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: "Eligible patients were randomly assigned via computer-generated numbering by a block randomization sequence. Randomization was done by an independent member, and the sequence was concealed to study investigators." Comment: Allocation sequence random. Allocation sequence concealed. |
Deviations from intervention |
Low |
Quote: "Open-label trial"
Comment: Unblinded study. No participant cross-over. Administration of co-interventions of interest (antivirals, corticosteroids, biologics) were reported and balanced between groups. Data were analyzed using intention-to-treat analysis or analyzed according to their randomized groups for the outcome (time to event data). Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Viral negative conversion (D7). Time to viral negative conversion.Clinical improvement (D28). Clinical improvement (D60 or more). Score WHO 7 and above (D28). Time to Score WHO 7 and above.Serious adverse events. Time to clinical improvement. Adverse events. |
Missing outcome data |
High |
Comment: 58 patients randomized; 58/57 patients analyzed.
One patient withdrew consent before any intervention. Mortality analyized 58 patients, whereas the analysis for the remaining outcomes is probably based on 57 patients. Data available for nearly all participants. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Clinical improvement (D28). Clinical improvement (D60 or more).Time to clinical improvement. Score WHO 7 and above (D28). Time to Score WHO 7 and above.Serious adverse events. Adverse events. For viral negative conversion, only 47 patients were analyzed. Data not available for all or nearly all participants. Reasons for missing data: not reported for 2 vs 8 participants. Likely that missingness depended on the true value of the outcome. Risk assessed to be high for the outcomes: Negative conversion (D7).Time to viral negative conversion. |
Measurement of the outcome |
Low |
Comment: Unblinded study
Comment: Method of measuring the outcome probably appropriate Measurement or ascertainment of outcome does not differ between groups. Mortality, viral negative conversion, Score WHO 7 and above and Serious adverse events are observer-reported outcomes not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Viral negative conversion (D28). Time to viral negative conversion. Time to Score WHO 7 and above. Score WHO 7 and above (D28) and Serious adverse events. For the outcomes Clinical improvement and Adverse events: Although the assessment could possibly be influenced by knowledge of the intervention assignment, we did not consider this likely to have happened in the context of a pandemic. Risk assessed to be some concerns for outcomes: Clinical improvement (D28). Clinical improvement (D60 or more). Time to clinical improvement. Adverse events |
Selection of the reported results |
Low |
Comment: Neither the protocol nor the statistical analysis plan was available.
The prospective registry was available and specified '30-day mortality'. Regarding viral negative conversion, the registry also specified 'median length of viral clearance', which in the context of selective reporting of incidence of viral negative conversion was considered as sufficient since that outcome is derived from the incidence of events. Hence, the results were not selected from multiple outcome measurements or analyses of the data. Trial was analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Viral negative conversion (D7). Time to viral negative conversion. Time to Score WHO 7 and above(D28). Score WHO 7 and above (D28). Serious adverse events.Clinical improvement (D28).Clinical improvement (D60 or more). Time to clinical improvement. Adverse events |
Overall risk of bias |
High |