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

Sponsor

Marinomed Biotech AG (Industry)

Overall Status

Completed

CT.gov ID

NCT04533906

Collaborator

(none)

Enrollment

Location

Arm

3.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Common Cold Viral Infection	Device: Coldamaris lozenges	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The saliva of subjects will be collected before and during sucking a Coldamaris lozenge.The saliva of subjects will be collected before and during sucking a Coldamaris lozenge.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 4, 2020

Actual Primary Completion Date :

Oct 4, 2020

Actual Study Completion Date :

Nov 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carrageenan Subjects sucking carageenan containing lozenge	Device: Coldamaris lozenges sucking carageenan containing lozenge Other Names: Betadine Quixx protect Quixx grip-protect

Arm

Intervention/Treatment

Experimental: Carrageenan

Subjects sucking carageenan containing lozenge

Device: Coldamaris lozenges

sucking carageenan containing lozenge

Other Names:

Betadine

Quixx protect

Quixx grip-protect

Outcome Measures

Primary Outcome Measures

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

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.