Efficacy and safety of azvudine in symptomatic adult COVID-19 participants who are at increased risk of progressing to critical illness: a study protocol for a multicentre randomized double-blind placebo-controlled phase III trial

Table 3 Schedule of screening, intervention and follow-up of the trial

Study periods	Screening	Treatment periods						Follow-up periods
Time line	Screening	d1	d3 + / − 1	d4 to d6^a	d7 + / − 1	d8 to d13^a	d14 + / − 2	D28^a + / − 3	3 M^a + / − 7	6 M^a + / − 7
Consent form	X
Check with inclusion and exclusion criteria	X
Demographic characteristics	X
Symptoms	X	X	X	X	X	X	X	X	X	X
Vital sign	X	X	X		X		X
Adverse event		X	X	X	X	X	X
Viral load		X	X		X		X
Chest image (DXR or CT)		X			X		X	X
Pregnancy test	X						X
Blood routine	X	X	X		X		X
Ferritin		X
Interleukin-6		X
Hypersensitive C-reactive protein		X	X		X		X
Blood biochemical test	X	X	X		X		X
Coagulation		X			X
Oxygen level	X
Cardiac troponin and N-terminal pro-brain natriuretic peptide		X			X
Concomitant medication		X

ISSN: 1745-6215