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. 2020 Dec 2;10(12):e040580. doi: 10.1136/bmjopen-2020-040580

Table 2.

Primary and secondary outcomes

Key primary outcome Key secondary outcomes
Mean change in the highest level of oxygenation (oxygen flow measured litre/min) in non-ventilated patients
Mean change in lowest PaO2 in ventilated patients
Mortality (ICU or in-hospital)
Duration of mechanical ventilation
Duration of oxygen therapy
Duration of hospitalisation
Length of stay in ICU
Other secondary outcomes
Adverse drug events
Acute kidney injury
Acute liver injury
Duration of vasopressor drugs
Sequential organ failure assessment respiratory score
Clinical improvement based on an eight-point ordinal scale recommended in the document published by WHO R&D Blueprint ‘Novel Coronavirus COVID-19 Therapeutic Trial Synopsis’.
  • Percentage of patients reporting each severity rating on an eight-point ordinal scale (time frame: day 14)

  • Time to improvement in one category from admission using the eight-point ordinal scale (time frame: up to day 28)

  • Mean change in the eight-point ordinal scale (time frame: up to day 28)

ICU, intensive care unit.