| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: "Once patients fulfilled inclusion and exclusion criteria and signed the consent
form, they were randomly assigned to each treatment arm in a 1:1
ratio by block randomization and a block size of 4. Sealed envelope
online software was used to randomize patients to the intervention and
control groups."
Comment: Allocation sequence concealed. Allocation sequence random. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No participant cross-over. No information on administration of co-interventions of interest: biologics, corticosteroids. Administration of antivirals was partially reported. Outcome data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 48 randomized, 48 analyzed.
Data available for all participants Risk assessed to be low for outcomes: Mortality. Incidence of clinical improvement. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study. Mortality is an observer-reported outcome not involving judgement.
Risk assessed to be low for outcome: Mortality. For incidence of clinical improvement (defined as hospital discharge alive), although the assessment could possibly be influenced by knowledge of the intervention assignment, we did not consider this likely to have happened in the context of a pandemic. Risk assessed to be some concerns for the outcome: Incidence of clinical improvement. |
| Selection of the reported results |
Some concerns |
Comment: The protocol and statistical analysis plan were not available. The registry was available and utilized.
No information on mortality or incidence of clinical improvement were registered but incidence of clinical improvement was reported as an outcome in the paper "frequency of recovery (discharge)". Mortality was not listed as an outcome in the Methods section. No information on whether the results were selected from multiple outcome measurements or analyses of the data. Risk assessed to be some concerns for the outcomes: Mortality. Incidence of clinical improvement. |
| Overall risk of bias |
Some concerns |