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 facilitated by a computer-generated random sequence using an interactive web-response system to allocate participants 1:1 to placebo or baricitinib 4-mg."
Comment: Allocation sequence random. Allocation sequence probably concealed. Imbalances in baseline characteristics appear to be compatible with chance. |
| Deviations from intervention |
Low |
Quote: "Participants, study staff, and investigators were masked to the study assignment"
Comment: Probably blinded study (participants and personnel/carers). MORTALITY, CLINICAL IMPROVEMENT, WHO SCORE 7 AND ABOVE, AE, SAE 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). Mortality (D60 or more). Time to death. Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). Adverse events. Serious adverse events. TIME TO CLINICAL IMPROVEMENT Participants were analyzed according to their randomized groups for the outcome. Of note, 6 vs 7 participants were excluded from the analysis post-randomization likely due to missing data which is accounted for in domain 3. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcome: Time to clinical improvement. |
| Missing outcome data |
Low |
Comment: 1525 participants randomized; 1502 to 1525 participants analyzed (depending on the outcome).
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Time to death. Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). 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. Probably blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Time to death. Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The prospective registry was available. The protocol and statistical analysis plan is available from the investigators upon request.
MORTALITY (D28) Outcome pre-specified. Results were not selected from multiple outcome measurements or analyses of the data. Outcome analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). MORTALITY (D60 OR MORE), CLINICAL IMPROVEMENT, TIME TO DEATH, WHO SCORE 7 AND ABOVE, AE, SAE Outcomes not pre-specified. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcomes: Mortality (D60 or more). Time to death. Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |