NCT07041671 Evaluation Viral RNA and Virus Infectivity in Exhaled Air Before and After Use of One Dose With ColdZyme Mouth Spray
| NCT ID | NCT07041671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lund University |
| Condition | URTI - Viral Upper Respiratory Tract Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-06-30 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07041671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying URTI - Viral Upper Respiratory Tract Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07041671 currently recruiting?
Yes, NCT07041671 is actively recruiting participants. Contact the research team at jakob.londahl@design.lth.se for enrollment information.
Where is the NCT07041671 trial being conducted?
This trial is being conducted at Lund, Sweden.
Who is sponsoring the NCT07041671 clinical trial?
NCT07041671 is sponsored by Lund University. The trial plans to enroll 200 participants.