Inhaled nebulised unfractionated heparin (UFH) for the treatment of
hospitalised patients with COVID-19: A randomised controlled pilot
study.
Abstract
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).