| 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: No information on allocation sequence concealment was provided. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No participant cross-over Co-intervention of interest: antivirals, corticosteroids and biologics were reported but not per arm for Arm A of the trial (no information on deviations). Data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 26 randomized, 26 analyzed.
Risk assessed to be low for outcomes. Mortality. WHO score 7 and above. Time to WHO score 7 and above. |
| Measurement of the outcome |
Low |
Comment: Unblinded study (outcome assessor).
Mortality is an observer-reported outcome not involving judgement. WHO Score 7 and above reflects decisions made by the intervention provider. However, we consider that the assessment of these outcomes cannot possibly be influenced by knowledge of the intervention assignment. Risk assessed to be low for outcome: Mortality. WHO score 7 and above. Time to WHO score 7 and above. |
| Selection of the reported results |
Low |
Comment: No protocol or statistical analysis plan were available. The registry was available and utilized.
Outcomes were registered and reported as such in the paper. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for outcomes. Mortality. WHO score 7 and above. Time to WHO score 7 and above. |
| Overall risk of bias |
Some concerns |