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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
2,000
Nasal spray medical devices used to form a protective barrier on the nasal mucosa to reduce viral entry.
Jeonbuk University Hospital
Jeonju, South Korea
Incidence of Respiratory Infection
Incidence of respiratory infections, including COVID-19 and influenza, during the 8-week study period.
Time frame: Week 8
Incidence of Respiratory Infection by Interval
Incidence of respiratory infection during each interval
Time frame: Up to Week 8
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