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Table 2 Scheduled protocol activities

From: A parallel-group, multicenter randomized, double-blinded, placebo-controlled, phase 2/3, clinical trial to test the efficacy of pyridostigmine bromide at low doses to reduce mortality or invasive mechanical ventilation in adults with severe SARS-CoV-2 infection: the Pyridostigmine In Severe COvid-19 (PISCO) trial protocol

  Baseline Day 3 Day 5 Day 7 Day 14 Day 28
Eligibility preliminary assessment X      
Eligibility confirmation X      
Informed consent & enrollment X      
Study medication supply X      
Adverse-effect assessmenta X X X X X  
Laboratory evaluationsa
• D-dimer X X X X X  
• Ferritin X X X X X  
• CPK X X X X X  
• Fibrinogen X X X X X  
• Creatinine X X X X X  
• Bilirubin X X X X X  
• CBC X X X X X  
• ABG X      
Storage of samples for posterior pooled analysisa
• IL-6 measurement X X X X X  
• Mass cytometry X X X X X  
Follow-up phone call       X
  1. aBlood sampling will be performed only while participants are hospitalized. Protocol does not require participants to return for further blood sampling after hospital discharge. Abbreviations: CBC Complete blood count, ABG Arterial blood gases, IL-6 Interleukin 6