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Table 1 Schedule of the assessments for each patient during the study

From: A multicenter randomized trial to assess the efficacy of CONvalescent plasma therapy in patients with Invasive COVID-19 and acute respiratory failure treated with mechanical ventilation: the CONFIDENT trial protocol

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
  1. aHemoglobin, Hematocrit, Platelet count, White blood cells count, Neutrophil, Lymphocyte, PaO2, FiO2, Na, K, urea, creatinine, protein, bilirubin, ferritin, CRP, D-dimers, fibrinogen, LDH, TGO, TGP, CPK
  2. bCreatinine, platelet count, bilirubin, CRP, WBC count, Ferritin, Lymphocyte count