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

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321369
• Other study ID #: 20-001
• Status: Completed
• Start date: March 9, 2020
• Est. completion date: March 23, 2020

Study information

• Verified date: April 2022
• Source: UnitedHealth Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cough
• COVID-19
• Fever
• Infections, Respiratory
• Respiratory Tract Infections

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.

Locations

Country	Name	City	State
United States	Everett Clinic	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
UnitedHealth Group	Bill and Melinda Gates Foundation, Quest Diagnostics-Nichols Insitute

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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

Frazee BW, Rodríguez-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 De — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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