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

Sponsor

Marinomed Biotech AG (Industry)

Overall Status

Completed

CT.gov ID

NCT04681001

Collaborator

(none)

300

Enrollment

Locations

Arms

8.3

Actual Duration (Months)

150

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Viral Infection Common Cold Severe Acute Respiratory Syndrome (SARS) Pneumonia COVID-19 Corona Virus Disease	Device: nasal spray	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized placebo-controlled double blindedRandomized placebo-controlled double blinded

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Dec 20, 2020

Actual Primary Completion Date :

Aug 20, 2021

Actual Study Completion Date :

Aug 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coldamaris pro One puff per nostril three puffs into mouth	Device: nasal spray application of nasal spray into nostrils and mouth
Placebo Comparator: Coldamaris sine One puff per nostril three puffs into mouth	Device: nasal spray application of nasal spray into nostrils and mouth

Arm

Intervention/Treatment

Experimental: Coldamaris pro

One puff per nostril three puffs into mouth

Device: nasal spray

application of nasal spray into nostrils and mouth

Placebo Comparator: Coldamaris sine

One puff per nostril three puffs into mouth

Device: nasal spray

application of nasal spray into nostrils and mouth

Outcome Measures

Primary Outcome Measures

Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary [84 days]
daily assessment of subjective COVID-19 symptom score

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gesundheitsverbund, Klinik Favoriten	Vienna		Austria	1100
2	Gesundheitsverbund Klinik Floridsdorf	Vienna		Austria	1210

Sponsors and Collaborators

Marinomed Biotech AG

Investigators

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