Study to Investigate if Sucking a Coldamaris Lozenge Elutes Sufficient Iota-carrageenan to Inactivate Usual Common Cold Viruses

Not Applicable

Completed

• Conditions: Common Cold; Viral Infection
• Interventions: Device: Coldamaris lozenges

• Registration Number: NCT04533906
• Lead Sponsor: Marinomed Biotech AG

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.

Study Timeline

• Study Start: 2020-08-04
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-09-01
• Status Verified: 2020-10
• Primary Completion: 2020-10-04
• Study Completion: 2020-11-10
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carrageenan	Coldamaris lozenges	Subjects sucking carageenan containing lozenge

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dr. Friedrich Ehrenreich; 🇦🇹 Vienna, Austria