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

• Main Author: Ramos da Silva Grillo, Vinicius Tadeu [UNESP]
• Publication Date: 2024
• Other Authors: Bertanha, Matheus [UNESP], da Silva Rodrigues, Lenize [UNESP], de Lima, Marcelo Andrade, Mellucci Filho, Pedro Luciano [UNESP], Rahal Guaragna Machado, Rafael, Durigon, Edson Luiz, Dias Sertorio, Nathália [UNESP], de Assis Golim, Marjorie [UNESP], Moroz, Andrei [UNESP], Marques Braz, Aline Márcia [UNESP], de Moraes, Leonardo Nazário [UNESP], Leite, Marco Antonio [UNESP], Bonciani Nader, Helena, de Campos, Gustavo Constantino, Rodrigues Guzzo Carvalho, Cristiane, Florença Cardoso, Fábio [UNESP], Magro, Angelo José [UNESP], Caputo Nunes, Helga, Tommasini Grotto, Rejane Maria [UNESP], de Cássia Alvarado, Rita [UNESP], de Moura Campos Pardini, Maria Inês [UNESP], Lima Sobreira, Marcone [UNESP], da Costa, Erika Alessandra Pellison Nunes [UNESP], Naime Barbosa, Alexandre [UNESP], Fortaleza, Carlos Magno Castelo Branco [UNESP]
• Format: Article
• Language: eng
• Source: Repositório Institucional da UNESP
• Download full: http://dx.doi.org/10.1038/s41598-024-70064-8; https://hdl.handle.net/11449/302870
• topic: COVID-19; Enriched heparin; Safety; SARS-CoV-2; Treatment

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.