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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of virus genome copies in exhaled aerosol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Active smokers
- •The Investigator considers the subject unlikely to comply with investigational procedures, restrictions and requirements.
研究组 & 干预措施
ColdZyme treatment
The subject will use ColdZyme mouth spray once. This will be performed after the first aerosol measurements and before the second.
干预措施: ColdZyme (Device)
No intervention
Subjects will only perform aerosol measurements, without ColdZyme mouth spray.
结局指标
主要结局
Number of virus genome copies in exhaled aerosol
时间窗: 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.
次要结局
- Infectivity of exhaled virus as quantified by TCID50 and MPN(20-60 minutes after inhalation of 1 dose treatment of ColdZyme)