| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
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. Allocation sequence was concealed. |
| 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). WHO score 7 and above (D28). Adverse events. Serious 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). WHO score 7 and above (D28). Data not available for all or nearly all participants for adverse events and serious adverse events. No evidence that the result is not biased. Missingness could depend on the true value of the outcome but it is not considered likely to. Risk assessed to be some concerns for outcomes: Adverse events. Serious 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). WHO score 7 and above (D28). Adverse events. Serious 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 and adverse events were 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). Adverse events. Serious adverse events Clinical improvement and WHO score 7 and above outcomes were retrieved from contact with authors. Results were not selected from multiple outcome measurements or analyses of the data. Trial probably analyzed as pre-specified. Risk assessed to be low for outcomes: Clinical improvement (D28). WHO score 7 and above (D28). |
| Overall risk of bias |
Some concerns |