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: "Phase 2 participants were randomized 3:1 to receive ARCT-021 or placebo" Comment: Allocation sequence probably random. No information on allocation concealment. |
| Deviations from intervention |
Low |
Quote: "Double-blinded"
Comment: Blinded study (participants and personnel/carers) 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 low for the outcomes: Mortality. sAb GMT. nAb GMT. Adverse events. Withdrawals due to adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 64 participants randomized; 64 participants analyzed.
Comment: Data available for all participants. Risk assessed to be low for the outcomes: Mortality. sAb GMT. nAb GMT. Adverse events. Withdrawals due to adverse events. 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. sAb GMT. nAb GMT. Adverse events. Withdrawals due to adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The trial registry was available (2020-07-22).
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. sAb GMT. nAb GMT. Adverse events. Withdrawals due to adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |