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Prophylactic Treatment With Carragelose Nasal Spary to Prevent SARS-CoV-2, COVID-19, Infections in Health Care Workers

Primary Purpose

Respiratory Viral Infection, Common Cold, Severe Acute Respiratory Syndrome (SARS) Pneumonia

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

nasal spray

About this trial

This is an interventional prevention trial for Respiratory Viral Infection focused on measuring Carragelose, Respiratory Virus, Iota-Carrageenan, Health CareWorker, Frontline Worker, Nasal Spray

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age ≥18 years
Study participants that have given informed consent before any study related procedures are performed, and received a copy of signed consent form
Healthcare workers (nurses, doctors) employed and working at Gesundheitsverbund
Healthcare workers looking after confirmed COVID-19 positive patients in a secondary care setting such as Accident and Emergency departments, wards, operating theatres, outpatient departments, High Dependency Unit or Intensive Care Units

Exclusion Criteria:

The subject is related to any study personnel or has any other close ties or conflicts of interest with the study sponsor.
The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study
Known hypersensitivity or allergy to any component of the test product
Severe cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or a history or any current disease that is considered by the investigator as a reason for exclusion.
The subject has a clinically significant disease that could interfere with participation in the study, with the intervention being studied, or with the evaluation of symptoms. Specific exclusions include immune deficiency, autoimmune disease, substantive cardiovascular, endocrinological, neurological, respiratory, or gastrointestinal disease.
Asymptomatic disease such as elevated blood pressure or cholesterol will not be a reason for exclusion. Those with well-controlled mental illness (e.g. depression, anxiety) will be eligible. The enrolling physician will be empowered to exclude potential subjects that s/he deems unreliable.
Pregnant women at the time of recruitment will be excluded from the study
Current medication other than oral contraception, that is considered by the investigator as a reason for exclusion e.g. intranasal medication
Participation in another antiviral clinical trial

Sites / Locations

Gesundheitsverbund, Klinik Favoriten
Gesundheitsverbund Klinik Floridsdorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Coldamaris pro

Coldamaris sine

Arm Description

One puff per nostril three puffs into mouth

Outcomes

Primary Outcome Measures

Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary

daily assessment of subjective COVID-19 symptom score

Secondary Outcome Measures

Nasal swabs for analysis of viruses by PCR

weekly assessment of SARS-CoV-2, Influenza A, Human Metapneumovirus, Influenza A - subtype H1, Adenovirus, Influenza A - subtype H3, Parainfluenza 1, Influenza A - subtype 2009 H1N1, Parainfluenza 2, Influenza B, Parainfluenza 3, Parainfluenza 4, Coronavirus HKU1, Respiratory Syncytial Virus A, Coronavirus N63L, Respiratory Syncytial Virus B, Coronavirus OC43, Rhinovirus/Enterovirus, Coronavirus 229E, Human Bocavirus, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila

Serology of antibodies against SARS-CoV-2

beginn and end of trial

Number of viral co-infections dedected by PCR

weekly nasal swabs for analysis of viruses

Full Information

NCT ID

NCT04681001

First Posted

December 21, 2020

Last Updated

August 24, 2022

Sponsor

Marinomed Biotech AG

1. Study Identification

Unique Protocol Identification Number

NCT04681001

Brief Title

Prophylactic Treatment With Carragelose Nasal Spary to Prevent SARS-CoV-2, COVID-19, Infections in Health Care Workers

Official Title

Clinical Trial to Evaluate the Efficacy of an Iota-Carrageenan Nasal Spray to Reduce Symptoms Caused by SARS-CoV-2 and Other Respiratory Viruses in Healthcare Workers Managing COVID-19 Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

December 20, 2020 (Actual)

Primary Completion Date

August 20, 2021 (Actual)

Study Completion Date

August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Marinomed Biotech AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a prospective, randomized placebo-controlled double blinded clinical trial in frontline healthcare workers managing COVID-19 patients. Participants will be weekly tested for SARS-CoV-2 and a panel of respiratory viruses. Treatment will be 3times a day for 84 days one puff into each nostirl and 3 puffs into mouth. Daily a symptom score will be recorded. The primary objective of the trial is to demonstrate that prophylactic treatment of health care workers managing COVID-19 patients with iota-carrageenan reduces symptoms of SARS-CoV-2 infections as well as infections with other respiratory viruses when compared to a placebo-treated control group.

