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

Study Overview
=================
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.

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)

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Drug: Iota-Carrageenan


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, randomized, double blind compared vs placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Participants in this arm will receive a nasal spray with placebo | Drug: Iota-Carrageenan<br>* Participants will received a nasal spray with Iota-Carrageenan or placebo 4 times a day during 21 days<br>* Other names: Placebo;|
| Experimental: Experimental<br>Participants in this arm will receive a nasal spray with Iota-Carrageenan | Drug: Iota-Carrageenan<br>* Participants will received a nasal spray with Iota-Carrageenan or placebo 4 times a day during 21 days<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnose of COVID19 disease | COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression to a more severe disease state, defined as need for oxygen therapy. | number of subjects who develop severe COVID19 disease | 28 days | 
| lasting of disease | number of days with clinical symptoms | 28 days | 
| Incidence of COVID-19 disease onset in the first week after treatment | number of subjects who develop the disease within one week after finishing treatment | 1 week after finishing treatment |