SARS Coronavirus 2 RT-PCR TestingNasal SwabNCT07469670
Nasal Swab Objective and Statistical Evaluation (NOSE Study)
An observational study of SARS Coronavirus 2 RT-PCR Testing, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS Coronavirus 2 RT-PCR Testing
- How many people
- 1,179 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to 16 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Employees and patients with recent (<2 weeks) COVID-19 diagnosis for themselves or a member of their home, or who are symptomatic with one or more COVID-19 symptoms are eligible.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this 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.
Read the 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.
- Conditions
- SARS Coronavirus 2 RT-PCR Testing
- Keywords
- Nasopharyngeal Swab, COVID-19 Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Ability for the alternative swab to correctly predict a positive test result from the standard of care swab (1st swab)
Measured: Day 1
Specificity
Ability for the alternative swab to correctly predict a negative test result from the standard of care swab (1st swab)
Measured: Day 1
Secondary outcomes (3)
Epistaxis rate
Rate of nosebleed, described as any detectable presence of blood on either swab
Measured: Day 1
Sensitivity
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.
Measured: Day 1
Specificity
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start5 Apr 2021
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS Coronavirus 2 RT-PCR TestingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,179 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joseph Iaquinto, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469670
- Sponsor's protocol ID
- F3767-I
- Other IDs
- 1I01RX003767
- Acronym
- Nasal Swab
- Status last verified
- Jul 2026
- First submitted
- 25 Feb 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Swab Objective and Statistical Evaluation (NOSE Study)
- ClinicalTrials.gov ID
- NCT07469670
- Acronym / sponsor ID
- Nasal Swab / F3767-I
- Conditions
- SARS Coronavirus 2 RT-PCR Testing
- Keywords
- Nasopharyngeal Swab, COVID-19 Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,179 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Employees and patients with recent (<2 weeks) COVID-19 diagnosis for themselves or a member of their home, or who are symptomatic with one or more COVID-19 symptoms are eligible.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
3 secondary outcomes
Epistaxis rate
Time frame: Day 1
Sensitivity
Time frame: Day 1
Specificity
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Iaquinto, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS Coronavirus 2 RT-PCR Testing, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.