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: "Allocation schedule was created with
a list of random numbers generated using a
random number generator program. Group assignment
was concealed in sequentially numbered,
opaque, sealed envelopes. The randomization
code was maintained by the pharmaceutical
company."
Comment: Allocation sequence random. Allocation sequence concealed. Imbalances in baseline characteristics 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 (participants and personnel/carers) 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). Incidence of viral negative conversion (D7). Adverse events. Serious adverse events. |
| Missing outcome data |
Some concerns |
Comment: 400 participants randomized; 363 participants analyzed for all outcomes except mortality (366 analyzed).
VIRAL NEGATIVE CONVERISON, AE, SAE Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: lost to follow up (15 vs 17), discontinued intervention due to adverse drug reaction (2 vs 0), death (0 vs 3). Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome (similar proportion of missingness) Risk assessed to be some concerns for the outcomes: Incidence of viral negative conversion (D7). Adverse events. Serious adverse events. MORTALITY Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: lost to follow up (15 vs 17), discontinued intervention due to adverse drug reaction (2 vs 0) Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome (similar proportion of missingness) Risk assessed to be some concerns for the outcome: Mortality (D28). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The trial registry (retrospective; dated 24th of August 2020), protocol and statistical analysis plan (retrospective; dated 24th of August 2020) were available. No information on whether the result was selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |