tetano
Editor, Senior Moderator
Sci Rep
. 2024 Aug 27;14(1):19902.
doi: 10.1038/s41598-024-70064-8. Nebulized enriched heparin improves respiratory parameters in patients with COVID-19: a phase I/II randomized and triple-blind clinical trial
Vinicius Tadeu Ramos da Silva Grillo[SUP] 1 [/SUP], Matheus Bertanha[SUP] 2 3 [/SUP], Lenize da Silva Rodrigues[SUP] 1 4 [/SUP], Marcelo Andrade de Lima[SUP] 5 [/SUP], Pedro Luciano Mellucci Filho[SUP] 1 [/SUP], Rafael Rahal Guaragna Machado[SUP] 6 [/SUP], Edson Luiz Durigon[SUP] 6 7 [/SUP], Nathália Dias Sertorio[SUP] 1 [/SUP], Marjorie de Assis Golim[SUP] 4 [/SUP], Andrei Moroz[SUP] 8 [/SUP], Aline Márcia Marques Braz[SUP] 4 [/SUP], Leonardo Nazário de Moraes[SUP] 4 [/SUP], Marco Antonio Leite[SUP] 9 [/SUP], Helena Bonciani Nader[SUP] 10 [/SUP], Gustavo Constantino de Campos[SUP] 11 [/SUP], Cristiane Rodrigues Guzzo Carvalho[SUP] 6 [/SUP], Fábio Florença Cardoso[SUP] 12 [/SUP], Angelo José Magro[SUP] 12 [/SUP], Helga Caputo Nunes[SUP] 13 [/SUP], Rejane Maria Tommasini Grotto[SUP] 4 14 [/SUP], Rita de Cássia Alvarado[SUP] 4 [/SUP], Maria Inês de Moura Campos Pardini[SUP] 15 [/SUP], Marcone Lima Sobreira[SUP] 1 [/SUP], Erika Alessandra Pellison Nunes da Costa[SUP] 16 [/SUP], Alexandre Naime Barbosa[SUP] 16 [/SUP], Carlos Magno Castelo Branco Fortaleza[SUP] 16 [/SUP]
Affiliations
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[SUB]2[/SUB]/FiO[SUB]2[/SUB] 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.
Keywords: COVID-19; Enriched heparin; SARS-CoV-2; Safety; Treatment.
. 2024 Aug 27;14(1):19902.
doi: 10.1038/s41598-024-70064-8. Nebulized enriched heparin improves respiratory parameters in patients with COVID-19: a phase I/II randomized and triple-blind clinical trial
Vinicius Tadeu Ramos da Silva Grillo[SUP] 1 [/SUP], Matheus Bertanha[SUP] 2 3 [/SUP], Lenize da Silva Rodrigues[SUP] 1 4 [/SUP], Marcelo Andrade de Lima[SUP] 5 [/SUP], Pedro Luciano Mellucci Filho[SUP] 1 [/SUP], Rafael Rahal Guaragna Machado[SUP] 6 [/SUP], Edson Luiz Durigon[SUP] 6 7 [/SUP], Nathália Dias Sertorio[SUP] 1 [/SUP], Marjorie de Assis Golim[SUP] 4 [/SUP], Andrei Moroz[SUP] 8 [/SUP], Aline Márcia Marques Braz[SUP] 4 [/SUP], Leonardo Nazário de Moraes[SUP] 4 [/SUP], Marco Antonio Leite[SUP] 9 [/SUP], Helena Bonciani Nader[SUP] 10 [/SUP], Gustavo Constantino de Campos[SUP] 11 [/SUP], Cristiane Rodrigues Guzzo Carvalho[SUP] 6 [/SUP], Fábio Florença Cardoso[SUP] 12 [/SUP], Angelo José Magro[SUP] 12 [/SUP], Helga Caputo Nunes[SUP] 13 [/SUP], Rejane Maria Tommasini Grotto[SUP] 4 14 [/SUP], Rita de Cássia Alvarado[SUP] 4 [/SUP], Maria Inês de Moura Campos Pardini[SUP] 15 [/SUP], Marcone Lima Sobreira[SUP] 1 [/SUP], Erika Alessandra Pellison Nunes da Costa[SUP] 16 [/SUP], Alexandre Naime Barbosa[SUP] 16 [/SUP], Carlos Magno Castelo Branco Fortaleza[SUP] 16 [/SUP]
Affiliations
- PMID: 39191809
- DOI: 10.1038/s41598-024-70064-8
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[SUB]2[/SUB]/FiO[SUB]2[/SUB] 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.
Keywords: COVID-19; Enriched heparin; SARS-CoV-2; Safety; Treatment.