| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "Eligible and consenting patients were assigned in a ratio of 2:1 to either usual standard of care or to usual standard of care plus dexamethasone 6 mg once daily (oral or intravenous) for up to 10 days (or until discharge if sooner) or to one of the other suitable and available treatment arms (see Supplementary Appendix) using web- based simple randomization". Comment: The allocation sequence was concealed. |
| Deviations from intervention |
Low |
Comment: Unblinded study.
In the intervention arm, 1975/2079 received dexamethasone. In the control arm, 336/4278 received dexamethasone. Deviation too small to affect the outcome. Administration of co-interventions of interest, antivirals and biologics were reported and balanced between arms. Data were analyzed using intention-to-treat analysis |
| Missing outcome data |
Low |
Comment: 6425 randomized, 6425 analyzed.
Risk assessed to be low for the outcomes: Mortality. Incidence of clinical improvement. WHO score 7 and above. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study (outcome assessor).
Mortality is an observer-reported outcome not involving judgement. For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: Mortality. WHO score 7 and above. Clinical improvement (defined as discharge) requires clinical judgement and could be affected by knowledge of intervention receipt which can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic. Risk assessed to be some concerns for outcome: Incidence of clinical improvement. |
| Selection of the reported results |
Low |
Comment: the protocol and statistical analysis plan were available.
Risk assessed to be low for the outcomes: Mortality. Incidence of clinical improvement. WHO score 7 and above. |
| Overall risk of bias |
Some concerns |