Bias | Author's judgement | Support for judgement |
Randomization |
Some concerns |
Quote: “block randomization by a computergenerated random number list prepared by an investigator with no clinical involvement in the trial”
Comment: Allocation sequence random. No information on allocation concealment. |
Deviations from intervention |
Some concerns |
Quote: “Trial participants, investigators, care givers, outcome assessors, and date analysts were not blinded to the group assignment”
Comment: Unblinded study. No participant cross-over. No information on administration of co-interventions of interest: antivirals. Corticosteroids and biologics were reported. More treatment patients (76%) than control patients (59%) received steroids. Data were analyzed using intention-to-treat analysis |
Missing outcome data |
Low |
Comment: 89 patients randomized; 89 patients analyzed.
Risk assessed to be low for the outcomes: Mortality. Incidence of clinical improvement. |
Measurement of the outcome |
Some concerns |
Comment: Unblinded study
Mortality is an observer-reported outcomes not involving judgement. Risk assessed to be low for the outcome: Mortality. Clinical improvement (defined as discharge) requires clinical judgement and could be affected by knowledge of intervention receipt but is not considered likely to in the context of a pandemic. Risk assessed to be some concerns for the outcome: Incidence of clinical improvement. |
Selection of the reported results |
Some concerns |
Comment: Neither the protocol nor the statistical analysis or registry were available.
No information on whether the trial was analyzed as pre-specified. No information on whether the results were selected from multiple outcome measurements or analyses of the data. Risk assessed to be some concerns for the outcomes: Mortality. Incidence of clinical improvement. |
Overall risk of bias |
Some concerns |