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: "This was a randomized, placebo-controlled, single-blinded, parallel-group, pilot study" "A randomization table, unknown to the investigator up to the assignment time was generated using the RANDOM software" Comment: Allocation sequence random. Unclear allocation concealment. |
Deviations from intervention |
Some concerns |
Quote: "single-blind"
Comment: Unclear blinding (participants blinded and unclear if personnel/carers blinded)
No participant cross-over. No information on the administration of co-interventions of interest: corticosteroids and biologics. 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). Incidence of viral negative conversion (D7). |
Missing outcome data |
High |
Comment: 46 participants randomized; 36 participants analyzed.
Data not available for all or nearly all participants randomized No evidence that the result is not biased Reasons for exclusions: did not receive an appropriate dose of NTZ (1 vs 0), discontinued treatment (7 vs 0), missing data on data on day 7 (1 vs 0), missing data (1 vs 0). Missingness could depend on the true value of the outcome. Likely that missingness depended on the true value of the outcome (unequal proportion between arms). Risk assessed to be high for the outcomes: Mortality (D28). 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. Unclear blinding (outcome assessor) Mortality and viral negative conversion are observer-reported outcomes not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). |
Selection of the reported results |
Low |
Comment: Only the trial registry was available (the protocol and/or statistical analysis plan were not available).
The July 7th and 13th, 2020 versions were consulted as these were considered to be posted before unblinded data were available. Outcomes were 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 outcomes: Mortality (D28). Incidence of viral negative conversion (D7). |
Overall risk of bias |
High |