Infections, RespiratoryNCT04321369
Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals
An observational study of Infections, Respiratory and Fever, run by UnitedHealth Group at 1 site in United States.
Trial summary
Operational project to compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections, Respiratory, Fever, Cough
- What is being tested?
- Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals
- How many people
- 530 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 23 Mar 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting symptoms indicative of an upper respiratory infection visiting one of the five Everett Clinic sites of during the study duration while the operational project is occurring are eligible to participate in the project.
Who may be able to join
- Able to consent and agree to participate in the project after discussing the project
- Coming to The Everett Clinic during the operational project duration
- Evidence of upper respiratory symptoms suggesting higher risk of testing positive for SARS-CoV-2 virus.
Who cannot join
- Not able to demonstrate understanding of the study
- Not willing to commit to having all four samples collected
- Medical history evidencing any of the following
- Active nosebleed in the past 24 hours
- Nasal surgery in the past two weeks
- Chemotherapy treatment with low platelet and low white blood cell counts
- Acute facial trauma
Trial locations and contacts
1 site in 1 country.
About this study
Operational project to compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting
Read the detailed description
This work will serve both the Everett Clinic and broader UnitedHealth Group patient populations as well as advance the public health emergency (PHE) response to the community spread of SARS-CoV-2 virus, especially as the number of cases and deaths continues to rise in many geographies. Leveraging our presence in the Seattle/Puget Sound area with Everett Clinic, we intend to develop a model that can screen a large number of patients at varying levels of risk and manifestation of clinical symptoms while conserving personal protective equipment (PPE) and decreasing transmission risk to health care workers. This will also serve to support the enterprise and public health response. Towards this goal, we must first assess the equivalence between clinician-collected nasopharyngeal (NP) samples to patient-collected tongue, nasal, and mid-turbinate (MT) samples to detect SARS-CoV-2 across a broad cross-section of the population.
- Conditions
- Infections, Respiratory, Fever, Cough
- Being tested
- Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals
- Medical subject headings
- Respiratory Tract Infections, Fever, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic IndividualsDiagnostic test
This is an operational project. Patients will collect a sample from the tongue, nasal cavity and MT and then clinicians will collect a NP sample from the nostril corresponding to each participant's dominant hand.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of patient administered tests
compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start9 Mar 2020
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infections, RespiratoryStudies 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
- Retrospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- UnitedHealth Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quest Diagnostics-Nichols Insitute, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Ethan Berke, MD, Principal investigator, UnitedHealth Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321369
- Sponsor's protocol ID
- 20-001
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2020
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All patients who participate in this operational pilot will have standard COVID-19 screening information entered into their electronic medical record. The collection locations and source of collection (medical personnel versus patient) will need to be clearly distinguished for the purposes of this project. Data resulting from analysis of the samples will also be stored in the electronic medical record and any positive results will be reported accordingly to public health officials as required. The data collected due to this operational effort will be extracted from the medical record and stored for additional research analysis to demonstrate equivalence between location in the nose for the collection of the sample and similarity between sample collected by medical personnel and samples collected by the patient. Data will be shared between the participating clinics, UHG and collaborating partners performing the analysis of the samples and returning results.
Publications
Coronavirus Disease 2019 (COVID-19) in the US. Centers for Disease Control and Prevention, accessed March 13, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html
Personal communication per Dr. Scott Lindquist, MD State of Washington Epidemiologist (March 2020
Anderson RM, Heesterbeek H, Klinkenberg D, Hollingsworth TD. How will country-based mitigation measures influence the course of the COVID-19 epidemic? Lancet. 2020 Mar 21;395(10228):931-934. doi: 10.1016/S0140-6736(20)30567-5. Epub 2020 Mar 9. No abstract available.
PubMed 32164834Frazee BW, Rodriguez-Hoces de la Guardia A, Alter H, Chen CG, Fuentes EL, Holzer AK, Lolas M, Mitra D, Vohra J, Dekker CL. Accuracy and Discomfort of Different Types of Intranasal Specimen Collection Methods for Molecular Influenza Testing in Emergency Department Patients. Ann Emerg Med. 2018 Apr;71(4):509-517.e1. doi: 10.1016/j.annemergmed.2017.09.010. Epub 2017 Nov 24.
