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|
|Quote: "Patients were randomly assigned (1:1) to either azithromycin plus standard care or standard care alone using a web-based automated service, with a minimisation algorithm to ensure balanced allocation"
Comment: Allocation sequence random. Allocation sequence concealed. Imbalances in baseline characteristics appear to be compatible with chance.
|Deviations from intervention||
|Quote: “Open-label. Patients, investigators, and health-care providers were not masked to study drug assignment.”
Comment: Unblinded study (participants and personnel/carers)
Deviations from intended intervention arising because of the study context:
No participant cross-over.
No information on administration of co-interventions of interest: Biologics, antivirals and corticosteroids.
Hence, no information on whether deviations arose because of the trial context.
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 some concerns for the outcomes: Hospitalization or death. Mortality (D28). WHO Score 7 and above (D28). Serious adverse events.
|Missing outcome data||
|Comment: 298 participants randomized; 292 participants analyzed.
Data available for nearly all participants randomized.
Risk assessed to be low for the outcomes: Hospitalization or death. Mortality (D28). WHO score 7 and above (D28). Serious adverse events.
|Measurement of the outcome||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Unblinded study (outcome assessor)
Mortality is an observer-reported outcome not involving judgement.
Risk assessed to be low for the outcome: Mortality (D28).
WHO SCORE 7 AND ABOVE, HOSPITALIZATION OR DEATH
For WHO score 7 and above and hospitalization or death, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment.
Risk assessed to be low for the outcomes: Hospitalization or death. WHO score 7 and above (D28).
SERIOUS ADVERSE EVENTS
The authors reported on 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 outcomes: Serious adverse events.
|Selection of the reported results||
|Comment: The protocol, statistical analysis plan were available but retrospective (dated February 7th, 2021 and March 18th, 2021 respectively). The trial registry was also available and prospective (dated May 7th, 2020), hence it was consulted.
MORTALITY, WHO SCORE 7 AND ABOVE, SAE
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). WHO score 7 and above (D28). Serious adverse events.
HOSPITALIZATION OR DEATH
Outcome not pre-specified.
No information on whether the result was selected from multiple outcome measurements or analyses of the data.
Trial probably not analyzed as pre-specified.
Risk assessed to be some concerns for the outcome: Hospitalization or death.
|Overall risk of bias||