One dose of ColdZyme mouth spray and virus levels in exhaled breath
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
This trial will test whether one dose of ColdZyme mouth spray can reduce the amount of virus people with a recent upper respiratory infection exhale.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lund University Academic / other |
| Locations | 1 site (Lund) |
| Trial ID | NCT07041671 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with sudden onset of at least one upper respiratory symptom (for example cough, sore throat, feverishness, runny nose, or myalgia) who are otherwise in general good health and can give informed consent.
Not a fit: People with chronic respiratory disease, recent immunosuppressive therapy, known allergy to ColdZyme, unhealed oral mucosal lesions, or those without active symptoms are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, ColdZyme might lower the amount of infectious virus people with colds exhale, reducing the risk they pass infection to others.
How similar studies have performed: Measuring effects on viruses in exhaled air is novel; ColdZyme has prior data for protecting mucous membranes but effects on airborne virus emission have not been previously measured.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lund
- Lund University — Lund, Sweden (Recruiting)
Study contacts
- Study coordinator: Jakob Löndahl, PhD
- Email: jakob.londahl@design.lth.se
- Phone: +46462220517
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.