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

Last updated: August 24, 2022
Sponsor: Marinomed Biotech AG
Overall Status: Completed

Phase

N/A

Condition

Common Cold

Acute Rhinitis

Covid-19

Treatment

N/A

Clinical Study ID

NCT04681001
COVID-19/CHC_20_04
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years
  • Study participants that have given informed consent before any study relatedprocedures 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 secondarycare setting such as Accident and Emergency departments, wards, operating theatres,outpatient departments, High Dependency Unit or Intensive Care Units

Exclusion

Exclusion Criteria:

  • The subject is related to any study personnel or has any other close ties or conflictsof interest with the study sponsor.
  • The subject has received any investigational drug or participated in a clinical trialwithin 4 weeks of entry to this study
  • Known hypersensitivity or allergy to any component of the test product
  • Severe cardiovascular, endocrinological, neurological, respiratory, gastrointestinaldisease or a history or any current disease that is considered by the investigator asa reason for exclusion.
  • The subject has a clinically significant disease that could interfere withparticipation in the study, with the intervention being studied, or with theevaluation of symptoms. Specific exclusions include immune deficiency, autoimmunedisease, substantive cardiovascular, endocrinological, neurological, respiratory, orgastrointestinal disease.
  • Asymptomatic disease such as elevated blood pressure or cholesterol will not be areason for exclusion. Those with well-controlled mental illness (e.g. depression,anxiety) will be eligible. The enrolling physician will be empowered to excludepotential 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 theinvestigator as a reason for exclusion e.g. intranasal medication
  • Participation in another antiviral clinical trial

Study Design

Total Participants: 300
Study Start date:
December 20, 2020
Estimated Completion Date:
August 30, 2021

Study 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

Connect with a study center

  • Gesundheitsverbund Klinik Floridsdorf

    Vienna, 1210
    Austria

    Site Not Available

  • Gesundheitsverbund, Klinik Favoriten

    Vienna, 1100
    Austria

    Site Not Available

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