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: “The study pharmacist generated the randomisation sequence, which was then entered into the online platform REDCap electronic data-capture tools hosted by the participating Danish regions. Patients were randomised 1:1 to azithromycin plus hydroxychloroquine or matching placebo capsules. The final allocation was blinded.”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: “All patients and study staff were blinded to participant treatment assignments. This included outcome assessors, investigators and study nurses, as well as research and clinical staff.”
Comment: Blinded study (participants and personnel/carers) Data for the outcome were analyzed using 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). WHO score 7 and above (D28). |
| Missing outcome data |
Low |
Comment: 117 participants randomized; 117 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Clinical improvement (D28). 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. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Clinical improvement (D28). WHO score 7 and above (D28). |
| Selection of the reported results |
Low |
Comment: The protocol (prospective, dated March 25th, 2020) statistical analysis plan and registry (prospective, dated March 26th, 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 outcomes: Mortality (D28). Time to death. Clinical improvement (D28). WHO score 7 and above (D28). |
| Overall risk of bias |
Low |