| 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: Double-blinded study.
Data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Some concerns |
Comment: 38 randomized, 35 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. Risk assessed to be low for outcomes: Mortality. Incidence of clinical improvement. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Risk assessed to be some concerns for outcomes: Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: This is a double-blinded study (participants and clinicians/carers).
Mortality is an observer-reported outcome not involving judgement. is For the outcome incidence of WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of the intervention assignment. Pneumonia (assessed via imaging) was the only serious adverse event reported and therefore not influenced by judgement. Risk assessed to be low for outcomes: Mortality. Incidence of WHO score 7 and above. Serious adverse events. Clinical improvement (defined as discharge from hospital) and incidence of WHO score 6 and above reflects decisions made by the intervention provider. Furthermore, adverse events reported contain both clinically- and laboratory-detected events. Assessment of these outcomes could possibly be influenced by knowledge of the intervention assignment but we did not consider this likely to have happened in the context of a pandemic. Risk assessed to be some concerns for the outcomes: Incidence of WHO score 6 and above. Adverse events. |
| Selection of the reported results |
Some concerns |
Comment: No protocol and statistical analysis plan were available. Risk assessed to be some concerns for the outcome: Mortality. Incidence of clinical improvement. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Adverse events. Serious adverse events |
| Overall risk of bias |
Some concerns |