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: “Research electronic data capture (REDCap; Vanderbilt University) online web-based forms hosted at the Population Health Research Institute in Hamilton, Canada, were used for the concealed sequential randomization process as well as collecting hospital stay, discharge from hospital, and 28-day follow-up data.14 Patients were assigned in a 1:1 ratio to receive usual care or usual care plus colchicine. Randomization was restricted with blocks of random sizes and stratified by mechanical ventilation status at baseline.”
Comment: Allocation sequence random Allocation sequence concealed Imbalances in baseline characteristics appear to be compatible with chance |
| Deviations from intervention |
Low |
Quote: “open-label”
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No participant cross-over for efficacy outcomes. For adverse events, those in the treatment arm who did not receive colchicine were analyzed in the usual care arm. Nevertheless, we considered the analysis to be probably appropriate to estimate the effect of assignment to intervention. Information on administration of co-interventions of interest: antivirals, corticosteroids and biologics were reported and balanced between groups. Hence, deviations did not arise because of the trial context. Our analysis for the binary outcome 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. WHO score 7 and above (D28). Time to WHO score 7 and above. Adverse events. |
| Missing outcome data |
Low |
Comment: 1279 participants randomized; 1279 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. WHO score 7 and above (D28). Time to WHO score 7 and above. Adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) MORTALITY, TIME TO DEATH Observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. (TIME TO) WHO SCORE 7 AND ABOVE For this outcome, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: WHO score 7 and above (D28). Time to WHO score 7 and above. ADVERSE EVENTS The authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected events, which 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 the outcome: Adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan, registry (dated March 30, 2020) were available.
Outcomes pre-specified. 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 outcome: Mortality (D28). Time to death. WHO score 7 and above (D28). Time to WHO score 7 and above. Adverse events. |
| Overall risk of bias |
Some concerns |