URTI - Viral Upper Respiratory Tract InfectionNCT07041671
Evaluation Viral RNA and Virus Infectivity in Exhaled Air Before and After Use of One Dose With ColdZyme Mouth Spray
A study testing ColdZyme in people with URTI - Viral Upper Respiratory Tract Infection, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- URTI - Viral Upper Respiratory Tract Infection
- What is being tested?
- ColdZyme
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 30 Jun 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Lund University
Lund, 22100
Jakob Löndahl, Professor, +46735518636, jakob.londahl@design.lth.se
Jakob Löndahl, Professor
About this study
Official title: 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
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.
Read the detailed description
The clinical investigation aims to increase the knowledge about the airborne spread of viruses causing upper respiratory tract infections. In particular, it will investigate whether participants with symptoms of a respiratory infection exhale less viruses causing upper respiratory tract infections after using the ColdZyme mouth spray and if the infectivity of exhaled virus particle is reduced. Data from this clinical investigation can possibly show that ColdZyme mouth spray can help reduce the risk of spreading upper respiratory tract virus to the environment.
This is a single centre open label randomized controlled trial. It is an interventional study where subjects are randomized to treatment group (ColdZyme mouth spray) or control group (no spray). The comparison is made between using a mouth spray and not, which cannot be blinded. There are two primary reasons for single centre. Firstly, this is the first study of treatment effects on exhaled viruses and thus feasibility and sensitivity of the methodology is uncertain. Secondly, only a few laboratories internationally have developed instrumentation to perform the measurements.
Subjects enrolled in the study will participate in two different visits, where only visit 1 is related to this clinical investigation regarding ColdZyme. Visit 2 is only for follow-up and the data collected during this visit is not used for investigation of the primary or secondary endpoints, but for explorative analysis that is not related to the hypothesis for ColdZyme. The reason for the second visit is to compare exhaled aerosol characteristics between healthy subjects and subjects with URTI symptoms.
The first visit takes place when the research subject has symptoms of respiratory illness. During the first visit, exhaled aerosol will be collected pre- and post-treatment for the treatment group, and before and after a waiting time of around 20 minutes for the control group. Lung function tests, nasal swabs and questionnaires will be conducted only once per visit and pre-treatment during the first visit.
The exhaled aerosols will be collected into an aerosol sampler (BioSpot, Aerosol Devices Inc.) and analyzed for virus content via qPCR at a later stage. Virus positive samples will be cultured if possible. The particle size distribution and the concentration of exhaled aerosols will be measured directly at the visit by an optical aerosol instrument (OPC, Grimm Aerosol Technik, GmbH). Basic lung function will be measured during both visits by spirometry, oscillometry and AiDA. Symptom scores are collected during both visits.
All measurements are estimated to be made within 2 hours. During the first visit, when the participants have symptoms of respiratory infection, a second sampling of exhaled aerosol will be initiated 20 minutes after use of the mouth spray, or after a waiting time for the control group. The aerosol sampling takes about 30 minutes.
For assessment of the primary variable for the clinical investigation, i.e. virus presence and concentration in the aerosol samples, polymerase chain reaction (PCR) will be used. Maintenance and calibration of the PCR instrument will be performed routinely at the laboratory, for instance by quality control of PCR data from known standard concentrations. Blank aerosol samples will be collected regularly to ensure that there is no cross-contamination or environmental contamination.
The secondary variable, infectivity of virus in the aerosol samples, will be assessed by infecting cell cultures. Negative control wells with uninfected cells will be present in each cell culture plate to ensure that cells were unaffected by other factors.
- Being tested
- ColdZyme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColdZymeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ColdZyme |
| No intervention | No intervention | Subjects will only perform aerosol measurements, without ColdZyme mouth spray. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20-60 minutes after inhalation of 1 dose treatment of ColdZyme
Secondary 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.
Measured: 20-60 minutes after inhalation of 1 dose treatment of ColdZyme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start30 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for URTI - Viral Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Enzymatica AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041671
- Sponsor's protocol ID
- CIV-24-11-049836
- Status last verified
- Mar 2026
- First submitted
- 26 May 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Some individual data will be presented in a table, such as age and gender. Individual data will be shared in a way that individuals can't be identified.
