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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

Tracking Information
First Submitted Date March 23, 2020
First Posted Date March 25, 2020
Last Update Posted Date April 13, 2020
Actual Study Start Date March 9, 2020
Actual Primary Completion Date March 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals
Official Title Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals
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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Four nasal swabs will be collected on each participant
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.
Condition
  • Infections, Respiratory
  • Fever
  • Cough
Intervention 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 23, 2020)
533
Original Actual Enrollment Same as current
Actual Study Completion Date March 23, 2020
Actual Primary Completion Date March 23, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04321369
Other Study ID Numbers 20-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Dr. Deneen Vojta, UnitedHealth Group
Study Sponsor Dr. Deneen Vojta
Collaborators
  • Quest Diagnostics
  • Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Ethan Berke, MD UnitedHealth Group
PRS Account UnitedHealth Group
Verification Date April 2020