Nebulized enriched heparin improves respiratory parameters in patients with COVID-19: a phase I/II randomized and triple-blind clinical trial.

Autor: 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.; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil. matheusbertanha@gmail.com., da Silva Rodrigues L; Department of Surgery and Orthopedics, Botucatu Medical School, São Paulo State University - UNESP, Clinical Hospital, Professor Montenegro Avenue, Botucatu, SP, 18618687, Brazil.; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil., de Lima MA; Centre for Glycoscience, School of Life Sciences, Keele University, Newcastle-Under-Lyme, Staffordshire, UK., Mellucci Filho PL; Department of Surgery and Orthopedics, Botucatu Medical School, São Paulo State University - UNESP, Clinical Hospital, Professor Montenegro Avenue, Botucatu, SP, 18618687, Brazil., Rahal Guaragna Machado R; Department of Microbiology, Institute of Biomedical Sciences, University of Sao Paulo, - USP, São Paulo, Brazil., Durigon EL; Department of Microbiology, Institute of Biomedical Sciences, University of Sao Paulo, - USP, São Paulo, Brazil.; Scientific Platform Pasteur USP (SPPU), University of São Paulo, São Paulo, Brazil., Dias Sertorio N; Department of Surgery and Orthopedics, Botucatu Medical School, São Paulo State University - UNESP, Clinical Hospital, Professor Montenegro Avenue, Botucatu, SP, 18618687, Brazil., de Assis Golim M; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil., Moroz A; Department of Bioprocess and Biotechnology, School of Pharmaceutical Sciences, São Paulo State University - UNESP, Araraquara, SP, Brazil., Marques Braz AM; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, 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; Clinical Hospital of the Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil., Bonciani Nader H; Department of Biochemistry, Federal University of São Paulo - UNIFESP, São Paulo, SP, Brazil., de Campos GC; Department of Orthopedics and Traumatology, School of Medical Sciences, University of Campinas - UNICAMP, Campinas, SP, Brazil., Rodrigues Guzzo Carvalho C; Department of Microbiology, Institute of Biomedical Sciences, University of Sao Paulo, - USP, São Paulo, Brazil., Florença Cardoso F; Department of Biophysics and Pharmacology, Institute of Biosciences, São Paulo State University - UNESP, Botucatu, SP, Brazil., Magro AJ; Department of Biophysics and Pharmacology, Institute of Biosciences, São Paulo State University - UNESP, Botucatu, SP, Brazil., Caputo Nunes H; Teaching and Research Center of the Albert Einstein Hospital, São Paulo, SP, Brazil., Tommasini Grotto RM; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil.; Bioprocessing and Biotechnology Department, School of Agriculture, São Paulo State University - UNESP, Botucatu, SP, Brazil., de Cássia Alvarado R; Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil., de Moura Campos Pardini MI; Internal Medicine Division, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil., Lima Sobreira M; Department of Surgery and Orthopedics, Botucatu Medical School, São Paulo State University - UNESP, Clinical Hospital, Professor Montenegro Avenue, Botucatu, SP, 18618687, Brazil., da Costa EAPN; Department of Infectious Diseases, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil., Naime Barbosa A; Department of Infectious Diseases, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil., Fortaleza CMCB; Department of Infectious Diseases, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, SP, Brazil.
Jazyk: angličtina
Zdroj: Scientific reports [Sci Rep] 2024 Aug 27; Vol. 14 (1), pp. 19902. Date of Electronic Publication: 2024 Aug 27.
DOI: 10.1038/s41598-024-70064-8
Abstrakt: 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 PaO 2 /FiO 2 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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