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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
ColdZyme
DeviceColdZyme 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: ColdZyme treatmentActive comparator 1 intervention
Group B: No interventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of virus genome copies in exhaled aerosol
Reduction compared to baseline of virus RNA concentrations in exhaled aerosol particles after 1 dose treatment of ColdZyme in subjects in early phase and/or with early common cold/flu-like symptoms (Baseline = virus RNA concentrations in exhaled aerosol particles in untreated participant, i.e before using ColdZyme). RNA copy number is determined by qPCR.
Time frame
20-60 minutes after inhalation of 1 dose treatment of ColdZymeSecondary outcomes
1
Infectivity of exhaled virus as quantified by TCID50 and MPN
Infectivity decrease of exhaled virus after 1 dose treatment of ColdZyme in subjects in early phase and/or with early common cold/flu-like symptoms, where the effect is measured in number of infectious virus. Infectivity is quantified by tissue culture infectious dose (TCID50) for screening of infectivity and most probable number MPN for more precise quantification.
Time frame
20-60 minutes after inhalation of 1 dose treatment of ColdZymeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lund University
Lead sponsor
Enzymatica AB
Collaborator
Source ClinicalTrials.gov