Table 1.

Data collection and conduct of the trial

Variables/visits	Daily data until ICU discharge or 90 days (whichever occurs first)	Specific measures at days 1 and 7	Last study visit (90-day and 180-day data)
Vital status	X		X
Location (ICU/date of discharge), hospital ward/date of discharge, rehabilitation centre, long-term facility, home/date of discharge			X
Protocol adherence (receipt of every IMP dose until treatment completion)	X		X
Cointerventions (mechanical ventilation, renal replacement therapy, vasopressors, unblinded corticosteroids, thiamine, vitamin C, other vitamins, nutrition, intravenous fluids, blood products, anticoagulants, sedatives, stress ulcer prophylaxis and antimicrobials)	X		X
Core temperature (daily lowest and highest value)	X		X
Vital signs (lowest and highest values for heart rate, systolic and diastolic blood pressure)	X		X
Central haemodynamic data	X
Standard laboratory data (serum and urinary electrolytes, creatinine, urea, cholesterol, triglycerides and glucose levels, arterial lactate levels, arterial oxygen tension and haemoglobin oxygen saturation, arterial pH, white cell counts, haemoglobin and haematocrit levels, INR, platelet count, total bilirubin level)	X
Microbiological or virological samples		X
Other sampling left at the physicians’ discretion	X
Whole blood samples for measurements of biomarkers		X
Glasgow Coma Scale cognitive function			X
Muscular Disability Rating Scale score			X
Health-related quality of life (EQ-5D-5L)27			X
PROMIS (fatigue 13a, ability to participate in social roles and activities 8a, physical function 8b, emotional distress-depression 8b, emotional distress-anxiety 8a, cognitive function 8a)			X

ICU, intensive care unit; IMP, investigational medicinal product; INR, international normalised ratio.