Evaluation Viral RNA and Virus Infectivity in Exhaled Air Before and After Use of One Dose With ColdZyme Mouth Spray
Evaluation of Number of Particles Containing Viral RNA and Their Virus Infectivity in Exhaled Air From Participants With Upper Respiratory Tract Infection Symptoms, Before and After Use of One Dose With ColdZyme Mouth Spray
Lund University
200 participants
Jun 30, 2025
INTERVENTIONAL
Conditions
Summary
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 ColdZyme could also contribute to decreased airborne transmission by decreasing the amount of (infectious) virus that is exhaled by an infected subject.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- 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.
- Diagnosed chronic respiratory disease that could potentially impact the investigation results, according to Investigator's judgement.
- Self-reported unhealed wounds/mucosal lesions in the mouth and/or throat.
- Participation in another clinical study or investigation within 30 days prior to Visit 1.
- Active smokers
- The Investigator considers the subject unlikely to comply with investigational procedures, restrictions and requirements.
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Interventions
ColdZyme is a medical device classified as a Class III device, certified according to the European Medical Devices Regulation (2017/745/EU) (MDR). It has been CE-marked since 2013. 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 viscous barrier catches the virus and thereby the contact between the virus and the epithelial cells are reduced and avoided, thus the barrier disables the viruses' ability to spread and multiply.
Locations(1)
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NCT07041671