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Nebulized enriched heparin improves respiratory parameters in patients with COVID-19: a phase I/II randomized and triple-blind clinical trial.
Ramos da Silva Grillo, Vinicius Tadeu; Bertanha, Matheus; da Silva Rodrigues, Lenize; de Lima, Marcelo Andrade; Mellucci Filho, Pedro Luciano; Rahal Guaragna Machado, Rafael; Durigon, Edson Luiz; Dias Sertorio, Nathália; de Assis Golim, Marjorie; Moroz, Andrei; Marques Braz, Aline Márcia; de Moraes, Leonardo Nazário; Leite, Marco Antonio; Bonciani Nader, Helena; de Campos, Gustavo Constantino; Rodrigues Guzzo Carvalho, Cristiane; Florença Cardoso, Fábio; Magro, Angelo José; Caputo Nunes, Helga; Tommasini Grotto, Rejane Maria; de Cássia Alvarado, Rita; de Moura Campos Pardini, Maria Inês; Lima Sobreira, Marcone; da Costa, Erika Alessandra Pellison Nunes; Naime Barbosa, Alexandre; Fortaleza, Carlos Magno Castelo Branco.
Afiliação
  • Ramos da Silva Grillo VT; Department of Surgery and Orthopedics, Botucatu Medical School, São Paulo State University - UNESP, Clinical Hospital, Professor Montenegro Avenue, Botucatu, SP, 18618687, Brazil.
  • Bertanha M; Department of Surgery and Orthopedics, Botucatu Medical School, São Paulo State University - UNESP, Clinical Hospital, Professor Montenegro Avenue, Botucatu, SP, 18618687, Brazil. matheusbertanha@gmail.com.
  • da Silva Rodrigues L; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil. matheusbertanha@gmail.com.
  • de Lima MA; Department of Surgery and Orthopedics, Botucatu Medical School, São Paulo State University - UNESP, Clinical Hospital, Professor Montenegro Avenue, Botucatu, SP, 18618687, Brazil.
  • Mellucci Filho PL; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil.
  • Rahal Guaragna Machado R; Centre for Glycoscience, School of Life Sciences, Keele University, Newcastle-Under-Lyme, Staffordshire, UK.
  • Durigon EL; Department of Surgery and Orthopedics, Botucatu Medical School, São Paulo State University - UNESP, Clinical Hospital, Professor Montenegro Avenue, Botucatu, SP, 18618687, Brazil.
  • Dias Sertorio N; Department of Microbiology, Institute of Biomedical Sciences, University of Sao Paulo, - USP, São Paulo, Brazil.
  • de Assis Golim M; Department of Microbiology, Institute of Biomedical Sciences, University of Sao Paulo, - USP, São Paulo, Brazil.
  • Moroz A; Scientific Platform Pasteur USP (SPPU), University of São Paulo, São Paulo, Brazil.
  • Marques Braz AM; Department of Surgery and Orthopedics, Botucatu Medical School, São Paulo State University - UNESP, Clinical Hospital, Professor Montenegro Avenue, Botucatu, SP, 18618687, Brazil.
  • de Moraes LN; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil.
  • Leite MA; Department of Bioprocess and Biotechnology, School of Pharmaceutical Sciences, São Paulo State University - UNESP, Araraquara, SP, Brazil.
  • Bonciani Nader H; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil.
  • de Campos GC; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil.
  • Rodrigues Guzzo Carvalho C; Clinical Hospital of the Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil.
  • Florença Cardoso F; Department of Biochemistry, Federal University of São Paulo - UNIFESP, São Paulo, SP, Brazil.
  • Magro AJ; Department of Orthopedics and Traumatology, School of Medical Sciences, University of Campinas - UNICAMP, Campinas, SP, Brazil.
  • Caputo Nunes H; Department of Microbiology, Institute of Biomedical Sciences, University of Sao Paulo, - USP, São Paulo, Brazil.
  • Tommasini Grotto RM; Department of Biophysics and Pharmacology, Institute of Biosciences, São Paulo State University - UNESP, Botucatu, SP, Brazil.
  • de Cássia Alvarado R; Department of Biophysics and Pharmacology, Institute of Biosciences, São Paulo State University - UNESP, Botucatu, SP, Brazil.
  • de Moura Campos Pardini MI; Teaching and Research Center of the Albert Einstein Hospital, São Paulo, SP, Brazil.
  • Lima Sobreira M; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil.
  • da Costa EAPN; Bioprocessing and Biotechnology Department, School of Agriculture, São Paulo State University - UNESP, Botucatu, SP, Brazil.
  • Naime Barbosa A; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil.
  • Fortaleza CMCB; Internal Medicine Division, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil.
Sci Rep ; 14(1): 19902, 2024 08 27.
Article em En | MEDLINE | ID: mdl-39191809
ABSTRACT
To evaluate the safety and the potential antiviral treatment of inhaled enriched heparin in patients with COVID-19. The specific objectives were to investigate the anticoagulation profile, antiviral and anti-inflammatory effects, and respiratory evolution of inhaled enriched heparin. We conducted a randomized, triple-blind, placebo-controlled Phase I/II clinical trial in hospitalized adults with COVID-19 receiving inhalation of enriched heparin or saline (placebo) every 4 h for 7 days. Among the 27 patients who completed the study, no changes in blood coagulation parameters were observed, indicating the safety of inhaled enriched heparin. The group receiving enriched heparin showed a significant reduction in the need for supplemental oxygen and improvement in respiratory parameters, such as the PaO2/FiO2 ratio. Inhalation of enriched heparin is shown to be safe and has also demonstrated potential therapeutic benefits for patients with COVID-19. These promising results justify the continuation of the study to the next phase, Phase II/III, to further evaluate the therapeutic efficacy of inhaled enriched heparin in the treatment of COVID-19-associated viral pneumonia.Trial registration ClinicalTrials.gov. 08/02/2021. Identifier NCT04743011.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Heparina / COVID-19 / Tratamento Farmacológico da COVID-19 / Anticoagulantes Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Sci Rep Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Heparina / COVID-19 / Tratamento Farmacológico da COVID-19 / Anticoagulantes Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Sci Rep Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido