Nasal Swab Objective and Statistical Evaluation (NOSE Study)

VA Office of Research and Development

Status: Completed

Conditions: SARS Coronavirus 2 RT-PCR Testing

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT07469670

1I01RX003767 (U.S. NIH Grant/Contract)

F3767-I

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,179 participants in 3 patient groups

Standard of Care / Standard of Care

Description:

Initial cohort to identify the effect of order on swab result. Swab order (standard of care first) was set to preserve clinical test result in case there was an impact to swab order.

1st Alt Swab / Standard of Care

Description:

Evaluation of 1st alternatively sourced swab to the standard of care swab

2nd Alt Swab / Standard of Care

Description:

Evaluation of 2nd alternatively sourced swab to the standard of care swab