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

Subjects Possibly Exposed to COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04681950
• Other study ID #: 00047586
• Status: Recruiting
• Start date: November 24, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2020
• Source: Biocerna LLC
• Contact: Christopher Sanders
• Phone: 240-280-2144
• Email: csanders[@]biocerna.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Influenza, Human
• Subjects Possibly Exposed to COVID-19

Locations

Country	Name	City	State
United States	Biocerna LLC	Fulton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Biocerna LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Matching results from different collection types	Samples will be collected by the patient and a HCP	3 days from the time of collection