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)

Ariel Dogliotti

Status and phase: Unknown; Phase 4

Conditions: Covid19

Treatments: Drug: Iota-Carrageenan

Study type: Interventional

Funder types: Other

Identifiers

NCT04521322

CEMIC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

400 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Participants in this arm will receive a nasal spray with placebo

Treatment:

Drug: Iota-Carrageenan

Experimental

Experimental group

Description:

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

Treatment:

Drug: Iota-Carrageenan