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|
|Quote: "Computerized generated sequence" (report). "Centralized" (trial registry).
Comment: Allocation sequence random. Allocation sequence concealed.
|Deviations from intervention||
|Quote: "The microbiological team was blinded to the randomization allocation and also to clinical status."
Comment: Single blind study (outcome assessors).
No participant cross-over.
No information on administration of co-interventions of interest: antivirals, biologics, corticosteroids.
Hence, no information on whether deviation arose because of the trial context.
Data were analyzed using a modified ITT analysis excluding 6 patients in the intervention arm and 5 patients in the control arm that tested negative on day 0 (enrolment errors).
Risk assessed to be some concerns for the outcomes: Incidence of viral negative conversion (D7). Serious adverse events.
|Missing outcome data||
|Comment: 60 participants randomized; 60 participants analyzed for serious adverse events/49 participants analyzed for viral negative conversion.
Data for more than 5% of the participants was missed for the outcome viral negative conversion.
11 participants were excluded due to enrolment errors (RT-PCR negative at baseline)therefore, we consider that the missingness in the outcome could not depend on its true value, and should not lead to bias.
Risk assessed to be low for the outcomes: Incidence of viral negative conversion (D7).Serious adverse events.
|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: Incidence of viral conversion (D7). Serious adverse events.
|Selection of the reported results||
|Comment: The prospective trial registry was available.
Negative viral conversion 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 outcome: Incidence of viral negative conversion (D7).
No information on whether the result of serious adverse events was selected from multiple outcome measurements or analyses of the data; the outcome was not pre-specified in the trial registry.
Trial may not have been analyzed as pre-specified.
Risk assessed to be some concerns for outcome: Serious adverse events.
|Overall risk of bias||