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Evaluation Viral RNA and Virus Infectivity in Exhaled Air Before and After Use of One Dose

Many respiratory diseases spread through aerosols. ColdZyme is a mouth spray that protects against upper respiratory tract viruses causing common cold and flu-like symptoms. ColdZyme forms a protective moisturizing barrier on the mucous membrane of the oral cavity and throat. The objective of this study is assessing if

Condition(s)URTI - Viral Upper Respiratory Tract Infection
StatusRecruiting
PhaseNA
Study typeInterventional
SummaryMany respiratory diseases spread through aerosols. ColdZyme is a mouth spray that protects against upper respiratory tract viruses causing common cold and flu-like symptoms. ColdZyme forms a protective moisturizing barrier on the mucous membrane of the oral cavity and throat. The objective of this study is assessing if ColdZyme could also contribute to decreased airborne transmission by decreasing the amount of (infectious) virus that is exhaled by an infected subject.
Who can participateInclusion criteria for subject selection: * Male and female subjects above age 18 (inclusive). * Presence of self-reported sudden onset of at least one of the following symptoms of upper respiratory tract infection case definitions for ILI and ARI (as defined by ECDC (EU 2008, 2012, 2022): Cough, sore throat, shortness of breath, non-allergic rhinitis, fever or feverishness, malaise, headache, myalgia. * Otherwise of general good health, according to Investigator's judgement. * Willing and able to give written informed consent for participation in the investigation. Exclusion criteria for subject selection. * Known allergy or hypersensitivity to the components of ColdZyme. * Current use of immunosuppressive therapy within the last 4 weeks prior to Visit 1 and during the investigation. * Di
Ages18 Years
SexAll
Lead sponsorLund University
LocationsLund, Sweden
Start date2025-06-30
NCT IDNCT07041671
Official listinghttps://clinicaltrials.gov/study/NCT07041671

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