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: "Randomization was accomplished by using a random table that was generated in Researcher IGZ v2.0
Software at 1:1. Each enrolled subject was given a number, randomly assigned to the FNC group and control group according to a predetermined random table and received treatment according to the corresponding treatment regimen... A physical report of the blinding will be generated as a safety measure and sent to the pharmacist for dispensing the investigational product and to the site coordinator in a sealed envelope."
Comment: Allocation sequence random. Allocation sequence probably concealed. Imbalances in baseline characteristics appear to be compatible with chance. |
| Deviations from intervention |
Low |
Quote: "double-blind, placebo-controlled clinical trial".
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: Mortality (D28). Hospitalization or death. Clinical improvement (D28). WHO score 7 and above (D28). Serious adverse events. |
| Missing outcome data |
Some concerns |
Comment: 312 participants randomized; 281 (90%) participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: 31 withdrew before completing treatment (13 vs 18). Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome. Risk assessed to be some concerns for the outcomes: Mortality (D28). Hospitalization or death. Clinical improvement (D28). WHO score 7 and above (D28). Serious adverse events. |
| 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: Mortality (D28). Hospitalization or death. Clinical improvement (D28). WHO score 7 and above (D28). Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan, and registry were available (dated September 2, 2021).
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 outcomes: Mortality (D28). Hospitalization or death. Clinical improvement (D28). WHO score 7 and above (D28). Serious adverse events. |
| Overall risk of bias |
Some concerns |