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Epub 2016 Jun 22

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As the primary efficacy outcomes, the following were compared between the two groups from baseline up to day 28 post-randomisation: (1) overall 28-day mortality, (2) clinical status on study day 28, using an 8-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020) 0 for uninfected, 1 for no limitation of activities (ambulatory), 2 for limitation of activities (ambulatory), 3 for hospitalised, no oxygen therapy (hospitalised mild disease), 4 for hospitalised, oxygen by mask or nasal prongs (hospitalised mild disease), 5 for hospitalised, noninvasive ventilation or high-flow oxygen (hospitalised severe disease), 6 for hospitalised, intubation and mechanical ventilation (hospitalised severe disease), 7 for hospitalised, ventilation plus additional organ support, pressors, renal replacement therapy, and ECMO (extracorporeal membrane oxygenation), and 8 = death, and proportion of patients who met recovery criteria which are defined with the WHO clinical status 1, 2, or 3

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