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 blocked randomization with random block sizes (of 3 or 6 allocations) and stratified by center was used. The randomization list was developed prior to study initiation and by means of a centralized eCRF/IWRS web system (Jazz Clinical, Buenos Aires, Argentina." Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Quote: “The
patients and center personnel were not blinded to the allocated
group. The outcome assessors (personnel in charge of viral load determinations) were blinded to the allocated group upon receiving the samples labeled with the randomization number and the visit
number"
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No participant crossover. No information on administration of co-interventions of interest: antivirals, corticosteroids, biologics. Hence no information on deviations that arose due to the trial context. 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 some concerns for outcome: Mortality (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 45 patients randomized; 32 patients analyzed for WHO score 7 and above. 45 patients analyzed for mortality, adverse events and serious adverse events.
Data available for all or nearly all participants for mortality, adverse events and serious adverse events. Data not available for all or nearly all participants for WHO score 7 and above. No evidence that the result is not biased. Reasons for missing data: viral load below limit of quantification at baseline [post-baseline exclusion of ineligible patients], withdrew consent and poor quality samples. Missingness could not depend on the true value of the outcome. Risk assessed to be low for the outcomes: Mortality (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study for outcomes of interest (outcome assessor). Mortality is an observer-reported outcome not involving judgement. For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: Mortality (D28). WHO score 7 and above (D28). The authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected events. All these outcomes can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcomes: Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: Neither the protocol nor the statistical analysis plan was available. The registry was available and utilized.
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). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |