Efficacy and safety of fondaparinux versus unfractionated heparin in patients hospitalised with severe COVID-19 pneumonia and coagulopathy: a randomised, open-label clinical trial
Abstract
Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): Syarifah Ambami Rato Ebu General Hospital, Bangkalan, East Java, Indonesia Background The use of unfractionated heparin (UFH) has been renowned to reduce mortality in COVID-19. There are no data about the efficacy and safety of fondaparinux (FPX) in COVID-19. Purpose To evaluate the efficacy and safety of FPX as compared to UFH in patients hospitalised with severe COVID-19 and coagulopathy. Methods This was a single-center, open-label, equally randomised, parallel-group study conducted between April 1st and July 15th, 2021. Eligible and consenting patients were randomly assigned (1:1 ratio) to receive either FPX or UFH, in prophylactic and therapeutic dose. The primary efficacy endpoint was 28-day all-cause mortality; and secondary efficacy endpoints were episode of acute myocardial infarction (MI), objectively confirmed venous (VTE) or arterial thromboembolism (ATE), progression to non-invasive ventilation (NIV) or invasive mechanical ventilation (IMV), progression to ARDS, sepsis, acute kidney injury (AKI) and acute lung oedema (ALO). The primary safety endpoint was major bleeding (MB); and secondary safety endpoint was clinically relevant non-major bleeding (CRNMB). All composite endpoints were analysed on a 28-day intention-to-treat basis. All patients received guideline-driven therapy throughout the study. Results During allocated period, 250 (71%) of 352 patients were…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 352 participants or records.
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