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Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04321369
Recruitment Status : Completed
First Posted : March 25, 2020
Last Update Posted : April 13, 2020
Sponsor:
Collaborators:
Quest Diagnostics
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Dr. Deneen Vojta, UnitedHealth Group

Study Description
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Brief 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

Condition or disease Intervention/treatment
Infections, Respiratory Fever Cough Diagnostic Test: Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals

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
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Study Type : Observational
Actual Enrollment : 533 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals
Actual Study Start Date : March 9, 2020
Actual Primary Completion Date : March 23, 2020
Actual Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals
    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.

Outcome Measures
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Primary Outcome Measures :
  1. 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


Biospecimen Retention:   None Retained
Four nasal swabs will be collected on each participant

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321369


Locations
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United States, Washington
Everett Clinic
Seattle, Washington, United States, 98133
Sponsors and Collaborators
Dr. Deneen Vojta
Quest Diagnostics
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Ethan Berke, MD UnitedHealth Group
More Information
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Publications of Results:
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

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Responsible Party: Dr. Deneen Vojta, Executive Vice President and Chief Medical Officer, UHG R&D, UnitedHealth Group
ClinicalTrials.gov Identifier: NCT04321369    
Other Study ID Numbers: 20-001
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: March 2020 - June 2020
Access Criteria: . Data will be shared between the participating clinics, UHG and collaborating partners performing the analysis of the samples and returning results as outlined in data sharing agreements.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases