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: "Eligible patients were randomly assigned (1:1) to either the control group or the colchicine group. The randomization sequence was prepared by a statistician not involved in the trial using R software version 3.6.2 (R Project for Statistical Computing), and the corresponding assignment was provided to site coordinators electronically on each patient enrollment."
Comment: Allocation sequence random. Allocation sequence concealed.
|Deviations from intervention||
|Comment: Unblinded study.
Deviations from intended intervention arising because of the study context:
No participant cross-over.
No information on administration of co-intervention of interest: corticosteroids. Antivirals and biologics were reported.
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). WHO score 7 and above (D28). Serious adverse events.
|Missing outcome data||
|Comment: 110 patients randomized; 105 patients analyzed.
Data available for all or nearly all participants.
Risk assessed to be low for the outcomes: Mortality (D28). WHO score 7 and above (D28). Serious adverse events
|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 the intervention assignment.
Risk assessed to be low for outcomes: Mortality (D28). WHO score 7 and above (D28).
Serious adverse events may contain both clinically- and laboratory-detected events. All these outcomes 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 outcomes: Serious adverse events.
|Selection of the reported results||
|Comment: the protocol and statistical analysis plan were available.
Results were not selected from multiple outcome measurements or analyses of the data.
Trial analyzed as pre-specified.
Risk assessed to be low for the outcomes: Mortality (D28). WHO score 7 and above (D28). Serious adverse events.
|Overall risk of bias||