Outcomes
death
SECONDARY
The primary outcome was the proportion of treatment failures defined by a composite endpoint consisting of the need for NIV (at two pressure levels) or intubation or death within 28 days of enrolment.The following secondary outcomes were compared between groups: the rate of endotracheal intubation at 28 days; the rate of NIV at 28 days; the rate of a two-point decrease in the clinical World Health Organization (WHO) ordinal scale (change in patient hospitalisation status using a seven-point ordinal severity: 1—not hospitalised, capable of resuming normal activities, 2—not hospitalised but unable to resume normal activities, 3—hospitalised, no oxygen therapy, 4—hospitalised and requiring oxygen therapy, 5—hospitalised and requiring NIV or nasal high-flow oxygen, 6—hospitalised and requiring mechanical ventilation, 7—hospitalised and requiring mechanical ventilation with other organ support (vasopressors, renal replacement therapy, extracorporeal life support), and 8—dead. An improvement is a decrease in the clinical WHO scale, and a clinical worsening is defined as an increase in the clinical WHO scale) [