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 |
Some concerns |
Quote: "Patients were randomised to one of two treatment groups (SNG001 or placebo) in a 1:1 ratio according to a prespecified randomisation schedule in addition to standard of care"
"Simple randomisation was done manually by use of sealed envelopes, with trained clinical research staff assigning the patient the next available randomisation number on the randomisation list." Comment: Allocation sequence probably random. Unclear allocation concealment. (No information on sequentially numbered, opaque envelopes) |
| Deviations from intervention |
Low |
Quote: "Study investigators, all research and analysis teams, and patients were masked to treatment allocation."
Comment: Blinded study (participants and investigators) Data were analyzed using intention-to-treat analysis |
| Missing outcome data |
Some concerns |
Comment: 101 randomised; 98 analysed.
Up to 29% missing data in the intervention group (15/51) and 22% in the control group (11/50) were imputed using the last-observation-carried-forward method. Risk assessed to be some concerns for the outcomes: Mortality. Incidence of clinical improvement. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Time to WHO score 6 and above. Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Blinded study (outcome assessor)
Risk assessed to be low for the outcomes: Mortality. Incidence of clinical improvement. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Time to WHO score 6 and above. Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The protocol and statistical analysis plan were available. There were some differences in outcomes measured and reported between the published article, study protocol and trial registry.
Risk assessed to be low for the outcomes: Mortality. Adverse events. Serious adverse events. Risk assessed to be some concerns for the outcomes: Incidence of clinical improvement. Incidence of WHO score 6 and above (OSCI ≥5). Time to WHO score 6 and above. Incidence of WHO score 7 and above (OSCI ≥6). Time to WHO score 7 and above (OSCI ≥6). |
| Overall risk of bias |
Some concerns |