Clinical trial NCT04533906: 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
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Viral Infection
Keywords: respiratory virus
carrageenan
coronavirus
influenza virus
human rhinovirus
coxsackie virus
Carragelose
Iota-carrageenan
Lead sponsor: Marinomed Biotech AG
Sponsor class: INDUSTRY
First posted: 2020-09-01
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The saliva of subjects will be collected before and during sucking a Coldamaris lozenge.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary outcome measure is the iota-carrageenan concentration in saliva.
timeFrame: 3 months
Secondary outcomes:
measure: The secondary outcome measure is the iota-carrageenan concetration in salvia.
timeFrame: 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dr. Friedrich Ehrenreich
Study officials:
References:
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.