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Table 1 Timeline of events in the trial

From: Evaluation of the efficacy and safety of icatibant and C1 esterase/kallikrein inhibitor in severe COVID-19: study protocol for a three-armed randomized controlled trial

 

Enrollment

Allocation

Post-allocation

Discharge

Close-out

Time point

− 1

0

D1–D4

D5–D7

D8–D14

D15–D28

  

Enrollment

 Screening

x

       

 Eligibility criteria

x

       

 Informed consent

x

       

 Allocation

 

x

      

 Randomization

 

x

      

 Baseline data collection

 

x

      

Interventions

 Icatibant/std care

  

x

     

 C1 inhib./std care

  

x

     

 Std care

x

x

x

x

x

x

x

 

Outcome/safety assessments

 CT of the chest

x

   

X (D14)

X (D28)

X

 

 Primary outcome

  

x

x

x

x

x

 

 Clinical symptoms

 

x

x

x

x

x

x

 

 Vital signs

x

x

x

x

x

x

x

x

 ECG

   

x

    

 Adverse events

x

x

x

x

x

x

x

x

 Time mechanical ventilation

       

x

 Death

       

x

 Length of stay

       

x

Laboratory tests*

Only every 4 days or at the discretion of the assistant physician

RT-PCR SARS-CoV-2

x

       

 Bradykinin

 

x

x

   

x

 

 SOFA score

 

x

x

x

x

x

x

 

 Blood routine

 

x

x

x

x

x

x

 

 Coagulation routine

 

x

x

x

x

x

x

 

 CRP

 

x

x

x

x

x

x

 

 Liver function

 

x

x

x

x

x

x

 

 Kidney function

 

x

x

x

x

x

x

 

d-dimer

 

x

x

x

x

x

x

 

 High-sensitivity troponin

 

x

x

x

x

x

x

 

 Pro-BNP

 

x

x

x

x

x

x

 

 Aspergillus antigen

 

x

x

x

x

x