Table 1

Data collected from baseline to follow-up visits


Study period
EnrolmentAllocationInterventionPostintervention
D-1D0D1D2D3D4D5D6Discharge30 days after discharge
Enrolment
 Consent form
 Basic information
 Inclusion and exclusion criteria
 Allocation
Intervention:
 XJXBCQ+budesonide (All)+WST 
 XJXBCQ+budesonide (half) +WST 
 XJXBCQ placebo +budesonide (All)+WST 
Outcome measure
 Clinical symptoms score
 TCM syndrome score
 Blood gas analysis (PH, PaO2, PaCO2
 Serum inflammatory markers (PCT, CRP, IL-6, TNF-α)
 Induced sputum and stool sample
Safety assessments:
 Adverse events recorded
 Physical examination
 Blood and urine routine
 Liver function (AST, ALT, Tbil, ALP, GGT)
 Kidney function (Scr, BUN, eGFR)
 ECG
  • ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; CRP, C reactive protein; eGFR, estimated glomerular filtration rate; GGT, Gamma glutamyl transferase; IL-6, interleukin-6; Paco2, alveolar carbon dioxide tension (or pressure); Pao2, arterial oxygen tension (or pressure); Scr, serum creatinine; Tbil, total bilirubin; TCM, traditional Chinese medicine; TNF-α, tumour necrosis factor-α; WST, western standard therapy.