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

• ClinicalTrials.gov Identifier: NCT04368260
• Recruitment Status: Recruiting
• First Posted: April 29, 2020
• Last Update Posted: April 29, 2020
• Sponsor: University of Virginia
• Information provided by (Responsible Party): University of Virginia

Tracking Information

• First Submitted Date: April 24, 2020
• First Posted Date: April 29, 2020
• Last Update Posted Date: April 29, 2020
• Actual Study Start Date: April 24, 2020
• Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 27, 2020)

Number of subjects for which the prototype swab and the control swab provide the same COVID-19 PCR result [ Time Frame: at time of enrollment ]

Both the prototype and control nasopharyngeal swabs will be utilized in each subject. The rate of agreement between the swabs will be determined by the number of subjects for which both swabs provide the same COVID-19 PCR result.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• 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: Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic
• Official Title: Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The primary objective of this study is to determine whether the newly designed nasopharyngeal swabs perform acceptably compared to standard swabs.

Masking: None (Open Label)
Primary Purpose: Other

• Condition: COVID19

Intervention

• Device: Control swab
  FDA-cleared nasopharyngeal swab
• Device: Prototype swab
  Injection molded polypropylene flocked nylon nasopharyngeal swab

Study Arms

• Active Comparator: Control swab
  FDA cleared swab
  Intervention: Device: Control swab
• Experimental: Prototype swab
  Injection molded polypropylene flocked nylon NP swab
  Intervention: Device: Prototype swab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 27, 2020): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2020
• Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 99 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Limor Steinberg; 434-243-9873; LIS5AY@virginia.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04368260
• Other Study ID Numbers: HSR200127
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: All individual participant data (IPD) that underlie results in a publication will be shared.
• Time Frame: Starting 6 months after publication
• Access Criteria: Requests to made to Principal Investigator

• Responsible Party: University of Virginia
• Study Sponsor: University of Virginia
• Collaborators: Not Provided

Investigators

• Principal Investigator: Amy Mathers, MD; University of Virginia

• PRS Account: University of Virginia
• Verification Date: April 2020