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In this small phase II study of therapeutic-dose enoxaparin versus routine venous thromboembolism prophylaxis, patients with severe COVID-19 infection requiring mechanical ventilation in the intervention arm were found to have a statistically significant increase in the PaO2/FiO2 ratio over 14 days (163 to 261; P < .01) as compared with the control arm (184 at baseline,168 after 7 days, and 195 after 14 days; P = .48).
Although bolstered by its randomization and prospective nature, the study is limited by its small sample size (N = 20) such that larger, multicenter trials are warranted to assess for an impact on mortality as well as safety outcomes.
– Emmett A. Kistler, MD
This abstract is available on the publisher's site.
Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state. Several autopsy studies have found microthrombi in pulmonary circulation.
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.
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.
Therapeutic enoxaparin improves gas exchange and decreases the need for mechanical ventilation in severe COVID-19.