami, Florida, United States
- Sunrise Research Institute — Sunrise, 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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