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

NCT04321369 | Completed

• 1 other identifier: 20-001
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 1

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

Conditions

Infections, Respiratory; Fever; Cough

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Interventions

Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals DIAGNOSTIC_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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UnitedHealth Group: lead
• Quest Diagnostics-Nichols Insitute: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Everett Clinic

Seattle, Washington, 98133, United States

Location

Related Publications (4)

• 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

  RESULT

• Personal communication per Dr. Scott Lindquist, MD State of Washington Epidemiologist (March 2020

  RESULT

• 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.

  PMID: 32164834 RESULT

• Frazee 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.

  PMID: 29174837 RESULT

Biospecimen

Retention: NONE RETAINED

Four nasal swabs will be collected on each participant

MeSH Terms

Conditions

Respiratory Tract Infections; Fever; Cough

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory

Study Officials

• Ethan Berke, MD

  UnitedHealth Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: March 9, 2020
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)