Efficacy of inhaled nebulised unfractionated heparin to prevent intubation or death in hospitalised patients with COVID-19: an investigator-initiated international meta-trial of randomised clinical studies

Background Inhaled nebulised unfractionated heparin (UFH) has a strong rationale as a treatment for severe respiratory infections, including COVID-19, due to its antiviral, anti-inflammatory, and anti-coagulant properties, which may prevent viral entry, lung injury progression, and pulmonary thrombo...

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Detalles Bibliográficos
Autores: Van Haren, FMP, Valle, SJ, Neto, AS, Schultz, MJ, Laffey, JG, Artigas, A, Dixon, B, Vilaseca, AB, Barbera, RA, Ismail, TI, Mahrous, RS, Badr, M, Denucci, G, Sverdloff, C, Camprubi-Rimblas, M, Cosgrave, DW, McNicholas, B, Cody, C, Curley, G, Smoot, TL, Staas, S, Sann, K, Sas, C, Belani, A, Hillman, C, Manggala, SK, Aditianingsih, D, Sugiarto, A, Yulianti, M, Herikurniawan, H, Sinto, R, Auerkari, AN, Permana, SA, Woodcock, A, Carroll, M, Wilkinson, T, Singh, D, Shute, JK, Page, C
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repositorio:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p6682
Acceso en línea:https://i3pt.portalinvestigacion.com/publicaciones/6682
https://www.scopus.com/inward/record.uri?eid=2-s2.0-105020474704&doi=10.1016%2Fj.eclinm.2025.103339&partnerID=40&md5=8978ae7c346aa79bedb0d8a74b4ba953
Access Level:acceso abierto
Palabra clave:COVID-19
ARDS
Inhaled heparin
Nebulised heparin
Unfractionated heparin
SARS-CoV-2
Respiratory failure
Pandemic
Randomised trial
Meta-trial
Intubation
Mortality
Descripción
Sumario:Background Inhaled nebulised unfractionated heparin (UFH) has a strong rationale as a treatment for severe respiratory infections, including COVID-19, due to its antiviral, anti-inflammatory, and anti-coagulant properties, which may prevent viral entry, lung injury progression, and pulmonary thrombosis. We aimed to evaluate the efficacy of inhaled nebulised UFH to prevent intubation or death in hospitalised COVID-19 patients. Methods In this prospective, a priori set up and defined, collaborative meta-trial of six randomised clinical studies, adult hospitalised but not intubated COVID-19 patients were randomly assigned to inhaled nebulised UFH on top of standard of care or standard of care alone. The dose and method of nebulisation was specific to each study. The primary outcome was intubation or death, assessed at the longest follow-up after randomisation. The meta-trial was registered at ClinicalTrials.gov ID NCT04635241. Findings Between June 2020 and December 2022, 478 patients from 10 hospitals in six countries (Argentina, Brazil, Egypt, Indonesia, Ireland and USA) were enrolled. The odds ratio (OR) for intubation or death was 0.43 (0.26-0.73, p = 0.001); the OR for in-hospital mortality was 0.26 (0.13-0.54, p < 0.001) with inhaled nebulised UFH compared to standard of care alone. There were no safety issues reported, including no instances of pulmonary or systemic bleeding in the nebulised UFH group. Interpretation In patients hospitalised but not intubated for COVID-19, inhaled nebulised UFH prevented intubation and reduced mortality, without causing pulmonary or systemic bleeding.

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