Clinical study comparing a nasal spray and a nasal saline solution in continuous jet in the prevention of the new coronavirus (COVID-19)

Phase 3

• Conditions: COVID-19

• Registration Number: RBR-6gjm5gr
• Lead Sponsor: Herbarium Laboratório Botânico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-27
• Study Completion: 2021-10-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Intervention
• Study Design: Not specified