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

Marinomed Biotech

Status: Completed

Conditions: Viral Infection; Common Cold

Treatments: Device: Coldamaris lozenges

Study type: Interventional

Funder types: Industry

Identifiers

NCT04533906

LOA_19_04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Carrageenan

Experimental group

Description:

Subjects sucking carageenan containing lozenge

Treatment:

Device: Coldamaris lozenges