Covid19
Conditions
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.
Interventions
DRUGIota-Carrageenan
Participants will received a nasal spray with Iota-Carrageenan or placebo 4 times a day during 21 days
Sponsors
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Ariel Dogliotti
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Multicenter, randomized, double blind compared vs placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnose of COVID19 disease | 28 days | COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression to a more severe disease state, defined as need for oxygen therapy. | 28 days | number of subjects who develop severe COVID19 disease |
| lasting of disease | 28 days | number of days with clinical symptoms |
| Incidence of COVID-19 disease onset in the first week after treatment | 1 week after finishing treatment | number of subjects who develop the disease within one week after finishing treatment |
Countries
Argentina
Contacts
Primary ContactMónica Lombardo, MD
Backup ContactRicardo Valentini, MD
Outcome results
None listed