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: "A computer-generated randomization list was created by the study statistician (BH) with a randomization schedule in blocks of four. At the time of randomization, the study personnel received a sealed opaque envelope with the treatment allocation number that indicated which vial to administer to the participant. Numbered study medications were stored in indvidual opaque bags in the study refrigerstor until use". "The study statistician maintained the masked randomization list on a secure server"
Comment: Allocation sequence random. Allocation sequence seems concealed. |
| Deviations from intervention |
Low |
Quote: "double-blind, placebo-controlled study".
"Because of the lack of an identical matching placebo, one of two study personnel administering the medication was aware of the treatment allocation. The participant was instructed to look away during the administration and there were no identifiable features on the syringe to unmask allocation to the participant." "Aside from the nurse administering the study medication, all other study personnel and study participants remained masked to treatment allocation until unblinding of the study." Comment: Participants were blinded. Personnel/carers were probably blinded. Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death. Incidence of viral negative conversion (D7).Serious adverse events. |
| Missing outcome data |
Low |
Comment: 60 patients randomized; 60 patients analyzed.
1 patient lost to follow-up Data available for all or nearly all of population. Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death. Incidence of viral negative conversion(D7). Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Appropriate method of measuring the outcome.
Measurement or ascertainment of outcome does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality(D28). Hospitalization or death. Incidence of viral negative conversion(D7). Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The study registry was available. The protocol and statistical analysis plan were not available though referenced in the paper.
Viral negative conversion events specified as reported in the paper. Mortality was not pre-specified in the registry but we considered the reporting of this outcome acceptable as mortality should be reported even if not planned. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death. Incidence of viral negative conversion (D7). Serious adverse events were specified in the registry at a timeframe from day 0 to day 30 but in the paper it was reported as day 14. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Serious adverse events. |
| Overall risk of bias |
Some concerns |