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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04533906
Recruitment Status : Completed
First Posted : September 1, 2020
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Common Cold Viral Infection Device: Coldamaris lozenges Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : August 4, 2020
Actual Primary Completion Date : October 4, 2020
Actual Study Completion Date : November 10, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The primary outcome measure is the iota-carrageenan concentration in saliva. [ Time Frame: 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 :
  1. The secondary outcome measure is the iota-carrageenan concetration in salvia. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533906


Locations
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Austria
Dr. Friedrich Ehrenreich
Vienna, Austria, 1170
Sponsors and Collaborators
Marinomed Biotech AG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marinomed Biotech AG
ClinicalTrials.gov Identifier: NCT04533906    
Other Study ID Numbers: LOA_19_04
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marinomed Biotech AG:
respiratory virus
carrageenan
coronavirus
influenza virus
human rhinovirus
coxsackie virus
Carragelose
Iota-carrageenan
Additional relevant MeSH terms:
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Virus Diseases
Common Cold
Infections
Respiratory Tract Infections
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents