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: “randomised using a secure, in-house, web-based randomisation system (Sortition version 2.3). Randomisation was stratified by age (< 65 years /≥ 65 years), and presence of comorbidity (yes/no) and probabilities were determined using response adaptive randomisation via regular interim analyses”
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. In the outpatient setting, we consider no important cointerventions of interest. Hence, no deviation arose 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). Hospitalization or death. WHO score 7 and above (D28). |
| Missing outcome data |
Some concerns |
Comment: 212 participants randomized to colchicine, number concurrently randomized to usual care unknown; 156 colchicine participants analyzed, 120 usual care participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: COLCHICINE: 212 randomized (2 ineligible, 4 withdrew consent); 206 received treatment (19 excluded because they provided no dairy information and 31 because they were PCR-negative, unknown or not tested); 156 included in analysis. USUAL CARE: N randomized concurrently unknown; 120 included in analysis, described as concurrent PCR-positive patients. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome. Risk assessed to be some concerns for the outcomes: Mortality (D28). Hospitalization or death. WHO score 7 and above (D28). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) HOSPITALIZATION OR DEATH Hospitalization and mortality are observer-reported outcomes not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). Hospitalization or death. WHO SCORE 7 AND ABOVE For WHO score 7 and above, 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). |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan and prospective registry were available.
Outcome 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 outcomes: Mortality (D28). Hospitalization or death. WHO score 7 and above (D28). |
| Overall risk of bias |
Some concerns |