Nebulized enriched heparin to treat no critical patients with Sars-Cov-2 Triple-blind clinical trial

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Bertanha, Matheus ^{[1, 2]} ; Rodrigues, Lenize da Silva ^[1] ; Mellucci Filho, Pedro Luciano ^[1] ; Moroz, Andrei ^[3] ; de Moura Campos Pardini, Maria Ines ^{[2, 4]} ; Sobreira, Marcone Lima ^[1] ; Durigon, Edison Luiz ^{[5, 6]} ; Guaragna Machado, Rafael Rahal ^[5] ; Tommasini Grotto, Rejane Maria ^{[2, 7]} ; de Lima, Marcelo Andrade ^[8] ; Nader, Helena Bonciani ^[9] ; de Moraes, Marli Leite ^[10] ; Barbosa, Alexandre Naime ^[11] ; Medolago, Natalia Bronzatto ^[12] ; Cardoso, Fabio Florenca ^[13] ; Magro, Angelo Jose ^[13] ; Guzzo Carvalho, Cristiane Rodrigues ^[5] ; de Moraes, Leonardo Nazario ^{[2, 7]} ; Alvarado, Rita de Cassia ^[2] ; Nunes, Helga Caputo ^[14] ; de Campos, Gustavo Constantino ^[15] ; Ramos da Silva Grillo, Vinicius Tadeu ^[1] ; Sertorio, Nathalia Dias ^[1] ; Castelo Branco Fortaleza, Carlos Magno ^[11]

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^[1] Sao Paulo State Univ, Botucatu Med Sch, Dept Surg & Orthoped, UNESP, Botucatu, SP - Brazil

^[2] Sao Paulo State Univ, Res Nucleus Clin Hosp, Botucatu Med Sch, Appl Biotechnol Lab, UNESP, Botucatu, SP - Brazil

^[3] Sao Paulo State Univ, Sch Pharmaceut Sci, Dept Bioproc & Biotechnol, UNESP, Araraquara, SP - Brazil

^[4] Sao Paulo State Univ, Botucatu Med Sch, Internal Med Div, UNESP, Botucatu, SP - Brazil

^[5] Univ Sao Paulo, Inst Biomed Sci, Dept Microbiol, Sao Paulo, SP - Brazil

^[6] Univ Sao Paulo, Sci Platform Pasteur, Sao Paulo, SP - Brazil

^[7] Sao Paulo State Univ, Sch Agr, Bioproc & Biotechnol Dept, UNESP, Botucatu, SP - Brazil

^[8] Kerala Univ, Sch Life Sci, Mol & Struct Biosci, Newcastle Under Lyme, Staffs - England

^[9] Fed Univ Sao Paulo UNIFESP, Dept Biochem, Sao Paulo, SP - Brazil

^[10] Fed Univ Sao Paulo UNIFESP, Inst Sci & Technol, Sao Jose Dos Campos, SP - Brazil

^[11] Sao Paulo State Univ, Botucatu Med Sch, Dept Infect Dis, UNESP, Botucatu, SP - Brazil

^[12] Sao Paulo State Univ, Botucatu Med Sch, Clin Res Unit, UNESP, Botucatu, SP - Brazil

^[13] Sao Paulo State Univ, Biosci Inst, UNESP, Botucatu, SP - Brazil

^[14] Cellavita Sci Res, Qual Control Lab, Valinhos, SP - Brazil

^[15] Univ Estadual Campinas, Sch Med Sci, Dept Orthoped & Traumatol, UNICAMP, Campinas, SP - Brazil

• Tipo de documento: Artigo Científico
• Fonte: MEDICINE; v. 100, n. 51 DEC 23 2021.
• Citações Web of Science: 0

Resumo

Background: Coronavirus disease 2019 (COVID-19) is a viral respiratory disease that spreads rapidly, reaching pandemic status, causing the collapse of numerous health systems, and a strong economic and social impact. The treatment so far has not been well established and there are several clinical trials testing known drugs that have antiviral activity, due to the urgency that the global situation imposes. Drugs with specific mechanisms of action can take years to be discovered, while vaccines may also take a long time to be widely distributed while new virus variants emerge. Thus, drug repositioning has been shown to be a good strategy for defining new therapeutic approaches. Studies of the effect of enriched heparin in the replication of severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) in vitro assays justify the advance for clinical tests. Methods and analysis: A phase I/II triple-blind parallel clinical trial will be conducted. Fifty participants with radiological diagnosis of grade IIA pneumonia will be selected, which will be allocated in 2 arms. Participants allocated in Group 1 (placebo) will receive nebulized 0.9% saline. Participants allocated in Group 2 (intervention) will receive nebulized enriched heparin (2.5 mg/mL 0.9% saline). Both groups will receive the respective solutions on a 4/4 hour basis, for 7 days. The main outcomes of interest will be safety (absence of serious adverse events) and efficacy (measured by the viral load). Protocols will be filled on a daily basis, ranging from day 0 (diagnosis) until day 8. (AU)

• Processo FAPESP: 20/12165-8 - Heparina de alto peso molecular por via inalatória para o tratamento de Sars-CoV-2
• Beneficiário: Carlos Magno Castelo Branco Fortaleza
• Modalidade de apoio: Auxílio à Pesquisa - Pesquisa em Políticas Públicas