Subjects Possibly Exposed to COVID-19NCT04681950
Assessment of Self-Collected Sample Compared to Clinician Collected Sample in COVID-19 and Influenza Program
An observational study of Subjects Possibly Exposed to COVID-19, run by Biocerna LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Subjects Possibly Exposed to COVID-19
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Biocerna LLC
Fulton, Maryland, 20759
Chris Sanders, 240-280-2911, csanders@biocerna.com
Erica Fye, 240-280-2911, erica_fye@biocerna.com
About this study
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
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.
Read the 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.
- Conditions
- Subjects Possibly Exposed to COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Matching results from different collection types
Samples will be collected by the patient and a HCP
Measured: 3 days from the time of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start24 Nov 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Possibly Exposed to COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocerna LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Sanders, Principal investigator, Vice President of Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681950
- Sponsor's protocol ID
- 00047586
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04681950
- Acronym / sponsor ID
- 00047586
- Conditions
- Subjects Possibly Exposed to COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Biocerna LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Matching results from different collection types
Time frame: 3 days from the time of collection
Samples will be collected by the patient and a HCP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Sanders principal investigator
Vice President of Clinical Operations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjects Possibly Exposed to COVID-19, run by Biocerna LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Sanders (240-280-2144, csanders@biocerna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matching results from different collection types (time frame: 3 days from the time of collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.