Table 1.

Timeline, data collection and outcomes of the study

Time points		Day 0	Daily from randomisation to ICU discharge				Day 90
			Day 1–7	Day 14	Day 21	Day 28
Eligibility screen		X
Informed consent		X or as soon as feasible
Allocation		X
Treatment:	Group 1	From day 0 to vasoactive drug discontinuation or day 7
	Group 2	From day 0 to day 3
Baseline characteristicsA		X
Physiological and process of care outcomesB1			X
Physiological and process of care outcomesB2			X	X	X	X
Primary outcome						X
Secondary outcomesC			X				X
			X			X

(A) Baseline characteristics: Demographic data (sex, date of birth), medical, medication and surgical history.

(B1) Physiological and process of care outcomes: Vital signs: mean arterial pressure, heart rate, respiratory rate, diuresis and systemic body temperature and fluid balance will be recorded daily from inclusion until ICU discharge (censored day 28), new blood, respiratory and urinary tract infections will be recorded from randomisation to day 28, viral reactivation measured by CMV DNA titres will be recorded from randomisation to day 28, need for renal replacement therapy: from randomisation to 28 days, IgM titres recovery/stabilisation: measured at day 28.

(B2) Physiological and process of care outcomes: Routine laboratory test parameters for organ function assessment: haemoglobin, platelet count, white blood cell count, troponin, coagulative parameters (INR, PT, aPTT), parameters for liver (AST, ALT, bilirubin) and renal function (creatinine) will be recorded daily from inclusion to day 7 and then at day 14, 21, 28, blood cell count, C-reactive protein and procalcitonin will be recorded daily from inclusion to day 7 and then at day 14, 21 and 28, ventilation mode (spontaneous breathing or mechanical ventilation), inspired oxygen fraction and arterial blood gas analysis parameters will be recorded daily from inclusion today 7 and then at day 14, 21 and 28.

(C) Secondary outcomes: 90-day survival; measured at day 90, occurrence of new organ dysfunction and grade of dysfunction: measured with SOFA score daily from randomisation to day 28 or ICU discharge, ICU free hours at 28 days; measured at day 28, hospital free days at 28 days; measured at day 28, ventilation free days at day 28; measured at day 28, vasopressor free days during the ICU stay; measured at day 28, antibiotic free days at day 28; measured at day 28, ICU acquired weakness; measured at 7, 28 and 90 days.

aPTT, activated partial thromboplastin time; AST, aspartate transaminase; CMV, cytomegalovirus; ICU, intensive care unit; INR, international ratio; PT, prothrombin time.