Procedures | Visits | ||||||||
---|---|---|---|---|---|---|---|---|---|
Screening | Inclusion | Treatment phase | Follow-up | ||||||
Day 1 | Day 7 | Day 14 | Day 21 | Day 28 | ICU Discharge | Day 90 | Day 365 | ||
Informed consent | x | ||||||||
Eligibility assessment | x | x | |||||||
Randomisation | x | ||||||||
Medical history | x | ||||||||
Comorbidities | |||||||||
Prior medications | |||||||||
APACHE II score | x | ||||||||
SOFA score | x | x | x | x | x | ||||
WHO disease progression scale | x | x | x | ||||||
CRP | x | x | x | x | x | ||||
Viral load (NP or tracheal PCR) | |||||||||
Clinical frailty scale | x | ||||||||
Concomitant drugs against SARS-CoV-2 | x | x | x | x | x | x | |||
Biological findings | xa | xb | xb | x b | xb | ||||
24 h-diuresis | x | x | x | x | x | ||||
Serum sample for central analysis | x | x | x | x | |||||
Mechanical ventilation | x | x | x | x | x | ||||
Renal replacement therapy | x | x | x | x | x | ||||
Vasoactive drugs | x | x | x | x | x | ||||
ECMO | x | x | x | x | x | ||||
Nosocomial infections | x | x | x | x | x | ||||
Iatrogenic events | x | x | x | x | x | ||||
Adverse events & Serious adverse event | x | x | x | x | x | ||||
ADL scale | x | x | x | ||||||
Anxiety-depression scale | x | x | |||||||
EQ-5D-5L scale | x | x | x |