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

Covid19 Clinical Trial

— CARR-COV-02  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04521322
• Other study ID #: CEMIC
• Status: Recruiting
• Phase: Phase 4
• Start date: July 24, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: August 2020
• Source: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Contact: Mónica Lombardo, MD
• Phone: 005491141763599
• Email: mlombardo[@]nobeltri.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Iota-Carrageenan
Participants will received a nasal spray with Iota-Carrageenan or placebo 4 times a day during 21 days

Locations

Country	Name	City	State
Argentina	centro de educación médica e investigaciones clinicas (CEMIC)	Buenos Aires	Capital Federal

Sponsors (2)

Lead Sponsor	Collaborator
Ariel Dogliotti	Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnose of COVID19 disease	COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test	28 days
Secondary	Progression to a more severe disease state, defined as need for oxygen therapy.	number of subjects who develop severe COVID19 disease	28 days
Secondary	lasting of disease	number of days with clinical symptoms	28 days
Secondary	Incidence of COVID-19 disease onset in the first week after treatment	number of subjects who develop the disease within one week after finishing treatment	1 week after finishing treatment