ABSTRACT
Background Prone positioning (PP) is routinely used among patients with COVID-19 requiring mechanical ventilation. However, its utility among spontaneously breathing patients is still debated. Methods In an open-label randomized controlled trial, we enrolled patients hospitalized with mild COVID-19 pneumonia, whose PaO2/FiO2 ratio was >200 mmHg and who did not require mechanical ventilation (MV) or non-invasive ventilation (NIV) at hospital admission. Patients were randomized 1:1 to PP on top of standard of care (intervention group) versus standard of care only (controls). The primary composite outcome included death, MV, NIV and PaO2/FiO2 <200 mmHg; secondary outcomes were oxygen weaning and hospital discharge. Results Sixty-one subjects were enrolled, 29 adjudicated to PP and 32 to the control group. By day 28, 11 patients required NIV, 4 MV and 3 died. Overall, 24/61 (39.3%) met the primary outcome. Using an intention-to-treat approach, 15/29 patients in PP group versus 9/32 controls met the primary outcome, corresponding to a significantly higher risk of progression among those randomized to PP (HR 2.38 95%CI 1.04-5.43; P=0.040). Using an as-treated approach, which included in the intervention group only patients who maintained PP for [≥]3 hours/day, no significant differences were found between the two groups (HR 1.77; 95%CI 0.79-3.94; P=0.165). Also, we did not find any statistically difference in terms of time to oxygen weaning or hospital discharge between study arms, in any of the analyses conducted. Conclusions We observed no clinical benefit from awake PP among spontaneously breathing patients with COVID-19 pneumonia requiring conventional oxygen therapy.