| Registry | NCT04533906 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 29 (Actual) |
| Sponsor | Marinomed Biotech AG (Industry) |
| Conditions | Common Cold, Viral Infection |
| Interventions | Coldamaris lozenges (Device) |
| Dates | start 2020-08-04, primary completion 2020-10-04, completion 2020-11-10, first posted 2020-09-01, last updated 2021-01-08 |
| Locations | 1 site in Austria |
Related Papers Related Patents Related Grants Related Experts
All trials for Common Cold All trials for Viral Infection All trials of Coldamaris lozenges
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Carrageenan | Experimental | Device: Coldamaris lozenges | Subjects sucking carageenan containing lozenge |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Dr. Friedrich Ehrenreich | Vienna | Austria |