CompletedNot Applicable

Nasal Swab Objective and Statistical Evaluation (NOSE Study)

United States1,179 participantsStarted 2021-04-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Sensitivity

Timeframe: Day 1

Specificity

Timeframe: Day 1

Trial details

NCT IDNCT07469670

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeOBSERVATIONAL

Primary completion2022-08-16

View on ClinicalTrials.gov More SARS Coronavirus 2 RT-PCR Testing trials