Back to results

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)

Primary Purpose

Covid19

Status

Unknown status

Phase

Phase 4

Locations

Argentina

Study Type

Interventional

Intervention

Iota-Carrageenan

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

centro de educación médica e investigaciones clinicas (CEMIC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Participants in this arm will receive a nasal spray with placebo

Participants in this arm will receive a nasal spray with Iota-Carrageenan

Outcomes

Primary Outcome Measures

diagnose of COVID19 disease

COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test

Secondary Outcome Measures

Progression to a more severe disease state, defined as need for oxygen therapy.

number of subjects who develop severe COVID19 disease

lasting of disease

number of days with clinical symptoms

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

Full Information

NCT ID

NCT04521322

First Posted

August 19, 2020

Last Updated

August 19, 2020

Sponsor

Ariel Dogliotti

Collaborators

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

1. Study Identification

Unique Protocol Identification Number

NCT04521322

Brief 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 Disease

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 24, 2020 (Actual)

Primary Completion Date

October 30, 2020 (Anticipated)

Study Completion Date

November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ariel Dogliotti

Collaborators

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Multicenter, randomized, double blind compared vs placebo

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Participants in this arm will receive a nasal spray with placebo

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Participants in this arm will receive a nasal spray with Iota-Carrageenan

Intervention Type

Drug

Intervention Name(s)

Iota-Carrageenan

Other Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

diagnose of COVID19 disease

Description

COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Progression to a more severe disease state, defined as need for oxygen therapy.

Description

number of subjects who develop severe COVID19 disease

Time Frame

28 days

Title

lasting of disease

Description

number of days with clinical symptoms

Time Frame

28 days

Title

Incidence of COVID-19 disease onset in the first week after treatment

Description

number of subjects who develop the disease within one week after finishing treatment

Time Frame

1 week after finishing treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mónica Lombardo, MD

Phone

005491141763599

mlombardo@nobeltri.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ricardo Valentini, MD

Phone

005491162036790

deptomedicina2@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan Figueroa, MD

Organizational Affiliation

Instituto Milstein-CONICET

Official's Role

Study Director

Facility Information:

Facility Name

centro de educación médica e investigaciones clinicas (CEMIC)

City

Buenos Aires

State/Province

Capital Federal

ZIP/Postal Code

1425

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mónica Lombardo, MD

Phone

541152990600

mlombardo@nobeltri.com

First Name & Middle Initial & Last Name & Degree

Ricardo c Valentini

Phone

+541152990600

rvalentini@cemic.edu.ar

12. IPD Sharing Statement

Citations:

PubMed Identifier

34629893

Citation

Figueroa JM, Lombardo ME, Dogliotti A, Flynn LP, Giugliano R, Simonelli G, Valentini R, Ramos A, Romano P, Marcote M, Michelini A, Salvado A, Sykora E, Kniz C, Kobelinsky M, Salzberg DM, Jerusalinsky D, Uchitel O. Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Postexposure Prophylaxis of COVID-19 in Hospital Personnel Dedicated to Patients Care with COVID-19 Disease. Int J Gen Med. 2021 Oct 1;14:6277-6286. doi: 10.2147/IJGM.S328486. eCollection 2021.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs