The randomized COVI-PRONE clinical trial demonstrated no difference in the risk of endotracheal intubation requirement at 30 days between awake prone positioning and standard positioning for patients with COVID-19 who suffered from acute hypoxemic respiratory failure. The trial results of COVI-PRONE were presented by Prof. Waleed Alhazzani (McMaster University, Canada) and simultaneously published in JAMA [1,2]. The rationale for this trial lies in previous studies suggesting that the prone position reduces the risk of mortality in COVID-19 patients undergoing invasive mechanical ventilation for acute respiratory distress, but it is not known whether awake prone positioning can prevent intubation or improve survival. “It is also not entirely known if awake prone positioning can actually cause harm due to delayed intubation,” said Prof. Alhazzani. The COVI-PRONE study (NCT04350723) sought to determine the efficacy and adverse events of awake prone positioning in adults with hypoxemic respiratory failure from COVID-19. It was a randomized, unblinded, parallel-group stratified clinical trial aiming to examine whether awake prone positioning in COVID-19 patients with hypoxemic respiratory failure reduced the risk of endotracheal requirement and mortality. This study was conducted at 21 hospitals and included adults who required at least 40% oxygen or non-invasive positive pressure ventilation and had not received invasive mechanical ventilation. Participants (n=400) were randomized to either the intervention group (n=205; prone position 8–10 hours per day) or the control group (n=195; no prone positioning). The primary outcome was endotracheal intubation within 30 days of randomization. Baseline characteristics between the groups were similar in the use of pharmacological agents, such as steroids, anti-virals, anti-coagulants, or immunomodulators. The results showed that the risk of endotracheal intubation did not significantly differ between groups at 30 days, with the prone group at 34.1% compared with the control group at 40.5% (HR 0.81; 95% 0.59–1.12; not significant). Similarly, the risk of mortality at 60 days was similar between groups (HR 0.93; 95% CI 0.62–1.40; not significant). No serious adverse events occurred in both groups, though the prone positioning group reported more overall adverse events (26 vs 0), mainly consisting of pain or discomfort attributable to the prone position. The authors concluded that this trial provided robust evidence that awake prone positioning did not decrease the risk of endotracheal intubation or mortality in patients with acute hypoxemic respiratory failure due to COVID-19.
- Alhazzani W, et al. COVI-PRONE trial. Session A84, ATS International Conference 2022, San Francisco, CA, USA, 13–18 May.
- Alhazzani W, et al. JAMA. 2022 May 15. doi: 10.1001/jama.2022.7993.
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