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.
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
Device: nasal spray
application of nasal spray into nostrils and mouth
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
Gesundheitsverbund, Klinik Favoriten
Vienna, Austria
Gesundheitsverbund Klinik Floridsdorf
Vienna, Austria
Iulia Niculescu, MD, Principal Investigator
Gesundheitsverbund; Klinik Favoriten;4. Medizinische Abteilung mit Infektions-und Tropenmedizin1100 Vienna