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

• ClinicalTrials.gov Identifier: NCT04681001
• Recruitment Status: Completed
• First Posted: December 23, 2020
• Last Update Posted: August 25, 2022
• Sponsor: Marinomed Biotech AG
• Information provided by (Responsible Party): Marinomed Biotech AG

Tracking Information

• First Submitted Date: December 21, 2020
• First Posted Date: December 23, 2020
• Last Update Posted Date: August 25, 2022
• Actual Study Start Date: December 20, 2020
• Actual Primary Completion Date: August 20, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 22, 2020)

Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary [ Time Frame: 84 days ]

daily assessment of subjective COVID-19 symptom score

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 22, 2020)

• Nasal swabs for analysis of viruses by PCR [ Time Frame: 84 days ]
  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 [ Time Frame: 84 days ]
  beginn and end of trial
• Number of viral co-infections dedected by PCR [ Time Frame: 84 days ]
  weekly nasal swabs for analysis of viruses

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

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

Intervention

Device: nasal spray

application of nasal spray into nostrils and mouth

Study Arms

• Experimental: Coldamaris pro
  One puff per nostril three puffs into mouth
  Intervention: Device: nasal spray
• Placebo Comparator: Coldamaris sine
  One puff per nostril three puffs into mouth
  Intervention: Device: nasal spray

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 22, 2020): 300
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 30, 2021
• Actual Primary Completion Date: August 20, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT04681001
• Other Study ID Numbers: COVID-19/CHC_20_04
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Marinomed Biotech AG
• Original Responsible Party: Same as current
• Current Study Sponsor: Marinomed Biotech AG
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Iulia Niculescu, MD; Gesundheitsverbund; Klinik Favoriten;4. Medizinische Abteilung mit Infektions-und Tropenmedizin1100 Vienna

• PRS Account: Marinomed Biotech AG
• Verification Date: August 2022