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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