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

Common Cold Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533906
• Other study ID #: LOA_19_04
• Status: Completed
• Phase: N/A
• Start date: August 4, 2020
• Est. completion date: November 10, 2020

Study information

• Verified date: October 2020
• Source: Marinomed Biotech AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 10, 2020
• Est. primary completion date: October 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Common Cold
• Viral Infection
• Virus Diseases

Intervention

Device:
• Coldamaris lozenges
sucking carageenan containing lozenge

Locations

Country	Name	City	State
Austria	Dr. Friedrich Ehrenreich	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Marinomed Biotech AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The secondary outcome measure is the iota-carrageenan concetration in salvia.	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.	3 months