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

Primary Purpose

Common Cold, Viral Infection

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Coldamaris lozenges
Sponsored by
Marinomed Biotech AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold focused on measuring respiratory virus, carrageenan, coronavirus, influenza virus, human rhinovirus, coxsackie virus, Carragelose, Iota-carrageenan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Dr. Friedrich Ehrenreich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carrageenan

Arm Description

Subjects sucking carageenan containing lozenge

Outcomes

Primary Outcome Measures

The primary outcome measure is the iota-carrageenan concentration in saliva.
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.
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.

Full Information

First Posted
August 21, 2020
Last Updated
January 7, 2021
Sponsor
Marinomed Biotech AG
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1. Study Identification

Unique Protocol Identification Number
NCT04533906
Brief Title
Study to Investigate if Sucking a Coldamaris Lozenge Elutes Sufficient Iota-carrageenan to Inactivate Usual Common Cold Viruses
Official Title
Study to Investigate if Sucking a Coldamaris Lozenge Elutes Sufficient Iota-carrageenan to Inactivate Usual Common Cold Viruses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
October 4, 2020 (Actual)
Study Completion Date
November 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marinomed Biotech AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold, Viral Infection
Keywords
respiratory virus, carrageenan, coronavirus, influenza virus, human rhinovirus, coxsackie virus, Carragelose, Iota-carrageenan

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The saliva of subjects will be collected before and during sucking a Coldamaris lozenge.
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carrageenan
Arm Type
Experimental
Arm Description
Subjects sucking carageenan containing lozenge
Intervention Type
Device
Intervention Name(s)
Coldamaris lozenges
Other Intervention Name(s)
Betadine, Quixx protect, Quixx grip-protect
Intervention Description
sucking carageenan containing lozenge
Primary Outcome Measure Information:
Title
The primary outcome measure is the iota-carrageenan concentration in saliva.
Description
The mean iota-carrageenan concentration in saliva during sucking an iota-carrageenan containing lozenge should reach published IC90 values for 2 human rhinoviruses.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The secondary outcome measure is the iota-carrageenan concetration in salvia.
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Information:
Facility Name
Dr. Friedrich Ehrenreich
City
Vienna
ZIP/Postal Code
1170
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34526804
Citation
Morokutti-Kurz M, Unger-Manhart N, Graf P, Rauch P, Kodnar J, Grosse M, Setz C, Savli M, Ehrenreich F, Grassauer A, Prieschl-Grassauer E, Schubert U. The Saliva of Probands Sucking an Iota-Carrageenan Containing Lozenge Inhibits Viral Binding and Replication of the Most Predominant Common Cold Viruses and SARS-CoV-2. Int J Gen Med. 2021 Sep 7;14:5241-5249. doi: 10.2147/IJGM.S325861. eCollection 2021.
Results Reference
derived

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

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