Table 2

Schedule of assessments

Visit nameScreeningRandomisationTreatment period
(treatment until hospital discharge or progression to WHO score 6 or above)
Final day of treatmentSafety follow-up
DayDay −2 or −1Day 1Day 2Day 3Day 4Day 5Day 6Day 7Day 8Day 9Day 10Day 11Day 12Day 13Day 14Day 15Day 16Day 17Day 18Day 19Day 20Day 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+++++
hs-Troponin and NT-proBNP samples++
SARS-CoV-2 PCR test+
Patient WHO clinical status record++++++++++++++++++++++
Concomitant/treatment record+++++++++++++++++++++++
Diabetic medication review++++++++++++++++++++++
Study drug/placebo administration+++++++++++++++++++++
HbA1c sample+
25-Hydroxyvitamin D+
Immunophenotyping blood sample++++
Immunochemistry blood sample++++
PK sample+++
Clotting factor sample++
Adverse events review++++++++++++++++++++++
  • NT-proBNP, N-terminal pro B-type natriuretic peptide; PK, pharmacokinetics.