COVID-19, Influenza, Respiratory Infection Virus
Conditions
Keywords
Nasal Spray, Medical Device, Infection prevention, ePRO, Real-World
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).
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.
Interventions
Nasal spray medical devices used to form a protective barrier on the nasal mucosa to reduce viral entry.
Sponsors
Study design
Eligibility
Inclusion criteria
* Adults aged ≥19 years * Able to provide informed consent
Exclusion criteria
* Hypersensitivity to device components * Current COVID-19 or influenza infection * Severe nasal disease * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Respiratory Infection | Week 8 | Incidence of respiratory infections, including COVID-19 and influenza, during the 8-week study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Respiratory Infection by Interval | Up to Week 8 | Incidence of respiratory infection during each interval |
Countries
South Korea