Detailed Description

This is a prospective, randomized placebo-controlled double blinded clinical trial in frontline healthcare workers managing COVID-19 patients. Screening - first day of treatment: After signing the informed consent form eligible participants will be included. Immediately after inclusion and after first nasal swab, participants start with their first treatment. In order to obtain nasal swabs and to assess adverse events the participants will visit the sites on a weekly basis over a period of 12 weeks. 3 times a day for 84 days (12 weeks): 1 puff of Coldamaris pro. nasal spray into each nostril (1.2 mg/ml; 140 µl per puff) and 3 puffs of Coldamaris pro. nasal spray into mouth Weekly sampling for testing of SARS-CoV-2 and respiratory virus panel (Influenza A, Human Metapneumovirus, Influenza A - subtype H1 Adenovirus, Influenza A - subtype H3 Parainfluenza 1, Influenza A - subtype 2009 H1N1, Parainfluenza 2, Influenza B Parainfluenza 3, SARS-CoV-2 Parainfluenza 4, Coronavirus HKU1 Respiratory Syncytial Virus A, Coronavirus N63L, Respiratory Syncytial Virus B, Coronavirus OC43, Rhinovirus/Enterovirus, Coronavirus 229E, Human Bocavirus) At begin and end of trial blood samples will be taken for differential blood count and for serology. The primary end point of the is the presence of COVID-19 symptoms including symptoms of respiratory viral infection. The primary hypothesis is a reduction of symptom days caused by SARS-CoV-2 and/or respiratory viral infection in health care workers treated with Coldamaris pro. nasal spray compared to placebo treated ones

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Viral Infection, Common Cold, Severe Acute Respiratory Syndrome (SARS) Pneumonia, COVID-19, Corona Virus Disease

Keywords

Carragelose, Respiratory Virus, Iota-Carrageenan, Health CareWorker, Frontline Worker, Nasal Spray

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized placebo-controlled double blinded

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Coldamaris pro

Arm Type

Experimental

Arm Description

One puff per nostril three puffs into mouth

Arm Title

Coldamaris sine

Arm Type

Placebo Comparator

Arm Description

One puff per nostril three puffs into mouth

Intervention Type

Device

Intervention Name(s)

nasal spray

Intervention Description

application of nasal spray into nostrils and mouth

Primary Outcome Measure Information:

Title

Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary

Description

daily assessment of subjective COVID-19 symptom score

Time Frame

84 days

Secondary Outcome Measure Information:

Title

Nasal swabs for analysis of viruses by PCR

Description

Time Frame

84 days

Title

Serology of antibodies against SARS-CoV-2

Description

beginn and end of trial

Time Frame

84 days

Title

Number of viral co-infections dedected by PCR

Description

weekly nasal swabs for analysis of viruses

Time Frame

84 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years Study participants that have given informed consent before any study related procedures are performed, and received a copy of signed consent form Healthcare workers (nurses, doctors) employed and working at Gesundheitsverbund Healthcare workers looking after confirmed COVID-19 positive patients in a secondary care setting such as Accident and Emergency departments, wards, operating theatres, outpatient departments, High Dependency Unit or Intensive Care Units Exclusion Criteria: The subject is related to any study personnel or has any other close ties or conflicts of interest with the study sponsor. The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study Known hypersensitivity or allergy to any component of the test product Severe cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or a history or any current disease that is considered by the investigator as a reason for exclusion. The subject has a clinically significant disease that could interfere with participation in the study, with the intervention being studied, or with the evaluation of symptoms. Specific exclusions include immune deficiency, autoimmune disease, substantive cardiovascular, endocrinological, neurological, respiratory, or gastrointestinal disease. Asymptomatic disease such as elevated blood pressure or cholesterol will not be a reason for exclusion. Those with well-controlled mental illness (e.g. depression, anxiety) will be eligible. The enrolling physician will be empowered to exclude potential subjects that s/he deems unreliable. Pregnant women at the time of recruitment will be excluded from the study Current medication other than oral contraception, that is considered by the investigator as a reason for exclusion e.g. intranasal medication Participation in another antiviral clinical trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iulia Niculescu, MD

Organizational Affiliation

Gesundheitsverbund; Klinik Favoriten;4. Medizinische Abteilung mit Infektions-und Tropenmedizin1100 Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gesundheitsverbund, Klinik Favoriten

City

Vienna

ZIP/Postal Code

1100

Country

Austria

Facility Name

Gesundheitsverbund Klinik Floridsdorf

City

Vienna

ZIP/Postal Code

1210

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Prophylactic Treatment With Carragelose Nasal Spary to Prevent SARS-CoV-2, COVID-19, Infections in Health Care Workers

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