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: “Participants were randomly assigned by a centralised computer system to one of the three arms with an allocation ratio of 1:1:1. The study biostatistician prepared the sequence of treatments, generated using SAS 9.4 software according to a randomised permuted blocks procedure. The treatment ID was obtained through RED- Cap, used as a web-based clinical data management system for the study.”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: "In order to keep investigators and participants blinded, the number of tablets to be administered was the same, irrespective of the study arm in which the participant was randomised. Placebo tablets were identical in appearance and taste to ivermectin. Also, the staff in charge of the laboratory analyses were blinded."
Comment: Blinded study (participants and personnel/carers) 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 outcomes: Incidence of viral negative conversion (D7). |
| Missing outcome data |
Some concerns |
Comment: 93 participants randomized; 87 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: withdrew consent (1 vs 2 vs 1), missing sample of viral load (0 vs 0 vs 2) Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome (similar proportion of missingness among arms) Risk assessed to be some concerns for the outcomes: Incidence of viral negative conversion (D7). |
| 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: Incidence of viral negative conversion (D7). |
| Selection of the reported results |
Low |
Comment: The prospective registry were available (dated June 18th 2020).
Outcome 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 outcome: Incidence of viral negative conversion (D7). |
| Overall risk of bias |
Some concerns |