|Bias||Author's judgement||Support for judgement|
"The computer-generated randomized allocation sequence will be imported into the eCRF system and made available to site personnel responsible for the participant enrolment. Randomization allocation will automatically be visible when enrolling a new eligible patient. This is an open-label study and no steps to conceal allocation are necessary."
Comment: Allocation sequence random. Allocation sequence not concealed.
|Deviations from intervention||
|Comment: Unblinded study.
No participant cross-over.
No information on administration of co-interventions of interest: antivirals, biologics and corticosteroids.
Data were analyzed using intention-to-treat analysis.
|Missing outcome data||
|Comment: 53 patients randomized; 51 patients analyzed.
Data available for >95% of population.
One patient in the intervention group excluded tue to missing baseline data, one patient in the control group withdrew consent (solely relevant for following outcomes: mortality,clinical improvement and Score 6/7 above; not relevant for AE and SAE)
Risk assessed to be low for the outcomes: Mortality. Clinical improvement. WHO score 6 and above. WHO score 7 and above. Adverse events. Serious adverse events.
|Measurement of the outcome||
|Comment: Unblinded study
Mortality is an observer-reported outcomes not involving judgement. For the 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. WHO score 7 and above.
Clinical improvement (defined as discharge from hospital), WHO score 6 and above, reflect decisions made by the intervention provider and assessment could be influenced by knowledge of the intervention assignment. Adverse events and serious adverse events 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: Incidence of clinical improvement. WHO score 6 and above. Adverse events. Serious adverse events
|Selection of the reported results||
|Comment: The protocol and statistical analysis plan were available.
Mortality, Incidence of clinical improvement, WHO score 6 and above, WHO score 7 and above (clinical status) were specified in the protocol and reported in the publication.
Adverse events and serious adverse events were neither specified as an outcome in the protocol nor the published paper, but mentioned in the protocol as safety measurement.
Results were not selected based on multiple outcome measurements or multiple analyses of the data.
Trial analyzed as prespecified.
Risk assessed to be low for the outcomes: Mortality. Incidence of clinical improvement. WHO score 6 and above. WHO score 7 and above, Adverse events. Serious adverse events.
|Overall risk of bias||