We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    carr cov
Previous Study | Return to List | Next Study

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04521322
Recruitment Status : Unknown
Verified August 2020 by Ariel Dogliotti, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE August 19, 2020
First Posted Date  ICMJE August 20, 2020
Last Update Posted Date August 21, 2020
Actual Study Start Date  ICMJE July 24, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2020)
diagnose of COVID19 disease [ Time Frame: 28 days ]
COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2020)
  • 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
  • lasting of disease [ Time Frame: 28 days ]
    number of days with clinical symptoms
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multicenter, randomized, double blind compared vs placebo
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE Drug: Iota-Carrageenan
Participants will received a nasal spray with Iota-Carrageenan or placebo 4 times a day during 21 days
Other Name: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Control
    Participants in this arm will receive a nasal spray with placebo
    Intervention: Drug: Iota-Carrageenan
  • Experimental: Experimental
    Participants in this arm will receive a nasal spray with Iota-Carrageenan
    Intervention: Drug: Iota-Carrageenan
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 19, 2020)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04521322
Other Study ID Numbers  ICMJE CEMIC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ariel Dogliotti, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ariel Dogliotti
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Investigators  ICMJE
Study Director: Juan Figueroa, MD Instituto Milstein-CONICET
PRS Account Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP