Bias | Author's judgement | Support for judgement |
Randomization |
Some concerns |
Comment: Allocation sequence generated randomly. No information about the method used for concealment of the allocation sequence. |
Deviations from intervention |
Some concerns |
Comment: Open label trial. No deviations from the intended intervention. No information about co-intervention of interest (antivirals, biologics, glucocorticoids, anticoagulants). Best supportive care was also given to all participants and may have been different and influenced by the knowledge of assignment to the treatment group. Appropriate method of analysis was used; participants were analyzed according to their assigned intervention. |
Missing outcome data |
Low |
Comment: 30 patients randomized/30 patients analyzed. Risk assessed to be low for the outcomes: Mortality, time to death, serious adverse events and adverse events. |
Measurement of the outcome |
Some concerns |
Comment: Unblinded study. Outcomes include only observer-reported events not involving judgement.Some concerns for total adverse events and serious adverse events as it was not well defined and may have been deferentially reported between institutions and doctors. Risk assessed to be low for the outcomes: Mortality and time to death. Risk assessed to be some concerns for the outcomes: adverse events and serious adverse events. |
Selection of the reported results |
Some concerns |
Comment: no protocol or statistical plan available. Risk assessed as some concerns for the outcomes: Mortality, time to death, adverse events and serious adverse events |
Overall risk of bias |
Some concerns |