|Bias||Author's judgement||Support for judgement|
|Quote: “A unique random allocation table was generated using the Sealed Envelope software. Once a patient had consented to participate in the study, they were allocated an envelope as per the sequence, assigning them to one of the two groups. The person doing the randomisation was not a part of the investigating team. One of these two groups was the intervention group and the other was the placebo group. However, up until the analysis of the data, this information was confined to the pharmacist dispensing the tablets”
Comment: Allocation sequence random. Allocation sequence concealed.
|Deviations from intervention||
|Report: “double blind randomized placebo-controlled” "identical looking placebo tablets"
Registry: "Blinding/Masking: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded"
Comment: Blinded study (participants and personnel/carers).
Data for the mortality and clinical improvement outcomes were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention.
Participants were analyzed according to their randomized groups for the viral negative conversion outcome.
Of note, 25 vs 14 participants were excluded from the analysis post-randomization for reasons related to missing data. Nevertheless, for this domain, we considered the analysis to be probably appropriate to estimate the effect of assignment to intervention.
Risk assessed to be low for outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28)
|Missing outcome data||
|Comment: 115 patients randomized; 112 patients analyzed for mortality and clinical improvement; 76 patients analyzed for negative viral conversion.
Data available for all or nearly participants for for mortality and clinical improvement.
Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28).
Data not available for all or nearly participants for viral negative conversion (32/57 vs 44/58).
No evidence that the result is not biased.
Reasons for missing data: lost to follow-up (1 vs 0), protocol violation (1 vs 1), discharged before day 6 (11 vs 3), sample not sent for unknown reason (2 vs 2), sample lost (6 vs 3), report inconclusive (4 vs 4), death (0 vs 1).
Missingness could be related to the true value of the outcome.
It is likely that missingness depended on the true value (based on differences in proportion of missing data between groups; reasons for missingness)
Risk assessed to be high for the outcome: Incidence of viral negative conversion (D7).
|Measurement of the outcome||
|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). Clinical improvement (D28).
|Selection of the reported results||
|Comment: The trial registry was available.
Viral negative conversion and clinical improvement (discharge) 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: Incidence of viral negative conversion (D7). Clinical improvement (D28).
No timepoint was specified for the outcome Mortality.
No information on whether the result was selected from multiple outcome measurements or analyses of the data.
Risk assessed to be some concerns for the outcome: Mortality (D28).
|Overall risk of bias||