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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
Sponsored by
Marinomed Biotech AG
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

First Posted
December 21, 2020
Last Updated
August 24, 2022
Sponsor
Marinomed Biotech AG
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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
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
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
No

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

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