Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centro de Educación Medica e Investigaciones ClÃnicas Norberto Quirno | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Participants in this arm will receive a nasal spray with placebo |
|
| Experimental | Experimental | Participants in this arm will receive a nasal spray with Iota-Carrageenan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iota-Carrageenan | Drug | Participants will received a nasal spray with Iota-Carrageenan or placebo 4 times a day during 21 days |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mónica Lombardo, MD | Contact | 005491141763599 | mlombardo@nobeltri.com | |
| Ricardo Valentini, MD | Contact | 005491162036790 | deptomedicina2@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Juan Figueroa, MD | Instituto Milstein-CONICET | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| centro de educación médica e investigaciones clinicas (CEMIC) | Recruiting | Buenos Aires | Buenos Aires F.D. | 1425 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34629893 | Derived | 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. |
Not provided
Not provided
Not provided
Multicenter, randomized, double blind compared vs placebo
Not provided
Not provided
Not provided
| 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 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002351 | Carrageenan |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided