Matheus Bertanha, Lenize da Silva Rodrigues, Pedro Luciano Mellucci Filho, Andrei Moroz, Maria Inês de Moura Campos Pardini, Marcone Lima Sobreira, Edison Luiz Durigon, Rafael Rahal Guaragna Machado, Rejane Maria Tommasini Grotto, Marcelo Andrade de Lima, Helena Bonciani Nader, Marli Leite de Moraes, Alexandre Naime Barbosa, Natália Bronzatto Medolago, Fábio Florença Cardoso, Angelo José Magro, Cristiane Rodrigues Guzzo Carvalho, Leonardo Nazário de Moraes, Rita de Cássia Alvarado, Helga Caputo Nunes, Gustavo Constantino de Campos, Vinicius Tadeu Ramos da Silva Grillo, Nathalia Dias Sertorio, Carlos Magno Castelo Branco Fortaleza, Universidade Estadual Paulista (UNESP), Universidade de São Paulo (USP), Keele University, Cellavita Scientific Research, and Universidade Estadual de Campinas (UNICAMP)
Made available in DSpace on 2022-04-29T08:38:17Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-12-23 Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) 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. Department of Surgery and Orthopedics São Paulo State University – UNESP Botucatu Medical School, SP Applied Biotechnology Laboratory Research Nucleus of Clinical Hospital São Paulo State University – UNESP Botucatu Medical School, SP Department of Bioprocess and Biotechnology São Paulo State University – UNESP School of Pharmaceutical Sciences, SP Internal Medicine Division São Paulo State University – UNESP Botucatu Medical School, SP Department of Microbiology Institute of Biomedical Sciences University of São Paulo – USP, SP Scientific Platform Pasteur University of São Paulo – USP, SP Bioprocessing and Biotechnology Department São Paulo State University – UNESP School of Agriculture, SP Molecular & Structural Biosciences School of Life Sciences Keele University, Newcastle-Under-Lyme Department of Biochemistry Federal University of São Paulo – UNIFESP, SP Institute of Science and Technology Federal University of São Paulo – UNIFESP, SP Department of Infectious Diseases São Paulo State University – UNESP Botucatu Medical School, SP Clinical Research Unit São Paulo State University – UNESP Botucatu Medical School, SP Biosciences Institute São Paulo State University UNESP, SP Quality Control Laboratory Cellavita Scientific Research, SP Department of Orthopedics and Traumatology University of Campinas – UNICAMP School of Medical Sciences, SP Department of Surgery and Orthopedics São Paulo State University – UNESP Botucatu Medical School, SP Applied Biotechnology Laboratory Research Nucleus of Clinical Hospital São Paulo State University – UNESP Botucatu Medical School, SP Department of Bioprocess and Biotechnology São Paulo State University – UNESP School of Pharmaceutical Sciences, SP Internal Medicine Division São Paulo State University – UNESP Botucatu Medical School, SP Bioprocessing and Biotechnology Department São Paulo State University – UNESP School of Agriculture, SP Department of Infectious Diseases São Paulo State University – UNESP Botucatu Medical School, SP Clinical Research Unit São Paulo State University – UNESP Botucatu Medical School, SP Biosciences Institute São Paulo State University UNESP, SP FAPESP: 2020/12165-8