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 |
Low |
Quote: “non-stratified 1:1 allocation ratio. A
third-party person not involved in the conduction of the
protocol was responsible for the randomization of patients
using sequentially numbered containers. The same person
was responsible for filling and labeling the pill containers
either with colchicine or placebo.”
Comment: Allocation sequence random Allocation sequence concealed |
| Deviations from intervention |
Low |
Quote: “triple-blinded: the patients and their treating physicians, and the statistician in charge of the statistical analysis were blinded for the treatment arm throughout the whole study”
Comment: Blinded study (participants and personnel/carers) Our analysis for the outcomes is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 116 participants randomized; 116 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). Time to WHO score 7 and above. 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 the outcomes: Mortality (D28). Time to death. Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The registry (dated April 29, 2020) and protocol were available.
MORTALITY. ADVERSE EVENTS. OutcomeS pre-specified in the protocol. 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). Time to death. Adverse events. TIME TO DEATH. (TIME TO) CLINICAL IMPROVEMENT. WHO SCORE 7 AND ABOVE. SERIOUS ADVERSE EVENTS. Outcome data acquired from direct contact with authors. Analysis performed by the COVID-NMA. Risk assessed to be low for the outcomes: Time to death. Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above. Serious adverse events. TIME TO SCORE 7 AND ABOVE. Outcome not pre-specified in the protocol/registry. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Time to WHO score 7 and above. |
| Overall risk of bias |
Some concerns |