| 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 |