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 |
Some concerns |
Quote: “Due to the small sample size, we used randomization by blocks of size four, using RStudio software, Version 1.2.1335," "A Contract Research Organization (Azidus, Brazil) generated the random allocation sequence and assigned participants to intervention groups.”
Comment: Allocation sequence probably random. Unclear allocation concealment. |
Deviations from intervention |
Some concerns |
Quote: “Double-blind”
"We recognize that the double-blind nature of a placebo-controlled study is compromised in the case of NTZ which produces effects visible to the naked eye in the urine color of some people using this drug" Comment: Blinding procedures were not described. Study authors acknowledged that participants might have been unmasked. Consequently, we assess that this is likely not to have been a fully blinded 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: antivirals, biologics, 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: Mortality (D28). WHO score 7 and above (D28). Adverse events. |
Missing outcome data |
Low |
Comment: 50 participants randomized; 50 participants analyzed.
Data available for all participants. Risk assessed to be low for the outcomes: Mortality (D28). WHO score 7 and above (D28). 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. Unclear blinding (outcome assessors) MORTALITY Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). WHO SCORE 7 AND ABOVE For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcome: WHO score 7 and above (D28). ADVERSE EVENTS Also, the authors reported on adverse events that may contain both clinically- and laboratory-detected events which can be influenced by knowledge of the intervention assignment. Risk assessed to be some concerns for the outcome: Adverse events. |
Selection of the reported results |
Some concerns |
Comment: The prospective trial registry was available and consulted (up to version dated April 20th, 2020).
MORTALITY, WHO SCORE 7 AND ABOVE Outcome pre-specified Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified for these outcomes. Risk assessed to be low for the outcomes: Mortality (D28). WHO score 7 and above (D28). ADVERSE EVENTS Adverse events were not pre-specified as an outcome in the trial registry. No information on whether the results for adverse events were selected from multiple outcome measurements or analyses of the data. Risk assessed to be some concerns for the outcome: Adverse events. |
Overall risk of bias |
Some concerns |