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

Table 2 Scheduled protocol activities

	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 assessment^a	X	X	X	X	X
Laboratory evaluations^a
• 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 analysis^a
• IL-6 measurement	X	X	X	X	X
• Mass cytometry	X	X	X	X	X
Follow-up phone call						X

^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

ISSN: 1471-2334