Assessment of Self-Collected Sample Compared to Clinician Collected Sample in COVID-19 and Influenza Program

Assessment of Unsupervised Self-Collected Saliva Sample Compared to Clinician CollectedSaliva Sample and Clinician Collected Anterior Nares Sample in a COVID-19 and Influenza A/Influenza B Screening Program

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.

Study Overview

• Status: Unknown
• Conditions: Subjects Possibly Exposed to COVID-19

Detailed Description

In some research studies, saliva has been shown to be as good as or even better than an anterior nares or nasopharyngeal specimen in detecting SARS-CoV-2; we are interested in making sure that is the case. Being able to collect a specimen at home and mail it in would help with patient compliance and would reduce the need for clinicians (nurses or other health care professionals) to use personal protective equipment (PPE), which is in short supply. Also, people would not have to go to a healthcare facility or other testing site to have the COVID-19 or the Influenza A/Influenza B testing done. We are using a sensitive method (RT-PCR) to look for the three viruses.

Once you have had the anterior nose swab collected by the study clinician, your participation would last only as long as it takes to complete the self-collected saliva collection and return the sample to the researchers. The self-collection of the saliva specimen should be collected as soon as possible after the collection of anterior nares and saliva samples by the clinician You will mail in the saliva swab in a prepaid mailer no later than 10 days after sample collection and the result will be available within one day of our lab receiving the swab. Once our lab receives your specimen, the gift card which you received will be activated and your participation will be complete. Biocerna, LLC (Fulton, Maryland), is the commercial laboratory to which the research subjects' samples will be shipped and tested.

We anticipate approximately 500 subjects will be enrolled. You qualify because you 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Fulton, Maryland, United States, 20759
      • Recruiting
      • Biocerna LLC
      • Contact: Erica Fye; Phone Number: 240-280-2911; Email: erica_fye@biocerna.com
      • Contact: Chris Sanders; Phone Number: 240-280-2911; Email: csanders@biocerna.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We anticipate approximately 500 subjects will be enrolled. You qualify because you 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.

Description

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:

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Matching results from different collection types	Samples will be collected by the patient and a HCP	3 days from the time of collection

Collaborators and Investigators

• Sponsor: Biocerna LLC
• Investigators: Principal Investigator: Christopher Sanders, Vice President of Clinical Operations

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 00047586

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No