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
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
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
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
Learn more about this trial
Study to Investigate if Sucking a Coldamaris Lozenge Elutes Sufficient Iota-carrageenan to Inactivate Usual Common Cold Viruses
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