NCT07516977

Brief 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. The study will also assess usability, satisfaction, and safety using electronic patient-reported outcomes (ePRO).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

April 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 1, 2026

Last Update Submit

April 1, 2026

Conditions

Respiratory Infection VirusCOVID-19Influenza

Keywords

Nasal SprayMedical DeviceInfection preventionePROReal-World

Outcome Measures

Primary Outcomes (1)

  • Incidence of Respiratory Infection

    Incidence of respiratory infections, including COVID-19 and influenza, during the 8-week study period.

    Week 8

Secondary Outcomes (1)

  • Incidence of Respiratory Infection by Interval

    Up to Week 8

Study Arms (1)

Noseguard Combined Use

EXPERIMENTAL

Participants will use Noseguard during daytime activities and Noseguard Night before sleep for 8 weeks.

Device: Noseguard and Noseguard Night

Interventions

Noseguard and Noseguard NightDEVICE

Nasal spray medical devices used to form a protective barrier on the nasal mucosa to reduce viral entry.

Noseguard Combined Use

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged ≥19 years
  • Able to provide informed consent

You may not qualify if:

  • Hypersensitivity to device components
  • Current COVID-19 or influenza infection
  • Severe nasal disease
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeonbuk University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

COVID-19Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOrthomyxoviridae Infections

Central Study Contacts

SoHeui Kim

CONTACT

82-10-2994-58872210325@daewoong.co.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 8, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

KR(1)