NCT04521322

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for phase_4 covid19

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 19, 2020

Last Update Submit

August 19, 2020

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • diagnose of COVID19 disease

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

    28 days

Secondary Outcomes (3)

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

    28 days

  • lasting of disease

    28 days

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

    1 week after finishing treatment

Study Arms (2)

Control

PLACEBO COMPARATOR

Participants in this arm will receive a nasal spray with placebo

Drug: Iota-Carrageenan

Experimental

EXPERIMENTAL

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

Drug: Iota-Carrageenan

Interventions

Iota-CarrageenanDRUG

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

Also known as: Placebo
ControlExperimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

centro de educación médica e investigaciones clinicas (CEMIC)

Buenos Aires, Buenos Aires F.D., 1425, Argentina

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34629893DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Carrageenan

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PolysaccharidesCarbohydrates

Study Officials

  • Juan Figueroa, MD

    Instituto Milstein-CONICET

    STUDY DIRECTOR

Central Study Contacts

Mónica Lombardo, MD

CONTACT

005491141763599mlombardo@nobeltri.com

Ricardo Valentini, MD

CONTACT

005491162036790deptomedicina2@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Multicenter, randomized, double blind compared vs placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PHYSICIAN

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 20, 2020

Study Start

July 24, 2020

Primary Completion

October 30, 2020

Study Completion

November 30, 2020

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations

AR(1)