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 |
High |
Quote: "Randomization was done using an odd-even methodology applied to registration numbers, in a consecutive fashion in a 1:1 ratio, by the hospital registration office".
Comment: Allocation sequence probably random. Allocation sequence probably not concealed. |
| Deviations from intervention |
Low |
Comment: Unblinded study.
Deviations from intended intervention arising because of the study context: No participant cross-over. In the outpatient setting, we consider no important cointerventions of interest. Hence, no deviation arose because of the trial context. Our analysis for the binary outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcome: Adverse events. |
| Missing outcome data |
Low |
Comment: 125 patients randomized; 116 patients analyzed.
Data not available for all or nearly all participants. 7% missing data (5% in Ivermection + Doxycycline arm; 10% in Hydroxychloroquine + Azithromycin arm). Reason: lost to follow-up (which is unrelated to the outcome). Missingness could not depend on the true value of the outcome. Risk assessed to be low for the outcomes: Adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate. Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) Adverse events contains clinically-reported 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 outcome: Adverse events. |
| Selection of the reported results |
Low |
Comment: The trial registry was available. The protocol and statistical analysis plan were not available.
Outcomes were registered as reported in the paper. Result was not selected from multiple outcome measurements or analyses of the data. Trial probably analyzed as pre-specified. Risk assessed to be low for the outcomes: Adverse events. |
| Overall risk of bias |
High |