Table 1

Assessment schedule

Screening and enrolmentTreatment and follow-up
Visit 1Visit 2Visit 3Visit 4
TimeBaseline24±2 hours after randomisation6±1 days after randomisation90±7 days after randomisation
Informed consent×
Inclusion/exclusion criteria×
Demographics×
Medical history×
SARS-CoV-2 infection×××
Physical examination×××
Swallowing function evaluation××
NIHSS×××
mRS××
EQ-5D×
Reperfusion therapy evaluation×
hs-CRP××
Routine laboratory test×*׆
Venous blood sample‡×××
Cerebral haemodynamic function (single-centre)×××
Outcome eventק××
ECG×
Primary diagnosis×
Final diagnosis×
Randomisation×
Compliance××
Drug dispense/retrieve×××
AE/SAE×××
Concomitant medication××××

  • *Routine blood counts, liver function, renal function, coagulation function and pregnancy test (for women of childbearing age) must be completed during screening.

  • †Results of routine blood counts, biochemical panels (including liver function, renal function, blood lipids, creatine kinase), glycosylated haemoglobin, homocysteine and coagulation function test should be recorded if completed in clinical.

  • ‡Venous blood samples will be collected, followed by the separation, packaging and freezing of plasma for storage.

  • §The assessment of outcome events at 24±2 hours and 6±1 days after randomisation included early neurological deterioration, stroke (ischaemic stroke and haemorrhagic stroke), myocardial infarction, death, symptomatic intracranial haemorrhage, any bleeding event, antibiotics-associated diarrhoea, enteritis and constipation.

  • ¶The assessment of outcome events at 90±7 days after randomisation included stroke (ischaemic and haemorrhagic strokes), myocardial infarction, death and any bleeding event.

  • AE, adverse event; EQ-5D, EuroQol-5 Dimension; hs-CRP, high-sensitivity C-reactive protein; mRS, modified Rankin Scale; NIHSS, National Institute of Health Stroke Scale; SAE, serious adverse event.