COVID-19 Pandemic Clinical Trial
Official title:
Prospective, Multi-Center, Non-Randomized Study to Evaluate the 3EO Health SARS-CoV-2 Molecular Diagnostic Test
Verified date | November 2022 |
Source | 3EO Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
3EO Health |
United States,
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 |
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