Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: All eligible participants were allocated to a randomization number which allocated him/her into one treatment group. The randomization numbers were computer-generated. Allocation concealment was achieved using a centralized web-based randomization system in which the participant identifier (hospitalization number) was entered before the allocation was revealed. The randomization number were used in case report form (CRF) pages. Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Quote: "The study was blind to participants, those physicians and radiologists who reviewed the data and radiological images, but open-label to clinicians who recruited patients and research staff."
Comment: Unclear blinding (participants blinded and unclear if personnel/carers blinded) Deviations from intended intervention arising because of the study context: No participant cross-over. Administration of all co-interventions of interest reported: antivirals, corticosteroids, biologics There was imbalance in the corticosteroid administration (6/35 vs 2/34 vs 2/17) This deviation was not balanced and could affect the outcome. Nevertheless, this domain was rated as some concern as it is impossible to distinguish deviation because of trial context and deviation because of intervention effect. Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be some concerns for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 or above (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 86 participants randomized, 86 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 or above (D28). Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Probably blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 or above (D28). Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: Neither the protocol nor the statistical analysis plan was available. The registry (dated February 5th, 2020) was available.
VIRAL NEGATIVE CONVERSION Outcome pre-specified. 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 outcome: Incidence of viral negative conversion (D7). MORTALITY Mortality outcome was not pre-specified in the registry, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for outcomes: Mortality (D28). WHO SCORE 7 AND ABOVE, AE, SAE Outcome not pre-specified No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: WHO score 7 or above (D28). Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |