| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: "Once patients passed the inclusion and exclusion criteria and signed the
consent form, they were randomly assigned to either the control arm or
the treatment arm in a 1:1 ratio using a computer-generated randomization
plan. Block randomization with a block size of 2 was used." Comment: No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No participant cross-over. No information on administration of co-interventions of interest reported: biologics. Antivirals (lopinavir/ritonavir) and corticosteroids were reported. Intention-to-treat analysis was used. |
| Missing outcome data |
Low |
Comment: 70 randomized, 66 analyzed. Data unavailable for >5% of population. Reason: "Randomized in error (met exclusion/inclusion criteria). All missing data occurred due to documented reasons unrelated to the outcome. Risk assessed to be low for outcomes: Mortality. Serious adverse events |
| Measurement of the outcome |
Low |
Quote: "The investigator,
outcome assessor and data analyser were masked." Risk assessed to be low for the outcomes: Mortality. Serious adverse events |
| Selection of the reported results |
Low |
Comment: No protocol or statistical analysis plan available. The registry was available and utilized.
Mortality and Serious adverse events were both registered with timepoints 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 the outcomes: Mortality. Serious adverse events |
| Overall risk of bias |
Some concerns |