RECOVERY SAP Version date: 09 June 2020 Version number: 1.0
RECOVERY SAP v1.0 09_06_20.DOCX Page 13 of 20
Main randomisation (part A and B)
Age at randomisation
Sex
Ethnicity
Time since COVID-19 symptoms onset
Time since hospitalisation
Current respiratory support requirement
Currently requiring renal dialysis or haemofiltration
Comorbidities (diabetes, heart disease, chronic lung disease, tuberculosis, human
immunodeficiency virus, severe liver disease, severe kidney impairment)
If female, known to be pregnant
Second randomisation
In addition to the above:
Type of ventilation support currently required (none, CPAP alone, non-invasive
ventilation, high-flow nasal oxygen, mechanical ventilation, ECMO)
Latest oxygen saturation measurement (%)
Latest CRP measurement (mg/L)
Latest ferritin measurement (ng/mL)
Latest creatinine measurement (µmol/L)
Allocation in first randomisation
Interval between first and second randomisation
The number and percentage will be presented for binary and categorical variables. The mean
and standard deviation or the median and the interquartile range will be presented for
continuous variables, or the range if appropriate. There will be no tests of statistical
significance performed nor confidence intervals calculated for differences between
randomised groups on any baseline variable.
4.3 Completeness of follow-up
All reasonable efforts will be taken to minimise loss to follow-up, which is expected to be
minimal as data collection for primary and secondary outcomes using trial-specific eCRFs is
combined with linkage to routine clinical data on study outcomes from NHS Digital, ICNARC,
and similar organisations in the devolved nations.
The number and percentage of participants with follow-up information at day 28 and at 6
months after the main randomisation will be reported. Data will be shown for each of the
following: all-cause mortality, hospital discharge status, ventilation status, and will be shown
for each randomised group for the main and second randomisation separately.
4.4 Adherence to treatment
The number and proportion of patients who did not receive the treatment they were
allocated to will be reported. If any other trial treatment options were known to be received,
instead of or in addition to, the allocated treatment during the 28 day follow-up period after