Clinical trial NCT04321369: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Respiratory
Fever
Cough
Lead sponsor: UnitedHealth Group
Sponsor class: INDUSTRY
Collaborators: name: Quest Diagnostics-Nichols Insitute
name: Bill and Melinda Gates Foundation
First posted: 2020-03-25
Enrollment: 530
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Accuracy of patient administered tests
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Everett Clinic
state: Washington
Study officials:
affiliation: UnitedHealth Group
name: Ethan Berke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: Personal communication per Dr. Scott Lindquist, MD State of Washington Epidemiologist (March 2020
citation: 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.
citation: 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.