Respiratory Infection VirusNCT07516977
Noseguard for Prevention of Respiratory Infections in Real-World Use
A study testing Noseguard and Noseguard Night in people with Respiratory Infection Virus and COVID-19, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study is a prospective clinical study to evaluate the effectiveness of combined use of two nasal protective medical devices (Noseguard and Noseguard Night) in reducing respiratory infection rates, including COVID-19 and influenza, in real-world conditions. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Respiratory Infection Virus, COVID-19, Influenza
- What is being tested?
- Noseguard and Noseguard Night
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥19 years
- Able to provide informed consent
Who cannot join
- Hypersensitivity to device components
- Current COVID-19 or influenza infection
- Severe nasal disease
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Jeonbuk University Hospital
Jeonju
SoHeui Kim, 82-10-2994-5887, 2210325@daewoong.co.kr
About this study
Official title: A Clinical Study to Evaluate the Effectiveness of Combined Use of Two Nasal Protective Medical Devices (Noseguard and Noseguard Night) for Reducing Respiratory Infection Rates and Assessing Usability
This study is a prospective clinical study to evaluate the effectiveness of combined use of two nasal protective medical devices (Noseguard and Noseguard Night) in reducing respiratory infection rates, including COVID-19 and influenza, in real-world conditions.
The study will also assess usability, satisfaction, and safety using electronic patient-reported outcomes (ePRO).
Read the detailed description
This study is a prospective clinical study conducted in Korea to evaluate the effectiveness of combined use of two nasal protective medical devices, Noseguard and Noseguard Night, for preventing respiratory infections.
A total of approximately 2,000 adult participants will be enrolled and followed for 8 weeks. Participants will use Noseguard during daytime activities and Noseguard Night before sleep.
Data will be collected using electronic patient-reported outcomes (ePRO) at baseline and at Weeks 2, 4, 6, and 8. The primary endpoint is the incidence of respiratory infections, including COVID-19 and influenza.
Secondary endpoints include symptom severity, duration of symptoms, usability, satisfaction, and safety outcomes such as adverse events.
This study aims to generate real-world evidence on the effectiveness and usability of nasal protective devices for respiratory infection prevention.
- Conditions
- Respiratory Infection Virus, COVID-19, Influenza
- Being tested
- Noseguard and Noseguard Night
- Keywords
- Nasal Spray, Medical Device, Infection prevention, ePRO, Real-World
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noseguard and Noseguard NightDevice
Nasal spray medical devices used to form a protective barrier on the nasal mucosa to reduce viral entry.
| Study group | Role | What they receive |
|---|---|---|
| Noseguard Combined Use | Experimental | Participants will use Noseguard during daytime activities and Noseguard Night before sleep for 8 weeks. Receives: Device: Noseguard and Noseguard Night |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Respiratory Infection
Incidence of respiratory infections, including COVID-19 and influenza, during the 8-week study period.
Measured: Week 8
Secondary outcomes (1)
Incidence of Respiratory Infection by Interval
Incidence of respiratory infection during each interval
Measured: Up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Infection VirusStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516977
- Sponsor's protocol ID
- DW_NG_01
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Effectiveness of Combined Use of Two Nasal Protective Medical Devices (Noseguard and Noseguard Night) for Reducing Respiratory Infection Rates and Assessing Usability
- ClinicalTrials.gov ID
- NCT07516977
- Acronym / sponsor ID
- DW_NG_01
- Conditions
- Respiratory Infection Virus, COVID-19, Influenza
- Keywords
- Nasal Spray, Medical Device, Infection prevention, ePRO, Real-World
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 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.
This study is a prospective clinical study to evaluate the effectiveness of combined use of two nasal protective medical devices (Noseguard and Noseguard Night) in reducing respiratory infection rates, including COVID-19 and influenza, in real-world conditions.
The study will also assess usability, satisfaction, and safety using electronic patient-reported outcomes (ePRO).
Detailed description
This study is a prospective clinical study conducted in Korea to evaluate the effectiveness of combined use of two nasal protective medical devices, Noseguard and Noseguard Night, for preventing respiratory infections.
A total of approximately 2,000 adult participants will be enrolled and followed for 8 weeks. Participants will use Noseguard during daytime activities and Noseguard Night before sleep.
Data will be collected using electronic patient-reported outcomes (ePRO) at baseline and at Weeks 2, 4, 6, and 8. The primary endpoint is the incidence of respiratory infections, including COVID-19 and influenza.
Secondary endpoints include symptom severity, duration of symptoms, usability, satisfaction, and safety outcomes such as adverse events.
This study aims to generate real-world evidence on the effectiveness and usability of nasal protective devices for respiratory infection prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noseguard Combined Use | Experimental | Device: Noseguard and Noseguard NightParticipants will use Noseguard during daytime activities and Noseguard Night before sleep for 8 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged ≥19 years
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Hypersensitivity to device components
- Current COVID-19 or influenza infection
- Severe nasal disease
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noseguard and Noseguard NightNasal spray medical devices used to form a protective barrier on the nasal mucosa to reduce viral entry. | Device | Noseguard Combined Use |
Primary outcome
Incidence of Respiratory Infection
Time frame: Week 8
Incidence of respiratory infections, including COVID-19 and influenza, during the 8-week study period.
1 secondary outcome
Incidence of Respiratory Infection by Interval
Time frame: Up to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noseguard and Noseguard Night in people with Respiratory Infection Virus and COVID-19, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Apr 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SoHeui Kim (82-10-2994-5887, 2210325@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Respiratory Infection (time frame: Week 8). 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 8 Apr 2026.