COVID-19
Conditions
Interventions
Experimental Product Group: 88 participants will use the Nasal Carrageenan Spray. Instructions for use: one application per nostril, three times a day, for 6 consecutive days
Control Product Group: 8
D09.698.152
D26.776.314.890
Sponsors
Herbarium Laboratório Botânico
Herbarium Laboratório Botânico
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Healthy men and women aged between 18 and 60 years; be asymptomatic and present oximetry > 94%, at rest; being a contact and living in the same household as a patient with positive clinical and laboratory diagnosis for coronavirus (SARS-CoV-2), with up to 7 days of clinical manifestations, seen in the emergency department of Hospital Mater Dei; no signs and symptoms of coronavirus-related illnesses (SARS-CoV-2), influenza, or cold in the past 6 months; agree with the study procedures and sign the consent form.
Exclusion criteria
Exclusion criteria: Participants with a history of positive diagnosis for coronavirus (SARS-CoV-2) in the last 6 months; participants already immunized with any type of vaccine for the coronavirus (SARS-CoV-2), even if they received only the first dose; diagnosis of poorly controlled rhinitis or respiratory allergy and/or in crisis, whether acute or chronic; chronic lung diseases in the process of aggravation or in crisis; chronic or obstructive clinical manifestations of the nose: septal deviation, nasal polyposis, chronic sinusitis; recurrent sinusitis (> 3 episodes) in the last 6 months; treatment with antibiotics, systemic or inhaled steroids in the last 4 weeks; breastfeeding and/or pregnancy; coagulation disorders; known or suspected hypersensitivity to the formula of the products under study; severe or decompensated cardiovascular disease, decompensated diabetes mellitus, kidney or liver dysfunction, malignancy or suspected malignancy; any other criteria or clinical history that could compromise the participant's well-being or interfere with the research results, in the researcher's opinion (example: chronic diseases).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| do not clinical present manifestations associated with COVID-19 or laboratory diagnostic confirmation for coronaviruses (SARS-CoV-2), during the 6-day follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| do not present nasal manifestations and assess safety and tolerability products under study through reports of adverse events from research participants. | — |
Countries
Brazil
Contacts
Public ContactCleverson Luiz Vigo
Outcome results
None listed