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Inhaled nebulised unfractionated heparin (UFH) for the treatment of hospitalised patients with COVID-19: A randomised controlled pilot study.
  • +9
  • Gilberto De Nucci,
  • Tom Wilkinson,
  • Carlos Sverdloff,
  • Tainah Babadopulos,
  • Ashley Woodcock,
  • Janis Shute,
  • Pedro Guazelli,
  • Federico Gerbasse,
  • Paulo AS Mourão,
  • Dave Singh,
  • Frank van Haren,
  • Clive Page
Gilberto De Nucci
University of Sao Paulo

Corresponding Author:[email protected]

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Tom Wilkinson
University of Southampton
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Carlos Sverdloff
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Tainah Babadopulos
University of Campinas
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Ashley Woodcock
The University of Manchester
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Janis Shute
University of Portsmouth
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Pedro Guazelli
Sao Roque Hospital
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Federico Gerbasse
Santa Casa de Sorocaba Hospital
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Paulo AS Mourão
Universidade Federal do Rio de Janeiro
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Dave Singh
University Of Manchester
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Frank van Haren
Australian National University
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Clive Page
Kings College London
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There is a strong scientific rationale to use nebulised unfractionated heparin (UFH) in COVID-19. This pilot study investigated whether nebulised UFH was safe and had any impact on mortality, length of hospitalisation and clinical progression, in the treatment of hospitalised patients with COVID-19. This parallel group, open label, randomised trial included adult patients with confirmed SARS-CoV-2 infection admitted hospital in Brazil. One hundred patients were planned to be randomised to either “standard of care” (SOC) or SOC plus nebulized UFH. The trial was stopped after randomisation of 75 patients due to falling COVID-19 hospitalisation rates. Significance tests were 1-sided test (10% significance level). The key analysis populations were intention to treat (ITT) and modified ITT (mITT) which excluded (from both arms) subjects admitted to ITU or who died within 24 hrs of randomisation. In the ITT population (n=75), mortality was numerically lower for nebulised UFH (6 out of 38 patients; 15.8%) versus SOC (10 out of 37 patients; 27.0%), but not statistically significant; odds ratio (OR) 0.51, p=0.24. In the mITT population, nebulised UFH reduced mortality (OR 0.2, p=0.035).