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May 2, 2022, 3:30 p.m. eu

Compare plitidepsin 1.5 or 2.5 mg versus control on the percentage of patients who achieve complete recovery by Day 8 (±1), defined as (i) meeting categories 0 to 2 on the 11-point WHO Clinical Progression Scale below, (ii) having Barthel Index >90/100 at the time of discharge, and (iii) with no re-admission for COVID-19 signs and symptoms through Day 31. 0. uninfected, no viral RNA detected 1. asymptomatic, viral RNA detected 2. symptomatic, independent 3. symptomatic, assistance needed 4. hospitalised, no oxygen therapy (if hospitalised for isolation only, record status as for ambulatory patient) 5. hospitalised, oxygen by mask or nasal prongs 6. hospitalised, oxygen by NIV or high flow 7. intubation and mechanical ventilation. pO2/FIO2 ≥150 or SpO2/FIO2 ≥200 8. mechanical ventilation pO2/FIO2 <150 (SpO2/FIO2 <200) or vasopressors 9. mechanical ventilation pO2/FIO2 <150 and vasopressors, dialysis, or ECMO 10. dead

Compare plitidepsin 1.5 or 2.5 mg versus control on the percentage of patients who achieve complete recovery by Day 8 (±1), defined as (i) meeting categories 0 to 2 on the 11-point WHO Clinical Progression Scale below, (ii) having Barthel Index >90/100 at the time of discharge, and (iii) with no re-admission for COVID-19 signs and symptoms through Day 31. 0. uninfected, no viral RNA detected 1. asymptomatic, viral RNA detected 2. symptomatic, independent 3. symptomatic, assistance needed 4. hospitalised, no oxygen therapy (if hospitalised for isolation only, record status as for ambulatory patient) 5. hospitalised, oxygen by mask or nasal prongs 6. hospitalised, oxygen by NIV or high flow 7. intubation and mechanical ventilation. pO2/FIO2 ≥150 or SpO2/FIO2 ≥200 8. mechanical ventilation pO2/FIO2 <150 (SpO2/FIO2 <200) or vasopressors 9. mechanical ventilation pO2/FIO2 <150 and vasopressors, dialysis, or ECMO 10. dead