Table 1 Schedule of assessments and procedures

Inclusion and exclusion criteria

X

Informed consent

X

Randomization (between day 0 and day 1)

X

Demographic data and comorbidities

X

Clinical data

X

X

X

Laboratory data (as appropriate)

X

X

X

Eosinophilic polynuclear cell count in blood (before 1st dose of protocol treatment) if data available

X

Radiological data (within 24 h)

X

Microbiological data (within 48 h)

X

SAPS II

X

SOFA (if data available)

X

Days 3, 7, 14, 21

X

RASS (if invasive mechanical ventilation)

X

X

X

Mechanical ventilation

X

X

X

NIV (duration/day, IP, PEEP, FiO₂)

X

X

X

Invasive MV (mode, IP or RR × tidal volume, PEEP, FiO₂)

X

X

X

Sedative drugs

X

X

X

Neuromuscular blockers

X

X

X

Catecholamine infusion

X

X

X

Adverse event potentially related to corticosteroids and/or changing study drug

X

X

Serious adverse event^b

X

X

X^b

X^c

ICU length of stay

X

X

X

Hospital length of stay

X

X

X

Number of new exacerbation(s)/hospitalization(s) since hospital discharge

X

Dyspnoea, comfort (patient-reported outcome)

X

X

X

Vital status

X

X

X