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Completed

NCT Number: NCT04533906

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

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.

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Key information

Conditions

Common Cold Coronaviridae Infections Coronavirus Infections Coxsackievirus Infections Enterovirus Infections Infections Nidovirales Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Viral Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Friedrich Ehrenreich

Vienna, 1170, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coldamaris lozenges

Device

sucking carageenan containing lozenge

Other names: Betadine, Quixx protect, Quixx grip-protect

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Marinomed Biotech AG

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2020
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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