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 |
| Randomization |
Some concerns |
Quote: "The randomization was performed 1:1 for placebo or colchicine by using the online
tool at https://www.randomizer.org/." Comment: Allocation sequence random. No information about concealment of the allo-cation sequence. |
| Deviations from intervention |
Low |
Comment: Blinded study (participants and personnel/carers).
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 low for outcomes: Mortality (D28). Clinical improvement (D28). Adverse events. |
| Missing outcome data |
Some concerns |
Comment: 38 patients randomized, 35 patients analyzed.
Following contact with authors, 2 patients who discontinued due to ICU admission were discharged after 23 and 26 days (outcome known). Safety event unknown in these 2 patients. Data now available for all or nearly all participants for mortality, clinical improvement and WHO score 7 and above outcomes. Risk assessed to be low for outcomes: Mortality (D28). Clinical improvement (D28). Adverse events |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for outcomes: Mortality (D28). Clinical improvement (D28). Adverse events. |
| Selection of the reported results |
Some concerns |
Comment: No protocol and statistical analysis plan were available. The trial registry was available but very retrospective.
No information on whether the results for mortality was selected from multiple outcome measurements or analyses of the data. no information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28). Clinical improvement (D28). Adverse events. |
| Overall risk of bias |
Some concerns |