|Bias||Author's judgement||Support for judgement|
|Quote:"randomly assigned (permuted blocks with concealed allocation) in a 1:1 ratio to hydroxychloroquine or azithromycin. Randomization was stratified by study site"
Comment: Allocation sequence probably random. Allocation sequence probably concealed
|Deviations from intervention||
Comment: Unblinded study.
In the hydroxychloroquine arm, 6 (14%) received nonrandomized azithromycin after study enrollment as original protocol allowed (generally as clinician-directed treatment for suspected pneumonia).
Administration of co-interventions of interest: antivirals, corticosteroids and biologics were reported. Remdesivir administration (given under an emergency use authorization) in the hydroxychloroquine vs azithromycin arms (8/42 vs. 1/43)
Data were analyzed using intention-to-treat analysis
|Missing outcome data||
|Comment: 85 patients randomized; 84 patients analyzed.
only one participant had a missing outcome for the 28-day analysis. That participant was excluded from the day 28 analysis.
Data available for nearly all participants randomized.
Risk assessed to be low for the outcomes: Mortality. Adverse events. Serious adverse events.
|Measurement of the outcome||
|Comment: Unblinded study
Mortality is an observer-reported outcome not involving judgement.
Risk assessed to be low for the outcome: Mortality.
Adverse events and serious adverse events may contain both clinically- and laboratory-detected outcomes 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: Adverse events. Serious adverse events.
|Selection of the reported results||
|Comment: The protocol and statistical analysis plan were reported as available but did not give any information on the outcomes. The registry was available and utilized.
Mortality was not pre-specified in the registry but we considered the reporting of this outcome acceptable as mortality should be reported even if not planned.
Result was 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.
Safety outcomes were also not pre-specified.
No information on whether the results were selected from multiple outcome measurements or analyses of the data.
Trial not analyzed as pre-specified.
Risk assessed to be some concerns for outcomes: Adverse events. Serious adverse events.
|Overall risk of bias||