PubMed 29174837
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals
- ClinicalTrials.gov ID
- NCT04321369
- Acronym / sponsor ID
- 20-001
- Conditions
- Infections, Respiratory, Fever, Cough
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- UnitedHealth GroupIndustry (pharma, biotech, devices)
- Collaborators
- Quest Diagnostics-Nichols Insitute, Bill and Melinda Gates Foundation
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 25 Mar 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.
Operational project to compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting
Detailed description
This work will serve both the Everett Clinic and broader UnitedHealth Group patient populations as well as advance the public health emergency (PHE) response to the community spread of SARS-CoV-2 virus, especially as the number of cases and deaths continues to rise in many geographies. Leveraging our presence in the Seattle/Puget Sound area with Everett Clinic, we intend to develop a model that can screen a large number of patients at varying levels of risk and manifestation of clinical symptoms while conserving personal protective equipment (PPE) and decreasing transmission risk to health care workers. This will also serve to support the enterprise and public health response. Towards this goal, we must first assess the equivalence between clinician-collected nasopharyngeal (NP) samples to patient-collected tongue, nasal, and mid-turbinate (MT) samples to detect SARS-CoV-2 across a broad cross-section of the population.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting symptoms indicative of an upper respiratory infection visiting one of the five Everett Clinic sites of during the study duration while the operational project is occurring are eligible to participate in the project.
Key inclusion criteria (3 listed)
- Able to consent and agree to participate in the project after discussing the project
- Coming to The Everett Clinic during the operational project duration
- Evidence of upper respiratory symptoms suggesting higher risk of testing positive for SARS-CoV-2 virus.
Key exclusion criteria (7 listed)
- Not able to demonstrate understanding of the study
- Not willing to commit to having all four samples collected
- Medical history evidencing any of the following
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic IndividualsThis is an operational project. Patients will collect a sample from the tongue, nasal cavity and MT and then clinicians will collect a NP sample from the nostril corresponding to each participant's dominant hand. | Diagnostic test | – |
Primary outcome
Accuracy of patient administered tests
Time frame: 2 weeks
compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Results publicationCoronavirus Disease 2019 (COVID-19) in the US. Centers for Disease Control and Prevention, accessed March 13, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html
- Results publicationPersonal communication per Dr. Scott Lindquist, MD State of Washington Epidemiologist (March 2020
- Results publication: PubMed 32164834Anderson RM, Heesterbeek H, Klinkenberg D, Hollingsworth TD. How will country-based mitigation measures influence the course of the COVID-19 epidemic? Lancet. 2020 Mar 21;395(10228):931-934. doi: 10.1016/S0140-6736(20)30567-5. Epub 2020 Mar 9. No abstract available.
- Results publication: PubMed 29174837Frazee BW, Rodriguez-Hoces de la Guardia A, Alter H, Chen CG, Fuentes EL, Holzer AK, Lolas M, Mitra D, Vohra J, Dekker CL. Accuracy and Discomfort of Different Types of Intranasal Specimen Collection Methods for Molecular Influenza Testing in Emergency Department Patients. Ann Emerg Med. 2018 Apr;71(4):509-517.e1. doi: 10.1016/j.annemergmed.2017.09.010. Epub 2017 Nov 24.
- Individual participant dataSharing planned: Yes. All patients who participate in this operational pilot will have standard COVID-19 screening information entered into their electronic medical record. The collection locations and source of collection (medical personnel versus patient) will need to be clearly distinguished for the purposes of this project. Data resulting from analysis of the samples will also be stored in the electronic medical record and any positive results will be reported accordingly to public health officials as required. The data collected due to this operational effort will be extracted from the medical record and stored for additional research analysis to demonstrate equivalence between location in the nose for the collection of the sample and similarity between sample collected by medical personnel and samples collected by the patient. Data will be shared between the participating clinics, UHG and collaborating partners performing the analysis of the samples and returning results.
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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.
Ethan Berke, MD principal investigator
UnitedHealth Group
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 Infections, Respiratory and Fever, run by UnitedHealth Group 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 4 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of patient administered tests (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04321369, which also lists 4 linked publications.
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 4 May 2022.