Table 2.

CATALYST schedule of events

	Baseline	Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7	Day 8	Day 9	Day 10	Day 11	Day 12	Day 13	Day 14	Day 15 – Day 27 *	Day 28†
Eligibility assessment	x
Consent	x
Weight/ height (estimated; BSA calculation)	x
Demographics‡	x
Pregnancy test (females only)	x
Frailty Score, Comorbidity assessment	x
Review of medical history	x
Randomisation	x
WHO clinical progression scale	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Routine blood tests §	x	x	(x)	x	(x)	x	(x)	x	{x}	x	(x)	(x)	(x)	(X)	x
Research Samples¶ optional—see section 8		x		x						x**
National Early Warning Score-2	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
FiO2 levels, O2 saturations, respiratory rate††	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Body temperature, pulse rate	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Adverse event review								x							x		x
Concomitant medication review	x
IMP Administration See additional schedules in online supplemental appendix 6		x

Notes:If the patient is discharged from the hospital before their next scheduled visit, the participant should be provided with the WHO clinical improvement scale diary and the visits on days 7, 14 and 28 should take place by telephone (if it is not possible to see the patient). If the visit is via telephone please perform an adverse event review including asking about any hospitalisations and a WHO clinical improvement scale assessment.

On day 1, tests and interventions should be recorded predose (if randomised to interventional arms).

*Information to be collected at day 28 if patient discharged. A collection tool will be available.

†Information on serious adverse events will be collected until 28 days after the last IMP administration, which may be after this time point.

‡To include age, sex and smoking status (if known).

§Full blood count (WCC, platelets, lymphocytes, neutrophils, monocytes, eosinophils, haemoglobin), D-dimer, C reactive protein, ferritin, lactate dehydrogenase, liver function test (alanine aminotransferase or aspartate aminotransferase, bilirubin, alkaline phosphatase, albumin), urea and electrolytes (urea, creatinine, sodium and potassium) NB. On day of IMP administration, this should be taken pre (up to 24 hours earlier). (x)—not mandatory for usual care but if undertaken for clinical or safety reasons, data will be collected.

¶The sample substudy is only open at specific sites. Samples can be taken±24 hours of day 1. On day 3, samples can be taken up to 24 hours before and up to 48 hours after the visit. Day 9 samples can be taken up to 24 hours before and up to 48 hours after the visit or at discharge if earlier. Please note the samples should be taken before IMP administration on day 1 where possible.

**Or on day of discharge if earlier.

††O₂ and saturation levels will be recorded twice daily.

BSA, body surface area; FiO₂, fractional inspired oxygen concentration; IMP, Investigational Medicinal Product; NB, nota bene; O₂, oxygen; WCC, white cell count.