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

NCT04681001 | Completed

• 1 other identifier: COVID-19/CHC_20_04
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Carragelose; Respiratory Virus; Iota-Carrageenan; Health CareWorker; Frontline Worker; Nasal Spray

Outcome Measures

Primary Outcomes (1)

• Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary

  daily assessment of subjective COVID-19 symptom score

  84 days

Secondary Outcomes (3)

• Nasal swabs for analysis of viruses by PCR

  84 days

• Serology of antibodies against SARS-CoV-2

  84 days

• Number of viral co-infections dedected by PCR

  84 days

Study Arms (2)

Coldamaris pro

EXPERIMENTAL

One puff per nostril three puffs into mouth

Device: nasal spray

Coldamaris sine

PLACEBO COMPARATOR

One puff per nostril three puffs into mouth

Device: nasal spray

Interventions

nasal spray DEVICE

application of nasal spray into nostrils and mouth

Coldamaris pro; Coldamaris sine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant women at the time of recruitment will be excluded from the study
• Participation in another antiviral clinical trial

Sponsors & Collaborators

• Marinomed Biotech AG: lead

Study Sites (2)

Gesundheitsverbund, Klinik Favoriten

Vienna, 1100, Austria

Location

Gesundheitsverbund Klinik Floridsdorf

Vienna, 1210, Austria

Location

MeSH Terms

Conditions

Common Cold; Severe Acute Respiratory Syndrome; Pneumonia; COVID-19

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Pneumonia, Viral

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Iulia Niculescu, MD

  Gesundheitsverbund; Klinik Favoriten;4. Medizinische Abteilung mit Infektions-und Tropenmedizin1100 Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized placebo-controlled double blinded

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 23, 2020
• Study Start: December 20, 2020
• Primary Completion: August 20, 2021
• Study Completion: August 30, 2021
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)