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: "Computer generated randomization code"
"The allocation was concealed by using sealed envelope" "The patients and the data collectors will be unaware about the group allocation of the drugs." Comment: Allocation sequence random. Allocation sequence concealed. Very few baseline characteristics were reported (age, sex) and imbalances appear to be compatible with chance. |
| Deviations from intervention |
Low |
Quote: "The participant and the clinicians/data collectors will be unaware of the treatment the participant receives"
Comment: Blinded study (patients and physicians). Data were analyzed using available case analysis. |
| Missing outcome data |
High |
Comment: 400 randomized/363 analyzed.
Authors excluded 17 and 20 participants. 21% of participants randomized not included in analysis, for reasons that could relate to outcomes: lost to follow-up in the intervention and control arm respectively. They also excluded 3 participants that died in the control group and 2 in the intervention group due to adverse events. Risk assessed to be high for the outcomes: Mortality. Incidence of viral negative conversion. Incidence of clinical improvement. Time to clinical improvement. 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 viral negative conversion. Incidence of clinical improvement. Time to clinical improvement. Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The trial registry, protocol and statistical analysis plan were available. Data analyzed and presented as pre-specified.
Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. Incidence of clinical improvement. Time to clinical improvement. Adverse events. Serious adverse events. |
| Overall risk of bias |
High |