Evaluation Viral RNA and Virus Infectivity in Exhaled Air Before and After Use of One Dose With ColdZyme Mouth Spray

Launched by LUND UNIVERSITY · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether ColdZyme mouth spray can reduce the amount of virus that people with a common cold or similar upper respiratory infection breathe out into the air. ColdZyme works by creating a protective, moisturizing layer in the mouth and throat to help block viruses. The study aims to find out if using just one dose of this spray can lower the amount of infectious virus in the air, which might help prevent spreading the illness to others.

Adults aged 18 and older who have recently started to experience symptoms like cough, sore throat, fever, or headache may be eligible to take part, as long as they are generally healthy and do not have allergies to ColdZyme or certain health conditions like chronic lung disease. Smokers and people on certain immune-suppressing medications won’t qualify. Participants will be asked to use the ColdZyme spray once, and researchers will measure the virus in the air they exhale before and after using it. This study is not recruiting yet, but it hopes to better understand how to reduce the spread of viruses through breath.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• • 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.