One dose of ColdZyme mouth spray and virus levels in exhaled breath

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, open-label randomized trial enrolls adults with sudden onset upper respiratory infection symptoms and randomizes them to a single dose of ColdZyme mouth spray or no spray. Investigators will collect exhaled air and measure viral RNA and the infectivity of exhaled virus particles before and after the intervention using specialized laboratory instrumentation. Only a limited number of laboratories can perform these sensitive measurements, which is why the study is confined to one center. A follow-up visit collects exploratory data that are not used for the primary endpoints.

Why it matters

Who can join: the full rules

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.

Where it's running

• Lund University
  Lund, Sweden Recruiting

Study contacts

• Study coordinator: Jakob Löndahl, PhD
• Email: jakob.londahl@design.lth.se
• Phone: +46462220517

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.