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OpenTrials
Completed

NCT Number: NCT07469670

Nasal Swab Objective and Statistical Evaluation (NOSE Study)

Supply chain disruptions have led to shortages in test swabs which are used to collect respiratory samples. Lack of these test swabs can reduce a hospital or state's ability to test patients for COVID-19.

To address this shortage, many manufacturers, hospitals and individuals have designed non-traditional 3D printed swabs for COVID-19 diagnosis that could potentially meet demands for nasal swabs. However, questions regarding the safety and effectiveness of these swabs remain.

This study will provide additional, statistically supported evidence as to the safety and efficacy of novel swabs.

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Key information

Conditions

SARS Coronavirus 2 RT-PCR Testing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

About this study

This is a prospective, multi-site, non-inferiority study providing a comparison between the performance of traditional, standard of care (SoC) and alternative (ALT) nasal swabs. Nasal swabs and swabbing site of interest for this study is the nasopharynx (NP swab). The primary outcomes of this study are the rate of adverse events and the agreement in laboratory viral detection between SoC and ALT swabs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic or COVID-19 positive (within the past 2 weeks)
  • Has a COVID-19 positive household member
  • Female and male Veterans or female and male VHA employees
  • Able and willing to give informed consent

Exclusion criteria

  • Self-reported history of frequent nosebleeds or a diagnosis of coagulopathy or any bleeding disorders
  • Unsuitability for mid-turbinate or nasopharyngeal swabbing due to prior surgery
  • Need for legally authorized representative for purpose of giving consent

Treatment and study plan

Primary outcomes

  1. Sensitivity

    Time frame: Day 1

    Ability for the alternative swab to correctly predict a positive test result from the standard of care swab (1st swab)

  2. Specificity

    Time frame: Day 1

    Ability for the alternative swab to correctly predict a negative test result from the standard of care swab (1st swab)

Secondary outcomes

  1. Epistaxis rate

    Time frame: Day 1

    Rate of nosebleed, described as any detectable presence of blood on either swab

  2. Sensitivity

    Time frame: Day 1

    Effect of order on the ability of a second swab, a standard of care swab, to correctly predict a positive test result from the first swab, also standard of care swab.

  3. Specificity

    Time frame: Day 1

    Effect of order on the ability of a second swab, a standard of care swab, to correctly predict a negative test result from the first swab, also standard of care swab.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: Nasal Swab

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.