Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
|Bias||Author's judgement||Support for judgement|
|Quote: “The selected patients were allocated to either the dexamethasone group
or the control group by block randomization. Ten blocks were generated
by the Online Randomizer website. Each block included five patients; of
these, two patients were assigned to the dexamethasone group and three
patients were assigned to the control group or vice versa.”
Comment: Allocation sequence random. No information on allocation concealment.
|Deviations from intervention||
|Quote: “Not blinded”
Comment: Unblinded study (participants and personnel/carers).
Deviations from intended intervention arising because of the study context:
No information on participant cross-over (no flow-chart).
No information on administration of co-interventions of interest: Biologics and corticosteroids. Antivirals were reported as being part of standard care, but it is not clear whether all patients received them.
Hence, no information on whether deviations arose because of the trial context.
Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention.
Risk assessed to be some concerns for outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28).
|Missing outcome data||
|Comment: 50 participants randomized; 50 participants analyzed.
Data available for all participants randomized.
Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28).
|Measurement of the outcome||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
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 (D28). WHO score 7 and above (D28).
Clinical improvement (defined as discharge from hospital) requires clinical judgement and could be affected by knowledge of intervention receipt.
Risk assessed to be some concerns for the outcome: Clinical improvement (D28).
|Selection of the reported results||
|Comment: The protocol and statistical analysis plan were not available. The trial registry was available but was retrospectively registered.
No information on whether the results were selected from multiple outcome measurements or analyses of the data.
No information on whether trial analyzed as pre-specified.
Risk assessed to be some concerns for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28).
|Overall risk of bias||