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: (protocol) "...randomized manner with random assignment to standard of care plus brequinar or standard of care plus placebo in a 1:1 ratio at each site. Randomization assignments will be provided by an independent statistician at Prosoft Clinical to the drug packaging company. The pharmacist/designated person will dispense the next number in sequence to the next patient who qualifies for the study at an individual site."
Comment: Allocation sequence probably random. Allocation sequence probably concealed. |
| Deviations from intervention |
Low |
Quote: “Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)”
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: Hospitalization or death. Mortality (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 115 participants randomized; 115 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Hospitalization or death. Mortality (D28). Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Quote from registry: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)"
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: Hospitalization or death. Mortality (D28). Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan and registry were available (dated 15 September 2020, 4 November 2020, and up to version dated November 20th, 2020, respectively).
Outcome pre-specified in the registry. 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: Hospitalization or death. Mortality (D28). Adverse events. Serious adverse events. |
| Overall risk of bias |
Low |