INTRODUCTION/HYPOTHESIS: Awake prone positioning (APP) has been increasingly used in patients with acute respiratory failure due to COVID-19; however, most data supporting this therapy are observational/retrospective. The aim of this trial was to compare the outcomes in COVID-19 patients managed with APP versus standard care (SC).METHODS: Randomized controlled superiority trial, which included patients with COVID-19 and requirement of oxygen through high-flow nasal cannula (HFNC). Patients were randomized to remain in APP as long as possible or SC while HFNC therapy was needed. The primary outcome was intubation rate; treatment failure, defined as intubation or death without intubation, and mortality were secondary, with a follow-up to 28 days. Baseline characteristics, physiological response to APP, factors associated to failure, and adverse events were also analyzed. RESULTS:We enrolled 216 patients to APP and 214 to SC. Baseline characteristics were similar. Intubation rate was 30% in APP and 43% in SC patients (RR 0.70; 95% CI 0.54-0.90, p=0.006); mortality was 33% and 37%, respectively (RR 0.89; 95% CI 0.69-1.15, p=0.37). At multivariate analysis, the factors associated to an increased risk of failure were respiratory rate at enrollment (p=< 0.001), SpO 2 /FiO 2 at enrollment (p=< 0.001), absence of silent hypoxemia (p=0.01), lung ultrasound score at enrollment (p=< 0.001) and D-dimer at hospital admission (p=< 0.001). Mean daily duration of APP was 9.4 h (5.6-12.9), with a median of 6 days (3.7-9.0). At ROC curve analysis, the best predictors of treatment failure were a daily duration of APP < 7.7h (AUROC 0.96, p=< 0.001), respiratory rate at enrollment ≥25 bpm (AUROC 0.93, p=< 0.001), D-dimer >1.4 mg/dL (AUROC 0.82, p=< 0.001), and a decrease in respiratory rate < 3 bpm after the first session of APP (AUROC 0.79, p=< 0.001). The most common adverse events were back pain in 16 (7.4%) patients and intravascular lines dislodgement in 14 (6.5%). CONCLUSIONS:We found APP is associated with a reduced risk of intubation, with no difference in mortality. As a safe and effective procedure, we suggest APP should be encouraged to all COVID-19 patients requiring oxygen support with HFNC, aiming for the longest daily duration as possible, with closer monitoring of patients with predictive factors of failure.

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