on-inferiority, prospective, phase III, single-center, open, randomized, parallel-group clinical study comparing Carrageenan nasal spray and 0.9% sodium chloride nasal saline in a continuous stream in the prevention of COVID-19

Herbarium Laboratório Botânico0 个研究点开始时间: 2021年7月27日最近更新: 2023年5月29日

试验速览

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•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.

•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).

发起方

Herbarium Laboratório Botânico