Objectives We evaluated the efficacy and acceptability of awake-prone positioning (APP) in a randomised controlled trial, using a dedicated APP implementation team and wearable continuous-monitoring devices to monitor position and oximetry.

Methods The trial was performed at a tertiary level hospital in Ho Chi Minh City, Vietnam, recruiting adults (≥18 years) hospitalised with moderate or severe COVID-19 and receiving supplemental oxygen therapy via nasal/facemask systems or high-flow nasal canulae. Participants were randomized (1:1) to standard care or APP. The primary outcome was escalation of respiratory support within 28 days of randomisation.

Results Ninety-three patients were enrolled between March 2022 and March 2023; 80 (86%) had received ≥2 doses of SARS-CoV2 vaccine. Significantly greater mean daily APP times were achieved in those allocated to APP, although most did not achieve the target 8 hours/day. We did not detect significant differences in the primary outcome (RR 0.85, 95% CI 0.40-1.78, p=0.67) or secondary outcomes, including intubation rate and 28-day mortality. Particpants reported prone positioning was comfortable, although almost all preferred supine positioning. No adverse events associated with the intervention were reported.

Conclusions APP was not associated with benefit, but was safe. Continuous monitoring with wearable devices was feasible and acceptable to patients.

Clinical Trials Registration NCT05083130

Funding Wellcome Trust Grant 089276/B/09/7, 217650/Z/19/Z and FDCO/Wellcome Trust 225437/Z/22/Z

The authors have declared no competing interest.

NCT05083130

https://wellcomeopenresearch.org/articles/8-235

The study was funded by the Wellcome Trust

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Ethics Committee of the Hospital for Tropical Diseases, Ho Chi Minh City and Oxford Tropical Research Ethics Committee approved this work.

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All data produced in the present study are available upon reasonable request to the authors