Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic

NCT ID: NCT04368260

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-24
• Study Completion Date: 2020-08-01

Brief Summary

The SARS-CoV-2 pandemic has resulted in an international shortage of the nasopharyngeal (NP) swabs used to collect sample for virological testing. This shortage has become a crisis as testing capacity is growing, and threatens to become the bottleneck at University of Virginia Health System and in the Commonwealth of Virginia, as it already is in other testing centers. To resolve this crisis, a team in the Clinical Microbiology Laboratories at University of Virginia Medical Center has been working closely with biomedical engineers in the University of Virginia (UVA), School of Engineering and with high volume domestic manufacturers developing injection molded polypropylene flocked nylon NP swab.

This prototype will be tested for non-inferiority relative to existing, already validated NP swabs ("control swab") for purposes of molecular microbiology: i.e. the polymerase chain reaction (PCR) tests used for virological testing for SARS-CoV-2. Specifically, the nasopharynx of patients with Covid-19 and patients under investigation (PUI) for Covid-19, the disease caused by SARS-CoV-2, will be swabbed using a prototype swab and a control swab (the standard of care swab), and test for concordance of SARS-CoV-2. In all cases the swab will be transported in validated FDA cleared viral transport medium (VTM) as per standard operating procedure at University of Virginia Medical Center.

Conditions

COVID19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control swab

FDA cleared swab

Group Type: ACTIVE_COMPARATOR

Control swab

Intervention Type: DEVICE

FDA-cleared nasopharyngeal swab

Prototype swab

Injection molded polypropylene flocked nylon NP swab

Group Type: EXPERIMENTAL

Prototype swab

Intervention Type: DEVICE

Injection molded polypropylene flocked nylon nasopharyngeal swab

Interventions

Control swab

FDA-cleared nasopharyngeal swab

Intervention Type: DEVICE

Prototype swab

Injection molded polypropylene flocked nylon nasopharyngeal swab

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Individuals presenting to the site for clinical care will be evaluated for clinical screening for Covid-19 testing or other respiratory infection testing.
• Individuals felt identified clinically as needing Covid-19 testing may be approached for study participation.
• Individuals already under clinical care that have tested positive for Covid-19 will be approached for study participation.
• Volunteer health care workers who have approached the Principal Investigator

Exclusion Criteria

• Known thrombocytopenia of <50,000 platelets/μl (risk of mild bleeding).
• Individuals presenting with an anatomically altered nasal cavity.
• Pregnant (self-reported)
• No other patients will be specifically excluded.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Amy Mathers, MD

Associate Professor, Department of Medicine, Infectious Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Mathers, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSR200127

Identifier Type: -

Identifier Source: org_study_id