Common Cold, Viral Infection
Conditions
Keywords
respiratory virus, carrageenan, coronavirus, influenza virus, human rhinovirus, coxsackie virus, Carragelose, Iota-carrageenan
Brief summary
Coldamaris lozenges are a medical device containing 10 mg carrageenan/lozenge. The goal of the study is to determine whether the iota-carrageenan content in the saliva of subjects who sucked Coldamaris® lozenges is sufficient to inhibit the replication of 4 of the most common respiratory viruses causing common cold. At least 29 subjects will be screened, in order to get 24 subjects included.
Detailed description
Coldamaris lozenges are a medical device containing 10 mg carrageenan/lozenge. The goal of the study is to determine whether the iota-carrageenan content in the saliva of subjects who sucked Coldamaris® lozenges is sufficient to inhibit the replication of 4 of the most common respiratory viruses causing common cold. At least 29 subjects will be screened, in order to get 24 subjects included. The primary objective is whether the mean iota-carrageenan concentration in saliva during sucking an iota-carrageenan containing lozenge reaches published IC90 values for HRV1a and HRV8. The secondary objectives are whether the mean iota-carrageenan concentration in saliva (µg/ml; base line corrected) during sucking an iota-carrageenan containing lozenge reaches the respective IC90/MIC values (paired t-tests) of the clinical saliva samples for HRV1a, HRV8, hCoV OC43, influenza virus H1N1n and Coxsackie virus A10.
Interventions
DEVICEColdamaris lozenges
sucking carageenan containing lozenge
Sponsors
Marinomed Biotech AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The saliva of subjects will be collected before and during sucking a Coldamaris lozenge.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* personally signed and dated informed consent * healthy respiratory tract, no acute infection * age \> 18 years
Exclusion criteria
* subjects with signs of an acute respiratory infection * subjects with a known hypersensitivity to one of the ingredients * presence of pregnancy confirmed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure is the iota-carrageenan concentration in saliva. | 3 months | The mean iota-carrageenan concentration in saliva during sucking an iota-carrageenan containing lozenge should reach published IC90 values for 2 human rhinoviruses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary outcome measure is the iota-carrageenan concetration in salvia. | 3 months | Iota-carrageenan concentration in saliva of subjects should be high enough to inhibit replication of human rhinoviruses, human Coronavirus OC43, human influenzavirus H1N1n, and Coxsackievirus A10. |
Countries
Austria
Outcome results
None listed