Table 2

Schedule of assessments

Visit name	Screening	Randomisation	Treatment period (treatment until hospital discharge or progression to WHO score 6 or above)																			Final day of treatment	Safety follow-up
Day	Day −2 or −1	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 16	Day 17	Day 18	Day 19	Day 20	Day 21 (or day of discharge/progression)	Day 28 (or 7 days after completion of treatment)
Obtain written informed consent	+
Demographic data	+
Medical history	+
Inclusion/exclusion criteria	+
Urine pregnancy test (females)	+																					+
Physical examination	+
Vital signs	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+
12-Lead ECG	+
Clinical chemistry and haematology	+	+							+							+						+
Urinalysis	+
hs-Troponin and NT-proBNP samples	+																					+
SARS-CoV-2 PCR test	+
Patient WHO clinical status record	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+
Concomitant/treatment record	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+
Diabetic medication review	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+
Randomisation		+
Study drug/placebo administration		+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+
HbA1c sample		+
25-Hydroxyvitamin D		+
Immunophenotyping blood sample		+							+			+										+
Immunochemistry blood sample		+							+			+										+
PK sample			+		+				+
Clotting factor sample		+							+
Adverse events review		+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+