Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Prophylaxis of COVID-19 Disease in Health Personnel Dedicated to Patients Care With COVID-19 Disease (CARR-COV-02)

August 19, 2020 updated by: Ariel Dogliotti

Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Prophylaxis of COVID-19 Disease in Health Personnel Dedicated to Patients Care With COVID-19. Multicenter, Randomized, Double-blind, Placebo-controlled Trial (CARR-COV-02)

Coronaviruses are enveloped viruses with an RNA genome. Carrageenans are sulfate polysaccharides synthesized by red algae. Studies conducted in adults and children with the common cold showed the effectiveness of the use of Carrageenan in nasal spray.

For decades, the antiviral action of Carrageenans has been described in numerous studies with different viruses that infect humans: herpes viruses types 1 and 2, human immunodeficiency virus, human papillomavirus, H1N1 influenza virus, dengue virus, rhinovirus, hepatitis A virus, and enteroviruses. Studies on the dynamics of COVID-19 disease show an intense and rapid pharyngeal multiplication in the first 3-5 days of the onset of symptoms, prior to the onset of pulmonary disease.

Finally, this molecule has shown a viricidal effect against SARS-Cov2 in vitro. All this underscores the potential value of a therapy that inhibits the virus in the rhinopharynx.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled trial assessing the use a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 disease in health-workers.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, 1425
        • Recruiting
        • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • physician, nurses, and physical therapist who usually attend hospitalized COVID19 patients.
  • No more than 48 hours since he/she assisted a COVID-19 patient
  • Able to understand and give written informed consent

Exclusion Criteria:

  • Participation in any other clinical trial of an experimental treatment for COVID-19
  • Not having a cell phone with WhatsApp for remote monitoring
  • Hypersensitivity or known allergy to any component of the product
  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Participants in this arm will receive a nasal spray with placebo
Drug: Iota-Carrageenan
Participants will received a nasal spray with Iota-Carrageenan or placebo 4 times a day during 21 days
Other Names:
  • Placebo
Experimental: Experimental
Participants in this arm will receive a nasal spray with Iota-Carrageenan
Drug: Iota-Carrageenan
Participants will received a nasal spray with Iota-Carrageenan or placebo 4 times a day during 21 days
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnose of COVID19 disease
Time Frame: 28 days
COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression to a more severe disease state, defined as need for oxygen therapy.
Time Frame: 28 days
number of subjects who develop severe COVID19 disease
28 days
lasting of disease
Time Frame: 28 days
number of days with clinical symptoms
28 days
Incidence of COVID-19 disease onset in the first week after treatment
Time Frame: 1 week after finishing treatment
number of subjects who develop the disease within one week after finishing treatment
1 week after finishing treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ariel Dogliotti

Collaborators

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Investigators

  • Study Director: Juan Figueroa, MD, Instituto Milstein-CONICET

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2020

Primary Completion (Anticipated)

October 30, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 21, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEMIC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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