| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "patients were assigned... using web-based simple (unstratified) randomisation with allocation concealed until after randomisation".
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. 55/5182 participants in the standard care group took azithromycin. In the intervention arm 1760/2582 received azithromycin. Deviation too small to affect the outcome. Administration of co-interventions of interest: antivirals, biologics, and corticosteroids were reported and balanced between groups. Data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 7764 patients randomized; 7764 patients analyzed.
24% missing data (23% in AZM group vs 24% in SC group) due to no follow-up form completed in this preliminary analysis. Missingness balanced across groups and unrelated to outcomes. Risk assessed to be low for the outcomes: Mortality. Clinical improvement. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study
Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality. Clinical improvement (defined as discharge from hospital alive) requires clinical judgement and could be affected by knowledge of intervention receipt, but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcome: Clinical improvement. |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan, and registry were available.
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. Clinical improvement. |
| Overall risk of bias |
Some concerns |