Evaluation Viral RNA and Virus Infectivity in Exhaled Air Before and After Use of One Dose With ColdZyme Mouth Spray

NCT07041671 | Not Yet Recruiting

• 1 other identifier: CIV-24-11-049836
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

URTI - Viral Upper Respiratory Tract Infection

Outcome Measures

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.

  20-60 minutes after inhalation of 1 dose treatment of ColdZyme

Secondary Outcomes (1)

• Infectivity of exhaled virus as quantified by TCID50 and MPN

  20-60 minutes after inhalation of 1 dose treatment of ColdZyme

Study Arms (2)

ColdZyme treatment

ACTIVE COMPARATOR

The subject will use ColdZyme mouth spray once. This will be performed after the first aerosol measurements and before the second.

Device: ColdZyme

No intervention

NO INTERVENTION

Subjects will only perform aerosol measurements, without ColdZyme mouth spray.

Interventions

ColdZyme DEVICE

ColdZyme 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.

ColdZyme treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lund University: lead
• Enzymatica AB: collaborator

Study Sites (1)

Lund University

Lund, 22100, Sweden

Location

Related Publications (1)

• Davison G, Schoeman M, Chidley C, Dulson DK, Schweighofer P, Witting C, Posch W, Matta GG, Consoli C, Farley K, McCullough C, Wilflingseder D. ColdZyme(R) reduces viral load and upper respiratory tract infection duration and protects airway epithelia from infection with human rhinoviruses. J Physiol. 2025 Mar;603(6):1483-1501. doi: 10.1113/JP288136. Epub 2025 Feb 28.

  PMID: 40019230 BACKGROUND

Central Study Contacts

Jakob Löndahl, PhD

CONTACT

+46462220517; jakob.londahl@design.lth.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 27, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Anonymized IPD and supporting information will be shared upon reasonable request after publication of major findings until at least 10 years after.
• Access Criteria: Contact principal investigator Jakob Löndahl (jakob.londahl@design.lth.se) or assoc. prof Malin Alsved (malin.alsved@design.lth.se) for IPD.

Locations

SE (1)