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

NCT04533906 | Completed

• 1 other identifier: LOA_19_04
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold; Viral Infection

Keywords

respiratory virus; carrageenan; coronavirus; influenza virus; human rhinovirus; coxsackie virus; Carragelose; Iota-carrageenan

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• The secondary outcome measure is the iota-carrageenan concetration in salvia.

  3 months

Study Arms (1)

Carrageenan

EXPERIMENTAL

Subjects sucking carageenan containing lozenge

Device: Coldamaris lozenges

Interventions

Coldamaris lozenges DEVICE

sucking carageenan containing lozenge

Also known as: Betadine, Quixx protect, Quixx grip-protect

Carrageenan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• personally signed and dated informed consent
• healthy respiratory tract, no acute infection
• age \> 18 years

You may not qualify if:

• subjects with signs of an acute respiratory infection
• subjects with a known hypersensitivity to one of the ingredients
• presence of pregnancy confirmed

Sponsors & Collaborators

• Marinomed Biotech AG: lead

Study Sites (1)

Dr. Friedrich Ehrenreich

Vienna, 1170, Austria

Location

Related Publications (1)

• 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.

  PMID: 34526804 DERIVED

MeSH Terms

Conditions

Common Cold; Virus Diseases; Coronavirus Infections; Coxsackievirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; Coronaviridae Infections; Nidovirales Infections; Enterovirus Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: September 1, 2020
• Study Start: August 4, 2020
• Primary Completion: October 4, 2020
• Study Completion: November 10, 2020
• Last Updated: January 8, 2021

Record last verified: 2020-10

Locations

AU (1)