| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "Randomization was accomplished by using a random table that was generated in SAS software at 1:1. Each enrolled subject (meeting all the inclusion criteria and not meeting any of the exclusion criteria) was given a number, randomly assigned to the FNC group and control group according to a predetermined random table (Figure S1, Supporting Information), and received treatment according to the corresponding treatment regimen."
Comment from contact with authors: Treatment allocation was concealed with the use of sequentially coded, sealed, opaque envelopes. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No patient cross-over. Co-intervention administration of antivirals, biologics and corticosteroids were reported Trialists used ITT analyses. |
| Missing outcome data |
Low |
Comment: 10 randomized; 10 analyzed. No missing outcome data Risk assessed to be low for the outcomes: Mortality. Viral negative conversion events. Time to negative viral conversion. Incidence of clinical improvement. WHO score 6 and above. WHO score 7 and above. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study. Mortality and viral negative conversion events are observer-reported outcomes not involving judgement. For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention receipt. Risk assessed to be low for outcomes: Mortality. Viral Negative Conversion events. Time to negative viral conversion. WHO score 7 and above. Clinical improvement (defined as discharge from hospital), WHO score 6 and above, adverse events and serious adverse events reflect a decision made by the intervention provider where the assessment could possibly be influenced by knowledge of the intervention assignment however we did not consider this likely in the context of a pandemic. Risk assessed to be some concerns for outcomes: Adverse events. Serious adverse events. Incidence of clinical improvement. WHO 6 and above. |
| Selection of the reported results |
Some concerns |
Comment: There is no protocol or statistical plan available in English. (Available in Chinese). The registry was available in English.
Incidence of clinical improvement and WHO score 6 and above and WHO score 7 and above were neither registered as outcomes nor reported as such in the paper. These results were probably not selected from multiple outcome measurements or analyses of the data. Trial probably analyzed as pre-specified. Risk assessed to be low for outcomes: Incidence of clinical improvement. WHO score 6 and above. WHO score 7 and above. Viral negative conversion (incidence and time to) and mortality were registered outcomes but with no timepoints. Adverse events and serious adverse events were not registered but were reported as safety outcomes in the paper. No information on whether these results were selected from multiple outcome measurements or analyses of the data. Risk assessed to be some concerns for the outcomes: Mortality. Incidence of viral negative conversion. Time to negative viral conversion. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |