Clinical trial NCT04521322: 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: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Covid19
Lead sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Sponsor class: OTHER
Collaborators: name: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
First posted: 2020-08-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, double blind compared vs placebo
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: diagnose of COVID19 disease
timeFrame: 28 days
Secondary outcomes:
measure: Progression to a more severe disease state, defined as need for oxygen therapy.
timeFrame: 28 days
measure: lasting of disease
timeFrame: 28 days
measure: Incidence of COVID-19 disease onset in the first week after treatment
timeFrame: 1 week after finishing treatment
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: centro de educación médica e investigaciones clinicas (CEMIC)
state: Capital Federal
Study officials:
affiliation: Instituto Milstein-CONICET
name: Juan Figueroa, MD
role: STUDY_DIRECTOR
References:
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.