Publications
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.
PubMed 40019230
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07041671
- Acronym / sponsor ID
- CIV-24-11-049836
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Enzymatica AB
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The clinical investigation aims to increase the knowledge about the airborne spread of viruses causing upper respiratory tract infections. In particular, it will investigate whether participants with symptoms of a respiratory infection exhale less viruses causing upper respiratory tract infections after using the ColdZyme mouth spray and if the infectivity of exhaled virus particle is reduced. Data from this clinical investigation can possibly show that ColdZyme mouth spray can help reduce the risk of spreading upper respiratory tract virus to the environment.
This is a single centre open label randomized controlled trial. It is an interventional study where subjects are randomized to treatment group (ColdZyme mouth spray) or control group (no spray). The comparison is made between using a mouth spray and not, which cannot be blinded. There are two primary reasons for single centre. Firstly, this is the first study of treatment effects on exhaled viruses and thus feasibility and sensitivity of the methodology is uncertain. Secondly, only a few laboratories internationally have developed instrumentation to perform the measurements.
Subjects enrolled in the study will participate in two different visits, where only visit 1 is related to this clinical investigation regarding ColdZyme. Visit 2 is only for follow-up and the data collected during this visit is not used for investigation of the primary or secondary endpoints, but for explorative analysis that is not related to the hypothesis for ColdZyme. The reason for the second visit is to compare exhaled aerosol characteristics between healthy subjects and subjects with URTI symptoms.
The first visit takes place when the research subject has symptoms of respiratory illness. During the first visit, exhaled aerosol will be collected pre- and post-treatment for the treatment group, and before and after a waiting time of around 20 minutes for the control group. Lung function tests, nasal swabs and questionnaires will be conducted only once per visit and pre-treatment during the first visit.
The exhaled aerosols will be collected into an aerosol sampler (BioSpot, Aerosol Devices Inc.) and analyzed for virus content via qPCR at a later stage. Virus positive samples will be cultured if possible. The particle size distribution and the concentration of exhaled aerosols will be measured directly at the visit by an optical aerosol instrument (OPC, Grimm Aerosol Technik, GmbH). Basic lung function will be measured during both visits by spirometry, oscillometry and AiDA. Symptom scores are collected during both visits.
All measurements are estimated to be made within 2 hours. During the first visit, when the participants have symptoms of respiratory infection, a second sampling of exhaled aerosol will be initiated 20 minutes after use of the mouth spray, or after a waiting time for the control group. The aerosol sampling takes about 30 minutes.
For assessment of the primary variable for the clinical investigation, i.e. virus presence and concentration in the aerosol samples, polymerase chain reaction (PCR) will be used. Maintenance and calibration of the PCR instrument will be performed routinely at the laboratory, for instance by quality control of PCR data from known standard concentrations. Blank aerosol samples will be collected regularly to ensure that there is no cross-contamination or environmental contamination.
The secondary variable, infectivity of virus in the aerosol samples, will be assessed by infecting cell cultures. Negative control wells with uninfected cells will be present in each cell culture plate to ensure that cells were unaffected by other factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ColdZyme treatment | Active comparator | Device: ColdZymeThe subject will use ColdZyme mouth spray once. This will be performed after the first aerosol measurements and before the second. |
| No intervention | No intervention | –Subjects will only perform aerosol measurements, without ColdZyme mouth spray. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColdZymeColdZyme 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. | Device | ColdZyme treatment |
Primary outcome
Number of virus genome copies in exhaled aerosol
Time frame: 20-60 minutes after inhalation of 1 dose treatment of ColdZyme
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.
1 secondary outcome
Infectivity of exhaled virus as quantified by TCID50 and MPN
Time frame: 20-60 minutes after inhalation of 1 dose treatment of ColdZyme
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 40019230Davison 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.
- Individual participant dataSharing planned: Yes. Some individual data will be presented in a table, such as age and gender. Individual data will be shared in a way that individuals can't be identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ColdZyme in people with URTI - Viral Upper Respiratory Tract Infection, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Löndahl, PhD (+46462220517, jakob.londahl@design.lth.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of virus genome copies in exhaled aerosol (time frame: 20-60 minutes after inhalation of 1 dose treatment of ColdZyme). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07041671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.