| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: “Patients were randomly assigned” (report)
"Random number table method" (registry) Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: "open-label trial"
Comment: Unblinded study. No participant cross-over. Administration of co-interventions of interest: biologics and corticosteroids were reported. Biologics administration between arms (3/26 vs 6/24). Appropriate analysis method used; participants analyzed according to assigned intervention. |
| Missing outcome data |
Low |
Comment: 50 patients randomized; 48 patients analyzed.
Two participants dropped out from the combination treatment group after adverse reactions. Data available for >95% of population Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. Incidence of clinical improvement. Adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study
Mortality and viral negative conversion are observer-reported outcomes not involving judgement. Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. Clinical improvement is defined as discharge whose criteria include "significant improvements of respiratory symptoms and CT imaging". Adverse events events reported contain both patient-reported and clinically-detected events. Both of 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. Adverse events. |
| Selection of the reported results |
Some concerns |
Comment: Neither the protocol nor the statistical analysis plan was available. The registry was available and utilized.
Mortality, Incidence of viral negative conversion and Incidence of clinical improvement (hospital length of stay/discharge) were not registered as outcomes nor reported as such in the paper. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial was probably analyzed as pre-specified. Risk assessed to be low for outcomes: Mortality. Incidence of viral negative conversion. Incidence of clinical improvement. Safety endpoints were not registered but were reported as outcomes in the paper. 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: Adverse events. |
| Overall risk of bias |
Some concerns |