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
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 2020
CompletedFirst Submitted
Initial submission to the registry
December 22, 2020
CompletedFirst Posted
Study publicly available on registry
December 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedDecember 23, 2020
December 1, 2020
1 month
December 22, 2020
December 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Matching results from different collection types
Samples will be collected by the patient and a HCP
3 days from the time of collection
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocerna LLClead
Study Sites (1)
Biocerna LLC
Fulton, Maryland, 20759, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Sanders
Vice President of Clinical Operations
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2020
First Posted
December 23, 2020
Study Start
November 24, 2020
Primary Completion
December 30, 2020
Study Completion
December 31, 2020
Last Updated
December 23, 2020
Record last verified: 2020-12