Prophylactic Treatment With Carragelose Nasal Spary to Prevent SARS-CoV-2, COVID-19, Infections in Health Care Workers
Condition: Respiratory Viral Infection; Common Cold; Severe Acute Respiratory Syndrome (SARS) Pneumonia; COVID-19; Corona Virus Disease
MeSH terms: Infections; COVID-19; Severe Acute Respiratory Syndrome; Virus Diseases; Common Cold
Study type: Interventional

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
    

Intervention name(s): nasal spray
Intervention type(s): Device
Intervention description(s): application of nasal spray into nostrils and mouth
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized placebo-controlled double blinded
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Carragelose; Respiratory Virus; Iota-Carrageenan; Health CareWorker; Frontline Worker; Nasal Spray