Evaluation Viral RNA and Virus Infectivity in Exhaled Air Before and After Use of One Dose With ColdZyme Mouth Spray
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLund University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ColdZyme
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lund University
Lead sponsor
Enzymatica AB
Collaborator
Source ClinicalTrials.gov