Table 1.

Study procedures, assessments and timing

Procedures	Screening Day −1	Enrolment/preintervention Day 0	Study intervention Days 1–5	Follow-up assessment Day 6	Follow-up assessment ICU discharge	Follow-up assessment Hospital discharge	Follow-up assessment 1 month post	Follow-up assessment 3 months post	Follow-up assessment 6 months post	Follow-up assessment 12 months post
Chart review for eligibility	X
Informed consent		X
Demographics		X
Medical history		X
Randomisation		X
Physical examination via chart review*			X	X	X	X
Vital signs			X	X	X	X
Biomarker assessment†		X		X
Laboratory assessment‡		X		X
Administer study intervention or control			X
Concomitant medication review		X ------------------------------------------------X
Questionnaires§							X	X	X	X
Adverse event review and evaluation		X ------------------------------------------------X
Complete case report forms (CRFs)	X ---------------------------------------------------------------------------------------------------------------------X

*COVID-19 symptom onset and positive test date, Glasgow Coma Scale score, respiratory support modality and settings.

†C-reactive protein, lactate dehydrogenase, D-dimer, interleukin-6.

‡Complete blood count with differential, complete metabolic panel, arterial blood gas.

§Patient-Reported Outcomes Measurement Information System (PROMIS): physical function, dyspnoea severity, anxiety, depression, sleep disturbance, post-traumatic stress disorder (PTSD) checklist.

ICU, intensive care unit.