Recruiting

Observational Study

Sponsor:

Biocerna LLC

Code:

NCT04681950

Conditions

Subjects Possibly Exposed to COVID-19

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

Brief summary:

We are trying to see whether a self-collected saliva swab in the home setting is as good as or better than a study clinician-collected anterior nose swab in evaluating whether you are positive for COVID-19 or Influenza A/Influenza B. You may have no symptoms, so you may be positive and capable of spreading the infection to others and you don't know it. Knowing whether you are positive is important because you would have to quarantine and not go out to prevent spreading the infection to others.

Conditions

Subjects Possibly Exposed to COVID-19

Study ID

NCT04681950

Start date

Nov 24, 2020

Status verified date

Dec, 2020

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Dec 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria: Patients will qualify because they live in a location which is reporting an increased number of COVID-19 positive cases. Incidence of Influenza A/Influenza B is also useful to track to find out whether social distancing and/or wearing masks decreases the number of Influenza A/Influenza B cases during the winter months.

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Exclusion Criteria:

-

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Matching results from different collection types [ Time Frame: 3 days from the time of collection ]

Central Contacts and Locations

Central contacts

Christopher Sanders

240-280-2144csanders@biocerna.com

Erica Fye

240-280-2911erica_fye@biocerna.com

Locations

Biocerna LLC

Recruiting

Fulton, Maryland, United States, 20759

Contacts

Chris Sanders

240-280-2911csanders@biocerna.com

Erica Fye

240-280-2911erica_fye@biocerna.com

More Information

Sponsor

Biocerna LLC

Last update posted

Dec 23, 2020

Last verified

Dec, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Biocerna LLC on 2020-12-23.