| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "The enrolled patients were randomly allocated into two groups (1:1 allocation ratio) by an independent statistician using permuted blocks of 4 for all sites. The whole process of randomization was masked to all treating physicians. Patient unique identification number and treatment allocation codes were provided by a clinical research associate in sequentially numbered opaque envelopes." |
| Deviations from intervention |
Low |
Comment: participants and staff were blinded except for the treating physicians. There was a slight imbalance in the receipt of biologic co-interventions ( 7 vs 11 participants in the treatment and the control arm, respectively). |
| Missing outcome data |
High |
Comment: 43 randomized/41 analyzed for all outcomes except for viral negative conversion (17 participants analyzed; the remaining participants tested negative at baseline). Risk assessed to be low for the outcomes: Mortality. Clinical improvement incidence. Time to clinical improvement. Total adverse events. Serious adverse events. Risk assessed to be high for the outcomes: Time to viral negative conversion. |
| Measurement of the outcome |
Some concerns |
Comment: Mortality and negative viral conversion are observer-measured outcomes. Clinical improvement is an observer-measured outcome that requires clinical judgment and could be affected by knowledge of intervention receipt. Adverse events could involve assessor judgment. The treating physician was not blinded in this study. Risk assessed to be low for the outcomes: Mortality. Time to viral negative conversion. Risk assessed to be some concerns for the outcomes: Clinical improvement incidence. Time to clinical improvement. Total adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: the protocol and statistical analysis plan were not available. Clinical improvement incidence is reported for days 7, 14 and 21 but not day 28. However selective reporting is unlikely to be due to the results on day 28, as the result on the reported days in not significant. Risk assessed to be some concerns for the outcomes: Mortality. Clinical improvement incidence. Time to clinical improvement. Time to viral negative conversion. Total adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |