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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)

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ClinicalTrials.gov Identifier: NCT04521322
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : August 21, 2020
Sponsor:
Collaborator:
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Information provided by (Responsible Party):
Ariel Dogliotti, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

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.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Iota-Carrageenan Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized, double blind compared vs placebo
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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)
Actual Study Start Date : July 24, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : November 30, 2020

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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. diagnose of COVID19 disease [ Time Frame: 28 days ]
    COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test


Secondary Outcome Measures :
  1. 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

  2. lasting of disease [ Time Frame: 28 days ]
    number of days with clinical symptoms

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04521322


Contacts
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Contact: Mónica Lombardo, MD 005491141763599 mlombardo@nobeltri.com
Contact: Ricardo Valentini, MD 005491162036790 deptomedicina2@gmail.com

Locations
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Argentina
centro de educación médica e investigaciones clinicas (CEMIC) Recruiting
Buenos Aires, Capital Federal, Argentina, 1425
Contact: Mónica Lombardo, MD    541152990600    mlombardo@nobeltri.com   
Contact: Ricardo c Valentini    +541152990600    rvalentini@cemic.edu.ar   
Sponsors and Collaborators
Ariel Dogliotti
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Investigators
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Study Director: Juan Figueroa, MD Instituto Milstein-CONICET
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Responsible Party: Ariel Dogliotti, PHYSICIAN, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
ClinicalTrials.gov Identifier: NCT04521322    
Other Study ID Numbers: CEMIC
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No