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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Standard of Care / Standard of Care 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 Evaluation of 1st alternatively sourced swab to the standard of care swab
2nd Alt Swab / Standard of Care Evaluation of 2nd alternatively sourced swab to the standard of care swab

Recruiting Locations

More Details

NCT ID
NCT07469670
Status
Completed
Sponsor
VA Office of Research and Development

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.