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Therapeutic versus prophylactic anticoagulation for severe COVID-19: A randomized phase II clinical trial (HESACOVID)

Open access
Lemos, Anna Cristina Bertoldi, do Espírito Santo, Douglas Alexandre, Salvetti, Maísa Cabetti, Gilio, Renato Noffs, Agra, Lucas Barbosa, Pazin-Filho, Antonio, Miranda, Carlos Henrique·2020·Thrombosis Research

Abstract

Introduction Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state. Several autopsy studies have found microthrombi in pulmonary circulation. Methods In this randomized, open-label, phase II study, we randomized COVID-19 patients requiring mechanical ventilation to receive either therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis. We evaluated the gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, 7, and 14 days after randomization, the time until successful liberation from mechanical ventilation, and the ventilator-free days. Results Ten patients were assigned to the therapeutic enoxaparin and ten patients to prophylactic anticoagulation. There was a statistically significant increase in the PaO2/FiO2 ratio over time in the therapeutic group (163 [95% confidence interval – CI 133–193] at baseline, 209 [95% CI 171–247] after 7 days, and 261 [95% CI 230–293] after 14 days), p = 0.0004. In contrast, we did not observe this improvement over time in the prophylactic group (184 [95% CI 146–222] at baseline, 168 [95% CI 142–195] after 7 days, and 195 [95% CI 128–262] after 14 days), p = 0.487. Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035–15.053]), p = 0.031 and more ventilator-free days (15 days [interquartile range IQR 6–16] versus 0 days [IQR 0–11]), p = 0.028 when compared to the prophylactic group. Conclusion Therapeutic enoxaparin improves gas exchange and decreases the need for mechanical ventilation in severe COVID–19. Trial registration REBEC RBR-949z6v.

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Metadata

Authors
Lemos, A. C. B., do Espírito Santo, D. A., Salvetti, M. C., Gilio, R. N., Agra, L. B., Pazin-Filho, A., & Miranda, C. H.
Venue
Thrombosis Research
Publisher
Elsevier BV
Published
2020-12
Volume
196
Pages
359-366
ISSN
0049-3848 (ISSN-L)
OpenAlex
W3087656790
Cited by
269
References
24
FWCI
7.09
Type
journal article
Language
en
Open access
bronze

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Lemos, A. C. B., do Espírito Santo, D. A., Salvetti, M. C., Gilio, R. N., Agra, L. B., Pazin-Filho, A., & Miranda, C. H. (2020). Therapeutic versus prophylactic anticoagulation for severe COVID-19: A randomized phase II clinical trial (HESACOVID). Thrombosis Research. https://doi.org/10.1016/j.thromres.2020.09.026

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