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: "patients
were randomly assigned in a 2:1 ratio to receive
Auxora plus standard of care or standard of care alone;
randomization was not center specific." Comment: Allocation sequence probably random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study (participants and personnel/carers).
Deviations from intended intervention arising because of the study context: No participant cross-over Co-intervention of interest: antivirals, corticosteroids and biologics were reported but not per arm for Arm A of the trial. 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). WHO score 7 and above (D28). Time to WHO score 7 and above. |
| Missing outcome data |
Low |
Comment: 26 participants randomized, 26 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for outcomes. Mortality (D28). WHO score 7 and above (D28). Time to WHO score 7 and above. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) MORTALITY Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). (TIME TO) WHO SCORE 7 AND ABOVE For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: WHO score 7 and above (D28). Time to WHO score 7 and above. |
| Selection of the reported results |
Some concerns |
Comment: No protocol or statistical analysis plan were available. The registry was available and utilized (up to version dated April 15th, 2020).
MORTALITY Mortality outcome was not pre-specified in the registry, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). (TIME TO) WHO SCORE 7 AND ABOVE Outcome 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 outcome: WHO score 7 and above (D28). Time to WHO score 7 and above. |
| Overall risk of bias |
Some concerns |